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    Clinical Trial Results:
    A phase III, randomised, open-label, multicentre, clinical trial to assess the safety and immunogenicity of GSK Biologicals’ HZ/su vaccine when administered intramuscularly according to a 0,2-month schedule, a 0,6-month schedule or a 0,12-month schedule in adults aged 50 years or older.

    Summary
    EudraCT number
    		 2012-004456-11
    Trial protocol
    		 EE  
    Global end of trial date
    08 Apr 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Nov 2020
    First version publication date
    22 Apr 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    116697
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01751165
    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
    20 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate vaccine response rate (VRR) for anti-glyoprotein E (gE) humoral immune responses at one month (1 mth) post-dose 2 (PD2) in the 0,6-mth and 0,12-mth schedule groups. Criterion: *The lower limit of the 97,5% confidence interval (CI) of the VRR for anti-gE ELISA antibody concentrations at 1 mth PD2 in the 0,6-mth or 0,12-mth schedule groups is at least 60%. If the objectives are met for the 0,6-mth and 0,12-mth schedules, the following objective will be evaluated: -Non-inferiority in terms of anti-gE humoral immune response 1 mth PD2 given according to a 0,6-mth schedule compared to a 0,2-mth schedule and a 0,12-mth schedule compared to a 0,2-mth schedule. Criteria for non-inferiority: *The upper limit of the 97,5% CI for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-mth schedule over 0,6-mth schedule) at 1 mth PD2 is <1.5. *The upper limit of the 97,5% CI for the anti-gE ELISA GMC ratio (0,2-mth schedule over 0,12-mth schedule) at 1 mth PD2 is <1.5.
    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
    12 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
    Estonia: 277
    Country: Number of subjects enrolled
    United States: 77
    Worldwide total number of subjects
    354
    EEA total number of subjects
    277
    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)
    194
    From 65 to 84 years
    159
    85 years and over
    1

    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.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1437173A-0,2 M Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Herpes Zoster (HZ) vaccine GSK1437173A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the study vaccine on a 0, 2 months schedule, by intramuscular injection into the deltoid region of the non-dominant arm.

    Arm title
    		 GSK1437173A-0,6 M Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Herpes Zoster (HZ) vaccine GSK1437173A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the study vaccine on a 0, 6 months schedule, by intramuscular injection into the deltoid region of the non-dominant arm.

    Arm title
    		 GSK1437173A-0,12 M Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Herpes Zoster (HZ) vaccine GSK1437173A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of the study vaccine on a 0, 12 months schedule, by intramuscular injection into the deltoid region of the non-dominant arm.

    Number of subjects in period 1
    		GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Started
    119
    119
    116
    Completed
    117
    116
    113
    Not completed
    2
    3
    3
         Adverse event, serious fatal
    1
    -
    1
         Consent withdrawn by subject
    -
    -
    1
         SAE
    -
    2
    -
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1437173A-0,2 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,6 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,12 M Group
    Reporting group description
    		 -

    Reporting group values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group Total
    Number of subjects
    		 119 119 116 354
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.5 ± 8.9 64 ± 8.6 64.1 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 90 77 79 246
        Male
    		 29 42 37 108

    End points

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    End points reporting groups
    Reporting group title
    GSK1437173A-0,2 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,6 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,12 M Group
    Reporting group description
    		 -

    Primary: Number of subjects with vaccine response to anti-glicoprotein E (anti-gE) antibodies as determined by the enzyme-linked immunosorbent assay (ELISA).

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    End point title
    		 Number of subjects with vaccine response to anti-glicoprotein E (anti-gE) antibodies as determined by the enzyme-linked immunosorbent assay (ELISA). [1] [2]
    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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
    End point type
    Primary
    End point timeframe
    At one month (M1) after Dose 2
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only required results for the groups on the 0,6 and 0,12 months vaccination schedule.
    End point values
    		 GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    114
    110
    Units: Subjects
        Anti-gE, M1 [N=114,110]
    110
    104
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against anti-gE as determined by ELISA.

