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    Clinical Trial Results:
    A Phase IIIb, open-label, multi-centric study to evaluate the immunogenicity of one dose of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly in healthy adolescents aged 10 to 15 years, previously primed with a MenC conjugate vaccine.

    Summary
    EudraCT number
    2013-004778-84
    Trial protocol
    SE   ES  
    Global end of trial date
    18 Jun 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Dec 2018
    First version publication date
    23 Dec 2018
    Other versions
    Summary report(s)
    Cancelled before active statement

    Trial information

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    Trial identification
    Sponsor protocol code
    116775
    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 Trials Call Center,GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center,GlaxoSmithKline Biologicals, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the vaccine response induced by one dose of MenACWY-TT administered to MenC-primed and MenC unprimed subjects.
    Protection of trial subjects
    The study was cancelled before active (see attached statement). No patient entered the study, therefore no results / data are available.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 49999
    Country: Number of subjects enrolled
    Sweden: 50000
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    50000
    Adolescents (12-17 years)
    49999
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    99999 is "Not applicable" value or 0 participants, the study was cancelled before active. No patient entered the study, therefore no results / data are available.

    Pre-assignment
    Screening details
    Study cancelled before active (see attached statement)

    Period 1
    Period 1 title
    Cancelled before active period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    No-Arm
    Arm description
    -
    Arm type
    cancelled before active

    Investigational medicinal product name
    study cancelled before active
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    cancelled before active

    Number of subjects in period 1
    No-Arm
    Started
    99999
    Completed
    0
    Not completed
    99999
         study was cancelled before active
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cancelled before active period
    Reporting group description
    -

    Reporting group values
    Cancelled before active period Total
    Number of subjects
    99999 99999
    Age categorical
    Units: Subjects
        Adolescents
    99999 99999
    Gender categorical
    Units: Subjects
        Female
    50000 50000
        Male
    49999 49999

    End points

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    End points reporting groups
    Reporting group title
    No-Arm
    Reporting group description
    -

    Primary: No endpoint results

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    End point title
    No endpoint results [1]
    End point description
    End point type
    Primary
    End point timeframe
    The study was cancelled before active (see attached statement)
    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 study was cancelled before active (see attached statement).
    End point values
    No-Arm
    Number of subjects analysed
    99999
    Units: Participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The study was cancelled before active (see attached statement)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The study was cancelled before active (see attached statement).

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Jun 2014
    The study was cancelled before active (see attached statement).
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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