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    Clinical Trial Results:
    A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months

    Summary
    EudraCT number
    		 2004-001896-21
    Trial protocol
    		 FI  
    Global end of trial date
    16 May 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2019
    First version publication date
    31 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P7
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Vaccines and Diagnostics, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Vaccines and Diagnostics, 41 613241111, Novartis.email@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine in healthy children aged 36-<60 months, as measured by the percentage of subjects with hSBA ≥1:4 (i.e., the percentage of responders) against N. meningitidis serogroups A, C, W and Y.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2005
    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
    Finland: 239
    Country: Number of subjects enrolled
    Poland: 384
    Worldwide total number of subjects
    623
    EEA total number of subjects
    623
    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)
    411
    Children (2-11 years)
    212
    Adolescents (12-17 years)
    0
    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 enrolled at one center in Finland and in two centers in Poland.

    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
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY-CRM(Ad+) 12 to 35 Months
    Arm description
    		 Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY conjugate vaccine with adjuvant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY conjugate vaccine with/without adjuvant was obtained by extemporaneous mixing just before injection of the lyophilized ManA component to be re-suspended with the Man CWY component.

    Arm title
    		 MenACWY-CRM(Ad-) 12 to 35 Months
    Arm description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY conjugate vaccine without adjuvant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY conjugate vaccine with/without adjuvant was obtained by extemporaneous mixing just before injection of the lyophilized ManA component to be re-suspended with the Man CWY component.

    Arm title
    		 MenACWY-CRM(Ad-) 36 to 59 Months
    Arm description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY conjugate vaccine without adjuvant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY conjugate vaccine with/without adjuvant was obtained by extemporaneous mixing just before injection of the lyophilized ManA component to be re-suspended with the Man CWY component.

    Arm title
    		 MenACWY-PS (36 to 59 Months)
    Arm description
    		 Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MenACWY capsular polysaccharide
    Investigational medicinal product code
    Other name
    Mencevax
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Mencevax was obtained by extemporaneous mixing just before injection of two vials: a vial containing the lyophilized purified polysaccharide of N. meningitides and a vial containing diluent.

    Number of subjects in period 1
    		MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-CRM(Ad-) 12 to 35 Months MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-PS (36 to 59 Months)
    Started
    207
    206
    128
    82
    Completed
    196
    198
    120
    74
    Not completed
    11
    8
    8
    8
         Consent withdrawn by subject
    1
    4
    6
    7
         Unable to classify
    3
    1
    -
    -
         AE or Death
    3
    1
    -
    -
         Lost to follow-up
    2
    1
    -
    -
         Inappropriate Enrollment
    1
    -
    1
    -
         Protocol deviation
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-CRM(Ad+) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

    Reporting group title
    MenACWY-CRM(Ad-) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

    Reporting group title
    MenACWY-CRM(Ad-) 36 to 59 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.

    Reporting group title
    MenACWY-PS (36 to 59 Months)
    Reporting group description
    		 Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.

    Reporting group values
    		 MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-CRM(Ad-) 12 to 35 Months MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-PS (36 to 59 Months) Total
    Number of subjects
    		 207 206 128 82 623
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: Months
        arithmetic mean (standard deviation)
    		 24.1 ± 6.4 23.7 ± 6.2 45.1 ± 6.7 44.7 ± 6.4 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 110 107 68 44 329
        Male
    		 97 99 60 38 294

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-CRM(Ad+) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

    Reporting group title
    MenACWY-CRM(Ad-) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

    Reporting group title
    MenACWY-CRM(Ad-) 36 to 59 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.

    Reporting group title
    MenACWY-PS (36 to 59 Months)
    Reporting group description
    		 Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.

    Subject analysis set title
    MenACWY-CRM(Ad-) (36 to 59 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.

    Subject analysis set title
    MenACWY-CRM(Ad-) (36 to 59 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337

    Subject analysis set title
    MenACWY-CRM(Ad-) (36 to 59 M6-)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).

    Subject analysis set title
    MenACWY-CRM( Ad-) (36 to 59 M12-)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).

    Subject analysis set title
    MenACWY-PS (36-59 M6PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).

    Subject analysis set title
    MenACWY-PS (36-59 M12PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).

