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    Clinical Trial Results:
    A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents with Either MenACWY Conjugate Vaccine or Menomune®

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-005059-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jul 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    18 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC needed to study because of EudraCT system glitch and updates to results are required.

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P6E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01018732
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics Inc.
    Sponsor organisation address
    350 Massachusetts Ave, Cambridge, United States, 02139
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics Inc., RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics Inc., RegistryContactVaccinesUS@novartis.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
    09 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the persistence of the antibody response at 5 years after one dose of MenACWY or Menomune®, as measured by the percentage of subjects with bactericidal activity using human complement (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y. 2. To evaluate the antibody response to one dose of MenACWY in subjects who had previously received one dose of MenACWY compared to the antibody response to one dose of MenACWY in meningococcal vaccine-naïve subjects, as measured by hSBA geometric mean titers (GMTs) directed against N. meningitidis serogroups A, C, W-135 and Y, at 28 days after vaccination.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    19 Jan 2010
    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: 155
    Worldwide total number of subjects
    155
    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)
    38
    Adults (18-64 years)
    117
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 3 centers in the US.

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was designed as an open-label study; all subjects received the same vaccine, their allocation had been previously revealed to the sites after unblinding of the parent study. Subjects, investigators, and other study personnel were not blinded. The only personnel who were blinded were the data analysts and the laboratory personnel who received the sera.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY-CRM Vaccine
    Arm description
    		 Subjects had been given one dose of Meningococcal (groups A, C, W, and Y) vaccine conjugated to CRM197 (cross-reactive material-mutant of diphtheria toxin) (MenACWY) 5 years ago.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    N/A
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of 0.5mL.

    Arm title
    		 Licensed Polysaccharide Meningococcal Vaccine
    Arm description
    		 Subjects had been given one dose of licensed Men ACWY (Menomune®) 5 years ago.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    N/A
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of 0.5mL.

    Arm title
    		 Meningococcal Naïve
    Arm description
    		 Subjects were between 16 years to 23 years (age-inclusive) and meningococcal vaccine naïve.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    N/A
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of 0.5mL.

    Number of subjects in period 1
    		MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Started
    50
    51
    54
    Completed
    49
    49
    50
    Not completed
    1
    2
    4
         Unable to classify
    -
    -
    1
         Inappropriate enrolment
    -
    1
    -
         Lost to follow-up
    -
    -
    3
         Protocol deviation
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-CRM Vaccine
    Reporting group description
    		 Subjects had been given one dose of Meningococcal (groups A, C, W, and Y) vaccine conjugated to CRM197 (cross-reactive material-mutant of diphtheria toxin) (MenACWY) 5 years ago.

    Reporting group title
    Licensed Polysaccharide Meningococcal Vaccine
    Reporting group description
    		 Subjects had been given one dose of licensed Men ACWY (Menomune®) 5 years ago.

    Reporting group title
    Meningococcal Naïve
    Reporting group description
    		 Subjects were between 16 years to 23 years (age-inclusive) and meningococcal vaccine naïve.

    Reporting group values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve Total
    Number of subjects
    		 50 51 54 155
    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)
    		 18.8 ( 1.9 ) 19.2 ( 2 ) 20.5 ( 2.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 28 33 83
        Male
    		 28 23 21 72
    Subject analysis sets

    Subject analysis set title
    Exposed Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects who actually received the study vaccination.

    Subject analysis set title
    Enrolled Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who signed an informed consent and underwent screening procedure(s).

    Subject analysis set title
    FAS, Immunogenicity after one dose of MenACWY (FAS Booster)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received the study vaccination, and provided at least one evaluable serum sample before or after baseline and whose assay result is available for at least one serogroup.

    Subject analysis set title
    Full Analysis Set, Antibody Persistence (FAS Persist)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population with an evaluable blood sample at day 1 and whose assay result was available for at least one serogroup.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Population who provided post-baseline safety data.

    Subject analysis sets values
    		 Exposed Population Enrolled Population FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Full Analysis Set, Antibody Persistence (FAS Persist) Safety Population
    Number of subjects
    153
    155
    148
    153
    153
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    19.5 ( 2.1 )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    83
        Male
    72

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-CRM Vaccine
    Reporting group description
    		 Subjects had been given one dose of Meningococcal (groups A, C, W, and Y) vaccine conjugated to CRM197 (cross-reactive material-mutant of diphtheria toxin) (MenACWY) 5 years ago.

