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    Clinical Trial Results:
    An observational follow up study of a phase II/III, open label, randomised study of the safety, reactogenicity and immunogenicity of a single dose of meningococcal ACWY conjugate vaccine (Menveo, Glaxosmithkline or Nimenrix, Pfizer) in adolescents who were primed with Meningitec, Menjugate or Neisvac-C during preschool vaccination.

    Summary
    EudraCT number
    		 2016-002381-31
    Trial protocol
    		 GB  
    Global end of trial date
    31 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Quadrimeningofollowu
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02811120
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Public Health England
    Sponsor organisation address
    Wellington House , London , United Kingdom, SE1 8UG
    Public contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House London SE1 8UG , +44 01980612922, elizabeth.coates@phe.gov.uk
    Scientific contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House London SE1 8UG , +44 01980612922, elizabeth.coates@phe.gov.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
    22 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Technical version: • To estimate and compare the serogroup A, C, Y and W-specific antibody titres following ~4-5 years after vaccination with either the Glaxosmithkline or Pfizer quadrivalent meningococcal vaccines and comparison between vaccines and over time. Lay version: To measure how much antibody against each of the four meningitis strains included in the vaccines is still in the blood 4-5 years after vaccination with the quadrivalent vaccine and to compare this between the two groups in the original study.
    Protection of trial subjects
    Fieldwork undertaken by specialist vaccine research nurses trained in venepuncture and participants offered local anaesthetic prior to venepuncture
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2016
    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: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 57 subjects who participated seven years earlier in a quadrivalent meningococcal conjugate vaccine trial were followed up to assess antibody persistence to each serogroup

    Pre-assignment
    Screening details
    		 Known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study

    Period 1
    Period 1 title
    PERIOD 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Arm title
    		 ARM1
    Arm description
    		 All subjects
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quadrivalent ACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml

    Number of subjects in period 1
    		ARM1
    Started
    57
    Completed
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PERIOD 1
    Reporting group description
    		 -

    Reporting group values
    		 PERIOD 1 Total
    Number of subjects
    		 57 57
    Age categorical
    Age group
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 57 57
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Age group
    		 0 0
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 37 37
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    ARM1
    Reporting group description
    		 All subjects

    Primary: Serogroup C

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    End point title
    		 Serogroup C [1]
    End point description
    End point type
    Primary
    End point timeframe
    7 years after initial vaccination
    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: Followup study . descriptive analysis only
    End point values
    		 ARM1
    Number of subjects analysed
    57
    Units: Percentage protected
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 hours following blood sample
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    ARM1
    Reporting group description
    		 -

    Serious adverse events
    		 ARM1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ARM1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    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: Followup study only involving one blood sample

    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? 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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