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    Clinical Trial Results:
    A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004446-95
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Jun 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V59P20E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01823536
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines & Diagnostics, Srl
    Sponsor organisation address
    350 Massachusetts Avenue, Massachusetts, United States, 02139
    Public contact
    Posting Director, Novartis Vaccines & Diagnostics, Srl, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines & Diagnostics, Srl, 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
    16 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the persistence of the antibody response at 5 years postvaccination in children who previously received one or two doses of MenACWY in study V59P20, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine was not injected into a blood vessel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 465
    Worldwide total number of subjects
    465
    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)
    368
    Adolescents (12-17 years)
    97
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 22 study sites in United States.

    Pre-assignment
    Screening details
    		 All 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
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 7-10_ACWY_2
    Arm description
    		 Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 7-10_ACWY_1
    Arm description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 7-10_Vaccine naive
    Arm description
    		 Vaccine naive subjects, age-matched to the 7-10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 11-15_ACWY_1
    Arm description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 11-15_Vaccine naive
    Arm description
    		 Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 Not Assigned
    Arm description
    		 Randomized to receive another meningococcal ACWY vaccine in the parent study and hence not eligible for enrolment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Number of subjects in period 1
    		7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive Not Assigned
    Started
    73
    103
    120
    66
    101
    2
    Completed
    71
    101
    119
    64
    99
    2
    Not completed
    2
    2
    1
    2
    2
    0
         Consent withdrawn by subject
    1
    1
    -
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    1
    1
    -
         Premature withdrawl
    -
    -
    1
    1
    1
    -
         Protocol deviation
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    7-10_ACWY_2
    Reporting group description
    		 Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Reporting group title
    7-10_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Reporting group title
    7-10_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the 7-10 years of age groups, received 1 injection of MenACWY-CRM vaccine.

    Reporting group title
    11-15_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.

    Reporting group title
    11-15_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine

    Reporting group title
    Not Assigned
    Reporting group description
    		 Randomized to receive another meningococcal ACWY vaccine in the parent study and hence not eligible for enrolment

    Reporting group values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive Not Assigned Total
    Number of subjects
    		 73 103 120 66 101 2 465
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 8.3 ± 1.1 8.1 ± 1.2 8.5 ± 1.1 13 ± 1.6 11.8 ± 1 8 ± 1.4 -
    Gender categorical
    Units: Subjects
        Female
    		 35 49 63 28 46 1 222
        Male
    		 38 54 57 38 55 1 243

    End points

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    End points reporting groups
    Reporting group title
    7-10_ACWY_2
    Reporting group description
    		 Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Reporting group title
    7-10_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Reporting group title
    7-10_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the 7-10 years of age groups, received 1 injection of MenACWY-CRM vaccine.

    Reporting group title
    11-15_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.

    Reporting group title
    11-15_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine

    Reporting group title
    Not Assigned
    Reporting group description
    		 Randomized to receive another meningococcal ACWY vaccine in the parent study and hence not eligible for enrolment

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All screened subjects who provided informed consent and provided demographic and/or baseline screening assessments, regardless of the treatment status in the trial and received a subject ID.

    Subject analysis set title
    Day 1 FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who provided immunogenicity data on day 1.

    Subject analysis set title
    Day 28 FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who received a study vaccination and provided immunogenicity data on day 28.

    Subject analysis set title
    Day 1 Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the day 1 FAS immunogenicity population who had no major protocol deviations as defined prior to analysis and were not excluded due to other reasons defined prior to analysis.

    Subject analysis set title
    Day 28 PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the day 28 FAS immunogenicity population who had no major protocol deviations as defined prior to analysis and were not excluded due to other reasons defined prior to analysis.

    Primary: 1. Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N.Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine

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    End point title
    		 1. Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N.Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine [1] [2]
    End point description
    The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA). The analysis was done on per-protocol population
    End point type
    Primary
    End point timeframe
    5 years post vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint.
    [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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 11-15_ACWY_1
    Number of subjects analysed
    70
    96
    64
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A (N=68, 96, 64)
    7 (2 to 16)
    14 (7 to 22)
    22 (13 to 34)
        Men C (N=69, 96, 64)
    48 (36 to 60)
    32 (23 to 43)
    56 (43 to 69)
        Men W-135 (N=69, 96, 64)
    83 (72 to 91)
    74 (64 to 82)
    80 (68 to 89)
        Men Y (N=70, 96, 64)
    50 (38 to 62)
    48 (38 to 58)
    53 (40 to 66)
    No statistical analyses for this end point

    Secondary: 2. Persisting Geometric Mean Titers Against N. meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.