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    End point title
    		 Concentrations of antibodies against anti-gE as determined by ELISA.
    End point description
    End point type
    Primary
    End point timeframe
    At one month (M1) after Dose 2
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    118
    114
    111
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, M1 [N=118,114,111]
    44376.3 (39697 to 49607.2)
    38153.7 (34205.8 to 42557.3)
    37435.8 (30813.8 to 45480.8)
    Statistical analysis title
    		 Anti-gE immune response for 0,2-0,6 months.
    Statistical analysis description
    To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.
    Comparison groups
    GSK1437173A-0,2 M Group v GSK1437173A-0,6 M Group
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.39
    Notes
    [3] - Non inferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5
    Statistical analysis title
    		 Anti-gE immune response for 0,2-0,12 months.
    Statistical analysis description
    To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.
    Comparison groups
    GSK1437173A-0,2 M Group v GSK1437173A-0,12 M Group
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.53
    Notes
    [4] - The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,12-month schedule) at one month post-dose 2 had to be below 1.5

    Secondary: Concentrations of antibodies against anti-gE as determined by ELISA.

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    End point title
    		 Concentrations of antibodies against anti-gE as determined by ELISA.
    End point description
    End point type
    Secondary
    End point timeframe
    Prior (PRE) to vaccination and twelve (M12) post Dose 2
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    118
    115
    110
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, PRE [N=118,114,110]
    1079.1 (891.9 to 1305.5)
    1066.1 (891.3 to 1275.3)
    1019.4 (858.6 to 1210.2)
        Anti-gE, M12 [N=117,115,110]
    14245.4 (12450.8 to 16298.6)
    12911.5 (11412.7 to 14607.2)
    11892.1 (10236.4 to 13815.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 7 day period (Days 0-6) following each vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any Pain, D1 [N=119,119,115]
    84
    77
    80
        Grade 3 Pain, D1 [N=119,119,115]
    1
    0
    2
        Any Redness, D1 [N=119,119,115]
    37
    39
    32
        Grade 3 Redness, D1 [N=119,119,115]
    0
    0
    1
        Any Swelling, D1 [N=119,119,115]
    17
    23
    25
        Grade 3 Swelling, D1 [N=119,119,115]
    0
    0
    0
        Any Pain, D2 [N=118,117,111]
    71
    83
    87
        Grade 3 Pain, D2 [N=118,117,111]
    6
    6
    10
        Any Redness, D2 [N=118,117,111]
    28
    27
    37
        Grade 3 Redness, D2 [N=118,117,111]
    2
    0
    0
        Any Swelling, D2 [N=118,117,111]
    15
    9
    24
        Grade 3 Swelling, D2 [N=118,117,111]
    0
    0
    0
        Any Pain, Across [N=119,119,116]
    91
    95
    98
        Grade 3, Across [N=119,119,116]
    7
    6
    12
        Any Redness, Across [N=119,119,116]
    48
    50
    53
        Grade 3 Redness, Across [N=119,119,116]
    2
    0
    1
        Any Swelling, Across [N=119,119,116]
    26
    28
    39
        Grade 3 Swelling, Across [N=119,119,116]
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (>) 39.0°C.
    End point type
    Secondary
    End point timeframe
    During the 7 day period (Days 0-6) following each vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any Fatigue, D1 [N=119,119,115]
    42
    50
    46
        Grade 3 Fatigue, D1 [N=119,119,115]
    3
    1
    0
        Related Fatigue, D1 [N=119,119,115]
    37
    49
