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    Clinical Trial Results:
    A Phase 2, randomised, observer-blind, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' GSK3277511A investigational vaccine when administered intramuscularly according to two different vaccine schedules in adults aged 40 to 80 years old

    Summary
    EudraCT number
    		 2017-002941-31
    Trial protocol
    		 DE   GB  
    Global end of trial date
    13 Nov 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    20 Aug 2021
    First version publication date
    30 Sep 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    207759
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03443427
    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
    05 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity profile of the NTHi-Mcat vaccine administered according to two vaccination schedules
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Mar 2018
    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
    Canada: 100
    Country: Number of subjects enrolled
    Germany: 50
    Country: Number of subjects enrolled
    United Kingdom: 50
    Worldwide total number of subjects
    200
    EEA total number of subjects
    50
    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)
    133
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects enrolled were included for analysis in this study

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    This is an observer blind study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Schedule 0-2-6 Group
    Arm description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).
    Arm type
    		 Experimental

    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
    One dose administered intramuscularly in the deltoid of the non-dominant arm

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

    Arm title
    		 Schedule 0-2-12 Group
    Arm description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
    Arm type
    		 Experimental

    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
    One dose administered intramuscularly in the deltoid of the non-dominant arm

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

    Number of subjects in period 1
    		Schedule 0-2-6 Group Schedule 0-2-12 Group
    Started
    100
    100
    Completed
    88
    89
    Not completed
    12
    11
         Adverse event, non-fatal
    2
    3
         Unspecified
    4
    6
         CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Schedule 0-2-6 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).

    Reporting group title
    Schedule 0-2-12 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).

    Reporting group values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group Total
    Number of subjects
    		 100 100 200
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 68 65 133
        From 65-84 years
    		 32 35 67
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 10.3 ) 59.8 ( 10.1 ) -
    Sex: Female, Male
    Units: Participants
        FEMALE
    		 46 43 89
        MALE
    		 54 57 111
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 0 1 1
        WHITE
    		 100 99 199

    End points

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    End points reporting groups
    Reporting group title
    Schedule 0-2-6 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).

    Reporting group title
    Schedule 0-2-12 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).

    Primary: Number of subjects reported with each solicited local adverse event (AE) (any and grade 3) within each vaccination schedule

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    End point title
    		 Number of subjects reported with each solicited local adverse event (AE) (any and grade 3) within each vaccination schedule [1]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) injection site. Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided solicited safety data.
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply for this endpoint.
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
        Pain, Any, Dose 1 (N-100,100)
    64
    64
        Pain, Grade 3, Dose 1 (N-100,100)
    2
    1
        Pain, Any, Dose 2(N-92,97)
    72
    69
        Pain, Grade 3, Dose 2(N-92,97)
    13
    3
        Pain, Any, Dose 3(N-89,97)
    67
    4
        Pain, Grade 3, Dose 3(N-89,97)
    12
    0
        Pain, Any, Dose 4(N-84,93)
    9
    73
        Pain, Grade 3, Dose 4(N-84,93)
    0
    8
        Redness, Any, Dose 1 (N-100,100)
    9
    18
        Redness, Grade 3, Dose 1 (N-100,100)
    0
    0
        Redness, Any, Dose 2(N-92,97)
    12
    11
        Redness, Grade 3, Dose 2(N-92,97)
    0
    0
        Redness, Any, Dose 3(N-89,97)
    13
    0
        Redness, Grade 3, Dose 3(N-89,97)
    1
    0
        Redness, Any, Dose 4(N-84,93)
    1
    12
        Redness, Grade 3, Dose 4(N-84,93)
    0
    1
        Swelling, Any, Dose 1(N-100,100)
    8
    10
        Swelling, Grade 3, Dose 1(N-100,100)
    0
    0
        Swelling, Any, Dose 2(N-92,97)
    7
    7
        Swelling, Grade 3, Dose 2(N-92,97)
    0
    0
        Swelling, Any, Dose 3(N-89,97)
    9
    0
        Swelling, Grade 3, Dose 3(N-89,97)
    1
    0
        Swelling, Any, Dose 4(N-84,93)
    1
    10
        Swelling, Grade 3, Dose 4(N-84,93)
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects reported with each solicited general adverse event (AE) (any and grade 3) within each vaccination schedule

