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    Clinical Trial Results:
    A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of Investigational Meningococcal ACWY Conjugate Vaccine when One Dose is Administered to Healthy Adolescents 11-18 Years of Age and to Compare the Safety and Immunogenicity of Investigational Meningococcal ACWY Conjugate Vaccine with that of Licensed Meningococcal ACWY Conjugate Vaccine (Menactra™) when One Dose is Administered to Healthy Subjects 11-55 Years of Age

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-003504-79
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Jan 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Jun 2016
    First version publication date
    03 Jan 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    The occurence rates were incorrectly entered, they need to be changed.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V59P13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00450437
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines & Diagnostics, Inc.
    Sponsor organisation address
    350 Massachusetts Ave, Cambridge, MA, United States, 02139
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000032-PIP01-07
    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
    04 Apr 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the lot to lot consistency, safety and immune response of the Investigational Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
    Protection of trial subjects
    This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study is conducted, and applicable standard operating procedures (SOPs). Specifically, this trial was based on adequately performed laboratory and animal experimentation; it was conducted under a protocol reviewed and approved by the Institutional Review Board (IRB) and by scientifically and medically qualified persons; the benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the trial did not find the hazards to outweigh the potential benefits; each subject, or where applicable, each subject's legally acceptable representative(s) gave his or her written informed consent before any protocol-driven tests or evaluations were performed. Copies of the ICH GCP guidelines and of the Declaration of Helsinki were included in the investigator's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 3539
    Worldwide total number of subjects
    3539
    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)
    349
    Adolescents (12-17 years)
    1669
    Adults (18-64 years)
    1521
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 44 centers.

    Pre-assignment
    Screening details
    		 All enrolled subjects were randomized 1:1:1:1 to Menveo Lot 1, Menveo Lot 2, Menveo Lot 3, or Menactra, and stratified by age group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational MenACWY Vaccine (11 to 18 Years)
    Arm description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
    Arm type
    		 Experimental

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

    Arm title
    		 Licensed Meningococcal Vaccine (11 to 18 Years)
    Arm description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
    Arm type
    		 Active comparator

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

    Arm title
    		 Investigational MenACWY Vaccine (19 to 55 Years)
    Arm description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
    Arm type
    		 Experimental

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

    Arm title
    		 Licensed Meningococcal Vaccine (19 to 55 Years)
    Arm description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
    Arm type
    		 Active comparator

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

    Number of subjects in period 1
    		Investigational MenACWY Vaccine (11 to 18 Years) Licensed Meningococcal Vaccine (11 to 18 Years) Investigational MenACWY Vaccine (19 to 55 Years) Licensed Meningococcal Vaccine (19 to 55 Years)
    Started
    1640
    540
    1023
    336
    Completed
    1594
    524
    999
    325
    Not completed
    46
    16
    24
    11
         Consent withdrawn by subject
    10
    2
    -
    1
         Inappropriate enrollment
    4
    1
    3
    -
         Protocol deviation
    -
    1
    -
    -
         Unable to classify
    1
    -
    1
    -
         Lost to follow-up
    31
    12
    19
    9
         Administrative reason
    -
    -
    1
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigational MenACWY Vaccine (11 to 18 Years)
    Reporting group description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.

    Reporting group title
    Licensed Meningococcal Vaccine (11 to 18 Years)
    Reporting group description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.

    Reporting group title
    Investigational MenACWY Vaccine (19 to 55 Years)
    Reporting group description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.

    Reporting group title
    Licensed Meningococcal Vaccine (19 to 55 Years)
    Reporting group description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.

    Reporting group values
    		 Investigational MenACWY Vaccine (11 to 18 Years) Licensed Meningococcal Vaccine (11 to 18 Years) Investigational MenACWY Vaccine (19 to 55 Years) Licensed Meningococcal Vaccine (19 to 55 Years) Total
    Number of subjects
    		 1640 540 1023 336 3539
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.2 ± 2.2 14.1 ± 2.2 39 ± 9.6 38.7 ± 9.9 -
    Gender categorical
    Units: Subjects
        Female
    		 769 251 774 252 2046
        Male
    		 871 289 249 84 1493
    Subject analysis sets

    Subject analysis set title
    Investigational MenACWY (11 to 55 Years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.

    Subject analysis set title
    Licensed MenACWY (11 to 55 Years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One vaccination of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 1 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 2 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY Lot 2 vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 3 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY Lot 3 vaccine was administered intramuscularly.