    Subject analysis set title
    MenACWY-CRM(Ad)- (36 to 59 M6-)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).

    Subject analysis set title
    MenACWY-CRM(Ad-) (36 to 59 M12-)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).

    Subject analysis set title
    MeMenACWY-PS (36-59 M12PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).

    Subject analysis set title
    MenACWY-PS (36-59 M6PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).

    Subject analysis set title
    MenACWY-PS (36-59 M12PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).

    Subject analysis set title
    MenACWY-PS (36-59 M12PS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).

    Subject analysis set title
    MenACWY-CRM(Ad+) (12 to 35 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) (12 to 35 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM( Ad-) (12 to 35 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad+) (12 to 35 Months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad+) 12-35M1+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M1-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).

    Subject analysis set title
    MenACWY-CRM (Ad+) 12-35M1+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).

    Subject analysis set title
    MenACWY-CRM (Ad-)12-35M1-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).

    Subject analysis set title
    MenACWY-CRM(Ad+) 12-35M6+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad+) 12-35M12+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M6-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M12-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) (12-35M12- )
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad+) 12-35M12+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M12-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad+) 12-35M6+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M6-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.

    Subject analysis set title
    MenACWY-CRM(Ad-) 12-35M1-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).

    Subject analysis set title
    MenACWY-PS 36 to 59 Months
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.

    Primary: Percentages of subjects with Human complement serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In subjects 36-59 Months Of age

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    End point title
    		 Percentages of subjects with Human complement serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In subjects 36-59 Months Of age [1] [2]
    End point description
    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Primary
    End point timeframe
    28 days after first 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: descriptive statistics.
    [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: descriptive statistics.
    End point values
    		 MenACWY-PS (36 to 59 Months) MenACWY-CRM(Ad-) (36 to 59 Months)
    Number of subjects analysed
    81
    101
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (Baseline; N=101,80)
    1 (0.032 to 7)
    2 (0 to 7)
        MenA (28 days after 1st vaccination; N=101,80)
    55 (43 to 66)
    75 (66 to 83)
        MenC (Baseline; N=99,79)
    10 (4 to 19)
    14 (8 to 23)
        MenC (28 days after 1st vaccination; N=99,79)
    52 (40 to 63)
    60 (49 to 69)
        MenW (Baseline; N=100,81)
    19 (11 to 29)
    17 (10 to 26)
        MenW (28 days after 1st vaccination; N=100,81)
    67 (55 to 77)
    91 (84 to 96)
        MenY (Baseline; N=100,79)
    11 (5 to 21)
    10 (5 to 18)
        MenY (28 days after 1st vaccination; N=100,79)
    67 (56 to 77)
    77 (68 to 85)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

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    End point title
    		 Percentages of subjects with hSBA titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [3]
    End point description
    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    28 days after first 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: descriptive statistics.
    End point values
    		 MenACWY-PS (36 to 59 Months) MenACWY-CRM(Ad-) (36 to 59 Months)
    Number of subjects analysed
    81
    101
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (Baseline)
    0 (0 to 5)
    2 (0 to 7)
        MenA (28 days after 1st vaccination)
    39 (28 to 50)
    61 (51 to 71)
        MenC (Baseline; N=99,79)
    8 (3 to 16)
    5 (2 to 11)
        MenC (28 days after 1st vaccination; N=99,79)
    39 (28 to 51)
    54 (43 to 64)
        MenW (Baseline; N=100,81)
    14 (7 to 23)
    15 (9 to 24)
        MenW (28 days after 1st vaccination; N=100,81)
    59 (48 to 70)
    84 (75 to 91)
        MenY (Baseline; N=100,79)
    6 (2 to 14)
    7 (3 to 14)
        MenY (28 days after 1st vaccination; N=100,79)
    57 (45 to 68)
    67 (57 to 67)
    No statistical analyses for this end point

    Secondary: hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In subjects 36-59 Months Of Age