    Reporting group title
    Licensed Polysaccharide Meningococcal Vaccine
    Reporting group description
    		 Subjects had been given one dose of licensed Men ACWY (Menomune®) 5 years ago.

    Reporting group title
    Meningococcal Naïve
    Reporting group description
    		 Subjects were between 16 years to 23 years (age-inclusive) and meningococcal vaccine naïve.

    Subject analysis set title
    Exposed Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects who actually received the study vaccination.

    Subject analysis set title
    Enrolled Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who signed an informed consent and underwent screening procedure(s).

    Subject analysis set title
    FAS, Immunogenicity after one dose of MenACWY (FAS Booster)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received the study vaccination, and provided at least one evaluable serum sample before or after baseline and whose assay result is available for at least one serogroup.

    Subject analysis set title
    Full Analysis Set, Antibody Persistence (FAS Persist)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population with an evaluable blood sample at day 1 and whose assay result was available for at least one serogroup.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Population who provided post-baseline safety data.

    Primary: 1. Percentages of Subjects With Serum Bactericidal Activity ≥8 at 5 Years After Primary Vaccination

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    End point title
    		 1. Percentages of Subjects With Serum Bactericidal Activity ≥8 at 5 Years After Primary Vaccination [1]
    End point description
    Persistence of antibody response was measured by the percentages of subjects who showed hSBA ≥8 [i.e. percentages of subjects with hSBA titer ≥8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera were tested against Neisseria meningitides (N. Meningitides) serogroups A, C, W-135 and Y. The analysis was done on the FAS, Antibody Persistence Population.
    End point type
    Primary
    End point timeframe
    Day 1 (5 years after primary vaccination).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    50
    50
    53
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A
    30 (18 to 45)
    44 (30 to 59)
    11 (4 to 23)
        Men C
    76 (62 to 87)
    62 (47 to 75)
    51 (37 to 65)
        Men W-135
    72 (58 to 84)
    56 (41 to 70)
    51 (37 to 65)
        Men Y
    76 (62 to 87)
    50 (36 to 64)
    55 (40 to 68)
    No statistical analyses for this end point