    Subject analysis sets values
    		 Investigational MenACWY (11 to 55 Years) Licensed MenACWY (11 to 55 Years) Investigational MenACWY Lot 1 (11 to 18 years) Investigational MenACWY Lot 2 (11 to 18 years) Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects
    2663
    876
    548
    548
    544
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    23.7 ± 13.6
    23.5 ± 13.6
    14 ± 2.2
    14.2 ± 2.2
    14.3 ± 2.3
    Gender categorical
    Units: Subjects
        Female
    1543
    373
    254
    259
    256
        Male
    1120
    503
    294
    289
    288

    End points

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    End points reporting groups
    Reporting group title
    Investigational MenACWY Vaccine (11 to 18 Years)
    Reporting group description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.

    Reporting group title
    Licensed Meningococcal Vaccine (11 to 18 Years)
    Reporting group description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.

    Reporting group title
    Investigational MenACWY Vaccine (19 to 55 Years)
    Reporting group description
    		 One dose of the investigational meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.

    Reporting group title
    Licensed Meningococcal Vaccine (19 to 55 Years)
    Reporting group description
    		 One dose of the licensed meningococcal ACWY conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY (11 to 55 Years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.

    Subject analysis set title
    Licensed MenACWY (11 to 55 Years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One vaccination of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 1 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 2 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY Lot 2 vaccine was administered intramuscularly.

    Subject analysis set title
    Investigational MenACWY Lot 3 (11 to 18 years)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    One dose of the investigational meningococcal ACWY Lot 3 vaccine was administered intramuscularly.

    Primary: Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

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    End point title
    		 Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
    End point description
    The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against Neisseria meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age).
    End point type
    Primary
    End point timeframe
    28 days after vaccination
    End point values
    		 Investigational MenACWY Lot 1 (11 to 18 years) Investigational MenACWY Lot 2 (11 to 18 years) Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects analysed
    359 [1]
    357 [2]
    359 [3]
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A
    29 (23 to 38)
    33 (25 to 42)
    31 (24 to 40)
        Serogroup C
    77 (58 to 102)
    58 (43 to 77)
    64 (48 to 86)
        Serogroup W
    87 (70 to 108)
    111 (89 to 138)
    82 (66 to 102)
        Serogroup Y
    48 (37 to 62)
    61 (47 to 79)
    53 (41 to 69)
    Notes
    [1] - N serogroup C: 499 N serogroup W: 340 N serogroup Y: 345
    [2] - N serogroup C: 493 N serogroup W: 341 N serogroup Y: 345
    [3] - N serogroup C: 491 N serogroup W: 343 N serogroup Y: 346
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenA
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.16
    Notes
    [4] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenA
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.23
    Notes
    [5] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenA
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.38
    Notes
    [6] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenC
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 990 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.6
    Notes
    [7] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenC
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 992 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.77
    Notes
    [8] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenC
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 984 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [9]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.2
    Notes
    [9] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenW
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 681 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [10]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.97
    Notes
    [10] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenW
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 683 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [11]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.13
    Notes
    [11] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenW
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 684 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [12]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.67
    Notes
    [12] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenY
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 690 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [13]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.02
    Notes
    [13] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenY
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [14]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.18
    Notes
    [14] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenY
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [15]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.5
    Notes
    [15] - The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.

    Primary: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years

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    End point title
    		 Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
    End point description
    Safety of Investigational Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity
    End point type
    Primary
    End point timeframe
    6 days after vaccination
    End point values
    		 Investigational MenACWY (11 to 55 Years) Licensed MenACWY (11 to 55 Years)
    Number of subjects analysed
    2649
    875
    Units: Number of subjects
    number (not applicable)
        Number of Participants With at Least One Severe Sy
    94
    24
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. sft.
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine; sft, safety
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    3524
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 2
    Notes
    [16] - MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction [MenACWY minus Menactra] was less than 6%.