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    End point title
    		 hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In subjects 36-59 Months Of Age [4]
    End point description
    Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    28 days after first vaccination
    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: descriptive statistics.
    End point values
    		 MenACWY-PS (36 to 59 Months) MenACWY-CRM(Ad-) (36 to 59 Months)
    Number of subjects analysed
    81
    101
    Units: titers
    geometric mean (confidence interval 95%)
        MenA (Baseline; N=101,80)
    2.03 (1.98 to 2.07)
    2.06 (2.02 to 2.1)
        MenA (28 days after 1st vaccination; N=101,80)
    6.82 (4.89 to 9.53)
    15 (11 to 20)
        MenC (Baseline; N=99,79)
    2.54 (2.3 to 2.8)
    2.42 (2.22 to 2.65)
        MenC (28 days after 1st vaccination; N=99,79)
    7.16 (5.31 to 9.65)
    7.12 (5.45 to 9.3)
        MenW (Baseline; N=100,81)
    3.14 (2.66 to 3.7)
    3.05 (2.63 to 3.53)
        MenW (28 days after 1st vaccination; N=100,81)
    12 (8.68 to 16)
    24 (18 to 31)
        MenY (Baseline; N=100,79)
    2.46 (2.21 to 2.73)
    2.42 (2.21 to 2.66)
        MenY (28 days after 1st vaccination; N=100,79)
    14 (9.99 to 21)
    21 (15 to 29)
    No statistical analyses for this end point

    Secondary: hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

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    End point title
    		 hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
    End point description
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-CRM(Ad-) (36 to 59 M6-) MenACWY-CRM( Ad-) (36 to 59 M12-) MenACWY-PS (36-59 M6PS) MenACWY-PS (36-59 M12PS)
    Number of subjects analysed
    48
    45
    32
    36
    Units: titers
    geometric mean (confidence interval 95%)
        MenA
    2.84 (2.17 to 3.73)
    2.51 (1.9 to 3.32)
    2.96 (2.03 to 4.32)
    2.78 (1.95 to 3.96)
        MenC (N=47,45,32,36)
    5.06 (3.43 to 7.46)
    4.3 (2.89 to 6.39)
    3.33 (2.04 to 5.43)
    3.89 (2.45 to 6.16)
        MenW (N=47,45,32,35)
    22 (14 to 33)
    20 (13 to 30)
    9.98 (5.86 to 17)
    13 (7.76 to 21)
        MenY (N=47,45,32,36)
    11 (7.14 to 18)
    18 (11 to 29)
    6.44 (3.86 to 11)
    5.29 (3.26 to 8.57)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with hSBA titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of age

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    End point title
    		 Percentage of subjects with hSBA titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of age
    End point description
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-PS (36-59 M6PS) MenACWY-PS (36-59 M12PS) MenACWY-CRM(Ad)- (36 to 59 M6-) MenACWY-CRM(Ad-) (36 to 59 M12-)
    Number of subjects analysed
    32
    36
    48
    45
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (Day 169)
    19 (7 to 36)
    14 (5 to 29)
    23 (12 to 37)
    13 (5 to 27)
        MenC (Day 169; N=47,45,32,36)
    28 (14 to 47)
    22 (10 to 39)
    45 (30 to 60)
    42 (28 to 58)
        MenW (Day 169; N=47,45,32,36)
    56 (38 to 74)
    61 (43 to 77)
    94 (82 to 99)
    84 (71 to 94)
        MenY (Day 169; N=47,45,32,36)
    53 (35 to 71)
    42 (26 to 59)
    70 (55 to 83)
    80 (65 to 90)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

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    End point title
    		 Percentages of subjects with hSBA titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
    End point description
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-CRM(Ad-) (36 to 59 M6-) MenACWY-CRM( Ad-) (36 to 59 M12-) MenACWY-PS (36-59 M6PS) MenACWY-PS (36-59 M12PS)
    Number of subjects analysed
    48
    45
    32
    36
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    10 (3 to 23)
    9 (2 to 21)
    16 (5 to 33)
    14 (5 to 29)
        MenC (N=47,45)
    32 (19 to 47)
    24 (13 to 40)
    19 (7 to 36)
    19 (8 to 36)
        MenW (N=47,45)
    77 (62 to 88)
    76 (60 to 87)
    53 (35 to 71)
    56 (38 to 72)
        Men Y (N=47,45)
    60 (44 to 74)
    64 (49 to 78)
    38 (21 to 56)
    36 (21 to 54)
    No statistical analyses for this end point