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    End point title
    		 Number of subjects reported with each solicited general adverse event (AE) (any and grade 3) within each vaccination schedule [2]
    End point description
    Assessed solicited general symptoms were chills, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), fatigue, myalgia, headache and fever [defined Oral cavity or axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided solicited safety data.
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply for this endpoint.
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
        Chills, Any, Dose 1 (N-100,100)
    6
    5
        Chills, Grade 3, Dose 1(N-100,100)
    0
    0
        Chills, Any, Dose 2(N-92,97)
    13
    8
        Chills, Grade 3, Dose 2(N-92,97)
    4
    1
        Chills, Any, Dose 3(N-89,97)
    12
    2
        Chills, Grade 3, Dose 3(N-89,97)
    4
    0
        Chills, Any, Dose 4(N-84,93)
    2
    18
        Chills, Grade 3, Dose 4(N-84,93)
    1
    1
        Gastrointestinal symptoms,Any,Dose 1(N-100,100)
    11
    7
        Gastrointestinal symptoms,Grade3,Dose 1(N-100,100)
    0
    0
        Gastrointestinal symptoms,Any,Dose 2(N-92,97)
    11
    10
        Gastrointestinal symptoms,Grade3,Dose 2(N-92,97)
    1
    1
        Gastrointestinal symptoms, Any, Dose 3(N-89,97)
    9
    7
        Gastrointestinal symptoms,Grade3,Dose 3(N-89,97)
    0
    0
        Gastrointestinal symptoms, Any,Dose 4(N-84,93)
    3
    15
        Gastrointestinal symptoms,Grade3,Dose 4(N-84,93)
    1
    1
        Fatigue, Any, Dose 1(N-100,100)
    22
    16
        Fatigue, Grade 3, Dose 1(N-100,100)
    0
    1
        Fatigue, Any, Dose 2(N-92,97)
    28
    32
        Fatigue, Grade 3, Dose 2(N-92,97)
    9
    1
        Fatigue, Any, Dose 3(N-89,97)
    20
    13
        Fatigue, Grade 3, Dose 3(N-89,97)
    4
    0
        Fatigue, Any, Dose 4(N-84,93)
    8
    35
        Fatigue, Grade 3, Dose 4(N-84,93)
    3
    5
        Myalgia, Any, Dose 1(N-100,100)
    17
    16
        Myalgia, Grade 3, Dose 1(N-100,100)
    1
    0
        Myalgia, Any, Dose 2(N-92,97)
    22
    23
        Myalgia, Grade 3, Dose 2(N-92,97)
    7
    1
        Myalgia, Any, Dose 3(N-89,97)
    20
    3
        Myalgia, Grade 3, Dose 3(N-89,97)
    6
    0
        Myalgia, Any, Dose 4(N-84,93)
    4
    28
        Myalgia, Grade 3, Dose 4(N-84,93)
    1
    5
        Headache, Any, Dose 1(N-100,100)
    13
    15
        Headache, Grade 3, Dose 1(N-100,100)
    0
    1
        Headache, Any, Dose 2(N-92,97)
    24
    21
        Headache, Grade 3, Dose 2(N-92,97)
    2
    1
        Headache, Any, Dose 3(N-89,97)
    24
    7
        Headache, Grade 3, Dose 3(N-89,97)
    4
    0
        Headache, Any, Dose 4(N-84,93)
    5
    27
        Headache, Grade 3, Dose 4(N-84,93)
    1
    1
        Fever, Any, Dose 1(N-100,100)
    3
    3
        Fever, Grade 3, Dose 1(N-100,100)
    0
    0
        Fever, Any, Dose 2(N-92,97)
    3
    6
        Fever, Grade 3, Dose 2(N-92,97)
    0
    0
        Fever, Any, Dose 3(N-89,97)
    4
    2
        Fever, Grade 3, Dose 3(N-89,97)
    0
    0
        Fever, Any, Dose 4(N-84,93)
    3
    5
        Fever, Grade 3, Dose 4(N-84,93)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects reported with any unsolicited adverse event (AE) within each vaccination schedule