    Primary: 2. Geometric Mean Titer After Booster Vaccination

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    End point title
    		 2. Geometric Mean Titer After Booster Vaccination
    End point description
    Immunogenicity was measured by hSBA and reported as hSBA Geometric Mean Titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naïve subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Population.
    End point type
    Primary
    End point timeframe
    Day 8, Day 29 (after a booster at 5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    49
    49
    50
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline, Men A
    5.16 (3.46 to 7.7)
    7.31 (4.94 to 11)
    3.06 (2.06 to 4.55)
        Day 8, Men A
    1059 (585 to 1917)
    45 (25 to 80)
    34 (19 to 61)
        Day 29, Men A, (N=48, 49, 50)
    819 (514 to 1305)
    147 (94 to 232)
    113 (72 to 179)
        Baseline, Men C
    20 (13 to 33)
    19 (12 to 31)
    7.34 (4.6 to 12)
        Day 8, Men C
    1603 (893 to 2877)
    36 (20 to 64)
    70 (39 to 124)
        Day 29, Men C
    1217 (717 to 2066)
    51 (30 to 86)
    127 (75 to 214)
        Baseline, Men W-135
    29 (17 to 49)
    12 (7.02 to 19)
    11 (6.31 to 18)
        Day 8, Men W-135
    1685 (1042 to 2725)
    34 (21 to 54)
    63 (39 to 101)
        Day 29, Men W-135
    1644 (1090 to 2481)
    47 (32 to 71)
    79 (52 to 118)
        Baseline, Men Y
    28 (18 to 45)
    7.8 (4.91 to 12)
    8.69 (5.45 to 14)
        Day 8, Men Y, (N=48, 49, 50)
    2561 (1526 to 4298)
    21 (13 to 35)
    64 (39 to 107)
        Day 29, Men Y
    2092 (1340 to 3268)
    63 (41 to 98)
    110 (70 to 170)
    Statistical analysis title
    		 Statistical Analysis 1 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    2.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 4.1
    Statistical analysis title
    		 Statistical Analysis 2 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.2
    Statistical analysis title
    		 Statistical Analysis 3 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 2.9
    Statistical analysis title
    		 Statistical Analysis 4 for GMT After Booster
    Statistical analysis description
    Day 8, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.91
    Statistical analysis title
    		 Statistical Analysis 5 for GMT After Booster
    Statistical analysis description
    Day 8, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 52
    Statistical analysis title
    		 Statistical Analysis 6 for GMT After Booster
    Statistical analysis description
    Day 8, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14
         upper limit
    		 69
    Statistical analysis title
    		 Statistical Analysis 7 for GMT After Booster
    Statistical analysis description
    Day 29, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.42
    Statistical analysis title
    		 Statistical Analysis 8 for GMT After Booster
    Statistical analysis description
    Day 29, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    5.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.01
         upper limit
    		 10
    Statistical analysis title
    		 Statistical Analysis 9 for GMT After Booster
    Statistical analysis description
    Day 29, Men A, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    7.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.86
         upper limit
    		 13
    Statistical analysis title
    		 Statistical Analysis 10 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 4.99
    Statistical analysis title
    		 Statistical Analysis 11 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.97
    Statistical analysis title
    		 Statistical Analysis 12 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    2.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 5.27
    Statistical analysis title
    		 Statistical Analysis 13 for GMT After Booster
    Statistical analysis description
    Day 8, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 1.13
    Statistical analysis title
    		 Statistical Analysis 14 for GMT After Booster
    Statistical analysis description
    Day 8, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21
         upper limit
    		 97
    Statistical analysis title
    		 Statistical Analysis 15 for GMT After Booster
    Statistical analysis description
    Day 8, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10
         upper limit
    		 51
    Statistical analysis title
    		 Statistical Analysis 16 for GMT After Booster
    Statistical analysis description
    Day 29, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.82
    Statistical analysis title
    		 Statistical Analysis 17 for GMT After Booster
    Statistical analysis description
    Day 29, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12
         upper limit
    		 48
    Statistical analysis title
    		 Statistical Analysis 18 for GMT After Booster
    Statistical analysis description
    Day 29, Men C, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    9.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.69
         upper limit
    		 20
    Statistical analysis title
    		 Statistical Analysis 19 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 2.21
    Statistical analysis title
    		 Statistical Analysis 20 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 4.96
    Statistical analysis title
    		 Statistical Analysis 21 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 5.57
    Statistical analysis title
    		 Statistical Analysis 22 for GMT After Booster
    Statistical analysis description
    Day 8, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.04
    Statistical analysis title
    		 Statistical Analysis 23 for GMT After Booster
    Statistical analysis description
    Day 8, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26
         upper limit
    		 94
    Statistical analysis title
    		 Statistical Analysis 24 for GMT After Booster
    Statistical analysis description
    Day 8, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14
         upper limit
    		 52
    Statistical analysis title
    		 Statistical Analysis 25 for GMT After Booster
    Statistical analysis description
    Day 29, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 1.04
    Statistical analysis title
    		 Statistical Analysis 26 for GMT After Booster
    Statistical analysis description
    Day 29, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20
         upper limit
    		 60
    Statistical analysis title
    		 Statistical Analysis 27 for GMT After Booster
    Statistical analysis description
    Day 29, Men W-135, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12
         upper limit
    		 36
    Statistical analysis title
    		 Statistical Analysis 28 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.69
    Statistical analysis title
    		 Statistical Analysis 29 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.94
         upper limit
    		 6.74
    Statistical analysis title
    		 Statistical Analysis 30 for GMT After Booster
    Statistical analysis description
    Day 1 (Pre-booster), Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    3.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.71
         upper limit
    		 6.13
    Statistical analysis title
    		 Statistical Analysis 31 for GMT After Booster
    Statistical analysis description
    Day 8, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.66
    Statistical analysis title
    		 Statistical Analysis 32 for GMT After Booster
    Statistical analysis description
    Day 8, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    Licensed Polysaccharide Meningococcal Vaccine v MenACWY-CRM Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    121
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 61
         upper limit
    		 241
    Statistical analysis title
    		 Statistical Analysis 33 for GMT After Booster
    Statistical analysis description
    Day 8, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20
         upper limit
    		 80
    Statistical analysis title
    		 Statistical Analysis 34 for GMT After Booster
    Statistical analysis description
    Day 29, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    Meningococcal Naïve v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.05
    Statistical analysis title
    		 Statistical Analysis 35 for GMT After Booster
    Statistical analysis description
    Day 29, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Licensed Polysaccharide Meningococcal Vaccine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 60
    Statistical analysis title
    		 Statistical Analysis 36 for GMT After Booster
    Statistical analysis description
    Day 29, Men Y, Pairwise comparison of geometric mean titer.
    Comparison groups
    MenACWY-CRM Vaccine v Meningococcal Naïve
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Vaccine Group Ratios
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10
         upper limit
    		 35