    Secondary: hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age

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    End point title
    		 hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad-) (36 to 59 M6-) MenACWY-CRM( Ad-) (36 to 59 M12-) MenACWY-PS (36-59 M6PS) MeMenACWY-PS (36-59 M12PS)
    Number of subjects analysed
    48
    45
    32
    36
    Units: titers
    geometric mean (confidence interval 95%)
        MenA
    51 (35 to 75)
    149 (99 to 222)
    72 (48 to 108)
    116 (79 to 169)
        MenC
    129 (83 to 200)
    472 (301 to 739)
    7.33 (4.22 to 13)
    17 (9.92 to 28)
        MenW
    371 (256 to 535)
    1120 (769 to 1632)
    38 (23 to 64)
    82 (50 to 134)
        MenY
    247 (168 to 364)
    911 (613 to 1353)
    22 (13 to 38)
    24 (14 to 40)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In subjects 36-59 Months Of Age

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    End point title
    		 Percentages of subjects with hSBA titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In subjects 36-59 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY–CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad-) (36 to 59 M6-) MenACWY-PS (36-59 M6PS) MenACWY-PS (36-59 M12PS) MenACWY-CRM(Ad-) (36 to 59 M12-)
    Number of subjects analysed
    48
    32
    36
    45
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    92 (80 to 98)
    100 (89 to 100)
    94 (81 to 99)
    98 (88 to 100)
        MenC (N=47,45)
    100 (92 to 100)
    44 (26 to 62)
    56 (38 to 72)
    100 (92 to 100)
        MenW (N=47,45)
    100 (92 to 100)
    97 (84 to 100)
    92 (78 to 98)
    100 (92 to 100)
        MenY (N=47,45)
    100 (92 to 100)
    75 (57 to 89)
    75 (58 to 88)
    100 (92 to 100)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after the second vaccination
    End point values
    		 MenACWY-CRM(Ad-) (36 to 59 M6-) MenACWY-CRM( Ad-) (36 to 59 M12-) MenACWY-PS (36-59 M6PS) MenACWY-PS (36-59 M12PS)
    Number of subjects analysed
    48
    45
    32
    36
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    90 (77 to 97)
    98 (88 to 100)
    97 (84 to 100)
    94 (81 to 99)
        MenC (N=47,45)
    96 (85 to 99)
    100 (92 to 100)
    34 (19 to 53)
    47 (30 to 65)
        MenW (N=47,45)
    100 (92 to 100)
    100 (92 to 100)
    78 (60 to 91)
    89 (74 to 97)
        MenY (N=47,45)
    100 (92 to 100)
    100 (92 to 100)
    66 (47 to 81)
    58 (41 to 74)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    28 days after first vaccination.
    End point values
    		 MenACWY-CRM(Ad+) (12 to 35 Months) MenACWY-CRM(Ad-) (12 to 35 Months)
    Number of subjects analysed
    200
    191
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (Baseline)
    0 (0 to 2)
    0 (0 to 2)
        MenA (28 days after 1st vaccination)
    82 (75 to 87)
    70 (63 to 77)
        MenC (Baseline; N=198,190)
    5 (2 to 9)
    1 (0 to 4)
        MenC (28 days after 1st vaccination; N=198,190)
    56 (49 to 63)
    49 (42 to 56)
        MenW (Baseline)
    8 (4 to 12)
    6 (3 to 10)
        MenW (28 days after 1st vaccination)
    82 (76 to 87)
    80 (73 to 85)
        MenY (Baseline; N=199,188)
    5 (2 to 8)
    3 (1 to 7)
        MenY (28 days after 1st vaccination; N=199,188)
    67 (60 to 74)
    67 (60 to 74)
    No statistical analyses for this end point

