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    Clinical Trial Results:
    An Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Responses Among Adolescents Who Previously Received MenACWY-CRM Conjugate Vaccine or Menactra®

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004903-63
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Nov 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P13E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00856297
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics Inc.
    Sponsor organisation address
    350 Massachusetts Avenue, Cambridge, United States, 02139
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at 21 months, 3 years, and 5 years after vaccination with either Novartis MenACWY Conjugate Vaccine or Menactra® in study V59P13 in terms of percentage of subjects with human SBA (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 389
    Worldwide total number of subjects
    389
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    117
    Adults (18-64 years)
    272
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 19 sites in US.

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

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY-CRM
    Arm description
    		 Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of MenACWY-CRM was administered by intramuscular (IM) injection in the anterolateral area of the left deltoid.

    Arm title
    		 Licensed Comparator
    Arm description
    		 Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal ACWY polysaccharide-protein conjugate vaccine
    Investigational medicinal product code
    Other name
    Menactra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of Menactra® was administered by IM injection in the anterolateral area of left deltoid area.

    Arm title
    		 Naive
    Arm description
    		 Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. One dose MenACWY-CRM conjugate vaccine or Licensed comparator was offered to naive subjects after blood draw at end.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of MenACWY-CRM was administered by intramuscular (IM) injection in the anterolateral area of the left deltoid.

    Investigational medicinal product name
    Meningococcal ACWY polysaccharide-protein conjugate vaccine
    Investigational medicinal product code
    Other name
    Menactra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of Menactra® was administered by IM injection in the anterolateral area of left deltoid area.

    Arm title
    		 MenACWY-CRM/MenACWY-CRM
    Arm description
    		 Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of MenACWY-CRM was administered by intramuscular (IM) injection in the anterolateral area of the left deltoid.

    Arm title
    		 Licensed Comparator /MenACWY-CRM
    Arm description
    		 Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal ACWY polysaccharide-protein conjugate vaccine
    Investigational medicinal product code
    Other name
    Menactra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of Menactra® was administered by IM injection in the anterolateral area of left deltoid area.

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of MenACWY-CRM was administered by intramuscular (IM) injection in the anterolateral area of the left deltoid.

    Number of subjects in period 1
    		MenACWY-CRM Licensed Comparator Naive MenACWY-CRM/MenACWY-CRM Licensed Comparator /MenACWY-CRM
    Started
    131
    76
    107
    44
    31
    Completed
    129
    76
    107
    44
    31
    Not completed
    2
    0
    0
    0
    0
         Unable to classify
    2
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

    Reporting group title
    Licensed Comparator
    Reporting group description
    		 Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.

    Reporting group title
    Naive
    Reporting group description
    		 Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. One dose MenACWY-CRM conjugate vaccine or Licensed comparator was offered to naive subjects after blood draw at end.

    Reporting group title
    MenACWY-CRM/MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Reporting group title
    Licensed Comparator /MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Reporting group values
    		 MenACWY-CRM Licensed Comparator Naive MenACWY-CRM/MenACWY-CRM Licensed Comparator /MenACWY-CRM Total
    Number of subjects
    		 131 76 107 44 31 389
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.4 ( 2.4 ) 18.8 ( 2.4 ) 19.3 ( 2.4 ) 19 ( 1.9 ) 19.7 ( 2.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 29 68 21 13 196
        Male
    		 66 47 39 23 18 193

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

    Reporting group title
    Licensed Comparator
    Reporting group description
    		 Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.

    Reporting group title
    Naive
    Reporting group description
    		 Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. One dose MenACWY-CRM conjugate vaccine or Licensed comparator was offered to naive subjects after blood draw at end.

    Reporting group title
    MenACWY-CRM/MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Reporting group title
    Licensed Comparator /MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Subject analysis set title
    All enrolled population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who had data in the DEMOG panel, signed an informed consent form, underwent screening procedures(s) and were randomized at visit 6.

    Subject analysis set title
    MITT Post-Booster Persistence Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who provided one evaluable serum sample before or after vaccination with MenACWY-CRM (at 3 years after vaccination inV59P13) and whose 5 year assay result was available for at least one serogroup.

