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    Clinical Trial Results:
    A phase II/III, randomised, observer-blind, placebo-controlled, multicentre, clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster GSK1437173A candidate vaccine when administered intramuscularly on a 0 and 1 to 2 months schedule to adults ≥ 18 years of age with solid tumours receiving chemotherapy.

    Summary
    EudraCT number
    		 2012-002966-11
    Trial protocol
    		 ES   GB   CZ  
    Global end of trial date
    20 May 2016

    Results information
    Results version number
    		 v3(current)
    This version publication date
    05 May 2021
    First version publication date
    02 Jul 2016
    Other versions
    		 v1 , v2
    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
    116427
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01798056
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    15 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only). Criteria to be used: The objective is met if the lower limit of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo Group over Placebo PreChemo Group) in anti-gE ELISA antibody concentrations is greater than 3. -To evaluate the safety and reactogenicity following administration of the GSK1437173A vaccine as compared to placebo up to 30 days post last vaccination in subjects with solid tumours receiving chemotherapy.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Mar 2013
    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
    Spain: 170
    Country: Number of subjects enrolled
    United Kingdom: 30
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 35
    Country: Number of subjects enrolled
    Canada: 6
    Worldwide total number of subjects
    266
    EEA total number of subjects
    225
    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)
    192
    From 65 to 84 years
    72
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 266
    Number of subjects completed
    		 232

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 34
    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer, Assessor
    Blinding implementation details
    Observer-blind for study vaccine but not for time of vaccination relative to chemotherapy.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1437173A Group
    Arm description
    		 Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK 1437173A
    Investigational medicinal product code
    Other name
    HZ/su vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Saline solution
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The placebo was administered intramuscularly into the deltoid muscle of the non-dominant arm.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This was an Observer-blind for study vaccine but not for time of vaccination relative to chemotherapy.
    Number of subjects in period 1 [2]
    		GSK1437173A Group Placebo Group
    Started
    117
    115
    Completed
    90
    90
    Not completed
    27
    25
         Consent withdrawn by subject
    12
    9
         Migrated/moved from study area
    1
    1
         Unspecified
    -
    2
         Lost to follow-up
    1
    1
         Serious Adverse Event
    13
    12
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: As there were subjects (34) who did not receive vaccine though they were enrolled in the study, there is present a difference in number of subjects enrolled in trial worldwide versus those reported in baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    		 Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Reporting group values
    		 GSK1437173A Group Placebo Group Total
    Number of subjects
    		 117 115 232
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.1 ± 10.8 58.5 ± 11.7 -
    Gender categorical
    Units: Subjects
        Female
    		 70 69 139
        Male
    		 47 46 93

    End points

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    End points reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    		 Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Subject analysis set title
    GSK1437173A-PreChemo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle.

    Subject analysis set title
    Placebo-PreChemo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle.

    Primary: Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups

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    End point title
    		 Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups
    End point description
    Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.
    End point type
    Primary
    End point timeframe
    At Month 2
    End point values
    		 GSK1437173A-PreChemo Placebo-PreChemo
    Number of subjects analysed
    65
    76
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Adjusted GMC of antibody titers
    24501.57 (19051.99 to 31509.94)
    1056.77 (990.37 to 1127.62)
    Statistical analysis title
    		 Adjusted GMC ratio
    Statistical analysis description
    The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only). Criteria used: The objective is met if the lower limit of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.
    Comparison groups
    GSK1437173A-PreChemo v Placebo-PreChemo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001
    Method
    		 Adjusted GMC ratio
    Parameter type
    		 Ratio
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.9
         upper limit
    		 30
    Notes
    [1] - Adjusted means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units to provide GMCs and GM ratios.

    Primary: Anti--Varicella Zoster Virus (VZV)-gE antibody concentrations

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    End point title
    		 Anti--Varicella Zoster Virus (VZV)-gE antibody concentrations [2]
    End point description
    Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.
    End point type
    Primary
    End point timeframe
    At Month 2
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    87
    98
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE
    18291.7 (14432.1 to 23183.5)
    1060.5 (873.9 to 1287.1)
    No statistical analyses for this end point

    Primary: 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) [3]
    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
    Primary
    End point timeframe
    During the 30-day (Days 0-29) post-vaccination period
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    117
    115
    Units: Subjects
        Any AE(s)
    100
    103
        Grade 3 AE(s)
    18
    15
        Related AE(s)
    10
    9
    No statistical analyses for this end point