    Secondary: 3. Percentages of Subjects With Serum Bactericidal Activity ≥4 at 5 Years After Primary Vaccination

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    End point title
    		 3. Percentages of Subjects With Serum Bactericidal Activity ≥4 at 5 Years After Primary Vaccination
    End point description
    Persistence was measured by percentages of subjects with hSBA ≥ 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against N. Meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Antibody Persistence (FAS Persist) Population.
    End point type
    Secondary
    End point timeframe
    Day 1 (5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    50
    50
    53
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A
    34 (21 to 49)
    50 (36 to 64)
    23 (12 to 36)
        Men C
    84 (71 to 93)
    68 (53 to 80)
    70 (56 to 82)
        Men W-135
    80 (66 to 90)
    58 (43 to 72)
    55 (40 to 68)
        Men Y
    76 (62 to 87)
    60 (45 to 74)
    60 (46 to 74)
    No statistical analyses for this end point

    Secondary: 4. Geometric Mean Titer at 5 Years After Primary Vaccination

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    End point title
    		 4. Geometric Mean Titer at 5 Years After Primary Vaccination
    End point description
    Persistence was measured by hSBA and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera were tested against Neisseria meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Antibody Persistence (FAS Persist) Population.
    End point type
    Secondary
    End point timeframe
    Day 1 (5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    50
    50
    53
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A
    5.21 (3.51 to 7.74)
    7.56 (5.12 to 11)
    3 (2.05 to 4.4)
        Men C
    20 (12 to 31)
    19 (12 to 30)
    7.62 (4.86 to 12)
        Men W-135
    28 (17 to 46)
    12 (7.17 to 20)
    11 (6.53 to 17)
        Men Y
    27 (17 to 43)
    7.67 (4.85 to 12)
    9.38 (5.98 to 15)
    No statistical analyses for this end point

    Secondary: 5. Percentages of Subjects With Serum Bactericidal Activity ≥4 After Booster Vaccination

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    End point title
    		 5. Percentages of Subjects With Serum Bactericidal Activity ≥4 After Booster Vaccination
    End point description
    Immunogenicity was measured by hSBA ≥ 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera were tested against Neisseria meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Population.
    End point type
    Secondary
    End point timeframe
    Day 7, Day 28 post booster (5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    49
    49
    50
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 7 post booster , Men A
    100 (93 to 100)
    76 (61 to 87)
    66 (51 to 79)
        Day 28 post booster, Men A
    98 (89 to 100)
    94 (83 to 99)
    92 (81 to 98)
        Day 7 post booster, Men C
    100 (93 to 100)
    82 (68 to 91)
    94 (83 to 99)
        Day 28 post booster, Men C
    100 (93 to 100)
    90 (78 to 97)
    98 (89 to 100)
        Day 7 post booster, Men W-135
    100 (93 to 100)
    86 (73 to 94)
    92 (81 to 98)
        Day 28 post booster, Men W-135
    100 (93 to 100)
    94 (83 to 99)
    94 (83 to 99)
        Day 7 post booster, Men Y
    98 (89 to 100)
    78 (63 to 88)
    92 (81 to 98)
        Day 28 post booster, Men Y
    100 (93 to 100)
    100 (93 to 100)
    100 (93 to 100)
    No statistical analyses for this end point

    Secondary: 6. Percentages of Subjects With Serum Bactericidal Activity ≥8 After Booster Vaccination

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    End point title
    		 6. Percentages of Subjects With Serum Bactericidal Activity ≥8 After Booster Vaccination
    End point description
    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) ≥ 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera were tested against Neisseria meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Population.
    End point type
    Secondary
    End point timeframe
    Day 7, Day 28 post booster (5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    49
    49
    50
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 7 post booster, Men A
    100 (93 to 100)
    73 (59 to 85)
    64 (49 to 77)
        Day 28 post booster, Men A
    98 (89 to 100)
    94 (83 to 99)
    92 (81 to 98)
        Day 7 post booster, Men C
    100 (93 to 100)
    78 (63 to 88)
    90 (78 to 97)
        Day 28 post booster, Men C
    100 (93 to 100)
    84 (70 to 93)
    98 (89 to 100)
        Day 7 post booster, Men W-135
    100 (93 to 100)
    84 (70 to 93)
    88 (76 to 95)
        Day 28 post booster, Men W-135
    100 (93 to 100)
    92 (80 to 98)
    94 (83 to 99)
        Day 7 post booster, Men Y
    98 (89 to 100)
    76 (61 to 87)
    90 (78 to 97)
        Day 28 post booster, Men Y
    100 (93 to 100)
    96 (86 to 100)
    98 (89 to 100)
    No statistical analyses for this end point

