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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 subcutaneously as compared to intramuscularly according to a 0,2-month schedule in adults aged 50 years and older.

    Summary
    EudraCT number
    		 2012-005671-14
    Trial protocol
    		 GB  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    		 v3(current)
    This version publication date
    11 Oct 2020
    First version publication date
    04 Feb 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
    116760
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01777321
    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, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    12 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the vaccine response rate (VRR) to the HZV vaccine (based on humoral immune response) when administered by SC injection compared to IM injection to subjects ≥ 50 YOA at Month 3 in all subjects. To assess the humoral immune response (Geometric Mean Concentration [GMC]) of the HZV vaccine when administered by SC compared to IM injection to subjects ≥ 50 YOA at Month 3 in all subjects. To assess the safety of the HZV vaccine when administered by SC injection to subjects ≥ 50 YOA up to Month 3.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jun 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
    Japan: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    0
    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)
    48
    From 65 to 84 years
    12
    85 years and over
    0

    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 Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SC HZ/su Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine GSK1437173A, HZ/su
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two doses of 0,5 ml reconstituted vaccine was administered in the subcutaneous tissue of the upper, non –dominant arm at 0 and 2 months schedule.

    Arm title
    		 IM HZ/su Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine GSK1437173A, HZ/su
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of 0,5 ml reconstituted vaccine was administered intramuscularly in the deltoid region of the non –dominant arm at 0 and 2 months schedule.

    Number of subjects in period 1
    		SC HZ/su Group IM HZ/su Group
    Started
    30
    30
    Completed
    30
    29
    Not completed
    0
    1
         Consent withdrawal (not due to an adverse event)
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SC HZ/su Group
    Reporting group description
    		 -

    Reporting group title
    IM HZ/su Group
    Reporting group description
    		 -

    Reporting group values
    		 SC HZ/su Group IM HZ/su Group Total
    Number of subjects
    		 30 30 60
    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)
    		 61.6 ± 7.59 62.2 ± 7.83 -
    Gender categorical
    Units: Subjects
        Female
    		 15 15 30
        Male
    		 15 15 30

    End points

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    End points reporting groups
    Reporting group title
    SC HZ/su Group
    Reporting group description
    		 -

    Reporting group title
    IM HZ/su Group
    Reporting group description
    		 -

    Primary: Number of subjects with anti Glicoprotein E (anti-E) antibody concentrations ≥18 mIU/mL

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    End point title
    		 Number of subjects with anti Glicoprotein E (anti-E) antibody concentrations ≥18 mIU/mL [1]
    End point description
    End point type
    Primary
    End point timeframe
    Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3).
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    29
    29
    Units: Subjects
        Anti-gE, PRE
    29
    29
        Anti-gE, M2
    29
    29
        Anti-gE, M3
    29
    29
    No statistical analyses for this end point

    Primary: Anti-gE antibody concentrations

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    End point title
    		 Anti-gE antibody concentrations [2]
    End point description
    End point type
    Primary
    End point timeframe
    Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3).
    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 endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    29
    29
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, PRE
    1424.3 (1042.6 to 1945.6)
    1116.8 (774.5 to 1610.3)
        Anti-gE, M2
    19902.5 (14846.9 to 26679.6)
    12842 (8558.4 to 19269.7)
        Anti-gE, M3
    44126.1 (36326.1 to 53601)
    45521.5 (37549.5 to 55185.9)
    No statistical analyses for this end point

    Primary: Number of subjects with vaccine response for anti-gE antibody concentrations

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    End point title
    		 Number of subjects with vaccine response for anti-gE antibody concentrations [3]
    End point description
    End point type
    Primary
    End point timeframe
    At two months after Dose 1 (M2) and three months after Dose 2 (M3).
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    29
    29
    Units: Subjects
        Anti-gE, M2
    28
    25
        Anti-gE, M3
    29
    29
    No statistical analyses for this end point

    Primary: Anti-gE antibody concentrations

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    End point title
    		 Anti-gE antibody concentrations [4]
    End point description
    End point type
    Primary
    End point timeframe
    Before vaccination (PRE), at two months after dose 1 (M2) and three months after Dose 2 (M3).
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    29
    29
    Units: mIU/mL
    median (standard deviation)
        Anti-gE, PRE
    1404.1 ± 1398.82
    946.3 ± 3231.78
        Anti-gE, M2
    19400.1 ± 24456.86
    14330.1 ± 14548.75
        Anti-gE, M3
    44182 ± 27990.99
    42444.8 ± 27555.21
    No statistical analyses for this end point

