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    Clinical Trial Results:
    A Phase IIB, randomised, observer-blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, reactogenicity and immunogenicity of the GSK Biologicals’ investigational vaccine GSK3277511A when administered intramuscularly according to a 0, 2 month schedule in COPD patients aged 40 to 80 years with a previous history of acute exacerbation (AECOPD)

    Summary
    EudraCT number
    		 2017-000880-34
    Trial protocol
    		 GB   BE   ES   DE   FR   IT  
    Global end of trial date
    12 Jun 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Mar 2021
    First version publication date
    03 Dec 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    207489
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03281876
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs
    Protection of trial subjects
    All subjects were supervised for 60 min after vaccination with appropriate medical treatment available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccine. Subjects were called by the investigator or a medically trained delegate one week after the vaccination. If the subject experienced an acute exacerbation, he/she was invited to visit the study site for follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 34
    Country: Number of subjects enrolled
    Canada: 93
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 118
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Spain: 55
    Country: Number of subjects enrolled
    United Kingdom: 67
    Country: Number of subjects enrolled
    United States: 160
    Worldwide total number of subjects
    606
    EEA total number of subjects
    286
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    241
    From 65 to 84 years
    365
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All enrolled subjects received the study intervention

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    This is an observer blind study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3277511A Group
    Arm 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
    Arm type
    		 Experimental

    Investigational medicinal product name
    NTHi Mcat investigational vaccine (GSK3277511A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered in the non-dominant arm

    Arm title
    		 Control Group
    Arm description
    		 Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered in the non-dominant arm

    Number of subjects in period 1
    		GSK3277511A Group Control Group
    Started
    304
    302
    Completed
    281
    263
    Not completed
    23
    39
         Consent withdrawn by subject
    11
    15
         Adverse event, non-fatal
    4
    15
         OTHER
    5
    5
         MIGRATED / MOVED FROM THE STUDY AREA
    2
    -
         Lost to follow-up
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3277511A Group
    Reporting group 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

    Reporting group title
    Control Group
    Reporting group description
    		 Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.

    Reporting group values
    		 GSK3277511A Group Control Group Total
    Number of subjects
    		 304 302 606
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 127 114 241
        From 65-84 years
    		 177 188 365
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.7 ( 7.5 ) 66.3 ( 7.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 120 125 245
        Male
    		 184 177 361
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 0 1 1
        Asian - Central / South Asian Heritage
    		 2 0 2
        Asian - South East Asian Heritage
    		 0 1 1
        Black Or African American
    		 5 4 9
        Other
    		 1 0 1
        White - Arabic / North African Heritage
    		 2 0 2
        White - Caucasian / European Heritage
    		 294 296 590

    End points

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    End points reporting groups
    Reporting group title
    GSK3277511A Group
    Reporting group 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

    Reporting group title
    Control Group
    Reporting group description
    		 Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.

    Primary: Rate of moderate and severe AECOPD (any cause)-analysis (87% Confidence Interval [CI]), post-dose 2 and lasting for 1 year

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    End point title
    		 Rate of moderate and severe AECOPD (any cause)-analysis (87% Confidence Interval [CI]), post-dose 2 and lasting for 1 year
    End point 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 AECOPD was as per investigator's judgement.
    End point type
    Primary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person-year
        number (confidence interval 87%)
    1.22 (1.09 to 1.36)
    1.17 (1.06 to 1.3)
    Statistical analysis title
    		 Vaccine efficacy-87%
    Statistical analysis description
    To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.8157
    Method
    		 Negative Binomial regression
    Parameter type
    		 Other: Vaccine Efficacy rate
    Point estimate
    -2.26
    Confidence interval
         level
    		 87%
         sides
    2-sided
         lower limit
    		 -18.27
         upper limit
    		 11.58
    Notes
    [1] - 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%.

    Primary: Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI), post-dose 2 and lasting for 1 year

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    End point title
    		 Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI), post-dose 2 and lasting for 1 year
    End point 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 AECOPD was as per investigator's judgement.
    End point type
    Primary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person-year
        number (confidence interval 95%)
    1.22 (1.05 to 1.41)
    1.17 (1.02 to 1.34)
    Statistical analysis title
    		 Vaccine efficacy-95%
    Statistical analysis description
    To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.8157
    Method
    		 Negative Binomial regression
    Parameter type
    		 Other: Vaccine Efficacy rate
    Point estimate
    -2.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.45
         upper limit
    		 15.29
    Notes
    [2] - 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.

