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    Clinical Trial Results:
    Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

    Summary
    EudraCT number
    		 2013-000373-76
    Trial protocol
    		 BE  
    Global end of trial date
    25 Apr 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 May 2021
    First version publication date
    07 Jan 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    117177
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02075515
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'institut 89, Rixensart, Belgium, 1330
    Public contact
    GlaxoSmithKline Biologicals, Clinical Trials Call Center, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GlaxoSmithKline Biologicals, Clinical Trials Call Center, 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 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate lot-to-lot consistency in terms of anti-gE humoral immunogenicity between three production lots of the HZ/su vaccine one month after the second dose (Month 3).  One month after the second dose, the two-sided 95 % confidence intervals (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots were within [0.67, 1.5].
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Any subject with an event of HZ between Visit 1 and Visit 2 did not receive the second dose.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Aug 2014
    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: 276
    Country: Number of subjects enrolled
    Canada: 93
    Country: Number of subjects enrolled
    United States: 282
    Worldwide total number of subjects
    651
    EEA total number of subjects
    276
    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)
    308
    From 65 to 84 years
    336
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At screening the following was performed: informed consent was obtained from & signed by subjects’ parents/gardians, check for inclusion/exclusion criteria and precautions was performed as regards contraindications to vaccination, and medical history of subjects was collected. Subjects’ pre-vaccination body temperature was evaluated.

    Pre-assignment period milestones
    Number of subjects started
    		 651
    Number of subjects completed
    		 651

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1437173A Lot A Group
    Arm description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Herpes zoster vaccine GSK1437173A
    Investigational medicinal product code
    HZ/su or gE/AS01B
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a dose from Lot A, B or C of the GSK1437173A vaccine at 0 and 2 months.

    Arm title
    		 GSK1437173A Lot B Group
    Arm description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Herpes zoster vaccine GSK1437173A
    Investigational medicinal product code
    HZ/su or gE/AS01B
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a dose from Lot A, B or C of the GSK1437173A vaccine at 0 and 2 months.

    Arm title
    		 GSK1437173A Lot C Group
    Arm description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Herpes zoster vaccine GSK1437173A
    Investigational medicinal product code
    HZ/su or gE/AS01B
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a dose from Lot A, B or C of the GSK1437173A vaccine at 0 and 2 months.

    Number of subjects in period 1
    		GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Started
    218
    217
    216
    Completed
    214
    212
    208
    Not completed
    4
    5
    8
         Consent withdrawn by subject
    2
    -
    1
         Non-Serious Adverse Event
    -
    1
    -
         Lost to follow-up
    1
    3
    6
         Serious Adverse Event
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1437173A Lot A Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot B Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot C Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group Total
    Number of subjects
    		 218 217 216
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 64.8 ( 8.8 ) 64.3 ( 9.4 ) 64.4 ( 8.8 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 116 130 114 360
        Male
    		 102 87 102 291

    End points

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    End points reporting groups
    Reporting group title
    GSK1437173A Lot A Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot B Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot C Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Primary: Number of subjects with anti-gE antibody concentrations equal to or above the cut-off value

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    End point title
    		 Number of subjects with anti-gE antibody concentrations equal to or above the cut-off value
    End point description
    Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    At Month 3
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    210
    210
    202
    Units: Subjects
    210
    210
    202
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    GSK1437173A Lot B Group v GSK1437173A Lot A Group
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.09
    Notes
    [1] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    GSK1437173A Lot C Group v GSK1437173A Lot A Group
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjustd GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.08
    Notes
    [2] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    GSK1437173A Lot B Group v GSK1437173A Lot C Group
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.1
    Notes
    [3] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5].

    Secondary: Anti-gE humoral immunogenicity

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    End point title
    		 Anti-gE humoral immunogenicity
    End point description
    Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0 and Month 3
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    210
    210
    202
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, Month 0
    1378.4 (1180 to 1610)
    1166.5 (1005.5 to 1353.4)
    1381.2 (1190.9 to 1601.9)
        Anti-gE, Month 3
    59556.1 (54587.6 to 64976.7)
    60733.8 (55995.2 to 65873.3)
    62058.3 (57422.3 to 67068.7)
    No statistical analyses for this end point

    Secondary: Number of vaccine responders for anti-gE concentrations as determined by ELISA

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    End point title
    		 Number of vaccine responders for anti-gE concentrations as determined by ELISA
    End point description
    Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    210
    210
    202
    Units: Subjects
    201
    205
    197
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    GSK1437173A Lot A Group v GSK1437173A Lot B Group
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.86
         upper limit
    		 1.72
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    GSK1437173A Lot A Group v GSK1437173A Lot C Group
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    -1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.79
         upper limit
    		 1.92
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    GSK1437173A Lot B Group v GSK1437173A Lot C Group
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 3.58