    Subject analysis set title
    Per Protocol (PP) Persistence Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Naive subjects: ▫ All subjects in the MITT population who had no major protocol deviations as defined prior to analysis. Subjects who previously participated in V59P13 study: ▫ All subjects in the MITT population who had no major protocol deviations as defined prior to analysis. A major deviation was defined as a protocol deviation that was considered to have a significant impact on the immunogenicity results of the subject.

    Subject analysis set title
    Modified Intention-to-treat (MITT) Persistence Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Naive subjects: ▫ All subjects in the enrolled population who provided one evaluable serum sample at baseline. Subjects who previously participated in V59P13 study: ▫ All subjects in the enrolled population who provided one serum sample with an assay result at any visit (i.e. MenACWY and Menactra groups: 21 months, 3 years and 5 years; ACWY/ACWY and Menac/ACWY groups: 3 years and 5 years).

    Subject analysis set title
    PP Post-Booster Persistence Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT population who: - correctly received the vaccine, and - provided at least one evaluable 5 year serum sample and whose assay result was available for at least one serogroup, - had no major protocol deviations as defined prior to analysis.

    Subject analysis set title
    All Exposed Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who received a study vaccination in V59P13 and subjects vaccinated after the amendment at 5 years.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population who provided postbaseline safety data. All groups at 5 years ▫ All subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases. MenACWY, Menactra and Naive group subjects (postvaccination safety follow-up): ▫ All subjects in the enrolled population who received a vaccination with meningococcal conjugate vaccine at 5 years (first visit for naive subjects enrolled at 5 years) and provided safety follow-up information for any period during the 28 day follow-up. In case of randomization errors, subjects were analyzed ‘as treated’ in the exposed and safety analyses.

    Subject analysis set title
    Post-Booster Solicited Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

    Subject analysis set title
    Post-vaccination Safety Follow-up Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects in the MenACWY and Menactra groups who were vaccinated at visit 6 with MenACWY or Menactra booster per ACIP recommendation and followed up to 28 days for safety.

    Subject analysis set title
    Licensed Comparator (Overall Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination. Analysis was done on the overall safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data during the whole study.

    Subject analysis set title
    MenACWY-CRM/MenACWY-CRM (Overall Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. Analysis was done on the overall safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data during the whole study.

    Subject analysis set title
    MenACWY-CRM (Overall Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. Analysis was done on the overall safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data during the whole study.

    Subject analysis set title
    Licensed Comparator /MenACWY-CRM (Overall Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. Analysis was done on the overall safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data during the whole study.

    Primary: 1. Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

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    End point title
    		 1. Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [1] [2]
    End point description
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y. Analysis was done on a subset of the 5-year PP persistence population - subjects who provided one evaluable serum sample at every visit (21 months, 3 years and 5 years) and had no major protocol deviations. Only subjects who also had evaluable blood samples at the 21-month and 3-year time points are included in this analysis.
    End point type
    Primary
    End point timeframe
    21 months, 3 years and 5 years postvaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: statistical analyses not applicable for this endpoint.
    [2] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM Licensed Comparator
    Number of subjects analysed
    100
    60
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA - 21 months
    45 (35 to 55)
    27 (16 to 40)
        MenA - 3 Years
    38 (28 to 48)
    18 (10 to 30)
        MenA - 5 Years
    35 (26 to 45)
    37 (25 to 50)
        Men C - 21 Months (N=100, 59)
    61 (51 to 71)
    63 (49 to 75)
        Men C - 3 Years (N=100, 59)
    68 (58 to 77)
    68 (54 to 79)
        Men C - 5 Years (N=100, 59)
    64 (54 to 73)
    63 (49 to 75)
        MenW- 21 Months (N=99, 57)
    86 (77 to 92)
    60 (46 to 72)
        MenW - 3 Years (N=99, 57)
    85 (76 to 91)
    65 (51 to 77)
        MenW - 5 Years (N=99, 57)
    85 (76 to 91)
    70 (57 to 82)
        MenY- 21 Months
    71 (61 to 80)
    53 (40 to 66)
        MenY - 3 Years
    69 (59 to 78)
    55 (42 to 68)
        MenY - 5 Years
    67 (57 to 76)
    55 (42 to 68)
    No statistical analyses for this end point

