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    Clinical Trial Results:
    A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).

    Summary
    EudraCT number
    		 2016-004420-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Dec 2015

    Results information
    Results version number
    		 v1
    This version publication date
    16 Mar 2017
    First version publication date
    16 Mar 2017
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    205213
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02451514
    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
    Final
    Date of interim/final analysis
    07 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the antibody persistence against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, as measured by the percentage of subjects with hSBA titers ≥ lower limit quantitation (LLQ) and other thresholds, hSBA Geometric Mean Titers (GMTs) and geometric mean ratios (GMRs). • To evaluate the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in vaccine-naïve subjects (VNS) of similar age, as measured by the percentage of subjects with hSBA titers ≥LLQ and other thresholds, hSBA GMTs and GMRs.
    Protection of trial subjects
    The study was conducted in compliance with the protocol, Good Clinical Practices (GCPs) and applicable regulatory requirement(s). This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations, Novartis codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2015
    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
    Chile: 13
    Country: Number of subjects enrolled
    Panama: 88
    Country: Number of subjects enrolled
    Colombia: 28
    Worldwide total number of subjects
    129
    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)
    0
    Adolescents (12-17 years)
    45
    Adults (18-64 years)
    84
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 5 sites in Panama, 3 sites in Colombia and 1 site in Chile.

    Pre-assignment
    Screening details
    		 Healthy adolescents and young adults, who previously participated in studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158) and who received a 2-dose series of MenABCWY+OMV or 1 dose of Menveo (MenACWY), were included in the present study, along with vaccine-naïve subjects of similar age.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was an open-label study. Therefore, no blinding procedures were utilized.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenABCWY+OMV Group
    Arm description
    		 Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose (0.5 mL)

    Arm title
    		 MenACWY Group
    Arm description
    		 Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses (0.5 mL each), 1 month apart

    Arm title
    		 Naive Group
    Arm description
    		 Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses (0.5 mL each), 1 month apart

    Number of subjects in period 1
    		MenABCWY+OMV Group MenACWY Group Naive Group
    Started
    33
    46
    50
    Completed
    33
    46
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenABCWY+OMV Group
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.

    Reporting group title
    MenACWY Group
    Reporting group description
    		 Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.

    Reporting group title
    Naive Group
    Reporting group description
    		 Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.

    Reporting group values
    		 MenABCWY+OMV Group MenACWY Group Naive Group Total
    Number of subjects
    		 33 46 50 129
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 12 14 19 45
        Adults (18-64 years)
    		 21 32 31 84
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 18.61 ( 2.207 ) 18.72 ( 1.87 ) 17.96 ( 2.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 27 25 74
        Male
    		 11 19 25 55

    End points

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    End points reporting groups
    Reporting group title
    MenABCWY+OMV Group
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.

    Reporting group title
    MenACWY Group
    Reporting group description
    		 Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.

    Reporting group title
    Naive Group
    Reporting group description
    		 Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.

    Primary: Percentage of subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains

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    End point title
    		 Percentage of subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [1]
    End point description
    Antibody levels against N. meningitidis serogroups A, C, W and Y and serogroup B test strains (H44/76, 5/99, M14459, M07-024184, M01-0240364, NZ98/254) in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects, as measured by the percentages of subjects with hSBA (human serum bactericidal assay) ≥ LLQ (lower limit of quantitation). The data were reported based on the FAS (Full Analysis Set) immunogenicity persistence population set, which included all subjects in the Enrolled population who provided at least one evaluable serum sample at baseline (Visit 1 in V102_02E2) and whose assay results were available for at least one strain.
    End point type
    Primary
    End point timeframe
    Day 1 (4 years persistence)
    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 immunogenicity results will be updated when they become available.
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Percentage
    number (confidence interval 95%)
        Serogroup A
    ( to )
    ( to )
    ( to )
        Serogroup C
    ( to )
    ( to )
    ( to )
        Serogroup W
    ( to )
    ( to )
    ( to )
        Serogroup Y
    ( to )
    ( to )
    ( to )
        H44/76
    ( to )
    ( to )
    ( to )
        5/99
    ( to )
    ( to )
    ( to )
        M14459
    ( to )
    ( to )
    ( to )
        M07-024184
    ( to )
    ( to )
    ( to )
        M01-0240364
    ( to )
    ( to )
    ( to )
        NZ98/254
    ( to )
    ( to )
    ( to )
    Notes
    [2] - The immunogenicity results will be updated when they become available.
    [3] - The immunogenicity results will be updated when they become available.
    [4] - The immunogenicity results will be updated when they become available.
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination