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    End point title
    		 Number of subjects reported with any unsolicited adverse event (AE) within each vaccination schedule [3]
    End point description
    An AE is 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. Unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided unsolicited safety data.
    End point type
    Primary
    End point timeframe
    During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply for this endpoint.
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
        Dose 1 (N-100,100)
    16
    20
        Dose 2 (N-93,98)
    15
    20
        Dose 3 (N-90,97)
    13
    11
        Dose 4 (N-85,93)
    7
    9
    No statistical analyses for this end point

    Primary: Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule

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    End point title
    		 Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule [4]
    End point description
    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician. Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided safety data.
    End point type
    Primary
    End point timeframe
    From first vaccination (Day 1) up to Day 541 (an average of 18 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply for this endpoint.
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
    12
    8
    No statistical analyses for this end point

    Primary: Number of subjects reported with any potential immune-mediated diseases (pIMDs) within each vaccination schedule

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    End point title
    		 Number of subjects reported with any potential immune-mediated diseases (pIMDs) within each vaccination schedule [5]
    End point description
    Potential immune-mediated diseases (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. Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided safety data.
    End point type
    Primary
    End point timeframe
    From first vaccination (Day 1) up to Day 541 (an average of 18 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply for this endpoint.
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
    3
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any SAE within each vaccination schedule

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    End point title
    		 Number of subjects reported with any SAE within each vaccination schedule
    End point description
    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.
    End point type
    Secondary
    End point timeframe
    From Day 541 up to Day 721 (an average of 6 months)
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
        Any SAEs (N=100, 100)
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any pIMDs within each vaccination schedule

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    End point title
    		 Number of subjects reported with any pIMDs within each vaccination schedule
    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 Day 541 up to Day 721 (an average of 6 months)
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    100
    100
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Anti–Protein D (PD) antibody concentrations, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Anti–Protein D (PD) antibody concentrations, as measured by ELISA, within each vaccination schedule
    End point description
    Anti–Protein D (PD) antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (153 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N-82,87)
    88 (79.2 to 97.9)
    88.1 (79.8 to 97.2)
        Day 91(N-79,82)
    1365.5 (1073.0 to 1737.8)
    1394.1 (1116.9 to 1740.1)
        Day 181(N-81,87)
    853.4 (665.4 to 1094.6)
    835.6 (665.4 to 1049.3)
        Day 211(N-81,84)
    2338 (1840.1 to 2970.8)
    679 (541.7 to 850.9)
        Day 361(N-82,87)
    1199 (942.8 to 1524.9)
    483.1 (386.4 to 603.9)
        Day 391(N-81,82)
    1064.1 (829.4 to 1365.2)
    2677 (2111.4 to 3394.1)
        Day 541(N-80,84)
    826.5 (646.3 to 1057.0)
    1346.4 (1072.1 to 1690.8)
        Day 721 (N-77,79)
    679.6 (529.5 to 872.1)
    900.4 (716.1 to 1132.2)
    No statistical analyses for this end point

    Secondary: Anti–Protein E (PE) antibody concentrations, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Anti–Protein E (PE) antibody concentrations, as measured by ELISA, within each vaccination schedule
    End point description
    Anti–Protein E (PE) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (16 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N-82,87)
    19.6 (15.1 to 25.5)
    18.4 (14.5 to 23.5)
        Day 91(N-79,82)
    5867.9 (4644.4 to 7413.8)
    5896.7 (4755.2 to 7312.3)
        Day 181(N-81,87)
    2649.1 (2113.3 to 3320.7)
    2787.1 (2266.0 to 3428.0)
        Day 211(N-80,84)
    7557.1 (6107.9 to 9350.0)
    2309.9 (1892.1 to 2819.8)
        Day 361(N-82,87)
    2735.3 (2196.7 to 3406.1)
    1298 (1058.6 to 1591.6)
        Day 391(N-81,82)
    2604.2 (2118.3 to 3201.5)
    9339.4 (7670.2 to 11372.0)
        Day 541(N-80,84)
    1762.2 (1443.9 to 2150.6)
    3620.7 (3009.9 to 4355.4)
        Day 721 (N-77,79)
    1348.3 (1085.6 to 1674.7)
    1942.0 (1591.0 to 2370.5)
    No statistical analyses for this end point