    Secondary: 2. Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

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    End point title
    		 2. Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [3]
    End point description
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y. Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations. Only subjects who also had evaluable blood samples at the 21-month and 3-year timepoints are included in this analysis.
    End point type
    Secondary
    End point timeframe
    21 months, 3 years and 5 years postvaccination
    Notes
    [3] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM Licensed Comparator
    Number of subjects analysed
    100
    60
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA - 21 months
    45 (35 to 55)
    32 (20 to 45)
        MenA - 3 Years
    39 (29 to 49)
    22 (12 to 34)
        MenA - 5 Years
    38 (28 to 48)
    37 (25 to 50)
        Men C - 21 Months (N=100, 59)
    73 (63 to 81)
    71 (58 to 82)
        Men C - 3 Years (N=100, 59)
    80 (71 to 87)
    78 (65 to 88)
        Men C - 5 Years (N=100, 59)
    72 (62 to 81)
    71 (58 to 82)
        MenW- 21 Months (N=99, 57)
    89 (81 to 94)
    61 (48 to 74)
        MenW - 3 Years (N=99, 57)
    88 (80 to 94)
    67 (53 to 79)
        MenW - 5 Years (N=99, 57)
    85 (76 to 91)
    70 (57 to 82)
        MenY- 21 Months
    79 (70 to 87)
    63 (50 to 75)
        MenY - 3 Years
    77 (68 to 85)
    63 (50 to 75)
        MenY - 5 Years
    74 (64 to 82)
    63 (50 to 75)
    No statistical analyses for this end point

    Secondary: 3. hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

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    End point title
    		 3. hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [4]
    End point description
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y. Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations. Only subjects who also had evaluable blood samples at the 21-month and 3-year timepoints are included in this analysis.
    End point type
    Secondary
    End point timeframe
    21 months, 3 years and 5 years postvaccination
    Notes
    [4] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM Licensed Comparator
    Number of subjects analysed
    100
    60
    Units: Geometric Mean Titers
    geometric mean (confidence interval 95%)
        MenA - 21 months
    6.57 (4.77 to 9.05)
    4.1 (2.82 to 5.97)
        MenA - 3 Years
    5.63 (3.97 to 7.99)
    3.67 (2.44 to 5.53)
        MenA - 5 Years
    4.43 (3.13 to 6.26)
    4.89 (3.26 to 7.33)
        Men C - 21 Months (N=100, 59)
    11 (8.12 to 15)
    7.64 (5.4 to 11)
        Men C - 3 Years (N=100, 59)
    16 (11 to 25)
    18 (11 to 29)
        Men C - 5 Years (N=100, 59)
    14 (8.83 to 24)
    20 (11 to 36)
        MenW- 21 Months (N=99, 57)
    18 (14 to 25)
    9.3 (6.57 to 13)
        MenW - 3 Years (N=99, 57)
    31 (21 to 46)
    17 (11 to 28)
        MenW - 5 Years (N=99, 57)
    32 (21 to 47)
    19 (12 to 31)
        MenY- 21 Months
    14 (10 to 19)
    6.77 (4.73 to 9.69)
        MenY - 3 Years
    14 (9.68 to 20)
    7.11 (4.65 to 11)
        MenY - 5 Years
    13 (8.8 to 20)
    8.02 (4.94 to 13)
    No statistical analyses for this end point

    Secondary: 4. Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8

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    End point title
    		 4. Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 [5]
    End point description
    Antibody levels of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [5] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 Naive
    Number of subjects analysed
    106
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA hSBA ≥ 1:4
    11 (6 to 19)
        MenA hSBA ≥ 1:8
    8 (3 to 14)
        MenC hSBA ≥ 1:4 (N=105)
    51 (41 to 61)
        MenC hSBA ≥ 1:8 (N=105)
    38 (29 to 48)
        MenW hSBA ≥ 1:4 (N=105)
    66 (56 to 75)
        MenW hSBA ≥ 1:8 (N=105)
    66 (56 to 75)
        MenY hSBA ≥ 1:4 (N=105)
    45 (35 to 55)
        MenY hSBA ≥ 1:8 (N=105)
    39 (30 to 49)
    No statistical analyses for this end point