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    End point title
    		 Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination
    End point description
    Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema, Swelling and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination. The data were reported based on the Solicited Safety Set, which included all subjects in the FAS Immunogenicity population who provided post-vaccination reactogenicity data.
    End point type
    Secondary
    End point timeframe
    Within 30 min after each vaccination
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Erythema (1st vacc.) (N=33;46;50)
    0
    1
    0
        Erythema (2nd vacc.) (N=0;44;50)
    0
    1
    0
        Induration (1st vacc.) (N=33;46;50)
    0
    0
    0
        Induration (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Pain (1st vacc.) (N=33;46;50)
    4
    8
    6
        Pain (2nd vacc.) (N=0;44;50)
    0
    3
    4
        Arthralgia (1st vacc.) (N=33;46;50)
    0
    0
    0
        Arthralgia (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Chills (1st vacc.) (N=33;46;50)
    0
    0
    0
        Chills (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Fatigue (1st vacc.) (N=33;46;50)
    0
    0
    0
        Fatigue (2nd vacc.) (N=0;44;50)
    0
    0
    1
        Headache (1st vacc.) (N=33;46;50)
    1
    0
    0
        Headache (2nd vacc.) (N=0;44;50)
    0
    0
    1
        Loss of Appetite (1st vacc.) (N=33;46;50)
    0
    0
    0
        Loss of Appetite (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Myalgia (1st vacc.) (N=33;46;50)
    0
    0
    0
        Myalgia (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Nausea (1st vacc.) (N=33;46;50)
    0
    0
    0
        Nausea (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Fever (1st vacc.) (N=33;46;50)
    0
    0
    0
        Fever (2nd vacc.) (N=0;44;50)
    0
    0
    0
        Prevention of Pain/Fever (1st vacc.) (N=33;45;50)
    0
    0
    0
        Prevention of Pain/Fever (2nd vacc.) (N=0;44;50)
    0
    0
    1
        Treatment of Pain/Fever (1st vacc.) (N=33;45;50)
    0
    0
    0
        Treatment of Pain/Fever (2nd vacc.) (N=0;44;50)
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local symptoms

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    End point title
    		 Number of subjects with any solicited local symptoms
    End point description
    Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. The data were reported based on the Solicited Safety Set, which included all subjects in the FAS Immunogenicity population who provided post-vaccination reactogenicity data.
    End point type
    Secondary
    End point timeframe
    From Day 1 (6 h) to Day 7 after each vaccination
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Any local AEs (1st vacc.) (N=33;46;50)
    31
    41
    47
        Erythema (1st vacc.) (N=33;45;50)
    8
    7
    8
        Induration (1st vacc.) (N=33;46;50)
    12
    7
    13
        Pain (1st vacc.) (N=33;46;50)
    31
    41
    47
        Any local AEs (2nd vacc.) (N=0;45;50)
    0
    35
    41
        Erythema (2nd vacc.) (N=0;45;49)
    0
    6
    7
        Induration (2nd vacc.) (N=0;45;50)
    0
    9
    8
        Pain (2nd vacc.) (N=0;45;50)
    0
    34
    41
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited systemic symptoms and other solicited data

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    End point title
    		 Number of subjects with solicited systemic symptoms and other solicited data
    End point description
    Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade. The data were reported based on the Solicited Safety Set, which included all subjects in the FAS Immunogenicity population who provided post-vaccination reactogenicity data.
    End point type
    Secondary
    End point timeframe
    From Day 1 (6 h) to Day 7 after each vaccination
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Any systemic AEs (1st vacc.) (N=33;46;50)
    24
    35
    37
        Arthralgia (1st vacc.) (N=33;46;50)
    8
    8
    15
        Chills (1st vacc.) (N=33;46;50)
    5
    11
    11
        Fatigue (1st vacc.) (N=33;45;50)
    14
    19
    24
        Headache (1st vacc.) (N=33;46;50)
    19
    20
    23
        Loss of Appetite (1st vacc.) (N=33;45;50)
    5
    9
    9
        Myalgia (1st vacc.) (N=33;46;50)
    18
    22
    23
        Nausea (1st vacc.) (N=33;46;50)
    4
    10
    13
        Fever (1st vacc.) (N=33;46;50)
    0
    4
    8
        Prevention of Pain/Fever (1st vacc.) (N=33;44;50)
    0
    1
    1
        Treatment of Pain/Fever (1st vacc.) (N=33;44;50)
    8
    7
    11
        Any systemic AEs (2nd vacc.) (N=0;45;50)
    0
    22
    28
        Arthralgia (2nd vacc.) (N=0;45;50)
    0
    4
    7
        Chills (2nd vacc.) (N=0;45;50)
    0
    5
    9
        Fatigue (2nd vacc.) (N=0;44;50)
    0
    10
    12
        Headache (2nd vacc.) (N=0;44;50)
    0
    11
    18
        Loss of Appetite (2nd vacc.) (N=0;45;50)
    0
    3
    5
        Myalgia (2nd vacc.) (N=0;45;50)
    0
    12
    14
        Nausea (2nd vacc.) (N=0;45;50)
    0
    4
    4
        Fever (2nd vacc.) (N=0;45;50)
    0
    4
    2
        Prevention of Pain/Fever (2nd vacc.) (N=0;45;50)
    0
    1
    3
        Treatment of Pain/Fever (2nd vacc.) (N=0;45;50)
    0
    2
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs

