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    Clinical Trial Results:
    A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline’s Meningococcal ACWY Conjugate Vaccine (Menveo),Administered to Healthy Individuals 15 through 55 years of age , approximately 4-6 years after primary ACWY vaccination

    Summary
    EudraCT number
    		 2016-003186-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Dec 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Aug 2018
    First version publication date
    20 Jul 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of timeframe in adverse events reporting section as per NIH comments.

    Trial information

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    Trial identification
    Sponsor protocol code
    205352
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02986854
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate a sufficient immune response following a booster dose of MenACWY-CRM (Menveo) vaccine, given to subjects who previously received Menveo, as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y at Day 29 after vaccination 2. To demonstrate a sufficient immune response following a booster dose of MenACWY-CRM (Menveo) vaccine, given to subjects who previously received Menactra, as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y at Day 29 after vaccination
    Protection of trial subjects
    All subjects were observed for at least 30 minutes after vaccine administration with appropriate medical treatment readily available in case of anaphylaxis. Vaccine was administered by qualified and trained personnel and vaccine was given only to eligible subjects that had no contraindications to any components of the vaccine. Subjects were followed for 6 months for selected safety assessments.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Dec 2016
    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: 694
    Country: Number of subjects enrolled
    Puerto Rico: 10
    Worldwide total number of subjects
    704
    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)
    480
    Adults (18-64 years)
    224
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 1 center in Puerto Rico and 37 centers in Unites States.

    Pre-assignment
    Screening details
    		 704 subjects were enrolled in this study. Out of 704 enrolled, 701 received the study vaccine.

    Pre-assignment period milestones
    Number of subjects started
    		 704
    Number of subjects completed
    		 701

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not randomized: 3
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was an open-labelled study. Therefore, no blinding procedures were utilized.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menveo-Menveo Group
    Arm description
    		 Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W and Y) oligosaccharide diphthe-ria CRM-197 conjugate Vaccine (Menveo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection of MenACWY-CRM at Day 1.

    Arm title
    		 Menactra-Menveo Group
    Arm description
    		 Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W and Y) oligosaccharide diphthe-ria CRM-197 conjugate Vaccine (Menveo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection of MenACWY-CRM at Day 1.

    Arm title
    		 Naive Group
    Arm description
    		 Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
    Arm type
    		 Control

    Investigational medicinal product name
    Meningococcal (groups A, C, W and Y) oligosaccharide diphthe-ria CRM-197 conjugate Vaccine (Menveo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection of MenACWY-CRM at Day 1.

    Number of subjects in period 1 [1]
    		Menveo-Menveo Group Menactra-Menveo Group Naive Group
    Started
    301
    300
    100
    Completed
    298
    288
    97
    Not completed
    3
    12
    3
         Consent withdrawn by subject
    -
    1
    1
         Lost to follow-up
    3
    11
    2
    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: Number of subjects reported in the baseline period are subjects who received vaccination (exposed set). Out of 704 subjects enrolled worldwide, 3 subjects were not randomized into any group and therefore did not receive any vaccination

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menveo-Menveo Group
    Reporting group description
    		 Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Menactra-Menveo Group
    Reporting group description
    		 Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Naive Group
    Reporting group description
    		 Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.

    Reporting group values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group Total
    Number of subjects
    		 301 300 100 701
    Age categorical
    Units: Subjects
        Adolescents
    		 247 228 4 479
        Adults
    		 54 72 96 222
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 17.1 ± 3.66 17.9 ± 4.54 38.8 ± 10.47 -
    Gender categorical
    Units: Subjects
        Female
    		 144 156 68 368
        Male
    		 157 144 32 333
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 6 1 9
        Asian
    		 4 14 3 21
        Black or African American
    		 24 23 12 59
        Native Hawaiian or other Pacific Islander
    		 3 1 0 4
        Unspecified
    		 17 23 5 45
        White
    		 251 233 79 563

    End points

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    End points reporting groups
    Reporting group title
    Menveo-Menveo Group
    Reporting group description
    		 Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Menactra-Menveo Group
    Reporting group description
    		 Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Naive Group
    Reporting group description
    		 Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.

    Subject analysis set title
    pooled group (menveo-menveo and menactra-menveo)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups

    Primary: Percentages of subjects with human Serum Bactericidal Antibody (hSBA) seroresponse against Neisseria meningitidis serogroups A, C, W and Y.

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    End point title
    		 Percentages of subjects with human Serum Bactericidal Antibody (hSBA) seroresponse against Neisseria meningitidis serogroups A, C, W and Y.
    End point description
    Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
    End point type
    Primary
    End point timeframe
    At Day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    571
    Units: Percentages of subjects
    number (confidence interval 95%)
        hSBA-Men A, Pre < 4 (N-246,234,85,480)
    97.97 (95.32 to 99.34)
    97.01 (93.93 to 98.79)
    64.71 (53.59 to 74.77)
    97.50 (95.67 to 98.70)
        hSBA-Men A, Pre ≥ 4(N-43,48,8,91)
    88.37 (74.92 to 96.11)
    93.75 (82.8 to 98.69)
    75.00 (34.91 to 96.81)
    91.21 (83.41 to 96.13)
        hSBA-Men A, Total seroresponse(N-289,282,93,571)
    96.54 (93.73 to 98.33)
    96.45 (93.58 to 98.29)
    65.59 (55.02 to 75.14)
    96.50 (94.64 to 97.85)
        hSBA-Men C, Pre < 4(N-85,103,43,188)
    100 (95.75 to 100)
    100 (96.48 to 100)
    55.81 (39.88 to 70.92)
    100 (98.06 to 100)
        hSBA-Men C, Pre ≥ 4(N-203,177,50,380)
    93.6 (89.3 to 96.55)
    93.79 (89.15 to 96.86)
    58.00 (43.21 to 71.81)
    93.68 (90.75 to 95.91)
        hSBA-Men C, Total seroresponse(N-288,280,93,568)
    95.49 (92.4 to 97.57)
    96.07 (93.08 to 98.02)
    56.99 (46.31 to 67.22)
    95.77 (93.78 to 97.27)
        hSBA-Men W, Pre < 4(N-52,58,33,110)
    100 (93.15 to 100)
    100 (93.84 to 100)
    54.55 (36.35 to 71.89)
    100 (96.70 to 100)
        hSBA-Men W, Pre ≥ 4(N-237,223,59,460)
    94.94 (91.32 to 97.36)
    91.48 (87.01 to 94.79)
    25.42 (14.98 to 38.44)
    93.26 (90.57 to 95.38)
        hSBA-Men W, Total seroresponse(N-289,281,92,570)
    95.85 (92.86 to 97.84)
    93.24 (89.64 to 95.88)
    35.87 (26.13 to 46.54)
    94.56 (92.37 to 96.28)
        hSBA-Men Y, Pre < 4(N-115,123,54,238)
    100 (96.84 to 100)
    97.56 (93.04 to 99.49)
    55.56 (41.40 to 69.08)
    98.74 (96.36 to 99.74)
        hSBA-Men Y, Pre ≥ 4(N-172,157,39,329)
    94.77 (90.3 to 97.58)
    91.72 (86.26 to 95.52)
    46.15 (30.09 to 62.82)
    93.31 (90.05 to 95.76)
        hSBA-Men Y, Total seroresponse(N-287,280,93,567)
    96.86 (94.13 to 98.56)
    94.29 (90.89 to 96.7)
    51.61 (41.01 to 62.11)
    95.59 (93.56 to 97.13)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    30.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.76
         upper limit
    		 41.25
    Notes
    [1] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    30.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.66
         upper limit
    		 41.17
    Notes
    [2] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    30.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.89
         upper limit
    		 41.12
    Notes
    [3] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.15
         upper limit
    		 3.36
    Notes
    [4] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    38.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.54
         upper limit
    		 48.9
    Notes
    [5] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    39.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.16
         upper limit
    		 49.46
    Notes
    [6] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    38.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.03
         upper limit
    		 49.06
    Notes
    [7] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.12
         upper limit
    		 2.92
    Notes
    [8] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    59.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.49
         upper limit
    		 69.32
    Notes
    [9] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    57.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 46.71
         upper limit
    		 66.88
    Notes
    [10] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    58.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48.32
         upper limit
    		 67.94
    Notes
    [11] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    2.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 6.62
    Notes
    [12] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    45.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.11
         upper limit
    		 55.47
    Notes
    [13] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    42.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.34
         upper limit
    		 53.04
    Notes
    [14] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    43.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.92
         upper limit
    		 54.14
    Notes
    [15] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Difference in percentages
    Point estimate
    2.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 6.3
    Notes
    [16] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes after vaccination
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    301
    300
    100
    601
    Units: Participants
        Any Unsolicited AEs
    0
    8
    1
    8
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local and systemic AEs