    Primary: Number of subjects with any and related serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any and related serious adverse events (SAEs) [4]
    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. Related = SAE assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    From Dose 1 up to 30 days post last vaccination period
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    117
    115
    Units: Subjects
        Any SAE(s)
    16
    14
        Related SAE(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any and related potential Immune Mediated Diseases (pIMDs)

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    End point title
    		 Number of subjects with any and related potential Immune Mediated Diseases (pIMDs) [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. Any = occurrence of the symptom regardless of intensity grade. Related = pIMDs assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    From first vaccination up to 30 days post last vaccination
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    117
    115
    Units: Subjects
        Any pIMD(s)
    0
    0
        Related pIMD(s)
    0
    0
    No statistical analyses for this end point

    Primary: 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 [6]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
    Notes
    [6] - 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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    112
    110
    Units: Subjects
        Any Pain, Dose 1 (N=112;110)
    83
    2
        Grade 3 Pain, Dose 1 (N=112;110)
    8
    0
        Any Redness, Dose 1 (N=112;110)
    33
    0
        Grade 3 Redness, Dose 1 (N=112;110)
    2
    0
        Any Swelling, Dose 1 (N=112;110)
    15
    1
        Grade 3 Swelling, Dose 1 (N=112;110)
    0
    0
        Any Pain, Dose 2 (N=98;105)
    52
    5
        Grade 3 Pain, Dose 2 (N=98;105)
    4
    0
        Any Redness, Dose 2 (N=98;105)
    20
    0
        Grade 3 Redness, Dose 2 (N=98;105)
    0
    0
        Any Swelling, Dose 2 (N=98;105)
    8
    0
        Grade 3 Swelling, Dose 2 (N=98;105)
    0
    0
        Any Pain, Across doses (N=112;110)
    90
    7
        Grade 3 Pain, Across doses (N=112;110)
    11
    0
        Any Redness, Across doses (N=112;110)
    40
    0
        Grade 3 Redness, Across doses (N=112;110)
    2
    0
        Any Swelling, Across doses (N=112;110)
    18
    1
        Grade 3 Swelling, Across doses (N=112;110)
    0
    0
    No statistical analyses for this end point

    Primary: Number of days with solicited local symptoms

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    End point title
    		 Number of days with solicited local symptoms [7]
    End point description
    The number of days with any local symptoms has been assessed during the post-vaccination period.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose
    Notes
    [7] - 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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    112
    110
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Pain, post-Dose 1 (N=83,2)
    2 (2 to 4)
    02 (1 to 3)
        Pain, post-Dose 2 (N=52,5)
    2 (1 to 3.5)
    1 (1 to 2)
        Redness, post-Dose 1 (N=33,0)
    3 (2 to 5)
    0 (0 to 0)
        Redness, post-Dose 2 (N=20,0)
    4 (2 to 5)
    0 (0 to 0)
        Swelling, post-Dose 1 (N=15,1)
    4 (2 to 5)
    7 (7 to 7)
        Swelling, post-Dose 2 (N=8,0)
    0 (0 to 0)
    3.5 (2 to 5.5)
    No statistical analyses for this end point