    38
        Any Gastrointestinal, D1 [N=119,119,115]
    22
    17
    17
        Grade 3 Gastrointestinal, D1 [N=119,119,115]
    3
    1
    0
        Related Gastrointestinal, D1 [N=119,119,115]
    19
    14
    12
        Any Headache, D1 [N=119,119,115]
    35
    39
    34
        Grade 3 Headache, D1 [N=119,119,115]
    1
    1
    0
        Related Headache, D1 [N=119,119,115]
    31
    31
    26
        Any Myalgia, D1 [N=119,119,115]
    43
    38
    46
        Grade 3 Myalgia, D1 [N=119,119,115]
    2
    2
    0
        Related Myalgia, D1 [N=119,119,115]
    36
    33
    40
        Any Shivering, D1 [N=119,119,115]
    25
    25
    29
        Grade 3 Shivering, D1 [N=119,119,115]
    1
    0
    0
        Related Shivering, D1 [N=119,119,115]
    22
    22
    26
        Any Temperature, D1 [N=119,119,115]
    21
    22
    14
        Grade 3 Temperature, D1 [N=119,119,115]
    1
    0
    0
        Related Temperature, D1 [N=119,119,115]
    19
    21
    13
        Any Fatigue, D2 [N=118,117,111]
    43
    46
    59
        Grade 3 Fatigue, D2 [N=118,117,111]
    4
    4
    4
        Related Fatigue, D2 [N=118,117,111]
    41
    41
    56
        Any Gastrointestinal, D2 [N=118,117,111]
    14
    5
    12
        Grade 3 Gastrointestinal, D2 [N=118,117,111]
    0
    1
    1
        Related Gastrointestinal, D2 [N=118,117,111]
    14
    5
    10
        Any Headache, D2 [N=118,117,111]
    36
    27
    37
        Grade 3 Headache, D2 [N=118,117,111]
    2
    3
    5
        Related Headache, D2 [N=118,117,111]
    32
    22
    33
        Any Myalgia, D2 [N=118,117,111]
    48
    42
    43
        Grade 3 Myalgia, D2 [N=118,117,111]
    5
    2
    3
        Related Myalgia, D2 [N=118,117,111]
    46
    39
    38
        Any Shivering, D2 [N=118,117,111]
    25
    23
    35
        Grade 3 Shivering, D2 [N=118,117,111]
    3
    3
    3
        Related Shivering, D2 [N=118,117,111]
    24
    20
    31
        Any Temperature, D2 [N=118,117,111]
    20
    16
    26
        Grade 3 Temperature, D2 [N=118,117,111]
    0
    0
    2
        Related Temperature, D2 [N=118,117,111]
    19
    16
    24
        Any Fatigue, Across [N=119,119,116]
    54
    63
    71
        Grade 3 Fatigue, Across [N=119,119,116]
    7
    5
    4
        Related Fatigue, Across [N=119,119,116]
    49
    57
    65
        Any Gastrointestinal, Across [N=119,119,116]
    27
    20
    27
        Grade 3 Gastrointestinal, Across [N=119,119,116]
    3
    2
    1
        Related Gastrointestinal, Across [N=119,119,116]
    26
    17
    21
        Any Headache, Across [N=119,119,116]
    47
    47
    53
        Grade 3 Headache, Across [N=119,119,116]
    2
    4
    5
        Related Headache, Across [N=119,119,116]
    41
    38
    45
        Any Myalgia, Across [N=119,119,116]
    63
    57
    64
        Grade 3 Myalgia, Across [N=119,119,116]
    7
    4
    3
        Related Myalgia, Across [N=119,119,116]
    57
    52
    57
        Any Shivering, Across [N=119,119,116]
    37
    35
    48
        Grade 3 Shivering, Across [N=119,119,116]
    4
    3
    3
        Related Shivering, Across [N=119,119,116]
    34
    29
    43
        Any Temperature, Across [N=119,119,116]
    32
    32
    33
        Grade 3 Temperature, Across [N=119,119,116]
    1
    0
    2
        Related Temperature, Across [N=119,119,116]
    29
    31
    30
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 30 Days (Day 0-29) following vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any AEs [N=119,119,116]
    27
    27
    23
        Grade 3 AEs [N=119,119,116]
    4
    4
    4
        Related AEs [N=119,119,116]
    9
    5
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs).