    Secondary: Anti–type IV pili subunit (PilA) antibody concentrations, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Anti–type IV pili subunit (PilA) antibody concentrations, as measured by ELISA, within each vaccination schedule
    End point description
    Anti–type IV pili subunit (PilA) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (8 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1(N-82,87)
    10.9 (8.5 to 14.2)
    8.3 (6.5 to 10.5)
        Day 91(N-79,82)
    992.5 (747.2 to 1318.5)
    893.1 (688.6 to 1158.3)
        Day 181(N-81,87)
    589.3 (442.8 to 784.3)
    504.2 (388.4 to 654.3)
        Day 211(N-81,84)
    1191.7 (920.0 to 1543.6)
    396.3 (310.9 to 505.2)
        Day 361(N-82,87)
    546.6 (418.1 to 714.5)
    250.3 (195.3 to 320.7)
        Day 391(N-81,82)
    456.4 (360.7 to 577.6)
    1163.9 (931.1 to 1454.9)
        Day 541(N-80,84)
    330.4 (260.5 to 419.1)
    524.3 (421.0 to 653.1)
        Day 721 (N-77,79)
    242.9 (186.4 to 316.5)
    305.5 (239.8 to 389.2)
    No statistical analyses for this end point

    Secondary: Anti–ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Anti–ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, as measured by ELISA, within each vaccination schedule
    End point description
    Anti–ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (28 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1(N-82,87)
    682.4 (544.4 to 855.4)
    544.9 (441.8 to 672.1)
        Day 91(N-79,82)
    1364.5 (1217.6 to 1529.1)
    1159.7 (1044.8 to 1287.2)
        Day 181(N-81,87)
    1019.7 (920.9 to 1129.0)
    915.2 (834.1 to 1004.3)
        Day 211(N-81,84)
    1270.9 (1138.1 to 1419.2)
    864.6 (779.5 to 959.1)
        Day 361(N-82,87)
    885.8 (801.7 to 978.8)
    730 (665.6 to 800.6)
        Day 391(N-81,82)
    909.9 (818.5 to 1011.4)
    1142.8 (1033.9 to 1263.3)
        Day 541(N-80,84)
    898.2 (811.5 to 994.2)
    847.4 (771.6 to 930.7)
        Day 721 (N-77,79)
    790.6 (705.1 to 886.6)
    715.2 (644.0 to 794.1)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PD antibody, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Number of seropositive subjects for anti-PD antibody, as measured by ELISA, within each vaccination schedule
    End point description
    A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 153 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: Participants
        Day 1(N-82,87)
    7
    12
        Day 91(N-79,82)
    78
    80
        Day 181(N-81,87)
    75
    80
        Day 211(N-81,84)
    81
    75
        Day 361(N-82,87)
    78
    71
        Day 391(N-81,82)
    77
    81
        Day 541(N-80,84)
    76
    79
        Day 721 (N-77,79)
    72
    74
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PE antibody, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Number of seropositive subjects for anti-PE antibody, as measured by ELISA, within each vaccination schedule
    End point description
    A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 16 EU/mL). Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: Participants
        Day 1(N-82,87)
    43
    43
        Day 91(N-79,82)
    79
    82
        Day 181(N-81,87)
    81
    87
        Day 211(N-80,84)
    80
    84
        Day 361(N-82,87)
    82
    87
        Day 391(N-81,82)
    81
    82
        Day 541(N-80,84)
    80
    84
        Day 721 (N-77,79)
    77
    79
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti- PilA antibody, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Number of seropositive subjects for anti- PilA antibody, as measured by ELISA, within each vaccination schedule
    End point description
    A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 8 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: Participants
        Day 1(N-82,87)
    40
    36
        Day 91(N-79,82)
    79
    82
        Day 181(N-81,87)
    81
    87
        Day 211(N-81,84)
    81
    83
        Day 361(N-82,87)
    82
    84
        Day 391(N-81,82)
    81
    82
        Day 541(N-80,84)
    80
    84
        Day 721 (N-77,79)
    75
    79
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti- UspA2 antibody, as measured by ELISA, within each vaccination schedule