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    End point title
    		 Number of subjects reporting solicited local and systemic AEs
    End point description
    Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)
    End point type
    Secondary
    End point timeframe
    From Day 1 (6 hours) through Day 7 after vaccination
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    296
    296
    97
    592
    Units: Participants
        Any Local symptom(N-296,296,97,592)
    119
    97
    41
    216
        Any Systemic symptom(N-296,296,97,592)
    162
    148
    35
    310
        Any Induration(N-286,286,92,592)
    15
    9
    8
    24
        Any Erythema(N-286,287,92,573)
    12
    8
    10
    20
        Any Pain(N-292,296,97,588)
    114
    96
    40
    210
        Any Nausea(N-294,294,97,588)
    48
    44
    13
    92
        Any Fatigue(N-295,296,97,591)
    113
    110
    19
    223
        Any Myalgia(N-294,296,97,590)
    55
    54
    15
    109
        Any Arthralgia(N-294,295,96,589)
    44
    38
    13
    82
        Any Headache(N-294,295,97,589)
    100
    82
    21
    182
        Any loss of apetite(N-294,296,97,590)
    37
    46
    6
    83
        Any chills(N-294,295,97,589)
    34
    35
    10
    69
        Fever(N-296,296,97,592)
    2
    5
    0
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting other indicators of reactogenicity

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    End point title
    		 Number of subjects reporting other indicators of reactogenicity
    End point description
    Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)
    End point type
    Secondary
    End point timeframe
    From Day 1 (6 hours) through Day 7 after vaccination
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    296
    296
    97
    592
    Units: Participants
        Analgesic/antipyretic-prophylaxis(N-294,295,96,589
    13
    15
    5
    28
        Analgesic/antipyretic-treatment(N-293,295,96 ,588)
    18
    24
    10
    42
        Body temp(36.0 - 36.4 ºC)(N-296,296,97,592)
    68
    57
    16
    125
        Body temp (36.5 - 36.9 ºC)(N-296,296,97,592)
    135
    141
    45
    276
        Body temp (37.0 - 37.4 ºC)(N-296,296,97,592)
    83
    77
    33
    160
        Body temp (37.5 - 37.9 ºC)(N-296,296,97,592)
    6
    9
    3
    15
        Body temp (38.0 - 38.4 ºC)(N-296,296,97,592)
    1
    2
    0
    3
        Body temp (38.5 - 38.9 ºC)(N-296,296,97,592)
    1
    3
    0
    4
        Body temp (39.0 - 39.4 ºC)(N-296,296,97,592)
    0
    0
    0
    0
        Body temp (39.5 - 39.9 ºC)(N-296,296,97,592)
    0
    0
    0
    0
        Body temp (>=40ºC)(N-296,296,97,592)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting all unsolicited AEs

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    End point title
    		 Number of subjects reporting all unsolicited AEs
    End point description
    An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 29 after vaccination
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    301
    300
    100
    601
    Units: Participants
        All unsolicited AEs
    74
    78
    22
    152
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting medically-attended AEs (MAAEs), AEs leading to withdrawal and serious AEs (SAEs)
    End point description
    Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 181 (entire study period)
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    301
    300
    100
    601
    Units: Participants
        Any MAAEs
    102
    79
    19
    181
        Any AEs leading to withdrawal
    0
    0
    0
    0
        Any SAEs
    3
    2
    3
    5
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup A

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    End point title
    		 Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup A
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    572
    Units: Percentages of subjects
    number (confidence interval 95%)
        hSBA-Men A ≥ 8, Day 1(N-289,282,93,571)
    12.46 (8.88 to 16.83)
    14.89 (10.95 to 19.59)
    4.3 (1.18 to 10.65)
    13.66 (10.95 to 16.75)
        hSBA-Men A ≥ 8, Day 4(N-144,138,48,282)
    11.11 (6.49 to 17.42)
    13.04 (7.92 to 19.83)
    4.17 (0.51 to 14.25)
    12.06 (8.5 to 16.44)
        hSBA-Men A ≥ 8, Day 6(N-146,140,44,286)
    53.42 (44.99 to 61.71)
    47.14 (38.66 to 55.75)
    9.09 (2.53 to 21.67)
    50.35 (44.4 to 56.29)
        hSBA-Men A ≥ 8, Day 29(N-290,282,93,572)
    98.62 (96.51 to 99.62)
    98.94 (96.92 to 99.78)
    70.97 (60.64 to 79.92)
    98.78 (97.49 to 99.51)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    8.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 13.41
    Notes
    [17] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between group differences in percentage
    Point estimate
    10.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.54
         upper limit
    		 16.14
    Notes
    [18] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between group differences in percentage
    Point estimate
    9.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.72
         upper limit
    		 13.58
    Notes
    [19] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between group differences in percentage
    Point estimate
    -2.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.17
         upper limit
    		 3.24
    Notes
    [20] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    6.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.57
         upper limit
    		 14.15
    Notes
    [21] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 16.52
    Notes
    [22] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    7.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 13.48
    Notes
    [23] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.84
         upper limit
    		 5.82
    Notes
    [24] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    44.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.25
         upper limit
    		 54.6
    Notes
    [25] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    38.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.93
         upper limit
    		 48.58
    Notes
    [26] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    41.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.15
         upper limit
    		 49.72
    Notes
    [27] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    6.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.31
         upper limit
    		 17.71
    Notes
    [28] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    27.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.25
         upper limit
    		 37.65
    Notes
    [29] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    27.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.6
         upper limit
    		 37.95
    Notes
    [30] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    27.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.5
         upper limit
    		 37.76
    Notes
    [31] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.56
         upper limit
    		 1.86
    Notes
    [32] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup C

