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    Clinical Trial Results:
    A phase III, open, randomized, controlled primary vaccination study to demonstrate the non-inferiority of meningococcal vaccine GSK134612 given intramuscularly versus Mencevax™ ACWY given subcutaneously to healthy subjects aged 2 through 10 years of age

    Summary
    EudraCT number
    		 2012-000283-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jan 2009

    Results information
    Results version number
    		 v2
    This version publication date
    11 Aug 2016
    First version publication date
    25 Apr 2015
    Other versions
    		 v1 , v3
    Version creation reason
    • Correction of full data set
    Data (typos) were corrected .

    Trial information

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    Trial identification
    Sponsor protocol code
    109495
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00514904
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000429-PIP01-08
    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
    20 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Within 4 days after vaccination, in all subjects: - To demonstrate the non-inferiority of meningococcal vaccine GSK134612 as compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptoms. One month after vaccination, in the immunogenicity subset corresponding to the first 1125 enrolled subjects: - To demonstrate the non-inferiority of the vaccine response induced by meningococcal vaccine GSK134612 when compared to the licensed Mencevax ACWY in terms of serum bactericidal antibodies.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the day of vaccination and the subsequent 30 days after the last vaccination administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2007
    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
    Saudi Arabia: 102
    Country: Number of subjects enrolled
    Lebanon: 201
    Country: Number of subjects enrolled
    Philippines: 800
    Country: Number of subjects enrolled
    India: 401
    Worldwide total number of subjects
    1504
    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)
    1504
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 1504
    Number of subjects completed
    		 1501

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination: 3
    Period 1
    Period 1 title
    Active+ESFU Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix™ Group
    Arm description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY conjugate vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, intramuscular injection into the deltoid region of the non-dominant arm at Month 0.

    Arm title
    		 Mencevax ACWY Group
    Arm description
    		 Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax ACWY
    Investigational medicinal product code
    MenACWY
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose, subcutaneous injection into the upper region of the non-dominant arm.

    Number of subjects in period 1 [1]
    		Nimenrix™ Group Mencevax ACWY Group
    Started
    1125
    376
    Completed
    1101
    371
    Not completed
    24
    5
         Consent withdrawn by subject
    3
    2
         Lost to follow-up
    21
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Details provided in the Pre-assignment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix™ Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.

    Reporting group values
    		 Nimenrix™ Group Mencevax ACWY Group Total
    Number of subjects
    		 1125 376 1501
    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)
    		 5.6 ± 2.49 5.5 ± 2.45 -
    Gender categorical
    Units: Subjects
        Female
    		 526 175 701
        Male
    		 599 201 800

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix™ Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.

    Primary: Number of subjects with vaccine response to N. meningitidis serogroups A (MenA), MenC, MenY and MenW-135

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    End point title
    		 Number of subjects with vaccine response to N. meningitidis serogroups A (MenA), MenC, MenY and MenW-135
    End point description
    Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
    End point type
    Primary
    End point timeframe
    One month after vaccination (Post-vaccination, study Month 1)
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    723
    240
    Units: Subjects
        rSBA-MenA [N=594;192]
    529
    124
        rSBA-MenC [N=691;234]
    664
    210
        rSBA-MenW-135 [N=691;236]
    673
    195
        rSBA-MenY [N=723;240]
    670
    165
    Statistical analysis title
    		 Difference vaccine response to anti-rSBA-MenW135
    Statistical analysis description
    To demonstrate the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine when compared to Mencevax ACWY vaccine for Neisseria meningitidis serogroup W-135 in terms of serum bactericidal antibodies using baby rabbit complement (rSBA).
    Comparison groups
    Nimenrix™ Group v Mencevax ACWY Group
    Number of subjects included in analysis
    963
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.26
         upper limit
    		 20.23
    Notes
    [1] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.
    Statistical analysis title
    		 Difference vaccine response to anti-rSBA-MenA
    Statistical analysis description
    To demonstrate the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine when compared to Mencevax ACWY vaccine for Neisseria meningitidis serogroup A in terms of serum bactericidal antibodies using baby rabbit complement (rSBA).
    Comparison groups
    Nimenrix™ Group v Mencevax ACWY Group
    Number of subjects included in analysis
    963
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    24.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.52
         upper limit
    		 31.87
    Notes
    [2] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.
    Statistical analysis title
    		 Difference vaccine response to anti-rSBA-MenC
    Statistical analysis description
    To demonstrate the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine when compared to Mencevax ACWY vaccine for Neisseria meningitidis serogroup C in terms of serum bactericidal antibodies using baby rabbit complement (rSBA).
    Comparison groups
    Nimenrix™ Group v Mencevax ACWY Group
    Number of subjects included in analysis
    963
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    6.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.68
         upper limit
    		 11.08
    Notes
    [3] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.
    Statistical analysis title
    		 Difference in vaccine response to anti-rSBA-MenY
    Statistical analysis description
    To demonstrate the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine when compared to Mencevax ACWY vaccine for Neisseria meningitidis serogroup Y in terms of serum bactericidal antibodies using baby rabbit complement (rSBA).
    Comparison groups
    Nimenrix™ Group v Mencevax ACWY Group
    Number of subjects included in analysis
    963
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    23.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.02
         upper limit
    		 30.3
    Notes
    [4] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.