    Primary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms [5]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6) post vaccination, after each dose and across doses
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any Arm movement impairment, D1 [N=30;30]
    10
    7
        Any Arm movement impairment, D2 [N=30;29]
    16
    11
        Any Arm movement impairment, Across [N=30;30]
    18
    12
        Grade 3 Arm movement impairment, D1 [N=30;30]
    1
    0
        Grade 3 Arm movement impairment, D2 [N=30;29]
    0
    0
        Grade 3 Arm movement impairment, Across [N=30;30]
    1
    0
        Any Injection site pruritus, D1 [N=30;30]
    19
    6
        Any Injection site pruritus, D2 [N=30;29]
    15
    8
        Any Injection site pruritus, Across [N=30;30]
    21
    10
        Grade 3 Injection site pruritus, D1 [N=30;30]
    0
    0
        Grade 3 Injection site pruritus, D2 [N=30;29]
    0
    0
        Grade 3 Injection site pruritus, Across [N=30;30]
    0
    0
        Any Pain, D 1 [N=30;30]
    28
    26
        Any Pain, D 2 [N=30;29]
    25
    21
        Any Pain, Across [N=30;30]
    28
    27
        Grade 3 Pain, D1 [N=30;30]
    2
    0
        Grade 3 Pain, D2 [N=30;29]
    1
    0
        Grade 3 Pain, Across [N=30;30]
    2
    0
        Any Redness, D 1 [N=30;30]
    23
    11
        Any Redness, D 2 [N=30;29]
    23
    12
        Any Redness, Across [N=30;30]
    26
    15
        Grade 3 Redness, D1 [N=30;30]
    12
    1
        Grade 3 Redness, D2 [N=30;29]
    12
    1
        Grade 3 Redness, Across [N=30;30]
    17
    2
        Any Swelling, D 1 [N=30;30]
    22
    7
        Any Swelling, D 2 [N=30;29]
    20
    11
        Any Swelling, Across [N=30;30]
    24
    12
        Grade 3 Swelling, D1 [N=30;30]
    8
    1
        Grade 3 Swelling, D2 [N=30;29]
    6
    1
        Grade 3 Swelling, Across [N=30;30]
    10
    2
    No statistical analyses for this end point

    Primary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms [6]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6) post vaccination, after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any Fatigue, D1 [N=30;30]
    14
    12
        Any Fatigue, D2 [N=30;29]
    16
    9
        Any Fatigue, Across [N=30;30]
    21
    16
        Grade 3 Fatigue, D1 [N=30;30]
    0
    0
        Grade 3 Fatigue, D2 [N=30;29]
    0
    1
        Grade 3 Fatigue, Across [N=30;30]
    0
    1
        Related Fatigues, D1 [N=30;30]
    14
    12
        Related Fatigue, D2 [N=30;29]
    16
    9
        Related Fatigues, Across [N=30;30]
    21
    16
        Any Fever/Axillary, D 1 [N=30;30]
    3
    2
        Any Fever/Axillary, D 2 [N=30;29]
    5
    6
        Any Fever/Axillary, Across [N=30;30]
    6
    7
        Grade 3 Fever/Axillary, D1 [N=30;30]
    0
    0
        Grade 3 Fever/Axillary, D2 [N=30;29]
    0
    0
        Grade 3 Fever/Axillary, Across [N=30;30]
    0
    0
        Related Fever/Axillary, D 1 [N=30;30]
    3
    2
        Related Fever/Axillary, D 2 [N=30;29]
    5
    6
        Related Fever/Axillary, Across [N=30;30]
    6
    7
        Any Gastrointestinal symptoms, D 1 [N=30;30]
    2
    4
        Any Gastrointestinal symptoms, D 2 [N=30;29]
    5
    3
        Any Gastrointestinal symptoms, Across [N=30;30]
    7
    5
        Grade 3 Gastrointestinal symptoms, D1 [N=30;30]
    0
    0
        Grade 3 Gastrointestinal symptoms, D2 [N=30;29]
    0
    1
        Grade 3 Gastrointestinal symptoms, Across [N=30;30
    0
    1
        Related Gastrointestinal symptoms,D1 [N=30;30]
    2
    4
        Related Gastrointestinal symptoms, D2 [N=30;29]
    5
    3
        Related Gastrointestinal symptoms, Across [N=30;30
    7
    5
        Any Headache, D1 [N=30;30]
    11
    8
        Any Headache, D2 [N=30;29]
    11
    10
        Any Headache, Across [N=30;30]
    17
    13
        Grade 3 Headache, D1 [N=30;30]
    0
    0
        Grade 3 Headache, D2 [N=30;29]
    0
    2
        Grade 3 Headache, Across [N=30;30]
    0
    2
        Related Headache, D1 [N=30;30]
    11
    8
        Related Headache, D2 [N=30;29]
    11
    10
        Related Headache, Across [N=30;30]
    17
    13
        Any Myalgia, D1 [N=30;30]
    2
    1
        Any Myalgia, D2 [N=30;29]
    5
    3
        Any Myalgia, Across [N=30;30]
    7
    4
        Grade 3 Myalgia, D1 [N=30;30]
    1
    0
        Grade 3 Myalgia, D2 [N=30;29]
    0
    1
        Grade 3 Myalgia, Across [N=30;30]
    1
    1
        Related Myalgia, D1 [N=30;30]
    2
    1
        Related Myalgia, D2 [N=30;29]
    5
    3
        Related Myalgia, Across [N=30;30]
    7
    4
        Any Shivering, D1 [N=30;30]
    3
    3
        Any Shivering, D2 [N=30;29]
    6
    6
        Any Shivering, Across [N=30;30]
    8
    7
        Grade 3 Shivering, D1 [N=30;30]
    0
    1
        Grade 3 Shivering, D2 [N=30;29]
    0
    0
        Grade 3 Shivering, Across [N=30;30]
    0
    1
        Related Shivering, D1 [N=30;30]
    3
    3
        Related Shivering, D2 [N=30;29]
    6
    6
        Related Shivering, Across [N=30;30]
    8
    7
    No statistical analyses for this end point