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    End point title
    		 Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup C
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination) , day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    281
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men C ≥ 8, Day 1(N-288,281,93,569)
    61.11 (55.22 to 66.77)
    53.74 (47.72 to 59.68)
    33.33 (23.89 to 43.87)
    57.47 (53.29 to 61.57)
        hSBA-Men C ≥ 8, Day 4 (N-144,138,48,282)
    70.83 (62.68 to 78.1)
    60.14 (51.47 to 68.38)
    43.75 (29.48 to 58.82)
    65.6 (59.74 to 71.13)
        hSBA-Men C ≥ 8, Day 6(N-145,139,44,284)
    87.59 (81.09 to 92.47)
    92.09 (86.28 to 95.98)
    43.18 (28.35 to 58.97)
    89.79 (85.66 to 93.05)
        hSBA-Men C ≥ 8, Day 29(N-290,281,93,571)
    100 (98.74 to 100)
    99.64 (98.03 to 99.99)
    87.1 (78.55 to 93.15)
    99.82 (99.03 to 100)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    27.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.23
         upper limit
    		 38.27
    Notes
    [33] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    20.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.78
         upper limit
    		 31.03
    Notes
    [34] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    24.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.28
         upper limit
    		 33.86
    Notes
    [35] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    7.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 15.42
    Notes
    [36] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    27.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.04
         upper limit
    		 42.14
    Notes
    [37] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    16.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 31.9
    Notes
    [38] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    21.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.73
         upper limit
    		 36.11
    Notes
    [39] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    10.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 21.6
    Notes
    [40] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    44.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.65
         upper limit
    		 58.93
    Notes
    [41] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    48.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.45
         upper limit
    		 63.13
    Notes
    [42] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    46.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.52
         upper limit
    		 60.59
    Notes
    [43] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.84
         upper limit
    		 2.69
    Notes
    [44] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.53
         upper limit
    		 21.22
    Notes
    [45] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [46]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    12.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.1
         upper limit
    		 20.89
    Notes
    [46] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    12.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.34
         upper limit
    		 21.05
    Notes
    [47] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 1.99
    Notes
    [48] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentage of subjects with hSBA titer ≥8 against N. meningitidis serogroup W

    		 Close Top of page
    End point title
    		 Percentage of subjects with hSBA titer ≥8 against N. meningitidis serogroup W
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination), day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men W ≥ 8, Day 1(N-289,282,93,571)
    75.43 (70.05 to 80.29)
    76.95 (71.59 to 81.74)
    61.29 (50.62 to 71.22)
    76.18 (72.47 to 79.62)
        hSBA-Men W ≥ 8, Day 4(144,138,48,282)
    81.94 (74.67 to 87.85)
    82.61 (75.24 to 88.53)
    62.5 (47.35 to 76.05)
    82.27 (77.3 to 86.54)
        hSBA-Men W ≥ 8, Day 6(N-146,140,44,286)
    93.84 (88.62 to 97.14)
    97.86 (93.87 to 99.56)
    63.64 (47.77 to 77.59)
    95.8 (92.79 to 97.81)
        hSBA-Men W ≥ 8, Day 29(N-290,281,92,571)
    100 (98.74 to 100)
    100 (98.7 to 100)
    84.78 (75.79 to 91.42)
    100 (99.36 to 100)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    14.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.46
         upper limit
    		 25.39
    Notes
    [49] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    15.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 26.89
    Notes
    [50] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    14.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.91
         upper limit
    		 25.62
    Notes
    [51] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [52]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.51
         upper limit
    		 5.5
    Notes
    [52] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.25
         upper limit
    		 34.83
    Notes
    [53] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [54]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    20.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.88
         upper limit
    		 35.5
    Notes
    [54] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [55]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.53
         upper limit
    		 34.58
    Notes
    [55] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [56]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.67
         upper limit
    		 8.4
    Notes
    [56] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [57]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    30.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.78
         upper limit
    		 45.45
    Notes
    [57] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [58]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    34.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.29
         upper limit
    		 49.2
    Notes
    [58] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [59]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    32.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.3
         upper limit
    		 47.13
    Notes
    [59] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -4.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.45
         upper limit
    		 0.74
    Notes
    [60] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    15.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.28
         upper limit
    		 23.95
    Notes
    [61] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    15.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.28
         upper limit
    		 23.95
    Notes
    [62] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [63]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    15.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.28
         upper limit
    		 23.94
    Notes
    [63] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [64]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.31
         upper limit
    		 1.35
    Notes
    [64] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup Y

    		 Close Top of page
    End point title
    		 Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup Y
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination), day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    281
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men Y ≥ 8, Day 1(N-287,281,93,568)
    54.01 (48.05 to 59.88)
    46.98 (41.02 to 52.99)
    32.26 (22.93 to 42.75)
    50.53 (46.33 to 54.72)
        hSBA-Men Y ≥ 8, Day 4(N-143,138,48,281)
    55.24 (46.71 to 63.56)
    55.8 (47.1 to 64.24)
    33.33 (20.4 to 48.41)
    55.52 (49.5 to 61.42)
        hSBA-Men Y ≥ 8, Day 6(N-145,140,44,285)
    85.52 (78.72 to 90.81)
    87.86 (81.27 to 92.76)
    45.45 (30.39 to 61.15)
    86.67 (82.16 to 90.39)
        hSBA-Men Y ≥ 8, Day 29(N-290,281,93,571)
    100 (98.74 to 100)
    99.64 (98.03 to 99.99)
    77.42 (67.58 to 85.45)
    99.82 (99.03 to 100)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [65]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    21.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.19
         upper limit
    		 32.25
    Notes
    [65] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [66]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    14.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.15
         upper limit
    		 25.29
    Notes
    [66] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [67]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    18.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.44
         upper limit
    		 27.92
    Notes
    [67] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [68]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    7.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 15.17
    Notes
    [68] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [69]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    21.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.57
         upper limit
    		 36.37
    Notes
    [69] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [70]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.05
         upper limit
    		 37
    Notes
    [70] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [71]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.89
         upper limit
    		 35.38
    Notes
    [71] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [72]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.11
         upper limit
    		 11.03
    Notes
    [72] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [73]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    40.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.26
         upper limit
    		 54.95
    Notes
    [73] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [74]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    42.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.71
         upper limit
    		 57.17
    Notes
    [74] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [75]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    41.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.12
         upper limit
    		 55.55
    Notes
    [75] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [76]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.41
         upper limit
    		 5.73
    Notes
    [76] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [77]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.26
         upper limit
    		 32.08
    Notes
    [77] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [78]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.86
         upper limit
    		 31.74
    Notes
    [78] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [79]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.08
         upper limit
    		 31.9
    Notes
    [79] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [80]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 1.99
    Notes
    [80] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup A

    		 Close Top of page
    End point title
    		 Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup A
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination), day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    572
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men A ≥ 16, Day 1(N-289,282,93,571)
    8.3 (5.39 to 12.1)
    9.57 (6.4 to 13.62)
    1.08 (0.03 to 5.85)
    8.93 (6.72 to 11.58)
        hSBA-Men A ≥ 16, Day 4(N-144,138,48,282)
    8.33 (4.38 to 14.1)
    8.7 (4.57 to 14.7)
    2.08 (0.05 to 11.07)
    8.51 (5.53 to 12.4)
        hSBA-Men A ≥ 16, Day 6(N-146,140,44,286)
    45.89 (37.62 to 54.33)
    41.43 (33.17 to 50.05)
    4.55 (0.56 to 15.47)
    43.71 (37.87 to 49.67)
        hSBA-Men A ≥ 16, Day 29(N-290,282,93,572)
    98.28 (96.02 to 99.44)
    97.52 (94.95 to 99)
    66.67 (56.13 to 76.11)
    97.9 (96.36 to 98.91)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [81]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    7.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.08
         upper limit
    		 11.23
    Notes
    [81] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [82]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    8.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.28
         upper limit
    		 12.74
    Notes
    [82] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [83]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    7.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.87
         upper limit
    		 10.78
    Notes
    [83] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [84]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 3.49
    Notes
    [84] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [85]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    6.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.04
         upper limit
    		 12.44
    Notes
    [85] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [86]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    6.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.71
         upper limit
    		 13.01
    Notes
    [86] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [87]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    6.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.66
         upper limit
    		 10.9
    Notes
    [87] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [88]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.27
         upper limit
    		 6.43
    Notes
    [88] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [89]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    41.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.85
         upper limit
    		 50.63
    Notes
    [89] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [90]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    36.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.39
         upper limit
    		 46.34
    Notes
    [90] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [91]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    39.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.61
         upper limit
    		 46.33
    Notes
    [91] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [92]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    4.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.04
         upper limit
    		 15.83
    Notes
    [92] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [93]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    31.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.68
         upper limit
    		 41.79
    Notes
    [93] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [94]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    30.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.85
         upper limit
    		 41.08
    Notes
    [94] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [95]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    31.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.39
         upper limit
    		 41.38
    Notes
    [95] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [96]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.81
         upper limit
    		 3.52
    Notes
    [96] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup C