    Primary: Percentage of Seroresponders, Ages 11 to 18 Years

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    End point title
    		 Percentage of Seroresponders, Ages 11 to 18 Years [17]
    End point description
    Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against Neisseria meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
    End point type
    Primary
    End point timeframe
    28 days after vaccination
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: there is no statistical analysis presented for this endpoint.
    End point values
    		 Investigational MenACWY Vaccine (11 to 18 Years) Licensed Meningococcal Vaccine (11 to 18 Years)
    Number of subjects analysed
    1075 [18]
    359 [19]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    75 (72 to 77)
    66 (61 to 71)
        Serogroup C
    75 (73 to 77)
    73 (69 to 77)
        Serogroup W
    75 (72 to 77)
    63 (57 to 68)
        Serogroup Y
    68 (65 to 71)
    41 (35 to 47)
    Notes
    [18] - N serogroup C: 1483 N serogroup W: 1024 N serogroup Y: 1036
    [19] - N serogroup C: 501 N serogroup W: 288 N serogroup Y: 294
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenA
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine.
    Comparison groups
    Investigational MenACWY Vaccine (11 to 18 Years) v Licensed Meningococcal Vaccine (11 to 18 Years)
    Number of subjects included in analysis
    1434
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [20]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 14
    Notes
    [20] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenC
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 1894 (instead of 1434, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (11 to 18 Years) v Licensed Meningococcal Vaccine (11 to 18 Years)
    Number of subjects included in analysis
    1434
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 7
    Notes
    [21] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenW
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 1312 (instead of 1434, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (11 to 18 Years) v Licensed Meningococcal Vaccine (11 to 18 Years)
    Number of subjects included in analysis
    1434
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [22]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 18
    Notes
    [22] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenY
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 1330 (instead of 1434, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (11 to 18 Years) v Licensed Meningococcal Vaccine (11 to 18 Years)
    Number of subjects included in analysis
    1434
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20
         upper limit
    		 33
    Notes
    [23] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

    Primary: Percentage of Seroresponders, Ages 19 to 55 Years

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    End point title
    		 Percentage of Seroresponders, Ages 19 to 55 Years [24]
    End point description
    Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against Neisseria meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
    End point type
    Primary
    End point timeframe
    28 days after vaccination
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: there is no statistical analysis presented for this endpoint.
    End point values
    		 Investigational MenACWY Vaccine (19 to 55 Years) Licensed Meningococcal Vaccine (19 to 55 Years)
    Number of subjects analysed
    963 [25]
    321 [26]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    67 (64 to 70)
    68 (63 to 73)
        Serogroup C
    67 (64 to 70)
    58 (53 to 64)
        Serogroup W
    50 (46 to 55)
    41 (35 to 47)
        Serogroup Y
    56 (51 to 60)
    40 (34 to 46)
    Notes
    [25] - N serogroup C: 961 N serogroup W: 484 N serogroup Y: 503
    [26] - N serogroup C: 318 N serogroup W: 292 N serogroup Y: 306
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenA
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine.
    Comparison groups
    Investigational MenACWY Vaccine (19 to 55 Years) v Licensed Meningococcal Vaccine (19 to 55 Years)
    Number of subjects included in analysis
    1284
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [27]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 5
    Notes
    [27] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenC
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 1279 (instead of 1284, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (19 to 55 Years) v Licensed Meningococcal Vaccine (19 to 55 Years)
    Number of subjects included in analysis
    1284
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [28]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 15
    Notes
    [28] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenW
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 776 (instead of 1284, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (19 to 55 Years) v Licensed Meningococcal Vaccine (19 to 55 Years)
    Number of subjects included in analysis
    1284
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [29]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 17
    Notes
    [29] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenY
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 809 (instead of 1284, which refers to MenA).
    Comparison groups
    Investigational MenACWY Vaccine (19 to 55 Years) v Licensed Meningococcal Vaccine (19 to 55 Years)
    Number of subjects included in analysis
    1284
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [30]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9
         upper limit
    		 23
    Notes
    [30] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

