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    Clinical Trial Results:
    A phase IV study to evaluate the primary and booster immune responses of UK preterm infants receiving licensed DTaP/Hib/IPV and meningococcal C conjugate vaccine and incorporating a randomisation study of a 3 dose accelerated versus a 2 dose and a 3 dose extended schedule of pneumococcal conjugate vaccine for primary immunisation.

    Summary
    EudraCT number
    		 2007-007535-23
    Trial protocol
    		 GB  
    Global end of trial date
    22 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2019
    First version publication date
    15 Nov 2019
    Other versions
    Summary report(s)
    		 End of Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    PUNS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St Georges University of London
    Sponsor organisation address
    Cranmer Terrace, London, United Kingdom, SW17 0RE
    Public contact
    Joint Research and Enterprise Services , St George's University of London, +44 (0)208725 1012, sponsor@sgul.ac.uk
    Scientific contact
    St George's University of London, Prof Paul Heath , +44 (0)20 8725 5980, pheath@sgul.ac.uk
    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
    13 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To compare the immunological responses of infants born prematurely to Prevenar after 2 doses at 2 and 4 months of age with 3 doses at 2, 3 and 4 months of age (“early protection”). 2. To evaluate the immunological responses of infants born prematurely to Prevenar when vaccinated under a 3-dose accelerated schedule (2, 3 and 4 months of age) compared with a 3-dose extended schedule (2, 4 and 6 months of age). 3. To evaluate the immunological responses of infants born prematurely when vaccinated under the new national schedule to: · Hib · Meningococcal C · Diphtheria · Tetanus
    Protection of trial subjects
    Local anaesthetic cream was used where appropriate to numb the skin prior to blood being taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 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
    United Kingdom: 210
    Worldwide total number of subjects
    210
    EEA total number of subjects
    210
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    210
    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 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Two hundred (200) subjects will be recruited from NHS sites in the UK in a 12 month active recruitment period.

    Pre-assignment
    Screening details
    		 infant (i) was born at <35 weeks gestation; and (ii) is aged between 7 weeks and <12 weeks at entry (as per protocol).

    Period 1
    Period 1 title
    Active (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    computerised block randomisation list will be produced by the Statistician as described Analytical Plan. Each centre will be allocated blocks of sequential numbers in accordance with the block size used for randomisation. On recruitment to the study, each subject will be allocated, in order of inclusion, the next available subject number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Prevenar13® administered at 2+4 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevenar13 vaccine

    Arm title
    		 Group 2
    Arm description
    		 Prevenar13® administered at 2+3+4 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    intramuscular injection with a 16mm

    Arm title
    		 Group 3
    Arm description
    		 Prevenar13® administered at 2+4+6 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevenar13 vaccine

    Number of subjects in period 1
    		Group 1 Group 2 Group 3
    Started
    69
    69
    72
    End of study
    69
    69
    72
    Completed
    68
    67
    71
    Not completed
    1
    2
    1
         Consent withdrawn by subject
    1
    2
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Prevenar13® administered at 2+4 months

    Reporting group title
    Group 2
    Reporting group description
    		 Prevenar13® administered at 2+3+4 months

    Reporting group title
    Group 3
    Reporting group description
    		 Prevenar13® administered at 2+4+6 months

    Primary: To compare the immunological responses of infants born prematurely to PCV13 after two doses at 2 and 4 months of age with three doses at 2, 3 and 4 months of age (“early protection”).

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    End point title
    		 To compare the immunological responses of infants born prematurely to PCV13 after two doses at 2 and 4 months of age with three doses at 2, 3 and 4 months of age (“early protection”).
    End point description
    End point type
    Primary
    End point timeframe
    After two doses at 2 and 4 months of age with three doses at 2, 3 and 4 months of age
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    68
    67
    71
    Units: OO
        number (not applicable)
    68
    67
    71
    Statistical analysis title
    		 Statisitical analysis
    Comparison groups
    Group 1 v Group 2 v Group 3
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 Not known
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAE and will be reported within 24 hours by the Study Nurse/Doctor to the sponsor and CI
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SmpC
    Dictionary version
    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: All adverse events data is reported in the Final Study Report

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2008
    Amendment 1 29 August 2008 Changes:  Addition of site in uk  Clarification of Indemnity & Funder in PIL
    12 Sep 2008
    Amendment 2 12 September 2008 Amendment 02 incorporated changes to notify the study to a “Clinical Trial of Investigational Medicinal Product”. UK CA (MHRA) approval for the study was received on 24th April 2008.

    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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    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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