    		 Close Top of page
    End point title
    		 Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup C
    End point description
    Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination) , day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    281
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men C ≥ 16, Day 1(N-288,281,93,569)
    47.22 (41.34 to 53.16)
    38.08 (32.38 to 44.04)
    17.2 (10.17 to 26.43)
    42.71 (38.6 to 46.89)
        hSBA-Men C ≥ 16, Day 4(N-144,138,48,282)
    54.17 (45.67 to 62.49)
    44.93 (36.46 to 53.62)
    29.17 (16.95 to 44.06)
    49.65 (43.66 to 55.64)
        hSBA-Men C ≥ 16, Day 6(N-145,139,44,284)
    82.07 (74.84 to 87.94)
    81.29 (73.81 to 87.4)
    31.82 (18.61 to 47.58)
    81.69 (76.69 to 86.01)
        hSBA-Men C ≥ 16, Day 29(N-290,281,93,571)
    99.66 (98.09 to 99.99)
    99.64 (98.03 to 99.99)
    69.89 (59.5 to 78.97)
    99.65 (98.74 to 99.96)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [97]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    30.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.55
         upper limit
    		 38.83
    Notes
    [97] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [98]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    20.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.48
         upper limit
    		 29.69
    Notes
    [98] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [99]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    25.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.79
         upper limit
    		 33.21
    Notes
    [99] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [100]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    9.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 17.16
    Notes
    [100] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [101]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.82
         upper limit
    		 38.9
    Notes
    [101] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [102]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    15.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 29.86
    Notes
    [102] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [103]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    20.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.32
         upper limit
    		 33.08
    Notes
    [103] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [104]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    9.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.45
         upper limit
    		 20.68
    Notes
    [104] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [105]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    50.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.09
         upper limit
    		 63.67
    Notes
    [105] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [106]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    49.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.21
         upper limit
    		 63.01
    Notes
    [106] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [107]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    49.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.42
         upper limit
    		 62.6
    Notes
    [107] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [108]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 9.92
    Notes
    [108] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [109]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    29.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.34
         upper limit
    		 39.75
    Notes
    [109] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [110]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    29.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.32
         upper limit
    		 39.74
    Notes
    [110] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [111]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    29.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.35
         upper limit
    		 39.73
    Notes
    [111] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [112]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 1.67
    Notes
    [112] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup W

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    End point title
    		 Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup W
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination), day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men W ≥ 16, Day 1(N-289,282,93,571)
    65.74 (59.96 to 71.2)
    66.31 (60.47 to 71.81)
    48.39 (37.89 to 58.99)
    66.02 (61.98 to 69.91)
        hSBA-Men W ≥ 16, Day 4(N-144,138,48,282)
    68.75 (60.5 to 76.21)
    76.81 (68.87 to 83.57)
    54.17 (39.17 to 68.63)
    72.7 (67.1 to 77.81)
        hSBA-Men W ≥ 16, Day 6(N-146,140,44,286)
    89.04 (82.81 to 93.6)
    92.14 (86.38 to 96.01)
    50 (34.56 to 65.44)
    90.56 (86.56 to 93.69)
        hSBA-Men W ≥ 16, Day 29(N-290,281,92,571)
    100 (98.74 to 100)
    100 (98.7 to 100)
    80.43 (70.85 to 87.97)
    100 (99.36 to 100)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [113]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    17.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.85
         upper limit
    		 28.67
    Notes
    [113] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [114]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    17.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.39
         upper limit
    		 29.25
    Notes
    [114] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [115]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    17.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.85
         upper limit
    		 28.28
    Notes
    [115] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [116]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.32
         upper limit
    		 7.2
    Notes
    [116] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [117]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    14.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 30.38
    Notes
    [117] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [118]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    22.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 38.16
    Notes
    [118] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [119]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    18.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.14
         upper limit
    		 33.37
    Notes
    [119] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [120]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -8.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.34
         upper limit
    		 2.38
    Notes
    [120] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [121]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    39.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.76
         upper limit
    		 54.07
    Notes
    [121] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [122]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    42.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.08
         upper limit
    		 56.98
    Notes
    [122] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [123]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    40.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.91
         upper limit
    		 55.15
    Notes
    [123] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [124]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2
         upper limit
    		 3.89
    Notes
    [124] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [125]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.74
         upper limit
    		 28.83
    Notes
    [125] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [126]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.74
         upper limit
    		 28.83
    Notes
    [126] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [127]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.75
         upper limit
    		 28.83
    Notes
    [127] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [128]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.31
         upper limit
    		 1.35
    Notes
    [128] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup Y

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    End point title
    		 Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup Y
    End point description
    For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
    End point type
    Secondary
    End point timeframe
    At day 1(pre-vaccination) , day 4, day 6 and day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    281
    93
    571
    Units: Percentage of subjects
    number (confidence interval 95%)
        hSBA-Men Y ≥ 16, Day 1(N-287,281,93,568)
    39.02 (33.35 to 44.93)
    34.88 (29.31 to 40.76)
    17.2 (10.17 to 26.43)
    36.97 (32.99 to 41.09)
        hSBA-Men Y ≥ 16, Day 4(N-143,138,48,281)
    39.16 (31.11 to 47.67)
    39.13 (30.94 to 47.8)
    20.83 (10.47 to 34.99)
    39.15 (33.4 to 45.12)
        hSBA-Men Y ≥ 16, Day 6(N-145,140,44,285)
    80.69 (73.31 to 86.77)
    80 (72.41 to 86.28)
    31.82 (18.61 to 47.58)
    80.35 (75.26 to 84.8)
        hSBA-Men Y ≥ 16, Day 29(N-290,281,93,571)
    100 (98.74 to 100)
    98.58 (96.4 to 99.61)
    64.52 (53.91 to 74.17)
    99.3 (98.22 to 99.81)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [129]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    21.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.44
         upper limit
    		 30.6
    Notes
    [129] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [130]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    17.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.34
         upper limit
    		 26.43
    Notes
    [130] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [131]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    19.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.09
         upper limit
    		 27.43
    Notes
    [131] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [132]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    4.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 12.04
    Notes
    [132] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [133]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    18.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.92
         upper limit
    		 30.99
    Notes
    [133] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [134]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    18.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.83
         upper limit
    		 31.06
    Notes
    [134] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [135]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    18.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.83
         upper limit
    		 29.39
    Notes
    [135] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [136]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.35
         upper limit
    		 11.39
    Notes
    [136] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [137]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    48.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.64
         upper limit
    		 62.38
    Notes
    [137] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [138]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    48.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.87
         upper limit
    		 61.79
    Notes
    [138] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [139]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    48.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.04
         upper limit
    		 61.31
    Notes
    [139] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [140]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 10.04
    Notes
    [140] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menveo-Menveo Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [141]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    35.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.5
         upper limit
    		 45.62
    Notes
    [141] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 other [142]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    34.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.94
         upper limit
    		 44.28
    Notes
    [142] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [143]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    34.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.78
         upper limit
    		 44.93
    Notes
    [143] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menactra-Menveo Group v Menveo-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [144]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Between groups differences in percentage
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.6
    Notes
    [144] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y