    Secondary: 5. hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination

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    End point title
    		 5. hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination [6]
    End point description
    Antibody levels of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y. Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [6] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 Naive
    Number of subjects analysed
    106
    Units: Geometric Mean Titers
    geometric mean (confidence interval 95%)
        MenA
    2.34 (1.73 to 3.16)
        MenC (N=105)
    4.33 (2.72 to 6.88)
        MenW (N=105)
    18 (12 to 27)
        MenY (N=105)
    5.4 (3.61 to 8.1)
    No statistical analyses for this end point

    Secondary: 6. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine

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    End point title
    		 6. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine [7]
    End point description
    Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. Analysis was done on PP post booster persistence population - subjects who correctly received the vaccine, provided at least one evaluable serum sample at the relevant timepoints (3 and 5 years), whose assay result was available for at least one serogroup, and had no major protocol deviations as defined prior to analysis.
    End point type
    Secondary
    End point timeframe
    1 month post booster vaccination
    Notes
    [7] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM/MenACWY-CRM Licensed Comparator /MenACWY-CRM
    Number of subjects analysed
    42
    30
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA hSBA ≥ 1:4
    100 (92 to 100)
    100 (88 to 100)
        MenC hSBA ≥ 1:4
    100 (92 to 100)
    100 (88 to 100)
        MenW hSBA ≥ 1:4 (N=41, 29)
    100 (91 to 100)
    100 (88 to 100)
        MenY hSBA ≥ 1:4
    100 (92 to 100)
    100 (88 to 100)
        MenA hSBA ≥ 1:8
    100 (92 to 100)
    100 (88 to 100)
        MenC hSBA ≥ 1:8
    100 (92 to 100)
    100 (88 to 100)
        MenW hSBA ≥ 1:8 (N=41, 29)
    100 (91 to 100)
    100 (88 to 100)
        MenY hSBA ≥ 1:8
    100 (92 to 100)
    100 (88 to 100)
    No statistical analyses for this end point

    Secondary: 7. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After a Booster Dose of MenACWY-CRM Conjugate Vaccine

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    End point title
    		 7. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After a Booster Dose of MenACWY-CRM Conjugate Vaccine [8]
    End point description
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations, whose assay result was available for at least one serogroup, and had no major protocol deviations as defined prior to analysis.
    End point type
    Secondary
    End point timeframe
    2 years post booster vaccination
    Notes
    [8] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM/MenACWY-CRM Licensed Comparator /MenACWY-CRM
    Number of subjects analysed
    44
    31
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA hSBA ≥ 1:4
    77 (62 to 89)
    87 (70 to 96)
        MenA hSBA ≥ 1:8
    77 (62 to 89)
    77 (59 to 90)
        MenC hSBA ≥ 1:4
    95 (85 to 99)
    97 (83 to 100)
        MenC hSBA ≥ 1:8
    95 (85 to 99)
    87 (70 to 96)
        MenW hSBA ≥ 1:4
    100 (92 to 100)
    97 (83 to 100)
        MenW hSBA ≥ 1:8
    100 (92 to 100)
    97 (83 to 100)
        MenY hSBA ≥ 1:4
    98 (88 to 100)
    94 (79 to 99)
        MenY hSBA ≥ 1:8
    95 (85 to 99)
    94 (79 to 99)
    No statistical analyses for this end point

    Secondary: 8. Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After a Booster Dose of MenACWY-CRM Conjugate Vaccine

