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    Clinical Trial Results:
    A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

    Summary
    EudraCT number
    		 2015-001030-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Feb 2016

    Results information
    Results version number
    		 v1
    This version publication date
    24 Jun 2016
    First version publication date
    24 Jun 2016
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    V102_16E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02285777
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    Interim
    Date of interim/final analysis
    16 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity at 1:4 dilution using enc-hSBA at one month after the 3-dose series, when compared to a single dose of MenACWY.
    Protection of trial subjects
    Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel. The measures of safety used in this study are routine clinical procedures. They include a close vigilance for, and stringent reporting of, selected local and systemic adverse events routinely monitored in vaccine clinical studies as indicators of reactogenicity. The period of observation for AEs extends from the time the subject signs informed consent until he or she completes the final study visit (Visit Month 4) or terminates the study early (whichever comes first).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2014
    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 States: 189
    Worldwide total number of subjects
    189
    EEA total number of subjects
    0
    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)
    81
    Adolescents (12-17 years)
    97
    Adults (18-64 years)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 An Interactive Response Technology (IRT) will be used in the study. At Month 6 Visit of the parent study, IRT will allocate the study vaccines (either MenABCWY or placebo) to the subject. Subjects will receive either a 3rd dose of MenABCWY or one dose of a placebo, depending on their assigned vaccine group in parent study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Trial is observer-blinded. Observer-blind means that during the course of study, the subject, the parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) will be unaware which vaccine was administered. The vaccine preparation and administration will be done by designated medical personnel who will not participate in any of the clinical study evaluations.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenABCWY
    Arm description
    		 Subjects who received 2 doses of MenABCWY vaccine in the parent study, now receive a 3rd dose of MenABCWY vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
    Investigational medicinal product code
    MenABCWY
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 millilitres

    Arm title
    		 MenACWY
    Arm description
    		 Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study, now receive 1 dose of placebo in the current study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 millilitres

    Number of subjects in period 1
    		MenABCWY MenACWY
    Started
    95
    94
    Completed
    90
    91
    Not completed
    5
    3
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenABCWY
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY vaccine in the parent study, now receive a 3rd dose of MenABCWY vaccine in the current study.

    Reporting group title
    MenACWY
    Reporting group description
    		 Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study, now receive 1 dose of placebo in the current study.

    Reporting group values
    		 MenABCWY MenACWY Total
    Number of subjects
    		 95 94 189
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.8 ( 2.36 ) 12.4 ( 2.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 33 73
        Male
    		 55 61 116

    End points

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    End points reporting groups
    Reporting group title
    MenABCWY
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY vaccine in the parent study, now receive a 3rd dose of MenABCWY vaccine in the current study.

    Reporting group title
    MenACWY
    Reporting group description
    		 Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study, now receive 1 dose of placebo in the current study.

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or baseline screening assessments, regardless of the subject’s assignment and treatment status in the study and received a Subject ID.

    Subject analysis set title
    All Exposed Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or baseline screening assessments, regardless of the subject’s assignment and treatment status in the study, received a Subject ID and a study vaccination.

    Subject analysis set title
    Safety Set (solicited AEs and other solicited reactions)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or baseline screening assessments, regardless of the subject’s assignment and treatment status in the study, received a Subject ID and a study vaccination, and provided post-vaccination reactogenicity data. AE = Adverse event.

    Subject analysis set title
    Safety Set (unsolicited adverse events)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or baseline screening assessments, regardless of the subject’s assignment and treatment status in the study, received a Subject ID and a study vaccination, and have post-vaccination unsolicited adverse event records.

    Subject analysis set title
    Safety Set (overall)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or baseline screening assessments, regardless of the subject’s assignment and treatment status in the study, received a Subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.

    Primary: The percentage of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitidis (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series.

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    End point title
    		 The percentage of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitidis (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series. [1]
    End point description
    The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The percentages of subjects will be averaged across all strains.
    End point type
    Primary
    End point timeframe
    Day 31, 1 month after the 3-dose vaccination series
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 MenABCWY MenACWY
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Percentage
        number (not applicable)
    Notes
    [2] - Results are not available yet.
    [3] - Results are not available yet.
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local or systemic Adverse Events (AEs).