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    End point title
    		 Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y
    End point description
    Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.
    End point type
    Secondary
    End point timeframe
    At Day 4 and Day 6
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    289
    282
    93
    571
    Units: Percentages of subjects
    number (confidence interval 95%)
        hSBA-Men A, Pre < 4, Day 4(N-123,117,45,240)
    0.81 (0.02 to 4.45)
    2.56 (0.53 to 7.31)
    0 (0 to 7.87)
    1.67 (0.46 to 4.21)
        hSBA-Men A, Pre ≥ 4, Day 4(N-21,21,3,42)
    4.76 (0.12 to 23.82)
    0 (0 to 16.11)
    0 (0 to 70.76)
    2.38 (0.06 to 12.57)
        hSBA-Men A,Total seroresponse,Day 4(144,138,48,282
    1.39 (0.17 to 4.93)
    2.17 (0.45 to 6.22)
    0 (0 to 7.4)
    1.77 (0.58 to 4.09)
        hSBA-Men A, Pre < 4, Day 6(N-123,113,39,236)
    39.84 (31.12 to 49.05)
    33.63 (25.01 to 43.12)
    2.56 (0.06 to 13.48)
    36.86 (30.7 to 43.37)
        hSBA-Men A, Pre ≥ 4, Day 6(N-22,27,5,49)
    36.36 (17.2 to 59.34)
    22.22 (8.62 to 42.26)
    20 (0.51 to 71.64)
    28.57 (16.58 to 43.26)
        hSBA-Men A,Total seroresponse,Day 6(145,140,44,285
    39.31 (31.31 to 47.76)
    31.43 (23.85 to 39.81)
    4.55 (0.56 to 15.47)
    35.44 (29.89 to 41.3)
        hSBA-Men C, Pre < 4, Day 4(N-36,51,20,87)
    0 (0 to 9.74)
    9.8 (3.26 to 21.41)
    5 (0.13 to 24.87)
    5.75 (1.89 to 12.9)
        hSBA-Men C, Pre ≥ 4, Day 4(N-107,86,28,193)
    3.74 (1.03 to 9.3)
    8.14 (3.34 to 16.05)
    7.14 (0.88 to 23.5)
    5.7 (2.88 to 9.97)
        hSBA-Men C,Total seroresponse,Day 4(143,137,48,280
    2.8 (0.77 to 7.01)
    8.76 (4.61 to 14.8)
    6.25 (1.31 to 17.2)
    5.71 (3.3 to 9.11)
        hSBA-Men C, Pre < 4, Day 6(N-49,51,23,100)
    65.31 (50.36 to 78.33)
    64.71 (50.07 to 77.57)
    13.04 (2.78 to 33.59)
    65 (54.82 to 74.27)
        hSBA-Men C, Pre ≥ 4, Day 6(N-95,88,21,183)
    44.21 (34.02 to 54.77)
    38.64 (28.44 to 49.62)
    9.52 (1.17 to 30.38)
    41.53 (34.31 to 49.03)
        hSBA-Men C,Total seroresponse,Day 6(144,139,44,283
    51.39 (42.92 to 59.8)
    48.2 (39.65 to 56.83)
    11.36 (3.79 to 24.56)
    49.82 (43.85 to 55.8)
        hSBA-Men W, Pre < 4, Day 4(N-21,30,17,51)
    9.52 (1.17 to 30.38)
    30 (14.73 to 49.4)
    11.76 (1.46 to 36.44)
    21.57 (11.29 to 35.32)
        hSBA-Men W, Pre ≥ 4, Day 4(N-123,108,31,231)
    1.63 (0.2 to 5.75)
    4.63 (1.52 to 10.47)
    3.23 (0.08 to 16.7)
    3.03 (1.23 to 6.14)
        hSBA-Men W,Total seroresponse,Day 4(144,138,48,282
    2.78 (0.76 to 6.96)
    10.14 (5.66 to 16.44)
    6.25 (1.31 to 17.2)
    6.38 (3.83 to 9.9)
        hSBA-Men W, Pre < 4, Day 6(N-31,28,16,59)
    64.52 (45.37 to 80.77)
    75 (55.13 to 89.31)
    25 (7.27 to 52.38)
    69.49 (56.13 to 80.81)
        hSBA-Men W, Pre ≥ 4, Day 6(N-114,112,28,226)
    46.49 (37.1 to 56.07)
    42.86 (33.55 to 52.55)
    3.57 (0.09 to 18.35)
    44.69 (38.09 to 51.43)
        hSBA-Men W,Total seroresponse,Day 6(145,140,44,285
    50.34 (41.93 to 58.75)
    49.29 (40.74 to 57.86)
    11.36 (3.79 to 24.56)
    49.82 (43.87 to 55.78)
        hSBA-Men Y, Pre < 4, Day 4(N-62,60,27,122)
    8.06 (2.67 to 17.83)
    6.67 (1.85 to 16.2)
    0 (0 to 12.77)
    7.38 (3.43 to 13.54)
        hSBA-Men Y, Pre ≥ 4, Day 4(N-80,77,21,157)
    7.5 (2.8 to 15.61)
    2.6 (0.32 to 9.07)
    0 (0 to 16.11)
    5.1 (2.23 to 9.79)
        hSBA-Men Y,Total seroresponse,Day 4(142,137,48,279
    7.75 (3.93 to 13.44)
    4.38 (1.62 to 9.29)
    0 (0 to 7.4)
    6.09 (3.59 to 9.58)
        hSBA-Men Y, Pre < 4, Day 6(N-52,62,27,114)
    63.46 (48.96 to 76.38)
    75.81 (63.26 to 85.78)
    11.11 (2.35 to 29.16)
    70.18 (60.89 to 78.38)
        hSBA-Men Y, Pre ≥ 4, Day 6(N-91,78,17,169)
    40.66 (30.48 to 51.47)
    42.31 (31.19 to 54.02)
    5.88 (0.15 to 28.69)
    41.42 (33.91 to 49.24)
        hSBA-Men Y,Total seroresponse,Day 6(143,140,44,283
    48.95 (40.51 to 57.44)
    57.14 (48.51 to 65.47)
    9.09 (2.53 to 21.67)
    53 (47.01 to 58.94)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [145]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.08
         upper limit
    		 4.94
    Notes
    [145] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [146]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.32
         upper limit
    		 6.21
    Notes
    [146] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [147]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.68
         upper limit
    		 4.09
    Notes
    [147] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [148]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.98
         upper limit
    		 3.01
    Notes
    [148] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [149]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    34.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.38
         upper limit
    		 44.07
    Notes
    [149] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [150]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    26.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.67
         upper limit
    		 36.13
    Notes
    [150] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [151]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    30.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.42
         upper limit
    		 37.97
    Notes
    [151] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [152]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    7.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.25
         upper limit
    		 18.81
    Notes
    [152] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [153]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -3.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.26
         upper limit
    		 2.35
    Notes
    [153] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [154]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 9.98
    Notes
    [154] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [155]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.35
         upper limit
    		 4.9
    Notes
    [155] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [156]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -5.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.25
         upper limit
    		 -0.57
    Notes
    [156] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [157]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    40.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.37
         upper limit
    		 50.92
    Notes
    [157] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [158]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    36.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.14
         upper limit
    		 47.9
    Notes
    [158] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [159]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    38.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.79
         upper limit
    		 47.57
    Notes
    [159] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [160]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    3.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.44
         upper limit
    		 14.73
    Notes
    [160] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 17
    Statistical analysis description
    Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [161]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -3.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.28
         upper limit
    		 2.31
    Notes
    [161] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 18
    Statistical analysis description
    Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [162]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    3.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 11.6
    Notes
    [162] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 19
    Statistical analysis description
    Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [163]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.7
         upper limit
    		 5.66
    Notes
    [163] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 20
    Statistical analysis description
    Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [164]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -7.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.89
         upper limit
    		 -1.8
    Notes
    [164] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 21
    Statistical analysis description
    Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [165]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    38.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.35
         upper limit
    		 49.88
    Notes
    [165] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 22
    Statistical analysis description
    Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [166]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    37.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.23
         upper limit
    		 48.95
    Notes
    [166] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 23
    Statistical analysis description
    Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [167]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    38.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.8
         upper limit
    		 47.56
    Notes
    [167] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 24
    Statistical analysis description
    Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [168]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.51
         upper limit
    		 12.6
    Notes
    [168] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 25
    Statistical analysis description
    Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [169]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    7.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 13.36
    Notes
    [169] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 26
    Statistical analysis description
    Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [170]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    4.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.15
         upper limit
    		 9.24
    Notes
    [170] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 27
    Statistical analysis description
    Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [171]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    6.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 9.55
    Notes
    [171] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 28
    Statistical analysis description
    Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [172]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    3.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.48
         upper limit
    		 9.54
    Notes
    [172] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 29
    Statistical analysis description
    Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 other [173]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    39.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.76
         upper limit
    		 50.29
    Notes
    [173] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 30
    Statistical analysis description
    Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)
    Comparison groups
    Menactra-Menveo Group v Naive Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [174]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    48.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.89
         upper limit
    		 58.34
    Notes
    [174] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 31
    Statistical analysis description
    Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 other [175]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    43.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.79
         upper limit
    		 52.37
    Notes
    [175] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method
    Statistical analysis title
    		 Statistical analysis 32
    Statistical analysis description
    Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    		 other [176]
    Method
    		 Miettinen & Nurminen score method
    Parameter type
    		 Differences in percentage
    Point estimate
    -8.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.61
         upper limit
    		 3.45
    Notes
    [176] - Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