    Primary: 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 [8]
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C) for oral, axillary or tympanic route]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
    Notes
    [8] - 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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    112
    110
    Units: Subjects
        Any Fatigue, Dose 1 (N=112;110)
    56
    44
        Grade 3 Fatigue, Dose 1 (N=112;110)
    10
    3
        Related Fatigue, Dose 1 (N=112;110)
    15
    10
        Any Gastrointestinal, Dose 1 (N=112;110)
    32
    21
        Grade 3 Gastrointestinal, Dose 1 (N=112;110)
    2
    5
        Related Gastrointestinal, Dose 1 (N=112;110)
    9
    2
        Any Headache, Dose 1 (N=112;110)
    28
    24
        Grade 3 Headache, Dose 1 (N=112;110)
    3
    1
        Related Headache, Dose 1 (N=112;110)
    10
    4
        Any Myalgia, Dose 1 (N=112;110)
    50
    17
        Grade 3 Myalgia, Dose 1 (N=112;110)
    8
    3
        Related Myalgia, Dose 1 (N=112;110)
    25
    3
        Any Shivering, Dose 1 (N=112;110)
    27
    13
        Grade 3 Shivering, Dose 1 (N=112;110)
    5
    2
        Related Shivering, Dose 1 (N=112;110)
    12
    4
        Any Fever, Dose 1 (N=112;110)
    13
    4
        Grade 3 Fever, Dose 1 (N=112;110)
    0
    0
        Related Fever, Dose 1 (N=112;110)
    11
    1
        Any Fatigue, Dose 2 (N=97;104)
    57
    57
        Grade 3 Fatigue, Dose 2 (N=97;104)
    9
    6
        Related Fatigue, Dose 2 (N=97;104)
    6
    8
        Any Gastrointestinal, Dose 2 (N=97;104)
    41
    39
        Grade 3 Gastrointestinal, Dose 2 (N=97;104)
    5
    3
        Related Gastrointestinal, Dose 2 (N=97;104)
    6
    2
        Any Headache, Dose 2 (N=97;104)
    29
    25
        Grade 3 Headache, Dose 2 (N=97;104)
    3
    2
        Related Headache, Dose 2 (N=97;104)
    7
    2
        Any Myalgia, Dose 2 (N=97;104)
    32
    23
        Grade 3 Myalgia, Dose 2 (N=97;104)
    4
    1
        Related Myalgia, Dose 2 (N=97;104)
    13
    4
        Any Shivering, Dose 2 (N=97;104)
    20
    17
        Grade 3 Shivering, Dose 2 (N=97;104)
    3
    1
        Related Shivering, Dose 2 (N=97;104)
    6
    4
        Any Fever, Dose 2 (N=97;104)
    8
    1
        Grade 3 Fever, Dose 2 (N=97;104)
    0
    0
        Related Fever, Dose 2 (N=97;104)
    4
    0
        Any Fatigue, Across doses (N=112;110)
    78
    68
        Grade 3 Fatigue, Across doses (N=112;110)
    16
    8
        Related Fatigue, Across doses (N=112;110)
    19
    14
        Any Gastrointestinal, Across doses (N=112;110)
    51
    49
        Grade 3 Gastrointestinal, Across doses (N=112;110)
    6
    7
        Related Gastrointestinal, Across doses (N=112;110)
    11
    3
        Any Headache, Across doses (N=112;110)
    43
    40
        Grade 3 Headache, Across doses (N=112;110)
    6
    3
        Related Headache, Across doses (N=112;110)
    16
    6
        Any Myalgia, Across doses (N=112;110)
    60
    31
        Grade 3 Myalgia, Across doses (N=112;110)
    12
    4
        Related Myalgia, Across doses (N=112;110)
    30
    5
        Any Shivering, Across doses (N=112;110)
    39
    25
        Grade 3 Shivering, Across doses (N=112;110)
    6
    3
        Related Shivering, Across doses (N=112;110)
    16
    5
        Any Fever, Across doses (N=112;110)
    20
    5
        Grade 3 Fever, Across doses (N=112;110)
    0
    0
        Related Fever, Across doses (N=112;110)
    14
    1
    No statistical analyses for this end point

    Primary: Number of days with solicited general symptoms

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    End point title
    		 Number of days with solicited general symptoms [9]
    End point description
    The number of days with solicited general symptoms was assessed during the solicited post-vaccination period.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose
    Notes
    [9] - 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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    112
    110
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Fatigue, post-Dose 1 (N=56,44)
    3 (1.5 to 6)
    5 (2 to 6)
        Fatigue, post-Dose 2 (N=57,57)
    5 (2 to 7)
    5 (3 to 7)
        Gastrointestinal symptoms, post-Dose 1 (N=32,21)
    2.5 (1.5 to 4)
    4 (2 to 6)
        Gastrointestinal symptoms, post-Dose 2 (N=41,39)
    4 (3 to 7)
    3 (2 to 7)
        Headache, post-Dose 1 (N=28,24)
    2 (1 to 3.5)
    2 (1.5 to 4.5)
        Headache, post-Dose 2 (N=29,25)
    2 (2 to 6)
    2 (1 to 5)
        Myalgia, post-Dose 1 (N=50,17)
    2.5 (1 to 4)
    2 (2 to 6)
        Myalgia, post-Dose 2 (N=32,23)
    3 (2 to 5.5)
    5 (3 to 7)
        Shivering, post-Dose 1 (N=27,13)
    2 (1 to 3)
    2 (1 to 2)
        Shivering, post-Dose 2 (N=20,17)
    3 (1 to 6)
    2 (1 to 4)
        Fever, post-Dose 1 (N=13,4)
    1 (1 to 2)
    1 (1 to 3)
        Fever, post-Dose 2 (N=8,1)
    1.5 (1 to 2.5)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations