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    End point title
    		 8. Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After a Booster Dose of MenACWY-CRM Conjugate Vaccine [9]
    End point description
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y. Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations, whose assay result was available for at least one serogroup, and had no major protocol deviations as defined prior to analysis.
    End point type
    Secondary
    End point timeframe
    One month and 2 years post booster vaccination
    Notes
    [9] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM/MenACWY-CRM Licensed Comparator /MenACWY-CRM
    Number of subjects analysed
    42
    30
    Units: Geometric Mean Titers
    geometric mean (confidence interval 95%)
        MenA (one month post booster)
    326 (215 to 494)
    390 (248 to 614)
        MenA (2 years post booster)
    22 (12 to 41)
    20 (10 to 39)
        MenC (one month post booster)(N=41,29)
    597 (352 to 1014)
    477 (268 to 849)
        MenC (2 years post booster)(N=41,29)
    124 (62 to 250)
    61 (29 to 132)
        MenW (one month post booster)
    673 (398 to 1137)
    1111 (631 to 1956)
        MenW (2 years post booster)
    93 (58 to 148)
    110 (67 to 183)
        MenY (one month post booster)
    532 (300 to 942)
    454 (243 to 846)
        MenY (2 years post booster)
    55 (30 to 101)
    46 (24 to 89)
    No statistical analyses for this end point

    Secondary: 9. Number of Subjects Reporting Solicited Local and Systemic Adverse Events

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    End point title
    		 9. Number of Subjects Reporting Solicited Local and Systemic Adverse Events
    End point description
    Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 7
    End point values
    		 MenACWY-CRM/MenACWY-CRM (Overall Safety) Licensed Comparator /MenACWY-CRM (Overall Safety)
    Number of subjects analysed
    83
    77
    Units: Subjects
        Any Local
    40
    40
        Injection site pain
    37
    37
        Injection site erythema
    6
    7
        Injection site induration
    9
    4
        Any systemic
    41
    39
        Chills
    9
    2
        Nausea
    9
    8
        Malaise
    4
    8
        Headache
    21
    21
        Myalgia
    30
    26
        Arthralgia
    6
    7
        Rash
    0
    0
        Fever ( >= 38C )
    2
    0
        Others
    15
    9
        Stayed home
    2
    1
        Analgesic Antipyretic
    14
    9
    No statistical analyses for this end point