    Primary: Number of subjects with grade 3 general symptoms (solicited and unsolicited)

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    End point title
    		 Number of subjects with grade 3 general symptoms (solicited and unsolicited)
    End point description
    Grade 3 symptom= symptom that prevented normal, everyday activities
    End point type
    Primary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    1125
    376
    Units: Subjects
        Subjects
    10
    1
    Statistical analysis title
    		 Relative Risk for Grade 3 symptoms
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix conjugate vaccine as compared to Mencevax ACWY vaccine in terms of the incidence of any grade 3 general (solicited and unsolicited) symptoms.
    Comparison groups
    Nimenrix™ Group v Mencevax ACWY Group
    Number of subjects included in analysis
    1501
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.2202
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    3.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 20.25
    Notes
    [5] - Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) titers greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) titers greater than or equal to the cut-off values
    End point description
    The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1),
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    742
    250
    Units: Subjects
        rSBA-MenA ≥ 1:8, M0 [N=599;194]
    491
    162
        rSBA-MenA≥ 1:8, M1 [N=739;247]
    739
    246
        rSBA-MenA ≥ 1:128, M0 [N=599;194]
    476
    155
        rSBA-MenA≥ 1:128, M1 [N=739;247]
    739
    246
        rSBA-MenC≥ 1:8, M0 [N=692;237]
    224
    77
        rSBA-MenC≥ 1:8, M1 [N=742;248]
    738
    241
        rSBA-MenC ≥ 1:128 M0 [N=692;237]
    157
    51
        rSBA-MenC ≥ 1:128 M1 [N=742;248]
    736
    234
        rSBA-MenW-135 ≥ 1:8, M0 [N=693;237]
    455
    152
        rSBA-MenW-135 ≥ 1:8, M1 [N=742;250]
    742
    245
        rSBA-MenW-135. ≥ 1:128 M0 [N=693;237]
    389
    133
        rSBA-MenW-135 ≥ 1:128 M1 [N=742;250]
    742
    245
        rSBA-MenY ≥ 1:8, M0 [N=725;241]
    630
    198
        rSBA-MenY ≥ 1:8, M1 [N=742;250]
    742
    248
        rSBA-MenY≥ 1:128 M0 [N=725;241]
    590
    188
        rSBA-MenY ≥ 1:128 M1 [N=742;250]
    742
    246
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers
    End point description
    Antibody titers were expressed as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1),
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    742
    250
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenA, M0 [N=599;194]
    219.1 (186.5 to 257.4)
    227.7 (172.9 to 299.9)
        rSBA-MenA, M1 [N=739;247]
    6343.3 (5998.3 to 6708.1)
    2283.2 (2022.6 to 2577.3)
        rSBA-MenC, M0 [N=692;237]
    14.5 (12.5 to 16.7)
    14.2 (11.1 to 18.1)
        rSBA-MenC, M1 [N=742;248]
    4813.1 (4342.1 to 5335.3)
    1317 (1042.9 to 1663.3)
        rSBA-MenW-135, M0 [N=693;237]
    80.1 (67.4 to 95.3)
    68.8 (51.3 to 92.3)
        rSBA-MenW-135, M1 [N=742;250]
    11543.2 (10872.7 to 12255.1)
    2157.8 (1815.2 to 2565.1)
        rSBA-MenY, M0 [N=725;241]
    310 (268.8 to 357.3)
    241.7 (185.3 to 315.3)
        rSBA-MenY, M1 [N=742;250]
    10825.1 (10232.7 to 11451.7)
    2613.1 (2236.9 to 3052.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-tetanus toxoid (anti-TT) concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-tetanus toxoid (anti-TT) concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-TT concentrations were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL respectively.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1),
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    743
    250
    Units: Subjects
        Anti-TT ≥ 0.1 IU/mL, M0 [N=743;250]
    635
    220
        Anti-TT ≥ 0.1 IU/mL, M1 [N=740;249]
    733
    218
        Anti-TT ≥ 1.0 IU/mL, M0 [N=743;250]
    296
    107
        Anti-TT ≥1.0 IU/mL, M1 [N=740;249]
    720
    107
    No statistical analyses for this end point