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    End point title
    		 Number of seropositive subjects for anti- UspA2 antibody, as measured by ELISA, within each vaccination schedule
    End point description
    A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 28 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL. Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    82
    87
    Units: Participants
        Day 1(N-82,87)
    82
    87
        Day 91(N-79,82)
    79
    82
        Day 181(N-81,87)
    81
    87
        Day 211(N-81,84)
    81
    84
        Day 361(N-82,87)
    82
    87
        Day 391(N-81,82)
    81
    82
        Day 541(N-80,84)
    80
    84
        Day 721 (N-77,79)
    77
    79
    No statistical analyses for this end point

    Secondary: Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells producing 2 or more markers upon in vitro stimulation with the antigen, by NTHi Antigen

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    End point title
    		 Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells producing 2 or more markers upon in vitro stimulation with the antigen, by NTHi Antigen
    End point description
    Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers [such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)]. The frequency of specific CD4+ T-cells are summarized with following descriptive statistics: Mean and standard deviation (SD) against each antigen (PD, PE,PilA and UspA2), by group and at each time point for which blood samples were collected for Cell-Mediated Immunity (CMI). The CMI sub-cohort subjects were selected from sites able to process the blood samples according to GSK procedures for peripheral blood mononuclear cell (PBMC) preparation.Analysis was performed on a subset of subjects (CMI sub cohort), which included approximately 20 subjects in each group,for which additional blood sample was taken at each pre-defined timepoint.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 91, Day 181, Day 211, Day 361 and Day 391
    End point values
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Number of subjects analysed
    21
    19
    Units: CD4+ T-cells/million cells
    arithmetic mean (standard deviation)
        NTHi.PD, Day 1(N-21,19)
    76.995 ( 142.760 )
    55.173 ( 109.539 )
        NTHi.PD, Day 91(N-19,19)
    865.933 ( 919.585 )
    1076.136 ( 970.670 )
        NTHi.PD, Day 181(N-17,19)
    381.265 ( 356.496 )
    463.939 ( 558.441 )
        NTHi.PD, Day 211(N-17,19)
    664.044 ( 610.930 )
    518.104 ( 513.462 )
        NTHi.PD, Day 361(N-17,17)
    444.129 ( 520.204 )
    378.78 ( 456.970 )
        NTHi.PD, Day 391(N-17,17)
    321.28 ( 316.073 )
    761.605 ( 974.791 )
        NTHi.PE, Day 1(N-21,19)
    28.869 ( 44.944 )
    21.223 ( 38.682 )
        NTHi.PE, Day 91(N-19,19)
    1406.663 ( 1900.558 )
    926.809 ( 785.046 )
        NTHi.PE, Day 181(N-17,19)
    551.444 ( 635.058 )
    352.471 ( 403.081 )
        NTHi.PE, Day 211(N-17,19)
    986.138 ( 1570.491 )
    463.076 ( 395.158 )
        NTHi.PE, Day 361(N-17,17)
    636.539 ( 995.486 )
    305.772 ( 337.400 )
        NTHi.PE, Day 391(N-17,17)
    590.426 ( 714.051 )
    481.133 ( 533.658 )
        NTHi.PilA, Day 1(N-21,19)
    81.03 ( 178.861 )
    79.205 ( 210.642 )
        NTHi.PilA, Day 91(N-19,19)
    615.698 ( 686.114 )
    523.195 ( 493.956 )
        NTHi.PilA, Day 181(N-17,19)
    356.275 ( 350.909 )
    265.097 ( 267.351 )
        NTHi.PilA, Day 211(N-17,19)
    524.754 ( 654.443 )
    257.806 ( 252.382 )
        NTHi.PilA, Day 361(N-17,17)
    341.58 ( 433.970 )
    205.388 ( 220.979 )
        NTHi.PilA, Day 391(N-17,17)
    334.088 ( 300.114 )
    368.693 ( 354.449 )
        M catarrhalis.UspA2,Day 1(N-21,19)
    85.785 ( 99.051 )
    53.391 ( 80.742 )
        M catarrhalis.UspA2, Day 91(N-19,19)
    964.521 ( 709.134 )
    730.725 ( 575.778 )
        M catarrhalis.UspA2, Day 181(N-17,19)
    559.062 ( 524.096 )
    355.992 ( 346.277 )
        M catarrhalis.UspA2, Day 211(N-17,19)
    846.177 ( 750.349 )
    424.981 ( 329.334 )
        M catarrhalis.UspA2, Day 361(N-17,17)
    635.022 ( 617.485 )
    347.65 ( 363.499 )
        M catarrhalis.UspA2, Day 391(N-17,17)
    545.436 ( 464.272 )
    474.238 ( 446.236 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected during the 7-day follow-up period after any vaccination, Unsolicited AEs during the 30-day follow-up period after any vaccination, and SAEs from Day 1 to Day 721.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Schedule 0-2-6 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).