    Secondary: Number of subjects reported with each solicited local Adverse Event (AE)

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    End point title
    		 Number of subjects reported with each solicited local Adverse Event (AE)
    End point description
    Assessed solicited local symptoms were pain, redness and swelling
    End point type
    Secondary
    End point timeframe
    During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    292
    291
    Units: Participants
        Pain, Dose 1(N-292,291)
    153
    16
        Pain, Dose 2(N-265,273)
    163
    13
        Redness (mm), Dose 1(N-292,291)
    18
    1
        Redness (mm), Dose 2(N-265,273)
    37
    0
        Swelling (mm), Dose 1(N-292,291)
    13
    2
        Swelling (mm), Dose 2(N-265,273)
    31
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reported with each solicited general AE

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    End point title
    		 Number of subjects reported with each solicited general AE
    End point 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.
    End point type
    Secondary
    End point timeframe
    During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    292
    291
    Units: Participants
        Chills, Dose 1(N-292,291)
    29
    35
        Chills, Dose 2(N-265,273)
    35
    28
        Fatigue, Dose 1(N-292,291)
    157
    167
        Fatigue, Dose 2(N-265,273)
    136
    130
        Fever, Dose 1(N-292,291)
    24
    25
        Fever, Dose 2(N-265,273)
    18
    11
        Gastrointestinal, Dose 1(N-292,291)
    47
    54
        Gastrointestinal, Dose 2(N-265,273)
    39
    35
        Headache, Dose 1(N-292,291)
    98
    76
        Headache, Dose 2(N-265,273)
    75
    64
        Myalgia, Dose 1(N-292,291)
    78
    72
        Myalgia, Dose 2(N-265,273)
    74
    43
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any unsolicited adverse event (AE)

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    End point title
    		 Number of subjects reported with any unsolicited adverse event (AE)
    End point 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.
    End point type
    Secondary
    End point timeframe
    During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered approximately at Day 1 and Day 61
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    304
    302
    Units: Participants
    110
    103
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any potential immune-mediated diseases (pIMDs)

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    End point title
    		 Number of subjects reported with any potential immune-mediated diseases (pIMDs)
    End point 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.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to Study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    304
    302
    Units: Participants
    6
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any Serious Adverse Event (SAE)

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    End point title
    		 Number of subjects reported with any Serious Adverse Event (SAE)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to Study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    304
    302
    Units: Participants
    89
    99
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person-year
    number (confidence interval 95%)
        FROM 0 TO 3 MONTHS(N-278,292)
    1.35 (1.1 to 1.66)
    1.15 (0.92 to 1.43)
        FROM 3 TO 6 MONTHS(N-274,288)
    1.33 (1.08 to 1.63)
    1.44 (1.19 to 1.75)
        FROM 6 TO 9 MONTHS(N-272,280)
    1.36 (1.11 to 1.67)
    1.19 (0.96 to 1.48)
        FROM 9 TO 12 MONTHS(N-271,272)
    0.87 (0.69 to 1.11)
    0.9 (0.71 to 1.14)
    No statistical analyses for this end point

    Secondary: Rate of any AECOPD case in vaccinated and control subjects, one year follow up starting 1 month post dose 2, by 3 months period

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    End point 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
    End point 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, 0-12 months.
    End point type
    Secondary
    End point timeframe
    During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months and 0-12 months (observation starting 1 month post-Dose 2)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person-year
    number (confidence interval 95%)
        FROM 0 TO 3 MONTHS(N-278,292)
    1.47 (1.21 to 1.79)
    1.33 (1.09 to 1.63)
        FROM 3 TO 6 MONTHS(N-274,288)
    1.56 (1.29 to 1.89)
    1.56 (1.29 to 1.88)
        FROM 6 TO 9 MONTHS(N-272,280)
    1.49 (1.23 to 1.82)
    1.29 (1.05 to 1.59)
        FROM 9 TO 12 MONTHS(N-271,272)
    0.98 (0.78 to 1.22)
    1.04 (0.84 to 1.3)
        FROM 0 TO 12 MONTHS
    1.36 (1.19 to 1.57)
    1.31 (1.15 to 1.48)
    Statistical analysis title
    		 Vaccine efficacy- Any AECOPD, any severity
    Statistical analysis description
    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
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.77
    Method
    		 Negative Binomial regression
    Parameter type
    		 Vaccine efficacy rate
    Point estimate
    -2.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.95
         upper limit
    		 14.19
    Notes
    [3] - 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.