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0-6) after each vaccine dose and across doses
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    217
    217
    215
    Units: Subjects
        Any Pain, Dose 1 (N=217;217;214)
    160
    179
    166
        Grade 3 Pain, Dose 1 (N=217;217;214)
    4
    6
    7
        Any Redness, Dose 1 (N=217;217;214)
    29
    48
    41
        Grade 3 Redness, Dose 1 (N=217;217;214)
    1
    1
    1
        Any Swelling, Dose 1 (N=217;217;214)
    24
    33
    26
        Grade 3 Swelling, Dose 1 (N=217;217;214)
    0
    0
    1
        Any Pain, Dose 2 (N=211;216;207)
    155
    152
    155
        Grade 3 Pain, Dose 2 (N=211;216;207)
    18
    13
    7
        Any Redness, Dose 2 (N=211;216;207)
    38
    47
    43
        Grade 3 Redness, Dose 2 (N=211;216;207)
    3
    2
    2
        Any Swelling, Dose 2 (N=211;216;207)
    22
    28
    25
        Grade 3 Swelling, Dose 2 (N=211;216;207)
    3
    1
    1
        Any Pain, Across Doses (N=217;217;215)
    188
    196
    185
        Grade 3 Pain, Across Doses (N=217;217;215)
    22
    16
    13
        Any Redness, Across Doses (N=217;217;215)
    52
    68
    62
        Grade 3 Redness, Across Doses (N=217;217;215)
    4
    3
    3
        Any Swelling, Across Doses (N=217;217;215)
    38
    44
    39
        Grade 3 Swelling, Across Doses (N=217;217;215)
    3
    1
    2
    No statistical analyses for this end point

    Secondary: Number of days with any solicited local symptoms

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    End point title
    		 Number of days with any solicited local symptoms
    End point description
    The number of days with any local symptoms reported during the solicited post-vaccination period.
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0-6) after each vaccine dose
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    217
    217
    215
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Pain post-Dose 1 (N=160,179,166)
    2 (2 to 3.5)
    3 (2 to 3)
    3 (2 to 4)
        Pain post-Dose 2 (N=155,152,155)
    2 (2 to 4)
    2 (2 to 3)
    2 (2 to 3)
        Redness post-Dose 1 (N=29,48,41)
    2 (2 to 3)
    3 (1.5 to 3)
    2 (2 to 4)
        Redness post-Dose 2 (N=38,47,43)
    3 (2 to 4)
    3 (2 to 3)
    3 (2 to 3)
        Swelling post-Dose 1 (N=24,33,26)
    2 (1 to 3)
    2 (1 to 3)
    3 (2 to 4)
        Swelling post-Dose 2 (N=22,28,25)
    3 (2 to 4)
    3 (2 to 4)
    3 (2 to 3)
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0-6) after each vaccine dose and across doses
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    217
    217
    216
    Units: Subjects
        Any Fatigue, Dose 1 (N=217;217;215)
    66
    68
    64
        Grade 3 Fatigue, Dose 1 (N=217;217;215)
    5
    4
    4
        Related Fatigue, Dose 1 (N=217;217;215)
    62
    63
    58
        Any Gastrointestinal, Dose 1 (N=217;217;215)
    23
    22
    26
        Grade 3 Gastrointestinal, Dose 1 (N=217;217;215)
    1
    0
    4
        Related Gastrointestinal, Dose 1 (N=217;217;215)
    19
    20
    23
        Any Headache, Dose 1 (N=217;217;215)
    63
    68
    49
        Grade 3 Headache, Dose 1 (N=217;217;215)
    5
    4
    4
        Related Headache, Dose 1 (N=217;217;215)
    59
    63
    43
        Any Myalgia, Dose 1 (N=217;217;215)
    85
    89
    76
        Grade 3 Myalgia, Dose 1 (N=217;217;215)
    4
    3
    4
        Related Myalgia, Dose 1 (N=217;217;215)
    71
    78
    62
        Any Shivering, Dose 1 (N=217;217;215)
    31
    21
    22
        Grade 3 Shivering, Dose 1 (N=217;217;215)
    1
    4
    0
        Related Shivering, Dose 1 (N=217;217;215)
    30
    19
    21
        Any Temperature, Dose 1 (N=217;217;215)
    28
    23
    22
        Grade 3 Temperature, Dose 1 (N=217;217;215)
    0
    0
    0
        Related Temperature, Dose 1 (N=217;217;215)
    24
    21
    19
        Any Fatigue, Dose 2 (N=212;216;208)
    91
    85
    82
        Grade 3 Fatigue, Dose 2 (N=212;216;208)
    14
    7
    6
        Related Fatigue, Dose 2 (N=212;216;208)
    89
    80
    76
        Any Gastrointestinal, Dose 2 (N=212;216;208)
    33
    34
    29
        Grade 3 Gastrointestinal, Dose 2 (N=212;216;208)
    2
    2
    5
        Related Gastrointestinal, Dose 2 (N=212;216;208)
    29
    29
    28
        Any Headache, Dose 2 (N=212;216;208)
    74
    80
    66
        Grade 3 Headache, Dose 2 (N=212;216;208)
    9
    11
    5
        Related Headache, Dose 2 (N=212;216;208)
    69
    76
    63
        Any Myalgia, Dose 2 (N=212;216;208)
    99
    91
    83
        Grade 3 Myalgia, Dose 2 (N=212;216;208)
    20
    11
    7
        Related Myalgia, Dose 2 (N=212;216;208)
    85
    81
    76
        Any Shivering, Dose 2 (N=212;216;208)
    67
    60
    44
        Grade 3 Shivering, Dose 2 (N=212;216;208)
    11
    5
    7
        Related Shivering, Dose 2 (N=212;216;208)
    66
    59
    43
        Any Temperature, Dose 2 (N=212;216;208)
    43
    34
    25
        Grade 3 Temperature, Dose 2 (N=212;216;208)
    2
    0
    1
        Related Temperature, Dose 2 (N=212;216;208)
    40
    33
    25
        Any Fatigue, Across Doses (N=217;217;216)
    114
    109
    107
        Grade 3 Fatigue, Across Doses (N=217;217;216)
    18
    11
    10
        Related Fatigue, Across Doses (N=217;217;216)
    111
    102
    103
        Any Gastrointestinal, Across Doses (N=217;217;216)
    46
    45
    50
        Grade3 Gastrointestinal,Across Doses(N=217;217;216
    3
    2
    9
        Any Headache, Across Doses (N=217;217;216)
    101
    108
    89
        Grade 3 Headache, Across Doses (N=217;217;216)
    13
    13
    9
        Related Headache, Across Doses (N=217;217;216)
    95
    101
    82
        Any Myalgia, Across Doses (N=217;217;216)
    128
    119
    113
        Grade 3 Myalgia, Across Doses (N=217;217;216)
    24
    12
    10
        Related Myalgia, Across Doses (N=217;217;216)
    112
    107
    102
        Any Shivering, Across Doses (N=217;217;216)
    80
    67
    60
        Grade 3 Shivering, Across Doses (N=217;217;216)
    12
    7
    7
        Related Shivering, Across Doses (N=217;217;216)
    79
    65
    58
        Any Temperature, Across Doses (N=217;217;216)
    59
    49
    43
        Grade 3 Temperature, Across Doses (N=217;217;216)
    2
    0
    1
        Related Temperature, Across Doses (N=217;217;216)
    53
    46
    41
        Related Gastrointest.,Across Doses(N=217;217;216)
    41
    39
    46
    No statistical analyses for this end point