    Reporting group title
    Schedule 0-2-12 Group
    Reporting group description
    		 Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).

    Serious adverse events
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 100 (12.00%)
    9 / 100 (9.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (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 / 100 (2.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth injury
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (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 myocardial infarction
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Right ventricular failure
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (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
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         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
    Death
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         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
    Pulmonary embolism
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (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 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Schedule 0-2-6 Group Schedule 0-2-12 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 100 (93.00%)
    97 / 100 (97.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Hypertension
         subjects affected / exposed
    0 / 100 (0.00%)
    4 / 100 (4.00%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Administration site pruritus
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    44 / 100 (44.00%)
    50 / 100 (50.00%)
         occurrences all number
    79
    97
    Chills
         subjects affected / exposed
    24 / 100 (24.00%)
    25 / 100 (25.00%)
         occurrences all number
    33
    34
    Feeling hot
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Injection site erythema
         subjects affected / exposed
    21 / 100 (21.00%)
    28 / 100 (28.00%)
         occurrences all number
    35
    41
    Influenza like illness
         subjects affected / exposed
    2 / 100 (2.00%)
    2 / 100 (2.00%)
         occurrences all number
    2
    2
    Injection site pain
         subjects affected / exposed
    89 / 100 (89.00%)
    92 / 100 (92.00%)
         occurrences all number
    213
    210
    Injection site pruritus
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Injection site swelling
         subjects affected / exposed
    16 / 100 (16.00%)
    20 / 100 (20.00%)
         occurrences all number
    25
    27
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    11 / 100 (11.00%)
    13 / 100 (13.00%)
         occurrences all number
    13
    16
    Illness
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 100 (1.00%)
         occurrences all number
    2
    1
    Nasal congestion
         subjects affected / exposed
    1 / 100 (1.00%)
    3 / 100 (3.00%)
         occurrences all number
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Stress
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 100 (2.00%)
    2 / 100 (2.00%)
         occurrences all number
    2
    2
    Headache
         subjects affected / exposed
    39 / 100 (39.00%)
    41 / 100 (41.00%)
         occurrences all number
    69
    71
    Hypoaesthesia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Nerve compression
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Vertigo
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 100 (1.00%)
    3 / 100 (3.00%)
         occurrences all number
    1
    3
    Dyspepsia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    Food poisoning
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    25 / 100 (25.00%)
    28 / 100 (28.00%)
         occurrences all number
    34
    40
    Haemorrhoids
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    2 / 100 (2.00%)
    4 / 100 (4.00%)
         occurrences all number
    2
    4
    Joint swelling
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    38 / 100 (38.00%)
    41 / 100 (41.00%)
         occurrences all number
    63
    73
    Pain in extremity
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 100 (2.00%)
         occurrences all number
    1
    2
    Infections and infestations
    Eye infection
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Alveolar osteitis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Infected bite
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Gingival abscess
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    6 / 100 (6.00%)
    6 / 100 (6.00%)
         occurrences all number
    6
    6
    Localised infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Ophthalmic herpes simplex
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 100 (2.00%)
         occurrences all number
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 100 (3.00%)
    0 / 100 (0.00%)
         occurrences all number
    3
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2018
    MedDRA list for pIMDs updated with addition of gout as musculoskeletal disorder of interest
    24 Jul 2019
    ELISA cut off levels for humoral antibody response updated. CMI testing for CD8+ T cells measurement moved from secondary endpoints to tertiary endpoints.

    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
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    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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