    Secondary: Exacerbation rate of any AECOPD cases, classified by severity, one year follow up starting 1 month post dose 2, by 3 months period

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    End point title
    		 Exacerbation rate of any AECOPD cases, classified by severity, one year follow up starting 1 month post dose 2, by 3 months period
    End point 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.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person
    arithmetic mean (standard deviation)
        MILD, FROM 0 TO 3 MONTHS(N-278,292)
    0.02 ( 0.15 )
    0.03 ( 0.20 )
        MILD, FROM 3 TO 6 MONTHS(N-274,288)
    0.05 ( 0.24 )
    0.02 ( 0.14 )
        MILD, FROM 6 TO 9 MONTHS(N-272,280)
    0.03 ( 0.19 )
    0.03 ( 0.18 )
        MILD, FROM 9 TO 12 MONTHS(N-271,272)
    0.03 ( 0.17 )
    0.03 ( 0.16 )
        MODERATE, FROM 0 TO 3 MONTHS(N-278,292)
    0.29 ( 0.62 )
    0.23 ( 0.48 )
        MODERATE, FROM 3 TO 6 MONTHS(N-274,288)
    0.27 ( 0.51 )
    0.3 ( 0.57 )
        MODERATE, FROM 6 TO 9 MONTHS(N-272,280)
    0.3 ( 0.56 )
    0.25 ( 0.51 )
        MODERATE, FROM 9 TO 12 MONTHS(N-271,272)
    0.2 ( 0.44 )
    0.17 ( 0.42 )
        SEVERE, FROM 0 TO 3 MONTHS(N-278,292)
    0.04 ( 0.24 )
    0.05 ( 0.23 )
        SEVERE, FROM 3 TO 6 MONTHS(N-274,288)
    0.05 ( 0.22 )
    0.06 ( 0.29 )
        SEVERE, FROM 6 TO 9 MONTHS(N-272,280)
    0.05 ( 0.29 )
    0.05 ( 0.24 )
        SEVERE, FROM 9 TO 12 MONTHS(N-271,272)
    0.01 ( 0.11 )
    0.05 ( 0.24 )
    No statistical analyses for this end point

    Secondary: Number of subjects with first moderate or severe AECOPD

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    End point title
    		 Number of subjects with first moderate or severe AECOPD
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
    158
    176
    Statistical analysis title
    		 Hazard ratio-Moderate or severe AECOPD
    Statistical analysis description
    Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 = 0.5751
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.758
         upper limit
    		 1.166
    Notes
    [4] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of subjects with first AECOPD of any severity

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    End point title
    		 Number of subjects with first AECOPD of any severity
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
    168
    188
    Statistical analysis title
    		 Hazard rate- Any AECOPD
    Statistical analysis description
    Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.5194
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.934
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.758
         upper limit
    		 1.15
    Notes
    [5] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of subjects with first AECOPD classified by severity

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    End point title
    		 Number of subjects with first AECOPD classified by severity
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
        AFTER 1 MONTH POST DOSE 2, MILD
    27
    27
        AFTER 1 MONTH POST DOSE 2, MODERATE
    144
    154
        AFTER 1 MONTH POST DOSE 2, SEVERE
    30
    41
    Statistical analysis title
    		 Hazard rate-Mild AECOPD
    Statistical analysis description
    Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.8581
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.616
         upper limit
    		 1.791
    Notes
    [6] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.
    Statistical analysis title
    		 Hazard rate-Moderate AECOPD
    Statistical analysis description
    Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.9634
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.995
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.792
         upper limit
    		 1.249
    Notes
    [7] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.
    Statistical analysis title
    		 Hazard rate-Severe AECOPD
    Statistical analysis description
    Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    P-value
    		 = 0.1755
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.722
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.157
    Notes
    [8] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of days with moderate and severe AECOPDs