    Secondary: Number of days with any solicited general symptoms

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    End point title
    		 Number of days with any solicited general symptoms
    End point description
    The number of days with any general symptoms reported during the solicited post-vaccination period.
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0-6) after each vaccine dose
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    217
    217
    216
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Fatigue post-Dose 1 (N=66,68,64)
    2 (1 to 2)
    2 (1 to 3)
    2 (1 to 3)
        Fatigue post-Dose 2 (N=91,85,82)
    2 (1 to 2)
    2 (1 to 3)
    1.5 (1 to 2)
        Gastrointestinal post-Dose 1 (N=23,22,26)
    1 (1 to 2)
    1 (1 to 2)
    1 (1 to 2)
        Gastrointestinal post-Dose 2 (N=33,34,29)
    1 (1 to 2)
    1 (1 to 2)
    1 (1 to 2)
        Headache post-Dose 1 (N=63,68,49)
    1 (1 to 2)
    1.5 (1 to 2)
    2 (1 to 3)
        Headache post-Dose 2 (N=74,80,66)
    1 (1 to 2)
    1 (1 to 2)
    2 (1 to 3)
        Myalgia post-Dose 1 (N=85,89,76)
    2 (1 to 3)
    2 (1 to 3)
    2 (1 to 3)
        Myalgia post-Dose 2 (N=99,91,83)
    2 (1 to 3)
    2 (1 to 3)
    2 (1 to 3)
        Shivering post-Dose 1 (N=31,21,22)
    1 (1 to 2)
    2 (1 to 2)
    1 (1 to 2)
        Shivering post-Dose 2 (N=67,60,44)
    1 (1 to 2)
    1 (1 to 1.5)
    1 (1 to 2)
        Temperature post-Dose 1 (N=28,23,22)
    1 (1 to 1)
    1 (1 to 2)
    1 (1 to 1)
        Temperature post-Dose 2 (N=43,34,25)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 2)
    No statistical analyses for this end point