    Secondary: hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup A, C, W and Y.

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    End point title
    		 hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup A, C, W and Y.
    End point description
    For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.
    End point type
    Secondary
    End point timeframe
    At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    290
    282
    93
    572
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-Men A, Day 1(N-289,282,93,571)
    2.81 (2.54 to 3.11)
    2.95 (2.67 to 3.27)
    2.27 (1.9 to 2.71)
    2.88 (2.68 to 3.09)
        hSBA-Men A, Day 4(N-144,138,48,282)
    2.83 (2.43 to 3.29)
    3 (2.57 to 3.51)
    2.25 (1.73 to 2.93)
    2.91 (2.61 to 3.25)
        hSBA-Men A, Day 6(N-146,140,44,286)
    12.87 (9.63 to 17.19)
    10.17 (7.57 to 13.66)
    2.48 (1.46 to 4.2)
    11.47 (9.32 to 14.1)
        hSBA-Men A, Day 29(N-290,282,93,572)
    210.1 (181.07 to 243.78)
    236.69 (203.56 to 275.2)
    32.11 (24.7 to 41.76)
    222.81 (200.43 to 247.7)
        hSBA-Men C, Day 1(N-288,281,93,569)
    16.11 (13.28 to 19.54)
    10.72 (8.82 to 13.03)
    5.06 (3.6 to 7.1)
    13.17 (11.48 to 15.12)
        hSBA-Men C, Day 4(N-144,138,48,282)
    22.96 (17.31 to 30.45)
    14.29 (10.71 to 19.07)
    6.69 (4.1 to 10.9)
    18.21 (14.86 to 22.31)
        hSBA-Men C, Day 6(N-145,139,44,284)
    92.27 (68.91 to 123.56)
    90.06 (66.84 to 121.35)
    6.71 (3.95 to 11.4)
    91.18 (74.04 to 112.3)
        hSBA-Men C, Day 29(N-290,281,93,571)
    1159.93 (977.33 to 1376.63)
    1057.66 (888.74 to 1258.68)
    59.7 (44.12 to 80.78)
    1108.42 (981.09 to 1252.27)
        hSBA-Men W, Day 1(N-289,282,93,571)
    22.07 (18.54 to 26.29)
    23.46 (19.66 to 28)
    12.21 (8.98 to 16.62)
    22.75 (20.09 to 25.76)
        hSBA-Men W, Day 4(N-144,138,48,282)
    25.9 (20.13 to 33.32)
    33.87 (26.18 to 43.82)
    13.8 (8.92 to 21.35)
    29.53 (24.66 to 35.37)
        hSBA-Men W, Day 6(N-146,140,44,286)
    112.49 (86.26 to 146.71)
    143.75 (109.61 to 188.54)
    15.98 (9.85 to 25.93)
    126.84 (104.9 to 153.37)
        hSBA-Men W, Day 29(N-290,281,92,571)
    1394.65 (1176.59 to 1653.11)
    1883.96 (1585.12 to 2239.15)
    55.31 (40.9 to 74.8)
    1617.11 (1431.93 to 1826.23)
        hSBA-Men Y, Day 1(N-287,281,93,568)
    9.24 (7.81 to 10.94)
    8.22 (6.93 to 9.75)
    4.56 (3.39 to 6.13)
    8.72 (7.74 to 9.83)
        hSBA-Men Y, Day 4(N-143,138,48,281)
    10.87 (8.26 to 14.32)
    12.12 (9.16 to 16.04)
    4.63 (2.88 to 7.44)
    11.47 (9.43 to 13.95)
        hSBA-Men Y, Day 6(N-145,140,44,285)
    63.3 (47.73 to 83.95)
    61.56 (46.18 to 82.05)
    6.44 (3.86 to 10.76)
    62.44 (51.06 to 76.34)
        hSBA-Men Y, Day 29(N-290,281,93,571)
    1066.66 (900.67 to 1263.25)
    1007.62 (848.53 to 1196.54)
    37.4 (27.75 to 50.42)
    1037.19 (919.46 to 1169.98)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [177]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.7
    Notes
    [177] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [178]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.82
    Notes
    [178] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [179]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.72
    Notes
    [179] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [180]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.17
    Notes
    [180] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [181]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    5.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.84
         upper limit
    		 9.47
    Notes
    [181] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [182]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.24
         upper limit
    		 7.5
    Notes
    [182] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [183]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    4.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.62
         upper limit
    		 8.15
    Notes
    [183] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [184]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.91
    Notes
    [184] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [185]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    6.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.84
         upper limit
    		 8.85
    Notes
    [185] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [186]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    7.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.44
         upper limit
    		 9.98
    Notes
    [186] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [187]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    6.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.23
         upper limit
    		 9.21
    Notes
    [187] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [188]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.1
    Notes
    [188] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [189]
    Method
    Parameter type
    		 between group GMT ratios
    Point estimate
    3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.95
         upper limit
    		 6.04
    Notes
    [189] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [190]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 3.77
    Notes
    [190] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [191]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 4.64
    Notes
    [191] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [192]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.4
    Notes
    [192] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 17
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [193]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    13.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.51
         upper limit
    		 25.19
    Notes
    [193] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 18
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [194]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    13.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.31
         upper limit
    		 24.66
    Notes
    [194] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 19
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [195]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    13.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.7
         upper limit
    		 24
    Notes
    [195] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 20
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [196]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.56
    Notes
    [196] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 21
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [197]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    19.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.73
         upper limit
    		 27.51
    Notes
    [197] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 22
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [198]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    17.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.5
         upper limit
    		 25.12
    Notes
    [198] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 23
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [199]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    18.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.4
         upper limit
    		 25.73
    Notes
    [199] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 24
    Statistical analysis description
    Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [200]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.4
    Notes
    [200] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 25
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [201]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 3.11
    Notes
    [201] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 26
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [202]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 4.08
    Notes
    [202] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 27
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [203]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.33
         upper limit
    		 3.44
    Notes
    [203] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 28
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [204]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.1
    Notes
    [204] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 29
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [205]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    7.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.05
         upper limit
    		 12.22
    Notes
    [205] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 30
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [206]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    8.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.16
         upper limit
    		 15.66
    Notes
    [206] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 31
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [207]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    7.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.72
         upper limit
    		 13.35
    Notes
    [207] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 32
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [208]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.14
    Notes
    [208] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 33
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [209]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    25.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.83
         upper limit
    		 35.65
    Notes
    [209] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 34
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [210]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    34.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.06
         upper limit
    		 48.23
    Notes
    [210] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 35
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [211]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    29.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.09
         upper limit
    		 40.52
    Notes
    [211] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 36
    Statistical analysis description
    Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [212]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.94
    Notes
    [212] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 37
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [213]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 4.07
    Notes
    [213] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 38
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [214]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 4.54
    Notes
    [214] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 39
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [215]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    2.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 4.14
    Notes
    [215] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 40
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [216]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.33
    Notes
    [216] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 41
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [217]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    9.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.47
         upper limit
    		 17.64
    Notes
    [217] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 42
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [218]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    9.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.31
         upper limit
    		 17.19
    Notes
    [218] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 43
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [219]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    9.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.59
         upper limit
    		 16.79
    Notes
    [219] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 44
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [220]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.54
    Notes
    [220] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 45
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)
    Comparison groups
    Menveo-Menveo Group v Naive Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 other [221]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    28.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.23
         upper limit
    		 40.2
    Notes
    [221] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 46
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)
    Comparison groups
    Naive Group v Menactra-Menveo Group
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 other [222]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    26.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.09
         upper limit
    		 38.02
    Notes
    [222] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 47
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)
    Comparison groups
    Naive Group v pooled group (menveo-menveo and menactra-menveo)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other [223]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    27.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.1
         upper limit
    		 38.26
    Notes
    [223] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified
    Statistical analysis title
    		 Statistical analysis 48
    Statistical analysis description
    Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)
    Comparison groups
    Menveo-Menveo Group v Menactra-Menveo Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 other [224]
    Method
    Parameter type
    		 Between group GMT ratios
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.35
    Notes
    [224] - GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified