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    End point title
    		 Number of days with moderate and severe AECOPDs
    End point description
    The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
        arithmetic mean (standard deviation)
    16.6 ( 14.29 )
    15.6 ( 13.93 )
    No statistical analyses for this end point

    Secondary: Number of days with AECOPDs of any severity

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    End point title
    		 Number of days with AECOPDs of any severity
    End point description
    The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
        arithmetic mean (standard deviation)
    15.9 ( 13.79 )
    15.3 ( 13.51 )
    No statistical analyses for this end point

    Secondary: Number of days with AECOPDs classified by severity

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    End point title
    		 Number of days with AECOPDs classified by severity
    End point description
    The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
    arithmetic mean (standard deviation)
        MILD, AFTER 1 MONTH POST DOSE 2
    8.9 ( 3.56 )
    12.3 ( 9.11 )
        MODERATE, AFTER 1 MONTH POST DOSE 2
    16.1 ( 13.90 )
    14.5 ( 10.50 )
        SEVERE, AFTER 1 MONTH POST DOSE 2
    20.4 ( 16.78 )
    21.2 ( 23.85 )
    No statistical analyses for this end point

    Secondary: Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD

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    End point title
    		 Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person-year
        number (confidence interval 95%)
    0.32 (0.25 to 0.42)
    0.32 (0.24 to 0.42)
    No statistical analyses for this end point

    Secondary: Rate of NTHi-associated and/ or Mcat-associated AECOPD of any severity

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    End point title
    		 Rate of NTHi-associated and/ or Mcat-associated AECOPD of any severity
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbation per person-year
        number (confidence interval 95%)
    0.39 (0.30 to 0.50)
    0.35 (0.27 to 0.45)
    No statistical analyses for this end point

    Secondary: Exacerbation rate of any NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity

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    End point title
    		 Exacerbation rate of any NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity
    End point 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
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: exacerbations per person
    arithmetic mean (standard deviation)
        MILD, AFTER 1 MONTH POST DOSE 2
    0.06 ( 0.28 )
    0.03 ( 0.21 )
        MODERATE, AFTER 1 MONTH POST DOSE 2
    0.3 ( 0.67 )
    0.31 ( 0.74 )
        SEVERE, AFTER 1 MONTH POST DOSE 2
    0.02 ( 0.18 )
    0.01 ( 0.11 )
    No statistical analyses for this end point

    Secondary: Number of subjects with first moderate or severe NTHi-associated and/or Mcat-associated AECOPD

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    End point title
    		 Number of subjects with first moderate or severe NTHi-associated and/or Mcat-associated AECOPD
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
    62
    62
    Statistical analysis title
    		 Hazard rate-Moderate or Severe AECOPD
    Statistical analysis description
    Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.9463
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.038
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.477
    Notes
    [9] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of subjects with first NTHi-associated and/or Mcat-associated AECOPD of any severity

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    End point title
    		 Number of subjects with first NTHi-associated and/or Mcat-associated AECOPD of any severity
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
    70
    67
    Statistical analysis title
    		 Hazard rate- Any AECOPD
    Statistical analysis description
    Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.6042
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.093
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.782
         upper limit
    		 1.528
    Notes
    [10] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of subjects with first NTHi-associated and/or Mcat-associated AECOPD, classified by severity

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    End point title
    		 Number of subjects with first NTHi-associated and/or Mcat-associated AECOPD, classified by severity
    End point 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.
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    278
    292
    Units: Participants
        AFTER 1 MONTH POST DOSE 2, MILD
    15
    7
        AFTER 1 MONTH POST DOSE 2, MODERATE
    58
    59
        AFTER 1 MONTH POST DOSE 2, SEVERE
    4
    4
    Statistical analysis title
    		 Hazard rate-Mid AECOPD
    Statistical analysis description
    Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.0777
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.243
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.914
         upper limit
    		 5.504
    Notes
    [11] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.
    Statistical analysis title
    		 Hazard rate-Moderate AECOPD
    Statistical analysis description
    Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.9121
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.021
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.467
    Notes
    [12] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.
    Statistical analysis title
    		 Hazard rate-Severe AECOPD
    Statistical analysis description
    Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2
    Comparison groups
    GSK3277511A Group v Control Group
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.8737
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.278
         upper limit
    		 4.502
    Notes
    [13] - The dependent variable is the time to first occurrence of the event. The reference is the Placebo.