    Secondary: Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years

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    End point title
    		 Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
    End point description
    The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
    End point type
    Secondary
    End point timeframe
    28 days after vaccination
    End point values
    		 Investigational MenACWY Lot 1 (11 to 18 years) Investigational MenACWY Lot 2 (11 to 18 years) Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects analysed
    359 [31]
    357 [32]
    359 [33]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Seroresponse in serogroup A
    71 (66 to 76)
    75 (70 to 79)
    77 (73 to 82)
        Seroresponse in serogroup C
    78 (74 to 82)
    73 (69 to 77)
    74 (70 to 78)
        Seroresponse in serogroup W
    74 (69 to 78)
    80 (75 to 84)
    70 (65 to 75)
        Seroresponse in serogroup Y
    66 (61 to 71)
    72 (67 to 77)
    65 (60 to 70)
        hSBA Titer ≥ 1:8 in serogroup A
    72 (67 to 77)
    76 (71 to 80)
    78 (74 to 82)
        hSBA Titer ≥ 1:8 in serogroup C
    86 (82 to 89)
    84 (81 to 87)
    83 (79 to 86)
        hSBA Titer ≥ 1:8 in serogroup W
    95 (92 to 97)
    97 (95 to 99)
    96 (93 to 98)
        hSBA Titer ≥ 1:8 in serogroup Y
    86 (82 to 89)
    89 (85 to 92)
    88 (85 to 92)
        hSBA Titer ≥ 1:4 in serogroup A
    76 (72 to 81)
    79 (74 to 83)
    81 (77 to 85)
        hSBA Titer ≥ 1:4 in serogroup C
    89 (86 to 91)
    88 (85 to 91)
    88 (85 to 91)
        hSBA Titer ≥ 1:4 in serogroup W
    95 (92 to 97)
    97 (95 to 99)
    97 (94 to 98)
        hSBA Titer ≥ 1:4 in serogroup Y
    89 (85 to 92)
    92 (89 to 95)
    93 (90 to 96)
    Notes
    [31] - N serogroup C: 499 N serogroup W: 340 N serogroup Y: 345
    [32] - N serogroup C: 493 N serogroup W: 341 N serogroup Y: 345
    [33] - N serogroup C: 491 N serogroup W: 343 N serogroup Y: 346
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [34]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 3
    Notes
    [34] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [35]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 0
    Notes
    [35] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [36]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 4
    Notes
    [36] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 992 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [37]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 10
    Notes
    [37] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 990 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [38]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 10
    Notes
    [38] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 984 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [39]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 5
    Notes
    [39] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 681 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [40]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 0
    Notes
    [40] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 683 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [41]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 11
    Notes
    [41] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 684 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [42]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 17
    Notes
    [42] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 690 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [43]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 1
    Notes
    [43] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [44]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 8
    Notes
    [44] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [45]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 14
    Notes
    [45] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [46]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 3
    Notes
    [46] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [47]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 0
    Notes
    [47] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [48]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 4
    Notes
    [48] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 992 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [49]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 6
    Notes
    [49] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 990 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [50]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 7
    Notes
    [50] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 984 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [51]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 6
    Notes
    [51] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 681 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [52]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 1
    Notes
    [52] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 683 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [53]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 2
    Notes
    [53] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 684 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [54]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 4
    Notes
    [54] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 690 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [55]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 2
    Notes
    [55] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [56]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 2
    Notes
    [56] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [57]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 5
    Notes
    [57] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [58]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 4
    Notes
    [58] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [59]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 1
    Notes
    [59] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenA
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [60]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 4
    Notes
    [60] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 992 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [61]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 5
    Notes
    [61] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 990 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [62]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 4
    Notes
    [62] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenC
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 984 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [63]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 4
    Notes
    [63] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 681 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [64]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 1
    Notes
    [64] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 683 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [65]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 2
    Notes
    [65] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenW
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 684 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [66]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 3
    Notes
    [66] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 2 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 690 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 2 (11 to 18 years) v Investigational MenACWY Lot 1 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [67]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 1
    Notes
    [67] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 1 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 718, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 1 (11 to 18 years) v Investigational MenACWY Lot 3 (11 to 18 years)
    Number of subjects included in analysis
    718
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [68]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 0
    Notes
    [68] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
    Statistical analysis title
    		 Equivalence Lot 2 and Lot 3 MenY
    Statistical analysis description
    Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%). The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 691 (instead of 716, which refers to MenA).
    Comparison groups
    Investigational MenACWY Lot 3 (11 to 18 years) v Investigational MenACWY Lot 2 (11 to 18 years)
    Number of subjects included in analysis
    716
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [69]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 3
    Notes
    [69] - The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.

