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    Clinical Trial Results:
    A phase II observer blind, randomised, controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccine GSK 692342 when administered to adults aged 18 to 59 years with TB disease

    Summary
    EudraCT number
    		 2012-001820-36
    Trial protocol
    		 EE  
    Global end of trial date
    10 Apr 2014

    Results information
    Results version number
    		 v1
    This version publication date
    03 Mar 2016
    First version publication date
    22 May 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    114886
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, 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
    Interim
    Date of interim/final analysis
    20 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of GSK Biologicals’ candidate TB vaccine M72/AS01E in the study population.
    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
    14 Nov 2011
    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: 36
    Country: Number of subjects enrolled
    Taiwan: 106
    Worldwide total number of subjects
    142
    EEA total number of subjects
    36
    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)
    142
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects’ pre-vaccination body temperature was evaluated.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    During the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoints have been unaware of which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TB Treatment GSK 692342 Group
    Arm description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK 692342
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of vaccine were administered intramuscularly in the deltoid region of the arm, on a 0, 1 Months schedule

    Arm title
    		 TB Treatment Saline Group
    Arm description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Doses were administered intramuscularly in the deltoid of the arm at Months 0 and 1

    Arm title
    		 TB Treated GSK 692342 Group
    Arm description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK 692342
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of vaccine were administered intramuscularly in the deltoid region of the arm, on a 0, 1 Months schedule

    Arm title
    		 TB Treated Saline Group
    Arm description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Doses were administered intramuscularly in the deltoid of the arm at Months 0 and 1

    Arm title
    		 TB Naive GSK 692342 Group
    Arm description
    		 Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK 692342
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of vaccine were administered intramuscularly in the deltoid region of the arm, on a 0, 1 Months schedule

    Arm title
    		 TB Naive Saline Group
    Arm description
    		 Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Doses were administered intramuscularly in the deltoid of the arm at Months 0 and 1

    Number of subjects in period 1
    		TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Started
    7
    6
    24
    25
    40
    40
    Completed
    6
    5
    22
    25
    40
    40
    Not completed
    1
    1
    2
    0
    0
    0
         Consent withdrawn by subject
    1
    1
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TB Treatment GSK 692342 Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treatment Saline Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treated GSK 692342 Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1

    Reporting group title
    TB Treated Saline Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive GSK 692342 Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive Saline Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group values
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group Total
    Number of subjects
    		 7 6 24 25 40 40 142
    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)
    		 42.9 ± 11.5 44.7 ± 11.8 44.5 ± 10.3 47 ± 9.8 33.8 ± 8.5 33.3 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 1 2 13 7 16 21 60
        Male
    		 6 4 11 18 24 19 82

    End points

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    End points reporting groups
    Reporting group title
    TB Treatment GSK 692342 Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treatment Saline Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treated GSK 692342 Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1

    Reporting group title
    TB Treated Saline Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive GSK 692342 Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive Saline Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Primary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6), after each vaccine dose
    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.
    End point values
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Number of subjects analysed
    7
    6
    24
    25
    40
    40
    Units: Subjects
        Pain, D1 (N=7,6,24,25,40,40)
    6
    1
    21
    2
    38
    5
        Redness, D1 (N=7,6,24,25,40,40)
    2
    0
    4
    0
    7
    0
        Swelling, D1 (N=7,6,24,25,40,40)
    2
    0
    5
    1
    4
    0
        Pain, D2 (N=6,5,21,25,39,39)
    5
    1
    19
    1
    36
    6
        Redness, D2 (N=6,5,21,25,39,39)
    3
    0
    7
    0
    6
    0
        Swelling, D2 (N=6,5,21,25,39,39)
    3
    0
    4
    0
    11
    0
        Pain, Across (N=7,6,24,25,40,40)
    6
    1
    22
    3
    39
    8
        Redness, Across (N=7,6,24,25,40,40)
    3
    0
    8
    0
    10
    0
        Swelling, Across (N=7,6,24,25,40,40)
    3
    0
    6
    1
    11
    0
    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 [2]
    End point description
    End point type
    Primary
    End point timeframe
    During the 7 day (Days 0-6), after each vaccine dose
    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
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Number of subjects analysed
    7
    6
    24
    25
    40
    40
    Units: Subjects
        Fatigue, D1 (N=7,6,24,25,40,40)
    1
    2
    14
    6
    19
    8
        Gastrointestinal symptoms, D1 (N=7,6,24,25,40,40)
    0
    0
    4
    2
    5
    5
        Headache, D1 (N=7,6,24,25,40,40)
    1
    0
    11
    4
    8
    5
        Malaise, D1 (N=7,6,24,25,40,40)
    1
    1
    11
    2
    14
    8
        Myalgia, D1 (N=7,6,24,25,40,40)
    2
    0
    13
    4
    24
    7
        Temperature/(Axillary), D1 (N=7,6,24,25,40,40)
    0
    0
    1
    0
    2
    0
        Fatigue, D2 (N=6,5,21,25,39,39)
    3
    1
    13
    5
    33
    7
        Gastrointestinal symptoms, D2 (N=6,5,21,25,39,39)
    2
    0
    7
    3
    13
    3
        Headache, D2 (N=6,5,21,25,39,39)
    3
    1
    12
    2
    22
    3
        Malaise, D2 (N=6,5,21,25,39,39)
    3
    2
    11
    5
    32
    3
        Myalgia, D2 (N=6,5,21,25,39,39)
    3
    1
    14
    4
    28
    3
        Temperature/(Axillary), D2 (N=6,5,21,25,39,39)
    4
    1
    9
    0
    16
    0
        Fatigue, Across (N=7,6,24,25,40,40)
    3
    2
    17
    8
    36
    10
        Gastrointestinal symptoms, Across (N=7,6,24,25,40,
    2
    0
    10
    4
    16
    6
        Headache, Across (N=7,6,24,25,40,40)
    3
    1
    18
    4
    24
    6
        Malaise, Across (N=7,6,24,25,40,40)
    3
    2
    16
    6
    35
    9
        Myalgia, Across (N=7,6,24,25,40,40)
    3
    1
    18
    5
    34
    7
        Temperature/(Axillary), Across (N=7,6,24,25,40,40)
    4
    1
    10
    0
    17
    0
    No statistical analyses for this end point