    Secondary: hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    28 days after first vaccination
    End point values
    		 MenACWY-CRM(Ad+) (12 to 35 Months) MenACWY-CRM( Ad-) (12 to 35 Months)
    Number of subjects analysed
    200
    191
    Units: titers
    geometric mean (confidence interval 95%)
        MenA (Baseline)
    2 (1.97 to 2.03)
    2 (1.97 to 2.03)
        MenA (28 days after 1st vaccination)
    18 (15 to 23)
    13 (11 to 16)
        MenC (Baseline; N=198,190)
    2.16 (2.03 to 2.3)
    2.05 (1.92 to 2.18)
        MenC (28 days after 1st vaccination; N=198,190)
    7.43 (6.15 to 8.97)
    5.9 (4.87 to 7.15)
        MenW (Baseline)
    2.38 (2.14 to 2.64)
    2.26 (2.03 to 2.52)
        MenW (28 days after 1st vaccination)
    17 (14 to 21)
    16 (13 to 20)
        MenY (Baseline; N=199,188)
    2.18 (2.04 to 2.34)
    2.12 (1.98 to 2.27)
        MenY (28 days after 1st vaccination; N=199,188)
    12 (9.39 to 15)
    12 (9.54 to 15)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    28 days after first vaccination.
    End point values
    		 MenACWY-CRM(Ad+) (12 to 35 Months) MenACWY-CRM(Ad-) (12 to 35 Months)
    Number of subjects analysed
    200
    191
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (Baseline)
    0 (0 to 2)
    0 (0 to 2)
        MenA (28 days after 1st vaccination)
    72 (65 to 78)
    61 (53 to 68)
        MenC (Baseline; N=198,190)
    3 (1 to 6)
    1 (0.013 to 3)
        MenC (28 days after 1st vaccination; N=198,190)
    47 (40 to 54)
    36 (29 to 44)
        MenW (Baseline)
    6 (3 to 10)
    4 (1 to 7)
        MenW (28 days after 1st vaccination)
    72 (65 to 78)
    69 (62 to 76)
        MenY (Baseline; N=199,188)
    4 (2 to 8)
    2 (1 to 5)
        MenY (28 days after 1st vaccination; N=199,188)
    60 (53 to 67)
    57 (50 to 64)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
    End point description
    Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M1+ MenACWY-CRM(Ad-) 12-35M1-
    Number of subjects analysed
    61
    48
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (N=61,47)
    98 (91 to 100)
    91 (80 to 98)
        MenC
    100 (94 to 100)
    94 (83 to 99)
        MenW
    97 (89 to 100)
    98 (89 to 100)
        MenY (N=61,47)
    97 (89 to 100)
    91 (80 to 98)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
    End point description
    Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M1+ MenACWY-CRM(Ad-) 12-35M1-
    Number of subjects analysed
    61
    48
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (N=61,47)
    98 (91 to 100)
    85 (72 to 94)
        MenC
    98 (91 to 100)
    90 (77 to 97)
        MenW
    97 (89 to 100)
    90 (77 to 97)
        MenY (N=61,47)
    97 (89 to 100)
    83 (69 to 92)
    No statistical analyses for this end point

    Secondary: hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM (Ad+) 12-35M1+ MenACWY-CRM (Ad-)12-35M1-
    Number of subjects analysed
    61
    48
    Units: titers
    geometric mean (confidence interval 95%)
        MenA (N=61,47)
    107 (80 to 143)
    39 (26 to 58)
        MenC
    117 (78 to 174)
    104 (67 to 161)
        MenW
    84 (57 to 122)
    61 (42 to 88)
        MenY (N=61,47)
    74 (50 to 110)
    41 (28 to 60)
    No statistical analyses for this end point

    Secondary: hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subject 12-35 Months Of Age

