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    Clinical Trial Results:
    An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule

    Summary
    EudraCT number
    		 2004-001823-39
    Trial protocol
    		 SE  
    Global end of trial date
    27 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2018
    First version publication date
    22 Dec 2018
    Other versions
    Summary report(s)
    		 Cancelled before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    103502
    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, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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
    27 Nov 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the immune response post-dose 2 elicited by GSK Biologicals’ candidate 11Pn-PD-DiT vaccine administered according to a 3, 5, 12 month vaccination schedule as part of a staggered vaccination schedule with co-administration of Infanrix™ penta and GSK Biologicals’ candidate HibMenC-TT vaccine at 2, 4 months of age.
    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
    01 Nov 2004
    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
    Sweden: 99999
    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)
    99999
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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

    Arms
    Arm title
    		 No-Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals’ 11-valent Pn-PD-DiT vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The product was not administered as the study was 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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    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
    9999
    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
    8.0
    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
    27 Nov 2012
    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
    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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