    Secondary: Within group hSBA Geometric Mean Ratios (GMRs)

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    End point title
    		 Within group hSBA Geometric Mean Ratios (GMRs)
    End point description
    Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.
    End point type
    Secondary
    End point timeframe
    At Day 4, Day 6, Day 29 compared to Day 1
    End point values
    		 Menveo-Menveo Group Menactra-Menveo Group Naive Group pooled group (menveo-menveo and menactra-menveo)
    Number of subjects analysed
    289
    282
    93
    571
    Units: Ratios
    geometric mean (confidence interval 95%)
        hSBA-Men A, Day 4/Day 1(N-144,138,48,282)
    1.02 (0.93 to 1.12)
    1.07 (0.97 to 1.17)
    0.99 (0.84 to 1.16)
    1.04 (0.98 to 1.11)
        hSBA-Men A, Day 6/Day 1(N-145,140,44,285)
    4.58 (3.49 to 6)
    3.25 (2.46 to 4.28)
    1.09 (0.66 to 1.78)
    3.87 (3.19 to 4.7)
        hSBA-Men A, Day 29/Day 1(N-289,282,93,571)
    75.02 (63.87 to 88.12)
    80.13 (68.09 to 94.3)
    14.14 (10.65 to 18.77)
    77.5 (69.12 to 86.9)
        hSBA-Men C, Day 4/Day 1(N-143,137,48,280)
    1.12 (0.99 to 1.28)
    1.35 (1.19 to 1.54)
    1.21 (0.97 to 1.51)
    1.23 (1.12 to 1.35)
        hSBA-Men C, Day 6/Day 1(N-144,139,44,283)
    7.25 (5.39 to 9.75)
    7.94 (5.87 to 10.73)
    1.45 (0.85 to 2.48)
    7.58 (6.14 to 9.36)
        hSBA-Men C, Day 29/Day 1(N-288,280,93,568)
    71.72 (58.88 to 87.37)
    97.13 (79.51 to 118.65)
    11.81 (8.34 to 16.71)
    83.29 (72.34 to 95.89)
        hSBA-Men W, Day 4/Day 1(N-144,138,48,282)
    1.05 (0.91 to 1.23)
    1.4 (1.2 to 1.63)
    1.14 (0.88 to 1.48)
    1.21 (1.09 to 1.35)
        hSBA-Men W, Day 6/Day 1(N-145,140,44,285)
    5.71 (4.37 to 7.45)
    6.27 (4.78 to 8.23)
    1.32 (0.81 to 2.15)
    5.98 (4.95 to 7.23)
        hSBA-Men W, Day 29/Day 1(N-289,281,92,570)
    63.63 (51.37 to 78.81)
    80.61 (64.88 to 100.14)
    4.57 (3.13 to 6.68)
    71.5 (61.38 to 83.27)
        hSBA-Men Y, Day 4/Day 1(N-142,137,48,279)
    1.35 (1.15 to 1.59)
    1.31 (1.11 to 1.54)
    0.99 (0.75 to 1.31)
    1.33 (1.19 to 1.49)
        hSBA-Men Y, Day 6/Day 1(N-143,140,44,283)
    6.09 (4.53 to 8.19)
    8.59 (6.37 to 11.59)
    1.48 (0.87 to 2.52)
    7.22 (5.85 to 8.92)
        hSBA-Men Y, Day 29/Day 1(N-287,280,93,567)
    116.58 (94.42 to 143.95)
    123.41 (99.69 to 152.78)
    8.21 (5.67 to 11.89)
    119.91 (103.21 to 139.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period(From Day 1 to Day 181)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Menveo-Menveo Group
    Reporting group description
    		 Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Naive Group
    Reporting group description
    		 Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.