    Secondary: Anti-tetanus toxoid (anti-TT) antibody concentrations

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    End point title
    		 Anti-tetanus toxoid (anti-TT) antibody concentrations
    End point description
    Antibody concentrations were expressed as geometric mean concentrations (GMCs)
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1),
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    743
    250
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-TT, M0 [N=743;250]
    0.65 (0.577 to 0.731)
    0.744 (0.609 to 0.908)
        Anti-TT, M1 [N=740;249]
    21.731 (19.821 to 23.825)
    0.709 (0.581 to 0.866)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide (anti-PS) concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-polysaccharide (anti-PS) concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-PS concentrations were ≥0.3 µg/mL and ≥2.0 µg/mL respectively FOR THE ant- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1).
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    370
    128
    Units: Subjects
        Anti-PSA ≥ 0.3 μg/mL, M0 [N=354;124]
    154
    41
        Anti-PSA ≥ 0.3 μg/mL, M1 [N=370;128]
    369
    126
        Anti-PSA ≥ 2.0 μg/mL, M0 [N=354;124]
    59
    12
        Anti-PSA ≥ 2.0 μg/mL, M1 [N=370;128]
    368
    123
        Anti-PSC ≥ 0.3 μg/mL, M0 [N=368;127]
    29
    7
        Anti-PSC ≥ 0.3 μg/mL, M1 [N=366;127]
    365
    127
        Anti-PSC ≥ 2.0 μg/mL, M0 [N=368;127]
    12
    2
        Anti-PSC ≥ 2.0 μg/mL M1 [N=366;127]
    363
    125
        Anti-PSW-135 ≥ 0.3 μg/mL, M0 [N=364;121]
    18
    11
        Anti-PSW-135 ≥ 0.3 μg/mL, M1 [N=370;121]
    368
    121
        Anti-PSW-135 ≥ 2.0 μg/mL M0 [N=364;121]
    5
    2
        Anti-PSW-135 ≥ 2.0 μg/mL M1 [N=370;121]
    353
    112
        Anti-PSY ≥ 0.3 μg/mL, M0 [N=368;121]
    28
    16
        Anti-PSY ≥ 0.3 μg/mL, M1 [N=370;122]
    369
    122
        Anti-PSY ≥ 2.0 μg/mL, M0 [N=368;121]
    11
    4
        Anti-PSY ≥ 2.0 μg/mL, M1 [N=370;122]
    362
    118
    No statistical analyses for this end point

    Secondary: Anti-polysaccharide (anti-PS) antibody concentrations

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    End point title
    		 Anti-polysaccharide (anti-PS) antibody concentrations
    End point description
    Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in µg/mL One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination (Pre vaccination, study Month 0 and post vaccination, study Month 1).
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    370
    128
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA, M0 [N=354,124]
    0.4 (0.35 to 0.46)
    0.29 (0.24 to 0.36)
        Anti-PSA, M1 [N=370,128]
    81.1 (71.34 to 92.2)
    25.43 (19.66 to 32.9)
        Anti-PSC, M0 [N=368,127]
    0.18 (0.17 to 0.19)
    0.17 (0.15 to 0.18)
        Anti-PSC, M1 [N=366,127]
    22.61 (20.24 to 25.25)
    25.69 (21.3 to 30.99)
        Anti-PSW-135, M0 [N=364,121]
    0.17 (0.16 to 0.18)
    0.17 (0.16 to 0.19)
        Anti-PSW-135, M1 [N=370,121]
    12.8 (11.32 to 14.48)
    13.85 (10.93 to 17.53)
        Anti-PSY, M0 [N=368,121]
    0.18 (0.17 to 0.2)
    0.2 (0.17 to 0.23)
        Anti-PSY, M1 [N=370,122]
    19.26 (17.1 to 21.69)
    22.71 (18.13 to 28.46)
    No statistical analyses for this end point

    Secondary: Number of subjects < 6 years of age with solicited local symptoms

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    End point title
    		 Number of subjects < 6 years of age with solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after vaccination.
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    575
    188
    Units: Subjects
        Any Pain
    104
    39
        Any Redness
    82
    31
        Any Swelling
    31
    15
    No statistical analyses for this end point

    Secondary: Number of subjects ≥ 6 years of age with solicited local symptoms

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    End point title
    		 Number of subjects ≥ 6 years of age with solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after vaccination.
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    542
    186
    Units: Subjects
        Any Pain
    105
    50
        Any Redness
    107
    36
        Any Swelling
    54
    16
    No statistical analyses for this end point