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    End point title
    		 2. Persisting Geometric Mean Titers Against N. meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. [3]
    End point description
    The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The analysis was done on per-protocol population.
    End point type
    Secondary
    End point timeframe
    5 years post-vaccination
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 11-15_ACWY_1
    Number of subjects analysed
    70
    96
    64
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A (N= 68, 96, 64)
    2.41 (2.09 to 2.78)
    2.95 (2.42 to 3.61)
    3.73 (2.74 to 5.06)
        Men C (N= 69, 96, 64)
    7.55 (5.44 to 10)
    6.5 (4.75 to 8.9)
    12 (7.72 to 19)
        Men W (N= 69, 96, 64)
    23 (17 to 31)
    19 (14 to 25)
    26 (18 to 38)
        Men Y
    8.57 (6.08 to 12)
    8.13 (6.11 to 11)
    10 (6.51 to 16)
    No statistical analyses for this end point

    Secondary: 3. Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects

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    End point title
    		 3. Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects [4]
    End point description
    The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects. The analysis was done on per protocol population.
    End point type
    Secondary
    End point timeframe
    5 years post-vaccination; baseline for naive
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive
    Number of subjects analysed
    70
    96
    118
    64
    100
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A (N= 68, 96, 118, 64, 100)
    7 (2 to 16)
    14 (7 to 22)
    0 (0 to 3)
    22 (13 to 34)
    5 (2 to 11)
        Men C (N= 69, 96, 118, 64, 99)
    48 (36 to 60)
    32 (23 to 43)
    21 (14 to 30)
    56 (43 to 69)
    21 (14 to 31)
        Men W (N= 69, 96, 118, 64, 100)
    83 (72 to 91)
    75 (64 to 82)
    52 (42 to 61)
    80 (68 to 89)
    54 (44 to 64)
        Men Y
    50 (38 to 62)
    48 (38 to 58)
    23 (16 to 32)
    53 (40 to 66)
    37 (28 to 47)
    No statistical analyses for this end point

    Secondary: 4. Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

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    End point title
    		 4. Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. [5]
    End point description
    The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8. The analysis was done on per protocol population.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive
    Number of subjects analysed
    65
    95
    110
    60
    85
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A (N= 63, 95, 109, 60, 85)
    98 (91 to 100)
    100 (96 to 100)
    75 (66 to 83)
    100 (94 to 100)
    80 (70 to 88)
        Men C (N= 65, 94, 109, 60, 85)
    100 (94 to 100)
    100 (96 to 100)
    82 (73 to 88)
    100 (94 to 100)
    86 (77 to 92)
        Men W (N= 63, 95, 110, 60, 85)
    100 (94 to 100)
    100 (96 to 100)
    94 (87 to 97)
    100 (94 to 100)
    92 (84 to 97)
        men Y (N= 65, 94, 110, 59, 85)
    100 (94 to 100)
    100 (96 to 100)
    85 (77 to 91)
    100 (94 to 100)
    82 (73 to 90)
    No statistical analyses for this end point

    Secondary: 5. Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

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    End point title
    		 5. Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. [6]
    End point description
    The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs. The analysis was done on per-protocol population.
    End point type
    Secondary
    End point timeframe
    Day 28 post vaccination
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive
    Number of subjects analysed
    65
    95
    110
    60
    85
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A (N= 63, 95, 109, 60, 85)
    321 (241 to 428)
    361 (299 to 436)
    28 (20 to 39)
    350 (265 to 463)
    31 (22 to 45)
        Men C (N= 65, 94, 109, 60, 85)
    760 (545 to 1059)
    498 (406 to 610)
    48 (33 to 70)
    712 (490 to 1036)
    102 (63 to 166)
        Men W (N= 63, 95, 110, 60, 85)
    1571 (1247 to 1980)
    1534 (1255 to 1873)
    55 (42 to 72)
    1556 (1083 to 2237)
    69 (48 to 99)
        Men Y (N= 65, 94, 110, 59, 85)
    1286 (992 to 1668)
    1693 (1360 to 2107)
    48 (34 to 66)
    1442 (1050 to 1979)
    45 (30 to 69)
    No statistical analyses for this end point

    Secondary: 6. Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

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    End point title
    		 6. Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. [7]
    End point description
    The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine and Vaccine-naive subjects. The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 7 post-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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive
    Number of subjects analysed
    69
    99
    119
    64
    98
    Units: Number of subjects
        Any local
    46
    61
    59
    38
    52
        Injection site pain (N= 68, 99, 117, 64, 98)
    39
    52
    42
    31
    47
        Injection site erythema (N= 68, 99, 117, 64, 98)
    10
    13
    10
    10
    6
        Injection site induration (N= 68, 99, 119, 64, 98)
    12
    12
    7
    7
    8
        Any Systemic
    23
    27
    34
    19
    35
        Chills (N= 68, 99, 117, 64, 98)
    5
    3
    6
    1
    2
        Malaise (N= 69, 99, 117, 64, 98)
    15
    14
    13
    11
    19
        Myalgia (N= 69, 99, 117, 64, 98)
    9
    8
    8
    4
    8
        Arthralgia (N= 69, 99, 117, 64, 98)
    8
    4
    5
    4
    8
        Headache (N= 69, 99, 117, 64, 97)
    13
    9
    22
    12
    21
        Nausea (N= 68, 99, 117, 64, 97)
    10
    11
    12
    7
    8
        Fever (≥38°C; N= 66, 99, 115, 64, 96)
    1
    0
    3
    1
    0
        Prophyl. use analg/antip (N= 68, 99, 118, 63, 97)
    0
    1
    2
    1
    1
        Therapeutic use anal/antipyr.(N= 69,99,118,64,97)
    11
    12
    11
    11
    6
    No statistical analyses for this end point