    Primary: Number of subjects with adverse events (AEs)

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    End point title
    		 Number of subjects with adverse events (AEs) [3]
    End point description
    End point type
    Primary
    End point timeframe
    During the 30 day (Days 0-29) after vaccination
    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 endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Number of subjects analysed
    7
    6
    24
    25
    40
    40
    Units: Subjects
        Any AEs
    1
    2
    14
    7
    19
    8
    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) [4]
    End point description
    End point type
    Primary
    End point timeframe
    Up to day 210
    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 endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Number of subjects analysed
    7
    6
    24
    25
    40
    40
    Units: Subjects
        Any SAEs
    0
    0
    2
    2
    1
    0
    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 (Days 0-6), after each vaccine dose, unsolicited AEs: During the 30 day (Days 0-29) after vaccination, SAEs: Up to day 210
    Adverse event reporting additional description
    Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    TB Treatment GSK 692342 Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treatment Saline Group
    Reporting group description
    		 Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Treated GSK 692342 Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1

    Reporting group title
    TB Treated Saline Group
    Reporting group description
    		 Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive GSK 692342 Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.

    Reporting group title
    TB Naive Saline Group
    Reporting group description
    		 Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

    Serious adverse events
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 24 (8.33%)
    2 / 25 (8.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TB Treatment GSK 692342 Group TB Treatment Saline Group TB Treated GSK 692342 Group TB Treated Saline Group TB Naive GSK 692342 Group TB Naive Saline Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    2 / 6 (33.33%)
    22 / 24 (91.67%)
    8 / 25 (32.00%)
    39 / 40 (97.50%)
    10 / 40 (25.00%)
    Investigations
    Hepatic enzyme increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 24 (8.33%)
    0 / 25 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    6 / 7 (85.71%)
    1 / 6 (16.67%)
    22 / 24 (91.67%)
    3 / 25 (12.00%)
    39 / 40 (97.50%)
    8 / 40 (20.00%)
         occurrences all number
    6
    1
    22
    3
    39
    8
    Redness
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 6 (0.00%)
    8 / 24 (33.33%)
    0 / 25 (0.00%)
    10 / 40 (25.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    8
    0
    10
    0
    Swelling
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 6 (0.00%)
    6 / 24 (25.00%)
    1 / 25 (4.00%)
    11 / 40 (27.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    6
    1
    11
    0
    Fatigue
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 6 (33.33%)
    17 / 24 (70.83%)
    8 / 25 (32.00%)
    36 / 40 (90.00%)
    10 / 40 (25.00%)
         occurrences all number
    3
    2
    17
    8
    36
    10
    Gastrointestinal symptoms
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    10 / 24 (41.67%)
    4 / 25 (16.00%)
    16 / 40 (40.00%)
    6 / 40 (15.00%)
         occurrences all number
    2
    0
    10
    4
    16
    6
    Headache (solicited)
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    18 / 24 (75.00%)
    4 / 25 (16.00%)
    24 / 40 (60.00%)
    6 / 40 (15.00%)
         occurrences all number
    3
    1
    18
    4
    24
    6
    Malaise
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 6 (33.33%)
    16 / 24 (66.67%)
    6 / 25 (24.00%)
    35 / 40 (87.50%)
    9 / 40 (22.50%)
         occurrences all number
    3
    2
    16
    6
    35
    9
    Myalgia
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    18 / 24 (75.00%)
    5 / 25 (20.00%)
    34 / 40 (85.00%)
    7 / 40 (17.50%)
         occurrences all number
    3
    1
    18
    5
    34
    7
    Temperature/(Axillary)
         subjects affected / exposed
    4 / 7 (57.14%)
    1 / 6 (16.67%)
    10 / 24 (41.67%)
    0 / 25 (0.00%)
    17 / 40 (42.50%)
    0 / 40 (0.00%)
         occurrences all number
    4
    1
    10
    0
    17
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    3 / 24 (12.50%)
    0 / 25 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    3 / 24 (12.50%)
    0 / 25 (0.00%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    3
    0
    4
    3
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 24 (8.33%)
    0 / 25 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 24 (8.33%)
    0 / 25 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2012
    • At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code. • Change in the number of participating countries in this study. • It has been clarified that TB treatment for subjects belonging to the TB-treatment cohort will be provided independent of this study. • Additional minor modifications have been implemented.
    18 Feb 2013
    This amendment aims to correct the centre-specific information provided in the protocol. However, as centre-specific information is available in other documents included in the clinical trial application, it was decided to remove centre-specific information from the protocol to avoid future amendments in case enrolment of subjects in the TB treated and TB treatment cohorts remains difficult and additional centres/countries might need to be added to the study.
    16 Jan 2014
    Due to a safety signal identified in the TB treatment cohort (increased local solicited symptoms post-dose 2), the protocol was amended to include exploratory testing on blood samples taken at Days 0, 7, 30, 37, 60 and 210.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Apr 2014
    A safety signal was observed during a planned interim safety review. In consequence the trial was put on hold. After careful consideration further conduct of this safety study is not considered the best course of action and enrolment in the study was terminated.
    -

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

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