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    End point title
    		 Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations
    End point description
    Vaccine response for anti-gE antibody ELISA concentrations 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 Months 1, 2, 6 and 13
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    87
    94
    Units: Subjects
        Vaccine responders, Month 1 (N=85;93)
    73
    0
        Vaccine responders, Month 2 (N=87;94)
    75
    0
        Vaccine responders, Month 6 (N=42;42)
    31
    1
        Vaccine responders, Month 13 (N=68;69)
    35
    0
    No statistical analyses for this end point

    Secondary: Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups

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    End point title
    		 Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups
    End point description
    Descriptive statistics were tabulated for CD4[2+] cells, which are gE-specific CD4+ T-cells with at least two activation markers ([2+]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method.
    End point type
    Secondary
    End point timeframe
    At Months 0, 1, 2 and 13
    End point values
    		 GSK1437173A-PreChemo Placebo-PreChemo
    Number of subjects analysed
    25
    30
    Units: CD4 T-cells per million T-cells
    median (inter-quartile range (Q1-Q3))
        CD4[2+] T-cells, Month 0 (N=25,27)
    127.3 (49.7 to 192.4)
    104.8 (27.5 to 151.5)
        CD4[2+] T-cells, Month 1 (N=25,30)
    391.9 (139.7 to 603.7)
    50.0 (1.0 to 179.4)
        CD4[2+] T-cells, Month 2 (N=22,29)
    778.8 (393.1 to 1098.2)
    61.8 (17.4 to 139.5)
        CD4[2+] T-cells, Month 13 (N=18;19)
    332.9 (114.9 to 604.6)
    51.2 (1 to 288.6)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups

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    End point title
    		 Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups
    End point description
    Vaccine response for gE-specific CD4[2+] T-cells was defined as: -For initially subjects with pre-vaccination T cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); -For initially subjects with pre-vaccination T cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T cell frequencies.
    End point type
    Secondary
    End point timeframe
    At Months 1, 2 and 13
    End point values
    		 GSK1437173A-PreChemo Placebo-PreChemo
    Number of subjects analysed
    25
    27
    Units: Subjects
        CD4[2+] T-cells, Month 1 (N=25,27)
    5
    0
        CD4[2+] T-cells, Month 2 (N=22,27)
    11
    0
        CD4[2+] T-cells, Month 13 (N=17;16)
    3
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with pIMDs

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    End point title
    		 Number of subjects with pIMDs
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    From 30 days post last vaccination up to study end at Month 13
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    117
    115
    Units: Subjects
        Any pIMD(s)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    		 Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    From 30 days post last vaccination up to study end at Month 13
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    117
    115
    Units: Subjects
        Any SAE(s)
    30
    31
        Related SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-VZV-gE antibody concentrations

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    End point title
    		 Anti-VZV-gE antibody concentrations
    End point description
    Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.
    End point type
    Secondary
    End point timeframe
    At Months 0, 1, 6 and 13
    End point values
    		 GSK1437173A Group Placebo Group
    Number of subjects analysed
    87
    97
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, Month 0 (N=87;94)
    1049.8 (865.8 to 1273)
    1116.7 (918.4 to 1358)
        Anti-gE, Month 1 (N=85;97)
    24793.1 (18747.8 to 32787.6)
    1107.2 (920 to 1332.6)
        Anti-gE, Month 6 (N=42;43)
    7730.4 (5358.4 to 11152.2)
    1380.2 (1066.3 to 1786.6)
        Anti-gE, Month 13 (N=68;70)
    4477.3 (3482.4 to 5756.3)
    1064.7 (845.9 to 1340.1)
    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: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 13).
    Adverse event reporting additional description
    Individual SAEs remain blinded as long as the study is ongoing.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    		 Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients’ current conditions, were based on the local standard of care for the patients.