    Secondary: Number of subjects < 6 years of age with solicited general symptoms

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    End point title
    		 Number of subjects < 6 years of age with solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after vaccination
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    575
    188
    Units: Subjects
        Any Drowsiness
    34
    5
        Fever ≥ 37.5°C
    50
    12
        Any Irritability
    31
    6
        Any Loss of apptite
    35
    6
    No statistical analyses for this end point

    Secondary: Number of subjects ≥ 6 years of age with solicited general symptoms

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    End point title
    		 Number of subjects ≥ 6 years of age with solicited general symptoms
    End point description
    Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after vaccination.
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    542
    186
    Units: Subjects
        Any Fatigue
    33
    19
        Fever ≥ 37.5°C
    48
    19
        Any Gastrointestinal
    25
    15
        Any Headache
    51
    19
    No statistical analyses for this end point

    Secondary: Number of subjects reporting specific adverse events (AEs)

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    End point title
    		 Number of subjects reporting specific adverse events (AEs)
    End point description
    Specific AEs include: − rash (hives, idiopathic thrombocytopenic purpura, petechiae), − new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), and/or: − conditions prompting emergency room (ER) visits or or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis)
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months after vaccination
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    1125
    376
    Units: Subjects
        Rash (es)
    45
    16
        NOCI (s)
    3
    1
        ER visit (s)
    15
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited symptoms

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    End point title
    		 Number of subjects reporting any unsolicited symptoms
    End point description
    Unsolicited symptom covers any symptom 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.
    End point type
    Secondary
    End point timeframe
    Up to one month (Day 0-Day 30) after vaccination
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    1125
    376
    Units: Subjects
        Any (AE’s)
    198
    75
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months after vaccination
    End point values
    		 Nimenrix™ Group Mencevax ACWY Group
    Number of subjects analysed
    1125
    376
    Units: Subjects
        Any (SAE’s)
    15
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
    Adverse event reporting additional description
    This is specific for each SAE/AE that is entered.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    MenACWY Group
    Reporting group description
    		 -

    Reporting group title
    MenACWY-TT Group
    Reporting group description
    		 -

    Serious adverse events
    		 MenACWY Group MenACWY-TT Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 376 (1.86%)
    15 / 1125 (1.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 376 (0.27%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 376 (0.80%)
    3 / 1125 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    2 / 376 (0.53%)
    2 / 1125 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 376 (0.27%)
    3 / 1125 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 376 (0.00%)
    2 / 1125 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 376 (0.00%)
    2 / 1125 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 376 (0.00%)
    2 / 1125 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 1125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 1125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 1125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Food intolerance
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 1125 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACWY Group MenACWY-TT Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 376 (13.30%)
    107 / 1125 (9.51%)
    General disorders and administration site conditions
    Pain (< 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    39 / 188 (20.74%)
    104 / 575 (18.09%)
         occurrences all number
    39
    104
    Redness (< 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    31 / 188 (16.49%)
    82 / 575 (14.26%)
         occurrences all number
    31
    82
    Swelling (< 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    15 / 188 (7.98%)
    31 / 575 (5.39%)
         occurrences all number
    15
    31
    Pain (≥ 6 years of age)
    Additional description: Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    50 / 186 (26.88%)
    105 / 542 (19.37%)
         occurrences all number
    50
    105
    Redness (≥ 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    36 / 186 (19.35%)
    107 / 542 (19.74%)
         occurrences all number
    36
    107
    Swelling (≥ 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    16 / 186 (8.60%)
    54 / 542 (9.96%)
         occurrences all number
    16
    54
    Drowsiness
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    5 / 188 (2.66%)
    34 / 575 (5.91%)
         occurrences all number
    5
    34
    Fever (Orally) (< 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    12 / 188 (6.38%)
    50 / 575 (8.70%)
         occurrences all number
    12
    50
    Irritability
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    6 / 188 (3.19%)
    31 / 575 (5.39%)
         occurrences all number
    6
    31
    Loss of appetite
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    6 / 188 (3.19%)
    35 / 575 (6.09%)
         occurrences all number
    6
    35
    Fatigue
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    19 / 186 (10.22%)
    33 / 542 (6.09%)
         occurrences all number
    19
    33
    Fever (Orally) (≥ 6 years of age)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    19 / 186 (10.22%)
    48 / 542 (8.86%)
         occurrences all number
    19
    48
    Gastrointestinal
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    15 / 186 (8.06%)
    25 / 542 (4.61%)
         occurrences all number
    15
    25
    Headache
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    19 / 186 (10.22%)
    51 / 542 (9.41%)
         occurrences all number
    19
    51
    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.
    [10] - 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.
    [11] - 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.
    [12] - 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.
    [13] - 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.
    [14] - 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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