    Primary: Number of days with local symptoms

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    End point title
    		 Number of days with local symptoms [7]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6) post vaccination, after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Days
    arithmetic mean (inter-quartile range (Q1-Q3))
        Days with arm movement, D1
    3.9 (2 to 7)
    3 (2 to 3)
        Days with pain, D1
    3.3 (2 to 4)
    2.7 (2 to 3)
        Days with injection site pruritus, D1
    5.2 (2 to 7)
    2.2 (1 to 3)
        Days with redness, D1
    6.5 (4 to 8)
    2.6 (2 to 3)
        Days with swelling, D1
    5 (3 to 6)
    3 (2 to 3)
        Days with arm movement, D2
    2.9 (2 to 3)
    2.2 (2 to 3)
        Days with pain, D2
    3.4 (2 to 4)
    2.3 (1 to 3)
        Days with injection site pruritus, D2
    4.9 (3 to 5)
    1.9 (1.5 to 2)
        Days with redness, D2
    5.9 (3 to 6)
    3.7 (3 to 4)
        Days with swelling, D2
    4.3 (3 to 6)
    2.8 (2 to 4)
    No statistical analyses for this end point

    Primary: Number of days with general symptoms

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    End point title
    		 Number of days with general symptoms [8]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6) post vaccination
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Days
    arithmetic mean (inter-quartile range (Q1-Q3))
        Days with fatigue, D1
    2.3 (1 to 3)
    2 (1 to 2)
        Days with fever, D1
    1.3 (1 to 2)
    1 (1 to 1)
        Days with gastrointestinal symptoms, D1
    2 (1 to 3)
    2 (2 to 2)
        Days with headache, D1
    1.8 (1 to 2)
    1.4 (1 to 2)
        Days with myalgia, D1
    6.5 (3 to 10)
    2 (2 to 2)
        Days with Shivering, D1
    1.3 (1 to 2)
    1.3 (1 to 2)
        Days with fatigue, D2
    2 (1 to 2)
    1.3 (1 to 2)
        Days with fever, D2
    1 (1 to 1)
    1 (1 to 1)
        Days with gastrointestinal symptoms, D2
    3.6 (2 to 5)
    1.3 (1 to 2)
        Days with headache, D2
    2 (1 to 2)
    1.3 (1 to 2)
        Days with myalgia, D2
    2 (1 to 2)
    1.3 (1 to 2)
        Days with Shivering, D2
    2.2 (1 to 2.2)
    1 (1 to 1)
    No statistical analyses for this end point

