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    Clinical Trial Results:
    An open label randomised controlled study to evaluate the induction of immune memory following infant vaccination with a glyco-conjugate Neisseria meningitidis serogroup C vaccine and to assess the immunological impact of administering routine infant immunisations in consistent versus alternating limbs

    Summary
    EudraCT number
    		 2009-016579-31
    Trial protocol
    		 GB  
    Global end of trial date
    13 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2019
    First version publication date
    28 Jul 2019
    Other versions
    Summary report(s)
    		 MALTA Clinical Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    OVG2008/6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01129518
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Oxford Vaccine Group, CCVTM, Churchill Hospital, Oxford, United Kingdom, OX3 7LE
    Public contact
    Prof. Andrew Pollard, Oxford Vaccine Group, University of Oxford, +44 (0)1865 611400,
    Scientific contact
    Prof. Andrew Pollard, Oxford Vaccine Group, University of Oxford, +44 (0)1865 611400,
    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
    16 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate non-inferiority of the geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA), 1 month after a 12 month dose of Hib-MenC vaccine in children receiving a single dose of MenC-CRM197vaccine at 3 months of age (single dose priming) compared with those receiving 2 doses at 3 and 4 months of age (2 dose priming). Non-inferiority of the MenC serum bactericidal antibody geometric mean titres (SBA GMTs) would imply that the reduced schedule of MenC immunisation would be a more cost effective method of providing sustained immunity against MenC disease through childhood.
    Protection of trial subjects
    Vaccination was performed by a registered doctor or nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 449
    Country: Number of subjects enrolled
    Malta: 60
    Worldwide total number of subjects
    509
    EEA total number of subjects
    509
    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)
    509
    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
    		 UK - eligible participants identified through the child health computers of the Primary Care Trusts, approach parents/carers opportunistically on post-natal wards, GPs and Health Visitors. Malta - eligible participants were identified through the Birth Register held at Mater Dei Hospital.

    Pre-assignment
    Screening details
    		 Measurement of axillary temperature together with a check of the inclusion and exclusion criteria to determine if the infant was healthy. Inclusion and exclusion criteria checked on the first visit during which enrolment and randomisation took place.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Single dose MenC-CRM 197 Group
    Arm description
    		 Single dose MenC-CRM 197 vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-CRM 197 V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MenC-CRM197 vaccine
    Investigational medicinal product code
    Other name
    Menjugate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses

    Arm title
    		 Two dose MenC-CRM 197 Group
    Arm description
    		 Two doses MenC-CRM 197 vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-CRM 197 V3 (age 4 months): DTaP-IPV-Hib + PCV13 + MenC-CRM 197 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MenC-CRM197
    Investigational medicinal product code
    Other name
    Menjugate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received 2 doses of the MenC-TT vaccine in the study.

    Arm title
    		 Control Group
    Arm description
    		 No MenC vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No MenC vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants did not receive a MenC vaccine in this study group

    Arm title
    		 Single dose MenC-TT Group
    Arm description
    		 Single dose MenC-TT vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-TT V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MenC-TT
    Investigational medicinal product code
    Other name
    NeisVac-C
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of the MenC-TT vaccine

    Number of subjects in period 1
    		Single dose MenC-CRM 197 Group Two dose MenC-CRM 197 Group Control Group Single dose MenC-TT Group
    Started
    165
    161
    66
    117
    Completed
    158
    153
    62
    105
    Not completed
    7
    8
    4
    12
         Moved out of area
    2
    2
    -
    6
         Consent withdrawn by subject
    4
    4
    4
    4
         Lost to follow-up
    1
    2
    -
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Single dose MenC-CRM 197 Group
    Reporting group description
    		 Single dose MenC-CRM 197 vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-CRM 197 V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR

    Reporting group title
    Two dose MenC-CRM 197 Group
    Reporting group description
    		 Two doses MenC-CRM 197 vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-CRM 197 V3 (age 4 months): DTaP-IPV-Hib + PCV13 + MenC-CRM 197 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR

    Reporting group title
    Control Group
    Reporting group description
    		 No MenC vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR

    Reporting group title
    Single dose MenC-TT Group
    Reporting group description
    		 Single dose MenC-TT vaccine with the following vaccination schedule: V1 (age 6-12 weeks): PCV13 + DTaP-IPV-Hib V2 (age 3 months): DTaP-IPV-Hib + MenC-TT V3 (age 4 months): DTaP-IPV-Hib + PCV13 V5 (age 5 months): PCV13 + Hib-MenC V7 (age 13 months): MMR

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    The difference in the MenC rSBA GMTs between the participants primed with two doses of MenC-CRM197 (Two Dose MenC Group, Group 2) and with one dose of MenC-CRM197 (Single Dose MenC-CRM197 Group, Group 1), one month following the Hib-MenC booster dose at 12 months.
    End point type
    Primary
    End point timeframe
    One month following Hib-MenC booster at 12 months.
    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: Please refer to the submitted clinical study plan for full details.
    End point values
    		 Single dose MenC-CRM 197 Group Two dose MenC-CRM 197 Group Control Group Single dose MenC-TT Group
    Number of subjects analysed
    136
    127
    55
    95
    Units: Geometic mean titre (GMT)
        number (not applicable)
    136
    127
    55
    95
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All SAEs (from all sites) reported to the University of Oxford (CTRG) within one working day of discovery or notification of the event. CTRG will perform an initial check of the information and ensure that it is reviewed at the next TSG meeting.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Protocol
    Dictionary version
    11
    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: Please refer to the submitted clinical study plan for full details.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2010
    PCV13 to replace PCV7 Menjugate Kit to replace NeisVac-C Delay criteria for vaccination
    23 Apr 2010
    Addition of new study group Addition of 24 month persistence sample
    29 Jun 2010
    Addition of new study sites, and site specific procedures. Clarification of statistical analyses, randomisation and blinding. Clarification of sample handling procedures. Clarification of concomitant vaccines permitted in the trial Addition of trial steering committee Correction of typographical error in Appendix C. Removal of repeated secondary endpoints. Addition of new objective and endpoint. Clarification of Group numbers
    26 Nov 2010
    Clarification of recruitment procedures Clarification of adverse event reporting procedures
    10 Mar 2011
    Clarification of recruitment procedures. Inclusion of Varicella Vaccine to list of non-study vaccines permitted.
    03 Jun 2011
    Inclusion of Hep A Vaccine to list of non-study vaccines permitted.
    10 Oct 2011
    Inclusion of interim analysis.
    03 Nov 2011
    Clarification of statistical analyses and inclusion of a second attempt to blood sampling if first is unsuccessful. Correction of typing errors.
    01 Jun 2012
    Re-wording of hypothesis tests.
    25 Sep 2012
    Clarification of V5 timelines and elimination criteria.

    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.
    Due to technical difficulties we have not been able to upload the data, please refer to the uploaded clinical study report.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28029540
    http://www.ncbi.nlm.nih.gov/pubmed/25832102
    http://www.ncbi.nlm.nih.gov/pubmed/25577661
    http://www.ncbi.nlm.nih.gov/pubmed/25020050
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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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