    Secondary: Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD

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    End point title
    		 Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD
    End point description
    The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
        arithmetic mean (standard deviation)
    14 ( 10.43 )
    12.3 ( 5.59 )
    No statistical analyses for this end point

    Secondary: Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity

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    End point title
    		 Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity
    End point description
    The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
        arithmetic mean (standard deviation)
    13.3 ( 9.76 )
    12.1 ( 5.72 )
    No statistical analyses for this end point

    Secondary: Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity

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    End point title
    		 Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity
    End point description
    The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
    End point type
    Secondary
    End point timeframe
    From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    279
    292
    Units: Days
    arithmetic mean (standard deviation)
        AFTER 1 MONTH POST DOSE 2, MILD
    9.5 ( 3.54 )
    9.9 ( 6.83 )
        AFTER 1 MONTH POST DOSE 2, MODERATE
    13.8 ( 10.41 )
    12.5 ( 5.62 )
        AFTER 1 MONTH POST DOSE 2, SEVERE
    17.3 ( 11.02 )
    7.5 ( 1.00 )
    No statistical analyses for this end point

    Secondary: Anti-PD antibody concentrations as measured by the Enzyme-Linked Immunosorbent Assay (ELISA)

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    End point title
    		 Anti-PD antibody concentrations as measured by the Enzyme-Linked Immunosorbent Assay (ELISA)
    End point 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.)
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    247
    256
    Units: EU/mL.
    geometric mean (confidence interval 95%)
        Day 1(N-247,256)
    103.7 (93.8 to 114.7)
    95.4 (86.3 to 105.4)
        Day 31(N-232,243)
    1048.1 (910.2 to 1206.8)
    98.2 (85.3 to 113.1)
        Day 61(N-239,253)
    654.6 (572.3 to 748.9)
    95.5 (83.6 to 109.1)
        Day 91(N-208,211)
    1521.4 (1357.6 to 1704.9)
    90.3 (80.6 to 101.3)
        Day 271(N-210,223)
    546 (480.3 to 620.8)
    94.8 (83.6 to 107.4)
        Day 451(N-221,216)
    444.1 (390.2 to 505.4)
    97.9 (85.9 to 111.5)
    No statistical analyses for this end point

    Secondary: Anti-PE antibody concentrations as measured by ELISA

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    End point title
    		 Anti-PE antibody concentrations as measured by ELISA
    End point 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    246
    256
    Units: EU/mL.
    geometric mean (confidence interval 95%)
        Day 1(N-246,256)
    20.9 (17.6 to 24.8)
    21.6 (18.2 to 25.7)
        Day 31(N-232,244)
    1108.1 (921.5 to 1332.5)
    20.7 (17.2 to 24.9)
        Day 61(N-239,251)
    872.8 (726.6 to 1048.3)
    20.5 (17.1 to 24.6)
        Day 91(N-208,211)
    6020 (5181.2 to 6994.7)
    20.1 (17.3 to 23.4)
        Day 271(N-210,223)
    1254.9 (1069.5 to 1472.5)
    19.3 (16.5 to 22.5)
        Day 451(N-221,215)
    835.2 (715.0 to 975.6)
    19.7 (16.8 to 23.0)
    No statistical analyses for this end point

    Secondary: Anti-PilA antibody concentrations as measured by ELISA

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    End point title
    		 Anti-PilA antibody concentrations as measured by ELISA
    End point 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    247
    256
    Units: EU/mL.
    geometric mean (confidence interval 95%)
        Day 1(N-247,256)
    8.3 (6.9 to 9.8)
    8.5 (7.1 to 10.1)
        Day 31(N-231,243)
    153 (124.2 to 188.6)
    9.2 (7.5 to 11.4)
        Day 61(N-238,251)
    134.2 (109.7 to 164.2)
    8.8 (7.2 to 10.8)
        Day 91(N-208,211)
    913.5 (770.5 to 1082.9)
    8.9 (7.5 to 10.5)
        Day 271(N-210,223)
    189.6 (159.2 to 225.7)
    8 (6.8 to 9.5)
        Day 451(N-221,216)
    126.5 (106.1 to 150.8)
    8.3 (6.9 to 9.9)
    No statistical analyses for this end point