    Secondary: 7. Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

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    End point title
    		 7. Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. [8]
    End point description
    The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal. The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.
    End point type
    Secondary
    End point timeframe
    Day1 to Day 28 Postvaccination.
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 7-10_ACWY_2 7-10_ACWY_1 7-10_Vaccine naive 11-15_ACWY_1 11-15_Vaccine naive
    Number of subjects analysed
    73
    102
    120
    65
    100
    Units: Number of subjects
        Any adverse event (AE)
    18
    23
    19
    18
    11
        Possibly/Probably related unsolicited AE
    4
    3
    4
    7
    5
        Any SAE
    0
    0
    1
    0
    1
        Possibly/Probably related SAE
    0
    0
    0
    0
    0
        AE leading to withdrawal
    0
    0
    0
    0
    0
        Death
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28).
    Adverse event reporting additional description
    All solicited AEs are reported as systematic assessment; all unsolicited AEs are reported as non-systematic assessment. Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    7-10_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Reporting group title
    7-10_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.

    Reporting group title
    11-15_Vaccine naive
    Reporting group description
    		 Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.

    Reporting group title
    11-15_ACWY_1
    Reporting group description
    		 Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.

    Reporting group title
    7-10_ACWY_2
    Reporting group description
    		 Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.

    Serious adverse events
    		 7-10_ACWY_1 7-10_Vaccine naive 11-15_Vaccine naive 11-15_ACWY_1 7-10_ACWY_2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 120 (0.83%)
    1 / 100 (1.00%)
    0 / 65 (0.00%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 120 (0.83%)
    0 / 100 (0.00%)
    0 / 65 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 120 (0.00%)
    1 / 100 (1.00%)
    0 / 65 (0.00%)
    0 / 73 (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 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 7-10_ACWY_1 7-10_Vaccine naive 11-15_Vaccine naive 11-15_ACWY_1 7-10_ACWY_2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 102 (68.63%)
    77 / 120 (64.17%)
    66 / 100 (66.00%)
    46 / 65 (70.77%)
    48 / 73 (65.75%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 102 (10.78%)
    23 / 120 (19.17%)
    23 / 100 (23.00%)
    15 / 65 (23.08%)
    14 / 73 (19.18%)
         occurrences all number
    13
    31
    26
    18
    17
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    3 / 102 (2.94%)
    6 / 120 (5.00%)
    2 / 100 (2.00%)
    2 / 65 (3.08%)
    5 / 73 (6.85%)
         occurrences all number
    3
    9
    2
    2
    6
    Injection site erythema
         subjects affected / exposed
    34 / 102 (33.33%)
    28 / 120 (23.33%)
    21 / 100 (21.00%)
    17 / 65 (26.15%)
    25 / 73 (34.25%)
         occurrences all number
    36
    31
    22
    17
    28
    Injection site induration
         subjects affected / exposed
    26 / 102 (25.49%)
    26 / 120 (21.67%)
    17 / 100 (17.00%)
    17 / 65 (26.15%)
    21 / 73 (28.77%)
         occurrences all number
    26
    27
    18
    18
    24
    Injection site pain
         subjects affected / exposed
    57 / 102 (55.88%)
    51 / 120 (42.50%)
    52 / 100 (52.00%)
    34 / 65 (52.31%)
    42 / 73 (57.53%)
         occurrences all number
    59
    56
    54
    35
    44
    Malaise
         subjects affected / exposed
    14 / 102 (13.73%)
    13 / 120 (10.83%)
    19 / 100 (19.00%)
    12 / 65 (18.46%)
    15 / 73 (20.55%)
         occurrences all number
    15
    14
    21
    13
    16
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 102 (11.76%)
    14 / 120 (11.67%)
    9 / 100 (9.00%)
    8 / 65 (12.31%)
    12 / 73 (16.44%)
         occurrences all number
    14
    15
    13
    9
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 102 (4.90%)
    5 / 120 (4.17%)
    9 / 100 (9.00%)
    4 / 65 (6.15%)
    8 / 73 (10.96%)
         occurrences all number
    5
    6
    12
    6
    9
    Myalgia
         subjects affected / exposed
    13 / 102 (12.75%)
    10 / 120 (8.33%)
    9 / 100 (9.00%)
    4 / 65 (6.15%)
    10 / 73 (13.70%)
         occurrences all number
    13
    13
    9
    5
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2014
    This amendment was done to change end of study definition and is defined as the completion of the testing of biological samples, to be achieved no later than 8 months after collection of the last biological sample visit at visit 2, day 28.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/20943209
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