    Serious adverse events
    		 GSK1437173A Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 117 (30.77%)
    42 / 115 (36.52%)
         number of deaths (all causes)
    12
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head and neck cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         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 / 117 (0.85%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumour haemorrhage
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uterine leiomyosarcoma
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombosis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominal hernia repair
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         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 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         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
    Bronchial obstruction
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (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
    Gastrostomy failure
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (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
    Bladder cancer
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 117 (1.71%)
    3 / 115 (2.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    6 / 117 (5.13%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 117 (1.71%)
    4 / 115 (3.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancytopenia
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Cholangitis acute
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin haemorrhage
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium bacteraemia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatitis c
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleural infection
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    2 / 117 (1.71%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sepsis
         subjects affected / exposed
    3 / 117 (2.56%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1437173A Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    113 / 117 (96.58%)
    103 / 115 (89.57%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 117 (0.85%)
    6 / 115 (5.22%)
         occurrences all number
    1
    6
    Headache
         subjects affected / exposed
    45 / 117 (38.46%)
    41 / 115 (35.65%)
         occurrences all number
    61
    52
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    11 / 117 (9.40%)
    14 / 115 (12.17%)
         occurrences all number
    12
    16
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    30 / 117 (25.64%)
    28 / 115 (24.35%)
         occurrences all number
    34
    32
    Chills
         subjects affected / exposed
    39 / 117 (33.33%)
    25 / 115 (21.74%)
         occurrences all number
    48
    30
    Fatigue
         subjects affected / exposed
    80 / 117 (68.38%)
    69 / 115 (60.00%)
         occurrences all number
    118
    109
    Mucosal inflammation
         subjects affected / exposed
    9 / 117 (7.69%)
    6 / 115 (5.22%)
         occurrences all number
    11
    8
    Pain
         subjects affected / exposed
    90 / 117 (76.92%)
    7 / 115 (6.09%)
         occurrences all number
    139
    7
    Pyrexia
         subjects affected / exposed
    22 / 117 (18.80%)
    9 / 115 (7.83%)
         occurrences all number
    23
    9
    Swelling
         subjects affected / exposed
    18 / 117 (15.38%)
    1 / 115 (0.87%)
         occurrences all number
    23
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    16 / 117 (13.68%)
    11 / 115 (9.57%)
         occurrences all number
    19
    11
    Diarrhoea
         subjects affected / exposed
    9 / 117 (7.69%)
    10 / 115 (8.70%)
         occurrences all number
    12
    10
    Dyspepsia
         subjects affected / exposed
    6 / 117 (5.13%)
    13 / 115 (11.30%)
         occurrences all number
    6
    13
    Gastrointestinal disorder
         subjects affected / exposed
    51 / 117 (43.59%)
    51 / 115 (44.35%)
         occurrences all number
    74
    63
    Nausea
         subjects affected / exposed
    31 / 117 (26.50%)
    28 / 115 (24.35%)
         occurrences all number
    36
    33
    Vomiting
         subjects affected / exposed
    10 / 117 (8.55%)
    14 / 115 (12.17%)
         occurrences all number
    10
    16
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    21 / 117 (17.95%)
    23 / 115 (20.00%)
         occurrences all number
    21
    23
    Erythema
         subjects affected / exposed
    43 / 117 (36.75%)
    1 / 115 (0.87%)
         occurrences all number
    58
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    62 / 117 (52.99%)
    33 / 115 (28.70%)
         occurrences all number
    88
    45
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 117 (7.69%)
    5 / 115 (4.35%)
         occurrences all number
    12
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2012
    The primary objective for immunogenicity response (based on Geometric Mean [GM] ratios) following the HZ/su vaccination compared to placebo will now be evaluated only in the PreChemo Groups. The secondary objectives have now been qualified to evaluate immunogenicity in either the PreChemo Groups (Vaccine Response Rates [VRR] in anti-gE humoral immunogenicity responses and VRR and GM ratio in gE-specific Cellular-Mediated Immunity [CMI]) or in all study subjects (VRR and GM ratio in anti-gE humoral immunogenicity responses). The CMI sub-cohort will now only be recruited in the PreChemo Groups. The timepoint for evaluation of the primary objective for safety/reactogenicity has been reworded for clarity (‘up to 30 days post last vaccination’ instead of ‘up to month 2’).
    11 Aug 2014
    The cut-off of the gE-specific ELISA assay has been changed from 18 to 97 mIU/mL. The definition of the according-to-protocol (ATP) cohort for safety was updated. (Section 9.4.2) Statistical section was updated to describe the descriptive cell-mediated immune (CMI) response analysis, to clarify other descriptive analysis for immunogenicity and safety. (Section 9.5.3)

    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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