    Secondary: 7. Geometric Mean Ratio After Booster Vaccination

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    End point title
    		 7. Geometric Mean Ratio After Booster Vaccination
    End point description
    Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1. The analysis was done on the FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Population.
    End point type
    Secondary
    End point timeframe
    Day 8 and Day 29 (at 5 Years After Primary Vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    49
    49
    50
    Units: Ratios
    geometric mean (confidence interval 95%)
        Men A (Day 8:1)
    205 (113 to 373)
    6.1 (3.4 to 11)
    11 (6.17 to 20)
        Men A (Day 29:1), N=48, N=49, N=50
    155 (92 to 262)
    20 (12 to 33)
    37 (22 to 62)
        Men C (Day 8:1)
    78 (47 to 130)
    1.85 (1.13 to 3.03)
    9.48 (5.76 to 16)
        Men C (Day 29:1)
    60 (37 to 97)
    2.64 (1.64 to 4.24)
    17 (11 to 28)
        Men W-135 (Day 8:1)
    58 (34 to 97)
    2.92 (1.75 to 4.87)
    5.95 (3.55 to 9.99)
        Men W-135 (Day 29:1)
    56 (33 to 95)
    4.06 (2.43 to 6.077)
    7.48 (4.46 to 13)
        Men Y (Day 8:1), N=48, N=49, N=50
    96 (56 to 167)
    2.69 (1.58 to 4.58)
    7.29 (4.26 to 12)
        Men Y (Day 29:1)
    74 (43 to 129)
    8.12 (4.73 to 14)
    13 (7.3 to 22)
    No statistical analyses for this end point

    Secondary: 8. Percentages of Subjects With hSBA Seroresponse After Booster Vaccination

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    End point title
    		 8. Percentages of Subjects With hSBA Seroresponse After Booster Vaccination
    End point description
    For a subject with hSBA titer <4 at baseline, seroresponse is defined as a post-vaccination hSBA titer ≥8; and for a subject with hSBA titer ≥4 at baseline, seroresponse is defined as a post-vaccination hSBA titer of at least 4 times the baseline. Sera were tested against Neisseria meningitidis serogroups A, C, W-135 and Y. The analysis was done on the FAS, Immunogenicity after one dose of MenACWY (FAS Booster) Population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 29 (5 years after primary vaccination).
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    49
    49
    50
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A, Day 8
    100 (93 to 100)
    51 (36 to 66)
    60 (45 to 74)
        Men A, Day 29
    100 (93 to 100)
    76 (61 to 87)
    90 (78 to 97)
        Men C, Day 8
    96 (86 to 100)
    16 (7 to 30)
    62 (47 to 75)
        Men C, Day 29
    96 (86 to 100)
    31 (18 to 45)
    80 (66 to 90)
        Men W-135, Day 8
    96 (86 to 100)
    37 (23 to 52)
    48 (34 to 63)
        Men W-135, Day 29
    98 (89 to 100)
    47 (33 to 62)
    58 (43 to 72)
        Men Y, Day 8
    94 (83 to 99)
    33 (20 to 48)
    54 (39 to 68)
        Men Y, Day 29
    94 (83 to 99)
    55 (40 to 69)
    76 (62 to 87)
    No statistical analyses for this end point

    Secondary: 9. Number of Subjects With at Least One Reactogenicity Sign After Booster Vaccination