    Reporting group title
    Menactra-Menveo Group
    Reporting group description
    		 Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

    Serious adverse events
    		 Menveo-Menveo Group Naive Group Menactra-Menveo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 301 (1.00%)
    3 / 100 (3.00%)
    2 / 300 (0.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Diabetic ketoacidotic hyperglycaemic coma
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Menveo-Menveo Group Naive Group Menactra-Menveo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    243 / 301 (80.73%)
    60 / 100 (60.00%)
    211 / 300 (70.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign bone neoplasm
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Lymphangiopathy
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Essential hypertension
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    119 / 301 (39.53%)
    41 / 100 (41.00%)
    106 / 300 (35.33%)
         occurrences all number
    124
    41
    113
    Fatigue
         subjects affected / exposed
    116 / 301 (38.54%)
    19 / 100 (19.00%)
    111 / 300 (37.00%)
         occurrences all number
    146
    21
    159
    Chills
         subjects affected / exposed
    34 / 301 (11.30%)
    10 / 100 (10.00%)
    37 / 300 (12.33%)
         occurrences all number
    36
    10
    50
    Injection site induration
         subjects affected / exposed
    17 / 301 (5.65%)
    8 / 100 (8.00%)
    10 / 300 (3.33%)
         occurrences all number
    17
    9
    11
    Injection site erythema
         subjects affected / exposed
    14 / 301 (4.65%)
    11 / 100 (11.00%)
    10 / 300 (3.33%)
         occurrences all number
    16
    14
    10
    Pyrexia
         subjects affected / exposed
    3 / 301 (1.00%)
    1 / 100 (1.00%)
    7 / 300 (2.33%)
         occurrences all number
    4
    1
    8
    Injection site pruritus
         subjects affected / exposed
    1 / 301 (0.33%)
    3 / 100 (3.00%)
    2 / 300 (0.67%)
         occurrences all number
    1
    3
    2
    Influenza like illness
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Medical device site erythema
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Medical device site swelling
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Vaccination site pruritus
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Axillary pain
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site bruising
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Anaphylactic reaction
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Allergy to animal
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    0
    0
    2
    Metrorrhagia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Pelvic congestion
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    7 / 301 (2.33%)
    1 / 100 (1.00%)
    5 / 300 (1.67%)
         occurrences all number
    7
    1
    5
    Asthma
         subjects affected / exposed
    7 / 301 (2.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    7
    0
    1
    Nasal congestion
         subjects affected / exposed
    2 / 301 (0.66%)
    1 / 100 (1.00%)
    6 / 300 (2.00%)
         occurrences all number
    2
    1
    6
    Cough
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    6 / 300 (2.00%)
         occurrences all number
    2
    0
    6
    Epistaxis
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    2
    0
    2
    Wheezing
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus congestion
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 100 (1.00%)
    2 / 300 (0.67%)
         occurrences all number
    1
    1
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    1
    0
    2
    Snoring
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Rhonchi
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 301 (1.66%)
    0 / 100 (0.00%)
    3 / 300 (1.00%)
         occurrences all number
    5
    0
    3
    Depression
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    0
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    2
    0
    2
    Major depression
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    2
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Sleep disorder
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Disruptive mood dysregulation disorder
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Cardiac murmur
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    0
    1
    Laceration
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    0
    1
    Ligament sprain
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    3 / 300 (1.00%)
         occurrences all number
    3
    0
    3
    Arthropod bite
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    3
    0
    0
    Concussion
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    2
    0
    2
    Procedural pain
         subjects affected / exposed
    2 / 301 (0.66%)
    1 / 100 (1.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    1
    1
    Limb injury
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    2
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    1
    0
    2
    Joint injury
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Arthropod sting
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament rupture
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural complication
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Road traffic accident
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    0
    0
    2
    Alcohol poisoning
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Conjunctival abrasion
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Facial bones fracture
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Pulmonary contusion
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    103 / 301 (34.22%)
    23 / 100 (23.00%)
    84 / 300 (28.00%)
         occurrences all number
    135
    27
    118
    Syncope
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    3 / 300 (1.00%)
         occurrences all number
    2
    0
    3
    Migraine
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Loss of consciousness
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine with aura
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Tension headache
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    4 / 300 (1.33%)
         occurrences all number
    0
    0
    4
    Presyncope
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Anaemia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    0
    0
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Middle ear effusion
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Oculogyric crisis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal tear
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Eye disorder
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Erythema of eyelid
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    51 / 301 (16.94%)
    15 / 100 (15.00%)
    44 / 300 (14.67%)
         occurrences all number
    65
    17
    55
    Abdominal pain
         subjects affected / exposed
    5 / 301 (1.66%)
    1 / 100 (1.00%)
    1 / 300 (0.33%)
         occurrences all number
    5
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    3 / 300 (1.00%)
         occurrences all number
    2
    0
    3
    Diarrhoea
         subjects affected / exposed
    2 / 301 (0.66%)
    3 / 100 (3.00%)
    2 / 300 (0.67%)
         occurrences all number
    2
    3
    2
    Vomiting
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    0
    1
    Tooth impacted
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    2
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Anal skin tags
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Salivary gland mucocoele
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Umbilical hernia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Biliary dyskinesia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    0
    1
    Acne
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    5 / 300 (1.67%)
         occurrences all number
    3
    0
    5
    Rash
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    0
    2
    Alopecia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Ecchymosis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Rash macular
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Polyuria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    57 / 301 (18.94%)
    15 / 100 (15.00%)
    55 / 300 (18.33%)
         occurrences all number
    63
    15
    72
    Arthralgia
         subjects affected / exposed
    46 / 301 (15.28%)
    13 / 100 (13.00%)
    41 / 300 (13.67%)
         occurrences all number
    60
    13
    50
    Pain in extremity
         subjects affected / exposed
    4 / 301 (1.33%)
    1 / 100 (1.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    2
    1
    Back pain
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    2
    0
    0
    Metatarsalgia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia intercostal
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Synovial cyst
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 301 (4.32%)
    2 / 100 (2.00%)
    5 / 300 (1.67%)
         occurrences all number
    16
    2
    5
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 301 (3.99%)
    3 / 100 (3.00%)
    9 / 300 (3.00%)
         occurrences all number
    12
    3
    9
    Acute sinusitis
         subjects affected / exposed
    11 / 301 (3.65%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    13
    1
    0
    Otitis media
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    4 / 300 (1.33%)
         occurrences all number
    4
    0
    4
    Bronchitis
         subjects affected / exposed
    4 / 301 (1.33%)
    1 / 100 (1.00%)
    3 / 300 (1.00%)
         occurrences all number
    4
    1
    3
    Pneumonia mycoplasmal
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    4
    0
    1
    Cellulitis
         subjects affected / exposed
    4 / 301 (1.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    4
    0
    0
    Influenza
         subjects affected / exposed
    3 / 301 (1.00%)
    3 / 100 (3.00%)
    7 / 300 (2.33%)
         occurrences all number
    3
    3
    7
    Pharyngitis
         subjects affected / exposed
    3 / 301 (1.00%)
    1 / 100 (1.00%)
    5 / 300 (1.67%)
         occurrences all number
    3
    1
    5
    Pharyngitis streptococcal
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    3 / 300 (1.00%)
         occurrences all number
    3
    0
    3
    Viral pharyngitis
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    4
    0
    2
    Otitis media acute
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    3
    0
    1
    Sinusitis
         subjects affected / exposed
    2 / 301 (0.66%)
    1 / 100 (1.00%)
    6 / 300 (2.00%)
         occurrences all number
    2
    1
    7
    Urinary tract infection
         subjects affected / exposed
    2 / 301 (0.66%)
    2 / 100 (2.00%)
    3 / 300 (1.00%)
         occurrences all number
    2
    4
    3
    Conjunctivitis
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    0
    1
    Otitis externa
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    2
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    6 / 300 (2.00%)
         occurrences all number
    1
    0
    6
    Pneumonia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    1
    0
    2
    Tooth abscess
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 100 (1.00%)
    1 / 300 (0.33%)
         occurrences all number
    1
    1
    1
    Folliculitis
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Viral rash
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
         occurrences all number
    0
    0
    3
    Bacterial vaginosis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    1
    1
    Bartholin's abscess
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Chlamydial infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Infectious mononucleosis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Kidney infection
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    37 / 301 (12.29%)
    6 / 100 (6.00%)
    48 / 300 (16.00%)
         occurrences all number
    50
    6
    63
    Hypoglycaemia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences all number
    0
    0
    1

    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
    For support, Contact us.
    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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