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    End point title
    		 Number of subjects reporting any solicited local or systemic Adverse Events (AEs).
    End point description
    Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.
    End point type
    Secondary
    End point timeframe
    Day 1 (6 hours) to Day 7 after vaccination
    End point values
    		 MenABCWY MenACWY
    Number of subjects analysed
    90
    87
    Units: Subjects
        Any (Vacc.1, N=90,87)
    62
    25
        Any Local Reactions (Vacc.1, N=90,87)
    60
    15
        Any Systemic Reactions (Vacc.1, N=90,87)
    27
    15
        Induration (mm) (Vacc.1, N=88,87)
    6
    0
        Erythema (mm) (Vacc.1, N=87,86)
    6
    0
        Pain (Vacc.1, N=88,87)
    59
    15
        Nausea (Vacc.1, N=87,87)
    5
    5
        Fatigue (Vacc.1, N=87,87)
    14
    11
        Myalgia (Vacc.1, N=87,85)
    13
    3
        Arthralgia (Vacc.1, N=86,85)
    9
    0
        Headache (Vacc.1, N=88,87)
    13
    9
        Fever (Vacc.1, N=90,85)
    0
    1
        Chills (Vacc.1, N=88,87)
    2
    3
        Loss of appetite (Vacc.1, N=88,87)
    3
    3
        Prevention of pain/fever (Vacc.1, N=85,84)
    0
    0
        Treatment of pain/fever (Vacc.1, N=85,84)
    12
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited AEs after any vaccination.

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    End point title
    		 Number of subjects reporting unsolicited AEs after any vaccination.
    End point description
    The number of subjects reporting unsolicited AEs after any vaccination is reported.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30 after any vaccination
    End point values
    		 MenABCWY MenACWY
    Number of subjects analysed
    93
    93
    Units: Subjects
        Any AEs
    14
    11
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious AEs (SAEs), medically-attended AEs and AEs leading to premature withdrawal.

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    End point title
    		 Number of subjects reporting any serious AEs (SAEs), medically-attended AEs and AEs leading to premature withdrawal.
    End point description
    The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported.
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 MenABCWY MenACWY
    Number of subjects analysed
    95
    94
    Units: Subjects
        Any SAEs (N=93,93)
    0
    0
        Any Medically Attended AEs (N=93,93)
    14
    20
        Any AEs leading to premature withdrawal (N=95,94)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs, medically attended AEs and AEs leading to withdrawal are collected for the whole duration of the study.
    Adverse event reporting additional description
    Data will be presented in terms of number of subjects reporting AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    MenABCWY
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY vaccine in the parent study, now receive the 3rd dose of MenABCWY vaccine in the current study.

    Reporting group title
    MenACWY
    Reporting group description
    		 Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study, now receive 1 dose of placebo in the current study.

    Serious adverse events
    		 MenABCWY MenACWY
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenABCWY MenACWY
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 95 (70.53%)
    42 / 94 (44.68%)
    Nervous system disorders
    Headache
         subjects affected / exposed [1]
    14 / 93 (15.05%)
    9 / 93 (9.68%)
         occurrences all number
    25
    27
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed [2]
    14 / 93 (15.05%)
    11 / 93 (11.83%)
         occurrences all number
    32
    24
    Injection site erythema
         subjects affected / exposed [3]
    16 / 93 (17.20%)
    4 / 93 (4.30%)
         occurrences all number
    44
    12
    Injection site induration
         subjects affected / exposed [4]
    16 / 93 (17.20%)
    3 / 93 (3.23%)
         occurrences all number
    57
    10
    Injection site pain
         subjects affected / exposed [5]
    60 / 93 (64.52%)
    15 / 93 (16.13%)
         occurrences all number
    155
    23
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed [6]
    5 / 93 (5.38%)
    5 / 93 (5.38%)
         occurrences all number
    9
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed [7]
    9 / 93 (9.68%)
    1 / 93 (1.08%)
         occurrences all number
    21
    1
    Myalgia
         subjects affected / exposed [8]
    13 / 93 (13.98%)
    3 / 93 (3.23%)
         occurrences all number
    33
    10
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed [9]
    6 / 93 (6.45%)
    1 / 93 (1.08%)
         occurrences all number
    6
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

    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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