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    End point title
    		 Number of subjects with 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, result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From first vaccination up to one month (30 Days) post last vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any SAEs [N=119,119,116]
    0
    4
    8
    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
    Serious Adverse Events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Starting from 30 Days post last vaccine administration up to study end at Month 24
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any SAEs [N=119,119,116]
    5
    6
    4
    No statistical analyses for this end point

    Secondary: Number of days with solicited local symptoms.

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    End point title
    		 Number of days with solicited local symptoms.
    End point description
    Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2
    End point type
    Secondary
    End point timeframe
    During the 7 Days (Day 0-6) following vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Days
        Days with Pain, D1 [N=119,119,116]
    84
    77
    80
        Days with Pain, D2 [N=119,119,116]
    71
    83
    87
        Days with Redness, D1 [119,119,116]
    37
    39
    32
        Days with Redness, D2 [119,119,116]
    28
    27
    37
        Days with Swelling, D1 [N=119,119,116]
    17
    23
    25
        Days with Swelling, D2 [N=119,119,116]
    15
    9
    24
    No statistical analyses for this end point

    Secondary: Number of days with solicited general symptoms.

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    End point title
    		 Number of days with solicited general symptoms.
    End point description
    Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2
    End point type
    Secondary
    End point timeframe
    During the 7 Days (Day 0-6) following vaccination
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Days
        Days with Fatigue, D1 [N=119,119,116]
    42
    50
    46
        Days with Fatigue, D2 [N=119,119,116]
    43
    46
    59
        Days with Gastrointestinal, D1 [119,119,116]
    22
    17
    17
        Days with Gastrointestinal, D2 [119,119,116]
    14
    5
    12
        Days with Headache, D1 [N=119,119,116]
    35
    39
    34
        Days with Headache, D2 [N=119,119,116]
    36
    27
    37
        Days with Myalgia, D1 [N=119,119,116]
    43
    38
    46
        Days with Myalgia, D2 [N=119,119,116]
    48
    42
    43
        Days with Shivering, D1 [N=119,119,116]
    25
    25
    29
        Days with Shivering, D2 [N=119,119,116]
    25
    23
    35
        Days with Temperature, D1 [N=119,119,116]
    21
    22
    14
        Days with Temperature, D2 [N=119,119,116]
    20
    16
    26
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune-mediated disease (pIMDs).

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    End point title
    		 Number of subjects with potential immune-mediated disease (pIMDs).
    End point description
    Potential immune-mediated diseases (pIMDs) are a subset of Adverse Events (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 Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any pIMDs [N=119,119,116]
    0
    0
    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
    Potential immune-mediated diseases (pIMDs) are a subset of Adverse Events (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 one month (30 Days) following the last vaccine administration up to study end at Month 24
    End point values
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Number of subjects analysed
    119
    119
    116
    Units: Subjects
        Any pIMDs [N=119,119,116]
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    GSK1437173A-0,2 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,6 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1437173A-0,12 M Group
    Reporting group description
    		 -

    Serious adverse events
    		 GSK1437173A-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 119 (4.20%)
    9 / 119 (7.56%)
    12 / 116 (10.34%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         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
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    0 / 116 (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, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Psychotic disorder
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Acute myocardial infarction
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Atrial fibrillation
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Bradycardia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Cardiovascular disorder
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Carotid artery disease
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Cerebral infarction
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 119 (1.68%)
    0 / 116 (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
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-weiss syndrome
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    0 / 116 (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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    0 / 116 (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
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    0 / 116 (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
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 119 (0.84%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 119 (0.00%)
    0 / 116 (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
    Infections and infestations
    Helicobacter gastritis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 119 (0.00%)
    1 / 116 (0.86%)
         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-0,2 M Group GSK1437173A-0,6 M Group GSK1437173A-0,12 M Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 119 (89.92%)
    106 / 119 (89.08%)
    107 / 116 (92.24%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    91 / 119 (76.47%)
    95 / 119 (79.83%)
    98 / 116 (84.48%)
         occurrences all number
    91
    95
    98
    Erythema
         subjects affected / exposed
    48 / 119 (40.34%)
    51 / 119 (42.86%)
    53 / 116 (45.69%)
         occurrences all number
    48
    50
    53
    Swelling
         subjects affected / exposed
    26 / 119 (21.85%)
    28 / 119 (23.53%)
    39 / 116 (33.62%)
         occurrences all number
    26
    28
    39
    Fatigue
         subjects affected / exposed
    54 / 119 (45.38%)
    63 / 119 (52.94%)
    71 / 116 (61.21%)
         occurrences all number
    54
    63
    71
    Gastrointestinal
         subjects affected / exposed
    27 / 119 (22.69%)
    20 / 119 (16.81%)
    27 / 116 (23.28%)
         occurrences all number
    27
    20
    27
    Headache
         subjects affected / exposed
    48 / 119 (40.34%)
    48 / 119 (40.34%)
    53 / 116 (45.69%)
         occurrences all number
    47
    47
    53
    Myalgia
         subjects affected / exposed
    63 / 119 (52.94%)
    57 / 119 (47.90%)
    64 / 116 (55.17%)
         occurrences all number
    63
    57
    64
    Chills
         subjects affected / exposed
    37 / 119 (31.09%)
    35 / 119 (29.41%)
    48 / 116 (41.38%)
         occurrences all number
    37
    35
    48
    Pyrexia
         subjects affected / exposed
    32 / 119 (26.89%)
    32 / 119 (26.89%)
    33 / 116 (28.45%)
         occurrences all number
    32
    32
    33

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2014
    The cut-off of the gE-specific ELISA assay has been changed from 18 to 97 mIU/mL. The definition of the ATP cohort for safety was updated. Other minor changes were implemented.

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

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

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