    Secondary: Anti-UspA2 antibody concentrations as measured by ELISA

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    End point title
    		 Anti-UspA2 antibody concentrations as measured by ELISA
    End point 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    246
    255
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1(N-246,255)
    540.3 (452.6 to 645.0)
    604.7 (507.2 to 721.0)
        Day 31(N-232,242)
    1092.1 (997.5 to 1195.5)
    485.2 (442.9 to 531.6)
        Day 61(N-238,251)
    848.7 (781.5 to 921.5)
    473.5 (436.2 to 513.9)
        Day 91(N-208,211)
    1223.7 (1110.8 to 1348.0)
    446 (404.5 to 491.8)
        Day 271(N-210,222)
    645.1 (582.1 to 714.8)
    445.4 (402.7 to 492.6)
        Day 451(N-221,215)
    575.9 (512.9 to 646.7)
    468.5 (416.5 to 527.1)
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    47
    41
    Units: T cells/million cells
    arithmetic mean (standard deviation)
        Day 1(N-47,41)
    56.6 ( 125.7 )
    59.7 ( 118.2 )
        Day 91(N-42,36)
    890.2 ( 988.8 )
    55.8 ( 88.2 )
        Day 271(N-42,41)
    364.6 ( 363.9 )
    51.8 ( 90.9 )
        Day 451(N-42,36)
    267 ( 282.6 )
    46.7 ( 101.1 )
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    47
    41
    Units: T cells/million cells
    arithmetic mean (standard deviation)
        Day 1(N-47,41)
    63.1 ( 211.4 )
    92.9 ( 266.0 )
        Day 91(N-42,36)
    797 ( 1082.9 )
    76.2 ( 195.0 )
        Day 271(N-42,41)
    384.8 ( 539.9 )
    61.4 ( 207.2 )
        Day 451(N-42,36)
    335.7 ( 493.7 )
    81.2 ( 258.9 )
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    47
    41
    Units: T cells/million cells
    arithmetic mean (standard deviation)
        Day 1(N-47,40)
    26.2 ( 45.4 )
    53.3 ( 95.9 )
        Day 91(N-42,36)
    305.8 ( 321.7 )
    44.6 ( 114.8 )
        Day 271(N-42,41)
    137.3 ( 163.2 )
    42.1 ( 78.2 )
        Day 451(N-42,36)
    141 ( 147.1 )
    42.4 ( 95.3 )
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 271 and at Day 451
    End point values
    		 GSK3277511A Group Control Group
    Number of subjects analysed
    47
    41
    Units: T cells/million cells
    arithmetic mean (standard deviation)
        Day 1(N-47,40)
    66.1 ( 177.1 )
    47.2 ( 85.8 )
        Day 91(N-42,36)
    646.3 ( 545.2 )
    70.3 ( 94.6 )
        Day 271(N-42,41)
    330.5 ( 278.5 )
    60.8 ( 80.0 )
        Day 451(N-42,35)
    331.3 ( 310.4 )
    61.5 ( 89.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    GSK3277511A Group
    Reporting group 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

    Reporting group title
    Control Group
    Reporting group description
    		 Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.