    Primary: Number of subjects with pIMDs

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    End point title
    		 Number of subjects with pIMDs [9]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 30 days post vaccination period
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any pIMDs
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs) [10]
    End point description
    End point type
    Primary
    End point timeframe
    Within 30 days (Days 0-29) post vaccination period
    Notes
    [10] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any AEs
    9
    6
        Grade 3 AEs
    1
    0
        Related AEs
    1
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs) [11]
    End point description
    End point type
    Primary
    End point timeframe
    From Month 0 to Month 3
    Notes
    [11] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any SAEs
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti Glycoprotein E (anti-E) antibody concentrations ≥97 mIU/mL

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    End point title
    		 Number of subjects with anti Glycoprotein E (anti-E) antibody concentrations ≥97 mIU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 14
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    28
    Units: Subjects
        Anti-gE, M14
    30
    28
    No statistical analyses for this end point

    Secondary: Anti-gE antibody concentrations

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    End point title
    		 Anti-gE antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 14
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    28
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-gE, M14
    15250.9 (12464 to 18660.9)
    13870.2 (10184.2 to 18890.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response for anti-gE antibody concentrations

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    End point title
    		 Number of subjects with vaccine response for anti-gE antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Twelve Months after Dose 2 (M14).
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    28
    Units: Subjects
        Anti-gE, M14
    25
    25
    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
    End point type
    Secondary
    End point timeframe
    Up to Month 14 post vaccination period
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any pIMDS
    0
    0
    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
    End point type
    Secondary
    End point timeframe
    Up to Month 14 post vaccination period
    End point values
    		 SC HZ/su Group IM HZ/su Group
    Number of subjects analysed
    30
    30
    Units: Subjects
        Any SAEs
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 7-day post-vaccination period. Unsolicited AEs during the 30-day post-vaccination period. SAEs up to Month 14 post vaccination.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    IM HZ/su Group
    Reporting group description
    		 -

    Reporting group title
    SC HZ/su Group
    Reporting group description
    		 -

    Serious adverse events
    		 IM HZ/su Group SC HZ/su Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Spinal compression fracture
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         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
    Mallet finger
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IM HZ/su Group SC HZ/su Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    28 / 30 (93.33%)
    General disorders and administration site conditions
    Arm movement
         subjects affected / exposed
    12 / 30 (40.00%)
    18 / 30 (60.00%)
         occurrences all number
    12
    18
    Injection site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 30 (33.33%)
    21 / 30 (70.00%)
         occurrences all number
    10
    21
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 30 (90.00%)
    28 / 30 (93.33%)
         occurrences all number
    27
    28
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 30 (50.00%)
    26 / 30 (86.67%)
         occurrences all number
    15
    26
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 30 (40.00%)
    24 / 30 (80.00%)
         occurrences all number
    12
    24
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 30 (53.33%)
    21 / 30 (70.00%)
         occurrences all number
    16
    21
    Fever/(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 30 (23.33%)
    6 / 30 (20.00%)
         occurrences all number
    7
    6
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 30 (23.33%)
         occurrences all number
    5
    7
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 30 (43.33%)
    17 / 30 (56.67%)
         occurrences all number
    13
    17
    Myalgia (muscle aches)
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 30 (13.33%)
    7 / 30 (23.33%)
         occurrences all number
    4
    7
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 30 (23.33%)
    8 / 30 (26.67%)
         occurrences all number
    7
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2014
    Prior to 18 May 2014, the anti-gE ELISA cut-off was 18 mIU/mL. Background signal has been measured with the anti-gE ELISA on samples from Varicella Zoster Virus (VZV) naïve paediatric subjects. This observation of background signal on VZV naïve samples was not part of the original validation of the assay and establishment of the assay cut-off. Background signal measured with the anti-gE ELISA has no impact on Zoster project clinical conclusions as the vast majority of the samples (at all timepoints) have high titers well above the unspecific response level measured on VZV naïve samples from Measles, Mumps, Rubella and Varicella (MMRV) studies and Zoster vaccine responses are very robust. However this finding triggered re-evaluation of the assay cut-off. Based on complementary validation experiments performed in line with Clinical and Laboratory Standards Institute (CLSI) guidelines and taking into account internal company guidelines the technical and seropositivity cut-off has recently been set at 97 mIU/mL. (Section 5.7.3, Table 7, and Appendix A).

    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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