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    End point title
    		 Number of subjects with unsolicited AEs
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination. The data were reported based on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Any AEs
    11
    21
    20
        Possibly or Probably Related AEs
    3
    11
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with medically attended AEs reported during the entire study period

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    End point title
    		 Number of subjects with medically attended AEs reported during the entire study period
    End point description
    Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. The data were reported based on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Medically attended AEs
    2
    6
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period

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    End point title
    		 Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period
    End point description
    The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination. The data were reported based on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        AEs leading to premature withdrawal
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) reported during the entire study period

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    End point title
    		 Number of subjects with serious adverse events (SAEs) reported during the entire study period
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination. The data were reported based on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
    End point values
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Number of subjects analysed
    33
    46
    50
    Units: Subjects
        Any SAEs
    0
    0
    0
        Possibly or probably related SAEs
    0
    0
    0
        AEs leading to death
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    MenABCWY+OMV Group
    Reporting group description
    		 Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.

    Reporting group title
    MenACWY Group
    Reporting group description
    		 Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.

    Reporting group title
    Naive Group
    Reporting group description
    		 Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.

    Serious adverse events
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 46 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenABCWY+OMV Group MenACWY Group Naive Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 33 (100.00%)
    44 / 46 (95.65%)
    48 / 50 (96.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 33 (57.58%)
    23 / 46 (50.00%)
    28 / 50 (56.00%)
         occurrences all number
    43
    84
    120
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    5 / 33 (15.15%)
    14 / 46 (30.43%)
    16 / 50 (32.00%)
         occurrences all number
    10
    25
    31
    Fatigue
         subjects affected / exposed
    14 / 33 (42.42%)
    20 / 46 (43.48%)
    27 / 50 (54.00%)
         occurrences all number
    29
    75
    82
    Injection site erythema
         subjects affected / exposed
    11 / 33 (33.33%)
    26 / 46 (56.52%)
    30 / 50 (60.00%)
         occurrences all number
    45
    135
    123
    Injection site induration
         subjects affected / exposed
    18 / 33 (54.55%)
    27 / 46 (58.70%)
    30 / 50 (60.00%)
         occurrences all number
    75
    173
    169
    Injection site pain
         subjects affected / exposed
    31 / 33 (93.94%)
    42 / 46 (91.30%)
    48 / 50 (96.00%)
         occurrences all number
    114
    295
    333
    Pyrexia
         subjects affected / exposed
    0 / 33 (0.00%)
    8 / 46 (17.39%)
    10 / 50 (20.00%)
         occurrences all number
    0
    12
    13
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 33 (12.12%)
    10 / 46 (21.74%)
    15 / 50 (30.00%)
         occurrences all number
    11
    30
    25
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 33 (24.24%)
    11 / 46 (23.91%)
    19 / 50 (38.00%)
         occurrences all number
    14
    35
    51
    Myalgia
         subjects affected / exposed
    18 / 33 (54.55%)
    25 / 46 (54.35%)
    26 / 50 (52.00%)
         occurrences all number
    42
    85
    96
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 33 (3.03%)
    6 / 46 (13.04%)
    1 / 50 (2.00%)
         occurrences all number
    1
    6
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 33 (15.15%)
    11 / 46 (23.91%)
    13 / 50 (26.00%)
         occurrences all number
    11
    25
    30

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2014
    Allow pregnancy test be performed in urine or blood sample.

    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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