    Serious adverse events
    		 GSK3277511A Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    89 / 304 (29.28%)
    99 / 302 (32.78%)
         number of deaths (all causes)
    1
    10
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypopharyngeal cancer stage IV
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukaemia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile cancer
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vein occlusion
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Condition aggravated
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal inflammation
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    7 / 304 (2.30%)
    7 / 302 (2.32%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atelectasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    41 / 304 (13.49%)
    53 / 302 (17.55%)
         occurrences causally related to treatment / all
    0 / 55
    0 / 83
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Dyspnoea
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 304 (0.66%)
    4 / 302 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drain site complication
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure to toxic agent
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal procedural complication
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute left ventricular failure
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 304 (1.32%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 304 (0.33%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegic migraine
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyschezia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileus paralytic
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS ventriculitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 304 (0.33%)
    4 / 302 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    4 / 304 (1.32%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 304 (1.64%)
    15 / 302 (4.97%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia pneumococcal
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK3277511A Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    276 / 304 (90.79%)
    247 / 302 (81.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Peripheral venous disease
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    Chills
         subjects affected / exposed
    52 / 304 (17.11%)
    52 / 302 (17.22%)
         occurrences all number
    64
    65
    Drug intolerance
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    195 / 304 (64.14%)
    197 / 302 (65.23%)
         occurrences all number
    297
    299
    Feeling hot
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Injection site bruising
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    43 / 304 (14.14%)
    1 / 302 (0.33%)
         occurrences all number
    55
    1
    Injection site pain
         subjects affected / exposed
    213 / 304 (70.07%)
    30 / 302 (9.93%)
         occurrences all number
    324
    31
    Injection site reaction
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Injection site swelling
         subjects affected / exposed
    35 / 304 (11.51%)
    3 / 302 (0.99%)
         occurrences all number
    45
    3
    Malaise
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    5 / 304 (1.64%)
    0 / 302 (0.00%)
         occurrences all number
    5
    0
    Pyrexia
         subjects affected / exposed
    39 / 304 (12.83%)
    32 / 302 (10.60%)
         occurrences all number
    42
    36
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Bartholin's cyst
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Scrotal pain
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Scrotal swelling
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    Dyspnoea
         subjects affected / exposed
    5 / 304 (1.64%)
    3 / 302 (0.99%)
         occurrences all number
    5
    3
    Epistaxis
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Haemoptysis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Increased upper airway secretion
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    Nasal polyps
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 304 (0.33%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Pharyngeal erythema
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Pleuritic pain
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Pulmonary mass
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Sputum discoloured
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Sputum increased
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Panic attack
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Chest injury
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Contusion
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Fall
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Meniscus injury
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Cardiac failure
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Mitral valve prolapse
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 304 (0.33%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    Epilepsy
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Focal dyscognitive seizures
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    127 / 304 (41.78%)
    111 / 302 (36.75%)
         occurrences all number
    178
    145
    Paraesthesia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Post polio syndrome
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Tension headache
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Vertigo
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Dermatochalasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Retinoschisis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Vitreous detachment
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Dental caries
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    3 / 304 (0.99%)
    9 / 302 (2.98%)
         occurrences all number
    3
    9
    Faecaloma
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    71 / 304 (23.36%)
    77 / 302 (25.50%)
         occurrences all number
    86
    90
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Intestinal polyp
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 304 (0.33%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    Pancreatic disorder
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dandruff
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Dermal cyst
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    Eczema
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Pruritus allergic
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Skin lesion
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Urine odour abnormal
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Costochondritis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    115 / 304 (37.83%)
    94 / 302 (31.13%)
         occurrences all number
    153
    116
    Osteoarthritis
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    Pain in extremity
         subjects affected / exposed
    1 / 304 (0.33%)
    4 / 302 (1.32%)
         occurrences all number
    1
    5
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Tendon disorder
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Chronic sinusitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    3 / 304 (0.99%)
    1 / 302 (0.33%)
         occurrences all number
    3
    1
    Ear infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 304 (0.33%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    Gastroenteritis viral
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    Gingivitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    2 / 304 (0.66%)
    3 / 302 (0.99%)
         occurrences all number
    2
    3
    Kidney infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Labyrinthitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Localised infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    13 / 304 (4.28%)
    13 / 302 (4.30%)
         occurrences all number
    13
    15
    Oral candidiasis
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Otitis media acute
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 304 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    3
    Respiratory tract infection
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 304 (0.00%)
    4 / 302 (1.32%)
         occurrences all number
    0
    4
    Sweat gland infection
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 304 (1.32%)
    3 / 302 (0.99%)
         occurrences all number
    4
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 304 (0.33%)
    4 / 302 (1.32%)
         occurrences all number
    1
    5
    Viral infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Hyperinsulinaemic hypoglycaemia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2017
    CD8+ T cell component removed from secondary endpoint, exclusion criteria was updated, cut-off values were updated for anti-PD, anti-PE, anti-PilA and anti-UspA2 antibody ELISA

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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