    Secondary: 10. Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator

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    End point title
    		 10. Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator
    End point description
    Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received at least one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.
    End point type
    Secondary
    End point timeframe
    Day 1 to 5 years
    End point values
    		 Licensed Comparator (Overall Safety) MenACWY-CRM/MenACWY-CRM (Overall Safety) MenACWY-CRM (Overall Safety) Licensed Comparator /MenACWY-CRM (Overall Safety)
    Number of subjects analysed
    284
    192
    83
    77
    Units: Subjects
        Circulatory system - 21 months (N=278, 192, 0, 0)
    1
    0
    0
    0
        Circulatory system -3 Years (N=284, 178, 83, 77)
    0
    0
    1
    0
        Circulatory system - 5 Years (N=131, 76, 44, 31)
    0
    0
    0
    0
        Digestive system- 21 months (N=278, 192, 0, 0)
    4
    1
    0
    0
        Digestive system- 3 years(N=284, 178, 83, 77)
    1
    0
    2
    0
        Digestive system- 5 years(N=131, 76, 44, 31)
    3
    1
    0
    0
        Congenital anomalies - 21 months(N=278, 192, 0, 0)
    0
    0
    0
    0
        Congenital anomalies - 3 years(N=284, 178, 83, 77)
    0
    1
    0
    0
        Congenital anomalies - 5 years(N=131, 76, 44, 31)
    0
    0
    0
    0
        Endoc. nutri. metab. imm. 21 months(N=278,192,0,0)
    2
    0
    0
    0
        Endoc. nutri. metab. imm. 3 years(N=284,178,83,77)
    0
    0
    0
    0
        Endoc. nutri. metab. imm. 5 years (N=131,76,44,31)
    2
    1
    0
    0
        Fact. influ. hlth. stat. 21 months(N=278,192,0,0)
    0
    1
    0
    0
        Fact. influ. hlth. stat. 3 years(N=284,178,83,77)
    0
    0
    1
    0
        Fact. influ. hlth. stat. 5 years(N=131, 76, 44, 31
    1
    0
    0
    0
        Mental disorders - 21 Months(N=278, 192, 0, 0)
    8
    5
    0
    0
        Mental disorders - 3 years(N=284, 178, 83, 77)
    10
    6
    7
    4
        Mental disorders - 5 years(N=131, 76, 44, 31)
    9
    5
    2
    2
        Muscul. sys. conn. tiss. 21 Months(N=278,192,0,0)
    0
    0
    0
    0
        Muscul. sys. conn. tiss. 3 years(N=284,178,83,77)
    1
    3
    0
    1
        Muscul. sys. conn. tiss. 5 years(N=131,76,44,31)
    0
    0
    0
    0
        Nervous syst. sense org. 21 Months(N=278,192,0,0)
    0
    2
    0
    0
        Nervous syst. sense org. 3 years(N=284,178,83,77)
    2
    0
    1
    1
        Nervous syst. sense org. 5 years(N=131,76,44,31)
    3
    0
    2
    0
        Pregnancy, childb. puerp. 21 Months(N=278,192,0,0)
    0
    0
    0
    0
        Pregnancy, childb. puerp. 3 years(N=284,178,83,77)
    0
    0
    0
    0
        Pregnancy, childb. puerp. 5 years(N=131,76,44,31)
    1
    0
    0
    0
        Respiratory system - 21 Months (N=278, 192, 0, 0)
    7
    3
    0
    0
        Respiratory system - 3 years(N=284, 178, 83, 77)
    5
    1
    5
    3
        Respiratory system - 5 years(N=131, 76, 44, 31)
    7
    2
    1
    0
        Skin and subcut. tiss. - 21 Months (N=278,192,0,0)
    0
    1
    0
    0
        Skin and subcut. tiss. - 3 years(N=284,178,83,77)
    1
    2
    0
    1
        Skin and subcut. tiss. - 5 years(N=131,76,44,31)
    2
    2
    0
    0
        Symptoms, signs, ill-def. 21 months(N=278,192,0,0)
    0
    0
    0
    0
        Symptoms, signs, ill-def. 3 years(N=284,178,83,77)
    2
    0
    1
    1
        Symptoms, signs, ill-def. 5 years(N=131,76,44,31)
    4
    3
    0
    1
        Genitourinary system - 21 months (N=278,192,0,0)
    1
    0
    0
    0
        Genitourinary system - 3 years(N=284, 178, 83, 77)
    0
    0
    0
    0
        Genitourinary system - 5 years(N=131, 76, 44, 31)
    3
    0
    1
    0
        Injury and poisoning- 21 months (N=0,0,0,0)
    0
    0
    0
    0
        Injury and poisoning- 3 Years (N= 131,76, 107,44)
    2
    0
    1
    0
    No statistical analyses for this end point

    Secondary: 11. Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

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    End point title
    		 11. Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [10]
    End point description
    Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination at the 5 year time point with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine. Post-vaccination Safety follow-up population: Subjects in the MenACWY and Menactra groups who were vaccinated at visit 6 with MenACWY or Menactra booster per ACIP recommendation and followed up to 28 days for safety.
    End point type
    Secondary
    End point timeframe
    28 days postvaccination
    Notes
    [10] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 MenACWY-CRM Licensed Comparator Naive
    Number of subjects analysed
    82
    53
    81
    Units: Subjects
        Ear and Labyrinth Disorders- Cerumen Impaction
    0
    1
    0
        Gastrointestinal Disorders - Stomatitis
    1
    0
    0
        Infections & Infestations - Acarodermatitis
    0
    0
    1
        Infections & Infestations -Acute Sinusitis
    1
    0
    0
        Infections & Infestations -Chlamydial Infection
    0
    0
    1
        Infections & Infestations- Genital Herpes
    0
    0
    1
        Infections & Inf-Genitourinary Chlamydia Infection
    1
    0
    0
        Infections & Infestations- Herpes Zoster
    0
    0
    1
        Infections & Infestations - Oral Herpes
    1
    0
    0
        Infections & Infestations - Sinusitis
    0
    0
    3
        Infections & Infestations - Urinary Tract Infec
    0
    0
    1
        Injury and Poisoning - Arthropod Bite
    0
    0
    1
        Investigation - Tuberculin Test
    0
    0
    1
        Skin & Subcutaneous Tissue Dis- Dermatitis Contact
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited and unsolicited AEs reported up to 1 month after vaccination. SAE occurring within 24 hours from last blood draw or within 28 days of vaccination.
    Adverse event reporting additional description
    Subjects in the MenACWY, Licensed comparator and naive groups were followed for 1 month for unsolicited reactions, if vaccinated at 5 year visit. For the booster groups, solicited AEs were collected for 7 days post booster; unsolicited AEs were collected for 1 month post booster.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Licensed Comparator /MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Reporting group title
    MenACWY-CRM/MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