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    End point title
    		 hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subject 12-35 Months Of Age
    End point description
    Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad-) 12-35M12-
    Number of subjects analysed
    57
    56
    56
    54
    Units: titers
    geometric mean (confidence interval 95%)
        MenA
    3.54 (2.67 to 4.69)
    2.54 (1.91 to 3.37)
    2.66 (2.07 to 3.42)
    2.41 (1.87 to 3.12)
        MenC
    10 (7.21 to 15)
    4.02 (2.78 to 5.82)
    9.07 (6.35 to 13)
    4.79 (3.33 to 6.88)
        MenW (N=57,54,56,54)
    21 (14 to 31)
    19 (12 to 28)
    14 (9.6 to 21)
    8.19 (5.5 to 12)
        MenY (N=57,55,55,52)
    12 (8.1 to 17)
    8.69 (5.88 to 13)
    10 (6.62 to 16)
    10 (6.39 to 16)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In subjects 12-35 Months Of Age
    End point description
    Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad-) (12-35M12- )
    Number of subjects analysed
    57
    56
    56
    54
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    26 (16 to 40)
    14 (6 to 26)
    18 (9 to 30)
    9 (3 to 20)
        MenC
    56 (42 to 69)
    34 (22 to 48)
    63 (49 to 75)
    33 (21 to 47)
        MenW
    82 (70 to 91)
    79 (66 to 88)
    77 (64 to 87)
    54 (40 to 67)
        MenY (N=57,56,55,52)
    65 (51 to 77)
    66 (52 to 78)
    67 (53 to 79)
    56 (41 to 70)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, with or without Adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, with or without Adjuvant, In subjects 12-35 Months Of Age
    End point description
    Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    6 months after first vaccination and 12 months after first vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad-) 12-35M12-
    Number of subjects analysed
    57
    56
    56
    54
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    21 (11 to 34)
    13 (5 to 24)
    11 (4 to 22)
    7 (2 to 18)
        MenC
    51 (37 to 64)
    25 (14 to 38)
    57 (43 to 70)
    26 (15 to 40)
        MenW
    72 (58 to 83)
    73 (60 to 84)
    70 (56 to 81)
    50 (36 to 64)
        MenY (N=57,56,55,52)
    58 (44 to 71)
    50 (36 to 64)
    55 (41 to 68)
    46 (32 to 61)
    No statistical analyses for this end point

    Secondary: hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age

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    End point title
    		 hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after the second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M12-
    Number of subjects analysed
    57
    56
    57
    56
    Units: titers
    geometric mean (confidence interval 95%)
        MenA (N=54,56,57,56)
    141 (104 to 191)
    66 (46 to 94)
    168 (116 to 242)
    328 (242 to 445)
        MenC (N=54,56,56,57)
    252 (168 to 377)
    297 (197 to 449)
    575 (381 to 866)
    586 (386 to 889)
        MenW (N=57,55,57,56)
    687 (465 to 1015)
    518 (370 to 726)
    1238 (878 to 1745)
    1263 (849 to 1879)
        MenY (N=52,56,57,55)
    489 (325 to 735)
    302 (211 to 432)
    915 (633 to 1322)
    983 (651 to 1483)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad-) 12-35M12-
    Number of subjects analysed
    57
    56
    56
    54
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    100 (94 to 100)
    100 (94 to 100)
    95 (85 to 99)
    96 (87 to 100)
        MenC
    100 (94 to 100)
    98 (90 to 100)
    100 (94 to 100)
    96 (87 to 100)
        MenW
    100 (94 to 100)
    98 (90 to 100)
    100 (94 to 100)
    100 (93 to 100)
        MenY (N=56,52,57,55)
    100 (94 to 100)
    100 (94 to 100)
    100 (94 to 100)
    100 (93 to 100)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, with or without adjuvant, In Subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, with or without adjuvant, In Subjects 12-35 Months Of Age
    End point description
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    21 days after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M6+ MenACWY-CRM(Ad+) 12-35M12+ MenACWY-CRM(Ad-) 12-35M6- MenACWY-CRM(Ad-) 12-35M12-
    Number of subjects analysed
    57
    56
    56
    54
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA
    100 (94 to 100)
    100 (94 to 100)
    91 (80 to 97)
    96 (87 to 100)
        MenC
    100 (94 to 100)
    98 (90 to 100)
    100 (94 to 100)
    96 (87 to 100)
        MenW
    100 (94 to 100)
    98 (90 to 100)
    100 (94 to 100)
    100 (93 to 100)
        MenY (N=56,52,57,55)
    100 (94 to 100)
    100 (94 to 100)
    100 (94 to 100)
    100 (93 to 100)
    No statistical analyses for this end point

    Secondary: hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subject 12-35 Months Of Age