    Secondary: Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years

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    End point title
    		 Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
    End point description
    Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
    End point type
    Secondary
    End point timeframe
    28 days after vaccination
    End point values
    		 Investigational MenACWY (11 to 55 Years) Licensed MenACWY (11 to 55 Years)
    Number of subjects analysed
    2038 [70]
    680 [71]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Seroresponse in serogroup A
    71 (69 to 73)
    67 (63 to 71)
        Seroresponse in serogroup C
    72 (70 to 74)
    67 (64 to 70)
        Seroresponse in serogroup W
    67 (64 to 69)
    52 (47 to 56)
        Seroresponse in serogroup Y
    64 (61 to 66)
    41 (37 to 45)
        hSBA≥1:8 in serogroup A
    72 (70 to 74)
    69 (65 to 72)
        hSBA≥1:8 in serogroup C
    83 (81 to 84)
    79 (76 to 82)
        hSBA≥1:8 in serogroup W
    95 (94 to 96)
    89 (86 to 91)
        hSBA≥1:8 in serogroup Y
    85 (83 to 87)
    70 (66 to 73)
        hSBA≥1:4 in serogroup A
    75 (74 to 77)
    73 (69 to 76)
        hSBA≥1:4 in serogroup C
    87 (86 to 88)
    85 (83 to 88)
        hSBA≥1:4 in serogroup W
    96 (95 to 97)
    91 (88 to 93)
        hSBA≥1:4 in serogroup Y
    90 (88 to 91)
    77 (74 to 81)
    Notes
    [70] - N serogroup C: 2444 N serogroup W: 1508 N serogroup Y: 1539
    [71] - N serogroup C: 819 N serogroup W: 580 N serogroup Y: 600
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenA
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine.
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [72]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 8
    Notes
    [72] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenC
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 3263 (instead of 2718, which refers to MenA).
    Comparison groups
    Licensed MenACWY (11 to 55 Years) v Investigational MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [73]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 9
    Notes
    [73] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenW
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 2088 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [74]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 20
    Notes
    [74] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenY
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 2139 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [75]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19
         upper limit
    		 28
    Notes
    [75] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenA
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine.
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [76]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 8
    Notes
    [76] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenC
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 3263 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [77]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 7
    Notes
    [77] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenW
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 2088 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [78]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 9
    Notes
    [78] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenY
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 2139 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [79]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12
         upper limit
    		 20
    Notes
    [79] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenA
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine.
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [80]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 7
    Notes
    [80] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenC
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 3263 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [81]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 4
    Notes
    [81] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenW
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 2088 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [82]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 8
    Notes
    [82] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
    Statistical analysis title
    		 Vaccine group difference Inv. Vac., Lic. Vac. MenY
    Statistical analysis description
    Abbreviations: Inv. Vac., Investigational MenACWY vaccine; Lic. Vac. Licensed MenaCWY vaccine. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 2139 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [83]
    Method
    		 ANOVA
    Parameter type
    		 Vaccine group difference
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9
         upper limit
    		 16
    Notes
    [83] - Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.

    Secondary: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years

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    End point title
    		 Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
    End point description
    Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
    End point type
    Secondary
    End point timeframe
    28 days after vaccination
    End point values
    		 Investigational MenACWY (11 to 55 Years) Licensed MenACWY (11 to 55 Years)
    Number of subjects analysed
    2038 [84]
    680 [85]
    Units: Titer
    geometric mean (confidence interval 95%)
        Titers in serogroup A
    29 (26 to 32)
    22 (19 to 26)
        Titers in serogroup C
    55 (49 to 62)
    39 (33 to 47)
        Titers in serogroup W
    100 (90 to 112)
    57 (49 to 66)
        Titers in serogroup Y
    53 (47 to 60)
    21 (18 to 25)
    Notes
    [84] - N serogroup C: 2444 N serogroup W: 1508 N serogroup Y: 1539
    [85] - N serogroup C: 819 N serogroup W: 580 N serogroup Y: 600
    Statistical analysis title
    		 Non-inferiority of Inv.vac., Lic.vac. MenA
    Statistical analysis description
    The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5.
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [86]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.56
    Notes
    [86] - The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.
    Statistical analysis title
    		 Non-inferiority of Inv.vac., Lic.vac. MenC
    Statistical analysis description
    The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5. The no. of subjects analyzed varied by serogroup. For MenC, the no. of subjects analyzed was 3263 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [87]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.67
    Notes
    [87] - The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.
    Statistical analysis title
    		 Non-inferiority of Inv.vac., Lic.vac. MenW
    Statistical analysis description
    The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5. The no. of subjects analyzed varied by serogroup. For MenW, the no. of subjects analyzed was 2088 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [88]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 2.05
    Notes
    [88] - The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.
    Statistical analysis title
    		 Non-inferiority of Inv.vac., Lic.vac. MenY
    Statistical analysis description
    The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5. The no. of subjects analyzed varied by serogroup. For MenY, the no. of subjects analyzed was 2139 (instead of 2718, which refers to MenA).
    Comparison groups
    Investigational MenACWY (11 to 55 Years) v Licensed MenACWY (11 to 55 Years)
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [89]
    Method
    		 ANOVA
    Parameter type
    		 hSBA GMT ratios
    Point estimate
    2.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.11
         upper limit
    		 2.95
    Notes
    [89] - The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.