    Secondary: Number of subjects with any potential Immune-Mediated Diseases (pIMDs)

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    End point title
    		 Number of subjects with any potential Immune-Mediated Diseases (pIMDs)
    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
    End point type
    Secondary
    End point timeframe
    From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    218
    217
    216
    Units: Subjects
        pIMDs from Month 0 to Month 3
    3
    0
    1
        pIMDs from Month 4 to Month 14
    2
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
    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 solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During 30 days (Days 0-29) after each vaccination
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    218
    217
    216
    Units: Subjects
        Any AE(s)
    72
    69
    76
        Grade 3 AE(s)
    13
    15
    9
        Related AE(s)
    23
    22
    27
    No statistical analyses for this end point

    Secondary: Number of subjects with any Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with any Serious Adverse Events (SAEs)
    End point description
    Serious adverse events (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 up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)
    End point values
    		 GSK1437173A Lot A Group GSK1437173A Lot B Group GSK1437173A Lot C Group
    Number of subjects analysed
    218
    217
    216
    Units: Subjects
        SAEs from Month 0 to Month 3
    5
    7
    4
        SAEs from Month 4 to Month 14
    10
    8
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    GSK1437173A Lot A Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot C Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Reporting group title
    GSK1437173A Lot B Group
    Reporting group description
    		 Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.

    Serious adverse events
    		 GSK1437173A Lot A Group GSK1437173A Lot C Group GSK1437173A Lot B Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 218 (5.96%)
    20 / 216 (9.26%)
    14 / 217 (6.45%)
         number of deaths (all causes)
    1
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 216 (0.46%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 218 (0.92%)
    2 / 216 (0.93%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuromyelitis optica spectrum disorder
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson’s disease
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Presyncope
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 218 (0.92%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral osteophyte
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 216 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreas infection
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 216 (0.46%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 216 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1437173A Lot A Group GSK1437173A Lot C Group GSK1437173A Lot B Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 218 (92.66%)
    198 / 216 (91.67%)
    201 / 217 (92.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    101 / 218 (46.33%)
    89 / 216 (41.20%)
    108 / 217 (49.77%)
         occurrences all number
    141
    115
    152
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    80 / 218 (36.70%)
    61 / 216 (28.24%)
    67 / 217 (30.88%)
         occurrences all number
    99
    67
    81
    Fatigue
         subjects affected / exposed
    114 / 218 (52.29%)
    107 / 216 (49.54%)
    109 / 217 (50.23%)
         occurrences all number
    157
    147
    153
    Pain
         subjects affected / exposed
    188 / 218 (86.24%)
    185 / 216 (85.65%)
    196 / 217 (90.32%)
         occurrences all number
    315
    321
    331
    Swelling
         subjects affected / exposed
    38 / 218 (17.43%)
    40 / 216 (18.52%)
    44 / 217 (20.28%)
         occurrences all number
    46
    52
    61
    Pyrexia
         subjects affected / exposed
    60 / 218 (27.52%)
    43 / 216 (19.91%)
    50 / 217 (23.04%)
         occurrences all number
    72
    48
    58
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    46 / 218 (21.10%)
    50 / 216 (23.15%)
    45 / 217 (20.74%)
         occurrences all number
    56
    55
    56
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    55 / 218 (25.23%)
    62 / 216 (28.70%)
    70 / 217 (32.26%)
         occurrences all number
    70
    84
    98
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    128 / 218 (58.72%)
    113 / 216 (52.31%)
    119 / 217 (54.84%)
         occurrences all number
    184
    160
    181
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 218 (3.21%)
    11 / 216 (5.09%)
    7 / 217 (3.23%)
         occurrences all number
    7
    11
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2014
    • At CBER’s request, the three production lots of the HZ/su vaccines will be randomly assigned unique combinations of three “consecutive” adjuvant lots DA01A056A, DA01A058A and DA01A059B with the three consecutive gE lots: DVZVA009, DVZVA010 and DVZVA011. • The descriptive secondary objective evaluating the consistency of the three vaccines lots in terms of vaccine response has been changed to a confirmatory objective with a criterion. Statistical methods for power calculation for this secondary objective has been added. • As a consequence, the number of subjects foreseen in the study has been increased from 150 subjects per group to 217 subjects per group: This increased sample size will give 195 evaluable subjects in each vaccine lot group to have at least 99% probability to reach the primary objective. Sample size and power calculation for the primary objective has been updated to this end. • List of potential immune-mediated diseases has been updated. • To control the type I error, a hierarchical procedure will be used for the primary and secondary (immunogenicity) objectives. Each objective can only be reached if all the associated criteria are met and all previous objectives have been reached.

    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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