    Reporting group title
    Licensed Comparator
    Reporting group description
    		 Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.

    Reporting group title
    Naive
    Reporting group description
    		 Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. One dose MenACWY-CRM conjugate vaccine or Licensed comparator was offered to naive subjects after blood draw at end.

    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

    Serious adverse events
    		 Licensed Comparator /MenACWY-CRM MenACWY-CRM/MenACWY-CRM Licensed Comparator Naive MenACWY-CRM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 83 (0.00%)
    1 / 178 (0.56%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Death
    Additional description: Another unrelated death occurred after the 3 year visit but before enrollment for the 5 year visit and has already been reported in the 3 years CSR.
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 83 (0.00%)
    1 / 178 (0.56%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 83 (0.00%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Licensed Comparator /MenACWY-CRM MenACWY-CRM/MenACWY-CRM Licensed Comparator Naive MenACWY-CRM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 77 (63.64%)
    55 / 83 (66.27%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 77 (27.27%)
    21 / 83 (25.30%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    29
    22
    0
    0
    0
    General disorders and administration site conditions
    Chills
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 77 (2.60%)
    9 / 83 (10.84%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    2
    10
    0
    0
    0
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 77 (5.19%)
    9 / 83 (10.84%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    4
    9
    0
    0
    0
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 77 (48.05%)
    37 / 83 (44.58%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    38
    38
    0
    0
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 77 (10.39%)
    4 / 83 (4.82%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    8
    4
    0
    0
    0
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 77 (9.09%)
    6 / 83 (7.23%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    7
    6
    0
    0
    0
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 77 (10.39%)
    9 / 83 (10.84%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    8
    10
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 77 (9.09%)
    6 / 83 (7.23%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    7
    7
    0
    0
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 77 (33.77%)
    30 / 83 (36.14%)
    0 / 178 (0.00%)
    0 / 343 (0.00%)
    0 / 284 (0.00%)
         occurrences all number
    28
    33
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2010
    Amendment No. 1: The primary rationale for this amendment was to allow for evaluation of antibody response at 1 month, 2 years, and 4 years after one dose of MenACWY in subjects who had previously received one dose of Menactra or MenACWY vaccine.
    09 Jun 2010
    Amendment No. 2: Updated several of the enrollment windows so as to increase the flexibility of enrollment; several other minor corrections and clarifications to the protocol.
    28 Feb 2012
    Amendment No. 3: - The study design was updated to remove the year 7 assessment. - Number of naive subjects was reduced from 400 to 300. - As per ACIP recommendation, subjects who received the first dose of MenACWY-CRM and Menactra® (MenACWY and Menactra groups) at the age of 11-15 years in the V59P13 study were offered a dose of either MenACWY-CRM or Menactra® after the blood draw at 5 years. - MenACWY-CRM was added as alternative vaccine to Menactra®, to be offered at the end of the study to subjects enrolled in Naive, MenACWY and Menactra groups.
    18 Jun 2012
    Amendment No. 4: Added a new requirement for a 28 day safety monitoring period after receipt of the optional dose of meningococcal conjugate vaccine at the 5 year time point.

    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/21339701
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