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    End point title
    		 9. Number of Subjects With at Least One Reactogenicity Sign After Booster Vaccination
    End point description
    Local and systemic reactions were solicited to assess safety and tolerability of vaccination. The analysis was done on the safety population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7.
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    50
    50
    53
    Units: Number of Subjects
    number (not applicable)
        Local Reactions (any-total)
    30
    32
    40
        Pain (any)
    29
    27
    33
        Erythema (any)
    8
    8
    15
        Induration (any)
    5
    8
    5
        Systemic Reactions (any-total)
    31
    25
    38
        Chills (any)
    7
    5
    3
        Nausea (any)
    8
    9
    11
        Malaise (any)
    10
    11
    15
        Myalgia (any)
    16
    13
    17
        Arthalgia (any)
    3
    5
    6
        Headache (any)
    21
    17
    31
        Fever ( ≥ 38C ) (any)
    0
    0
    1
        Stayed Home (any)
    0
    2
    2
        Analges Antipyr Meds Used (any)
    10
    8
    9
    No statistical analyses for this end point

    Secondary: 10. Number of Subjects With Unsolicited Adverse Events After Booster Vaccination

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    End point title
    		 10. Number of Subjects With Unsolicited Adverse Events After Booster Vaccination
    End point description
    Number of subjects with unsolicited Adverse Events (AEs) within 7 days (day 1-7) after the vaccination. The analysis was done on the safety population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7.
    End point values
    		 MenACWY-CRM Vaccine Licensed Polysaccharide Meningococcal Vaccine Meningococcal Naïve
    Number of subjects analysed
    50
    50
    53
    Units: Subjects
        Any-Adverse Event
    12
    7
    10
        Ear & Labyrinth Disorders
    0
    0
    1
        Eye Disorders
    1
    0
    1
        Gastrointestinal Disorders
    1
    1
    0
        Gen. Disorders & Admin. Site Cond.
    2
    3
    4
        Infections & Infestations
    4
    1
    2
        Injury & Poisoning
    0
    1
    1
        Musculo., Connect. Tis. & Bone Dis.
    4
    0
    2
        Nervous System Disorders
    4
    2
    4
        Resp., Thoracic & Mediastinal Dis.
    0
    1
    0
        Skin & Subcutaneous Tis. Disorders
    2
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety was assessed up to 28 days after vaccination.
    Adverse event reporting additional description
    All the AEs reported were solicited post-injection reactions.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    MenACWY-CRM Vaccine
    Reporting group description
    		 Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diphtheria toxin) 5 years ago.

    Reporting group title
    Meningococcal Naïve
    Reporting group description
    		 Subjects were between 16 years to 23 years (age-inclusive) and meningococcal vaccine naïve.

    Reporting group title
    Licensed Polysaccharide Meningococcal Vaccine
    Reporting group description
    		 Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune®) 5 years ago.

    Serious adverse events
    		 MenACWY-CRM Vaccine Meningococcal Naïve Licensed Polysaccharide Meningococcal Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 53 (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
    		 MenACWY-CRM Vaccine Meningococcal Naïve Licensed Polysaccharide Meningococcal Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 50 (76.00%)
    46 / 53 (86.79%)
    36 / 50 (72.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    21 / 50 (42.00%)
    31 / 53 (58.49%)
    17 / 50 (34.00%)
         occurrences all number
    26
    43
    24
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    7 / 50 (14.00%)
    3 / 53 (5.66%)
    5 / 50 (10.00%)
         occurrences all number
    8
    4
    6
    Injection site erythema
         subjects affected / exposed
    8 / 50 (16.00%)
    15 / 53 (28.30%)
    8 / 50 (16.00%)
         occurrences all number
    8
    15
    9
    Injection site induration
         subjects affected / exposed
    5 / 50 (10.00%)
    5 / 53 (9.43%)
    8 / 50 (16.00%)
         occurrences all number
    5
    5
    8
    Injection site pain
         subjects affected / exposed
    29 / 50 (58.00%)
    33 / 53 (62.26%)
    27 / 50 (54.00%)
         occurrences all number
    31
    39
    28
    Malaise
         subjects affected / exposed
    10 / 50 (20.00%)
    15 / 53 (28.30%)
    11 / 50 (22.00%)
         occurrences all number
    12
    18
    12
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 50 (16.00%)
    11 / 53 (20.75%)
    9 / 50 (18.00%)
         occurrences all number
    8
    15
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 50 (6.00%)
    6 / 53 (11.32%)
    5 / 50 (10.00%)
         occurrences all number
    4
    6
    6
    Myalgia
         subjects affected / exposed
    18 / 50 (36.00%)
    18 / 53 (33.96%)
    13 / 50 (26.00%)
         occurrences all number
    21
    25
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2010
    Update of some analysis collection, physical assessment and study visits procedures.

    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.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23114372
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