    Secondary: Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years

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    End point title
    		 Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
    End point description
    Safety profile following a single injection of MenACWY (3 lots combined) or a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).
    End point type
    Secondary
    End point timeframe
    Days 1 to 7
    End point values
    		 Investigational MenACWY (11 to 55 Years) Licensed MenACWY (11 to 55 Years)
    Number of subjects analysed
    2649
    875
    Units: Number of participants
    number (not applicable)
        Pain
    1105
    424
        Erythema
    414
    126
        Induration
    324
    88
        Chills
    168
    50
        Nausea
    260
    65
        Malaise
    279
    99
        Myalgia
    452
    149
        Arthralgia
    197
    54
        Headache
    731
    237
        Rash
    69
    20
        Fever ≥38°C
    32
    6
        Any Other Reaction
    555
    183
        Analgesic/Antipyretic Medication Used
    533
    178
        Stayed Home
    69
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were collected from study day 1 to 180.
    Adverse event reporting additional description
    A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Licensed Meningococcal Vaccine (11 to 55 years)
    Reporting group description
    		 One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

    Reporting group title
    Investigational MenACWY Vaccine (11 to 55 years)
    Reporting group description
    		 One dose of the investigational meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.

    Serious adverse events
    		 Licensed Meningococcal Vaccine (11 to 55 years) Investigational MenACWY Vaccine (11 to 55 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 875 (0.57%)
    23 / 2649 (0.87%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dislocation Of Sternum
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 875 (0.00%)
    2 / 2649 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 875 (0.00%)
    3 / 2649 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Vitello-Intestinal Duct Remnant
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory Collapse
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dystonia
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonic Epilepsy
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Simple Partial Seizures
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression Suicidal
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 875 (0.00%)
    2 / 2649 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Epiphysiolysis
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 875 (0.11%)
    0 / 2649 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Viral
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 875 (0.00%)
    1 / 2649 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Licensed Meningococcal Vaccine (11 to 55 years) Investigational MenACWY Vaccine (11 to 55 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    572 / 875 (65.37%)
    1613 / 2649 (60.89%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    240 / 875 (27.43%)
    740 / 2649 (27.94%)
         occurrences all number
    308
    969
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    50 / 875 (5.71%)
    169 / 2649 (6.38%)
         occurrences all number
    56
    210
    Injection site induration
         subjects affected / exposed
    88 / 875 (10.06%)
    324 / 2649 (12.23%)
         occurrences all number
    91
    348
    Injection site erythema
         subjects affected / exposed
    126 / 875 (14.40%)
    414 / 2649 (15.63%)
         occurrences all number
    133
    449
    Malaise
         subjects affected / exposed
    100 / 875 (11.43%)
    280 / 2649 (10.57%)
         occurrences all number
    111
    323
    Injection site pain
         subjects affected / exposed
    424 / 875 (48.46%)
    1106 / 2649 (41.75%)
         occurrences all number
    471
    1234
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    66 / 875 (7.54%)
    265 / 2649 (10.00%)
         occurrences all number
    78
    320
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    150 / 875 (17.14%)
    453 / 2649 (17.10%)
         occurrences all number
    169
    514
    Arthralgia
         subjects affected / exposed
    59 / 875 (6.74%)
    211 / 2649 (7.97%)
         occurrences all number
    67
    250

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2007
    Amendment 1 issues dealt with 1) Changing two former immunogenicity secondary objectives to primary objectives, as well as changing immunogenicity endpoint from 4-fold rise in hSBA titer to seroresponse (defined as either an hSBA titer ≥ 1:8 or 4-fold rise in titer depending on the subject’s baseline titer level). Changes were made to the endpoints to harmonize endpoint definitions across different regulatory agency input. 2) Increasing the number of adults aged 35 -55 years in each of the vaccine group, for a total of 400 more adults aged 35 -55 years.
    20 Dec 2007
    Amendment 2 issues dealt with modifying the calculations of power to demonstrate non-inferiority.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/19812260
    http://www.ncbi.nlm.nih.gov/pubmed/19476428
    For support, Contact us.
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