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    Clinical Trial Results:
    A phase IV study to evaluate the primary and booster immune responses of UK infants receiving a licensed 6-in-1 DTaP/IPV/Hib/HBV vaccine(Infanrix-Hexa™) with a 13-valent pneumococcal conjugate vaccine and incorporating a randomisation study of a single dose of 3 different meningococcal group C conjugate vaccines at 3 months of age.

    Summary
    EudraCT number
    		 2012-003026-25
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jun 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
    RSRSG12-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01896596
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Public Health England
    Sponsor organisation address
    Wellington House, London, United Kingdom, SE1 8UG
    Public contact
    Dr Elizabeth Coates PHE, SE1 8UG, Public Health England Wellington House, SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
    Scientific contact
    Dr Elizabeth Coates PHE, SE1 8UG, Public Health England Wellington House, 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
    30 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will assess the immune responses of infants receiving a licensed 6-in-1 vaccine (Infanrix-Hexa™) instead of the current 5-in-1 vaccine (Pediacel™) when given at the UK schedule of 2-3-4 months when given with one of three licensed meningococcal group C (MenC) vaccines at 3 months and the pneumococcal vaccine at 2 and 4 months of age. The study will primarily ensure that this new schedule protects infants against Haemophilus influenzae group B (Hib) and Meningococcal group C (MenC) disease as responses to these components of the vaccine have been shown in the past to be susceptible to changes in vaccine type and dosing schedule.
    Protection of trial subjects
    Venepuncture by experience paediatric nurses and anaesthetic cream offered
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    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: 171
    Worldwide total number of subjects
    171
    EEA total number of subjects
    171
    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)
    171
    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
    		 171 infants offered hepatitis B containing DTaP/IPV vaccine

    Pre-assignment
    Screening details
    		 History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B. History of maternal acute or chronic hepatitis B infection. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV).Bleeding disorders and/or prolonged bleeding

    Period 1
    Period 1 title
    PERIOD 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ARM 1
    Arm description
    		 Infants receiving Infanrix hexa
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa
    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
    		ARM 1
    Started
    171
    Completed
    171

    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
    		 171 171
    Age categorical
    Infants age
    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)
    		 171 171
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    SEX
    Units: Subjects
        Female
    		 82 82
        Male
    		 89 89

    End points

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    End points reporting groups
    Reporting group title
    ARM 1
    Reporting group description
    		 Infants receiving Infanrix hexa

    Primary: Proportion with Protective Hib Antibody levels

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    End point title
    		 Proportion with Protective Hib Antibody levels [1]
    End point description
    End point type
    Primary
    End point timeframe
    4-6 weeks after primary 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: Descriptive analysis only
    End point values
    		 ARM 1
    Number of subjects analysed
    165
    Units: Percentage
        Greater than 0.15 ug/ml
    147
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From 1st dose until 4 weeks after the last dose
    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
    		 -

    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: This was an immunogenicity study
    Serious adverse events
    		 ARM1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 171 (5.26%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    surgical
         subjects affected / exposed
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    7 / 171 (4.09%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 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 / 171 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2012
    Participant Information Leaflet simplified as per ethics committee request
    25 May 2012
    Minor typographical changes following sponsorship submission
    25 Mar 2013
    HPA replaced with PHE throughout text Rotavirus added to schedule 6.2. Schedule Table updated 6.3.1. Inclusion criteria amended 6.3.2. Exclusion criteria amended 6.4.5 Booster vaccine sites amended Appendix 1.2 – amended Appendix 1.6. Consent form amended
    11 Jul 2014
    The protocol has been updated throughout to reflect the addition of St George’s as a site and that study procedures may be carried out by both medics and nurses there. A detailed description of the recruitment process there is given on p.28 as well as associated patient information in appendix 1.
    19 Jun 2015
    1. Menjugate is no longer available in the UK so this arm has to be closed. 2. Addition of Bexsero vaccine as per national schedule change, announced by DH for commencement 1 Sept 2015
    24 Nov 2015
    Minor typographical corrections, no systematic changes throughout and no material changes to conduct of the study. Clarification that Bexsero was introduced in Sept 2015, previous wording indicated Dept Health’s intent to introduce the vaccine. Minor amendment to REC.
    04 Apr 2016
    Identification of a lack of mention of pertussis testing in objectives, though already mentioned in endpoints section. Agreed with PHE R&D Office this was an administrative amendment as did not materially alter any procedures already in place and was for clarification only.

    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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