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    End point title
    		 hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With adjuvant or without adjuvant, In subject 12-35 Months Of Age
    End point description
    Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    12 months after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M1+ MenACWY-CRM(Ad-) 12-35M1-
    Number of subjects analysed
    61
    49
    Units: titers
    geometric mean (confidence interval 95%)
        MenA (N=61,48)
    5.24 (3.98 to 6.89)
    4.15 (3.16 to 5.45)
        MenC
    13 (8.86 to 18)
    18 (12 to 28)
        MenW (N=61,47)
    29 (20 to 42)
    25 (17 to 37)
        MenY (N=61,48)
    19 (13 to 27)
    19 (12 to 31)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, with adjuvant or without adjuvant, In subjects 12-35 Months Of Age
    End point description
    Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    12 months after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M1+ MenACWY-CRM(Ad-) 12-35M1-
    Number of subjects analysed
    61
    49
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (N=61,48)
    43 (30 to 56)
    29 (17 to 44)
        MenC
    66 (52 to 77)
    73 (59 to 85)
        MenW (N=61,47)
    89 (78 to 95)
    87 (74 to 95)
        MenY
    80 (68 to 89)
    81 (67 to 91)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
    End point description
    Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    12 months after second vaccination
    End point values
    		 MenACWY-CRM(Ad+) 12-35M1+ MenACWY-CRM(Ad-) 12-35M1-
    Number of subjects analysed
    61
    49
    Units: percentages of subjects
    number (confidence interval 95%)
        MenA (N=61,48)
    38 (26 to 51)
    23 (12 to 37)
        MenC
    59 (46 to 71)
    63 (48 to 77)
        MenW (N=61,47)
    87 (76 to 94)
    85 (72 to 94)
        MenY (N=61,48)
    69 (56 to 80)
    71 (56 to 83)
    No statistical analyses for this end point

    Secondary: Numbers of subjects 12 to 59 Months of age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

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    End point title
    		 Numbers of subjects 12 to 59 Months of age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [5]
    End point description
    Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
    End point type
    Secondary
    End point timeframe
    From day 1 through day 7 after first or second vaccination(s)
    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: descriptive statistics.
    End point values
    		 MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-CRM(Ad-) 12 to 35 Months MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-PS 36 to 59 Months
    Number of subjects analysed
    205
    206
    125
    81
    Units: Subjects
        Any Local
    100
    109
    70
    48
        Injection site tenderness
    73
    79
    57
    42
        Injection site erythema
    60
    63
    37
    19
        Injetion site induration
    37
    38
    25
    15
        Any systemic
    98
    103
    53
    26
        Change in Eating Habits
    31
    46
    20
    10
        Irritability
    68
    74
    31
    12
        Vomiting
    17
    15
    9
    2
        Diarrhea
    22
    24
    12
    1
        Fever (≥ 38°C)
    18
    23
    10
    5
        Other
    44
    38
    22
    11
        Analgesic/Antipyretic Med Used
    39
    35
    20
    11
    No statistical analyses for this end point

    Secondary: Numbers of subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination

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    End point title
    		 Numbers of subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination [6]
    End point description
    Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician’s visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.
    End point type
    Secondary
    End point timeframe
    28 days after first vaccination and 21 days after second 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: descriptive statistics.
    End point values
    		 MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-CRM(Ad-) 12 to 35 Months MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-PS 36 to 59 Months
    Number of subjects analysed
    205
    206
    125
    81
    Units: Subjects
        Any AE
    117
    99
    64
    41
        Possibly/probably related AE
    9
    9
    3
    1
        SAE
    13
    12
    11
    9
        AE leading to discontinuation
    3
    1
    0
    0
        Possibly/probably related SAE
    0
    0
    0
    0
        Death
    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 adverse events (AEs) were collected upto day 7 after each vaccination.
    Adverse event reporting additional description
    SAEs, AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    MenACWY-CRM(Ad+) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

    Reporting group title
    MenACWY-PS (36 to 59 Months)
    Reporting group description
    		 Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.

    Reporting group title
    MenACWY-CRM(Ad-) 36 to 59 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.

    Reporting group title
    MenACWY-CRM(Ad-) 12 to 35 Months
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

    Serious adverse events
    		 MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-PS (36 to 59 Months) MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-CRM(Ad-) 12 to 35 Months
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 205 (6.34%)
    9 / 81 (11.11%)
    11 / 125 (8.80%)
    12 / 206 (5.83%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain Neoplasm
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 81 (1.23%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    1 / 125 (0.80%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb Injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    1 / 125 (0.80%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Epiglottitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 205 (1.46%)
    0 / 81 (0.00%)
    1 / 125 (0.80%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    0 / 81 (0.00%)
    2 / 125 (1.60%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 81 (1.23%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis Media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 81 (1.23%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 205 (2.93%)
    6 / 81 (7.41%)
    6 / 125 (4.80%)
    8 / 206 (3.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's Disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 81 (0.00%)
    0 / 125 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACWY-CRM(Ad+) 12 to 35 Months MenACWY-PS (36 to 59 Months) MenACWY-CRM(Ad-) 36 to 59 Months MenACWY-CRM(Ad-) 12 to 35 Months
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    155 / 205 (75.61%)
    58 / 81 (71.60%)
    97 / 125 (77.60%)
    158 / 206 (76.70%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    36 / 205 (17.56%)
    12 / 81 (14.81%)
    29 / 125 (23.20%)
    45 / 206 (21.84%)
         occurrences all number
    36
    12
    29
    45
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    60 / 205 (29.27%)
    19 / 81 (23.46%)
    37 / 125 (29.60%)
    63 / 206 (30.58%)
         occurrences all number
    60
    19
    37
    63
    Injection Site Induration
         subjects affected / exposed
    37 / 205 (18.05%)
    15 / 81 (18.52%)
    25 / 125 (20.00%)
    38 / 206 (18.45%)
         occurrences all number
    37
    15
    25
    38
    Injection Site Pain
         subjects affected / exposed
    73 / 205 (35.61%)
    42 / 81 (51.85%)
    57 / 125 (45.60%)
    79 / 206 (38.35%)
         occurrences all number
    73
    42
    57
    79
    Irritability
         subjects affected / exposed
    68 / 205 (33.17%)
    12 / 81 (14.81%)
    31 / 125 (24.80%)
    74 / 206 (35.92%)
         occurrences all number
    68
    12
    31
    74
    Pyrexia
         subjects affected / exposed
    26 / 205 (12.68%)
    10 / 81 (12.35%)
    15 / 125 (12.00%)
    33 / 206 (16.02%)
         occurrences all number
    26
    10
    15
    33
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 205 (11.22%)
    1 / 81 (1.23%)
    13 / 125 (10.40%)
    25 / 206 (12.14%)
         occurrences all number
    23
    1
    13
    25
    Vomiting
         subjects affected / exposed
    17 / 205 (8.29%)
    2 / 81 (2.47%)
    9 / 125 (7.20%)
    16 / 206 (7.77%)
         occurrences all number
    17
    2
    9
    16
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 205 (6.34%)
    12 / 81 (14.81%)
    6 / 125 (4.80%)
    5 / 206 (2.43%)
         occurrences all number
    13
    12
    6
    5
    Psychiatric disorders
    Eating Disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    31 / 205 (15.12%)
    10 / 81 (12.35%)
    20 / 125 (16.00%)
    46 / 206 (22.33%)
         occurrences all number
    31
    10
    20
    46
    Infections and infestations
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 205 (4.88%)
    3 / 81 (3.70%)
    3 / 125 (2.40%)
    11 / 206 (5.34%)
         occurrences all number
    10
    3
    3
    11
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 205 (5.37%)
    2 / 81 (2.47%)
    3 / 125 (2.40%)
    7 / 206 (3.40%)
         occurrences all number
    11
    2
    3
    7
    Otitis Media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 205 (9.27%)
    4 / 81 (4.94%)
    9 / 125 (7.20%)
    16 / 206 (7.77%)
         occurrences all number
    19
    4
    9
    16
    Upper Respiratory Tract Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 205 (8.78%)
    7 / 81 (8.64%)
    14 / 125 (11.20%)
    19 / 206 (9.22%)
         occurrences all number
    18
    7
    14
    19
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 205 (6.34%)
    4 / 81 (4.94%)
    6 / 125 (4.80%)
    7 / 206 (3.40%)
         occurrences all number
    13
    4
    6
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2004
    1) added a second site in Poland 2) changed comparator from Menomune to another licensed meningococcal ACWY Polysaccharide vaccine (GSK Mencevax), due to lack of availability of Menomune in EU countries.
    03 Sep 2004
    To reduce the number of Finnish sites from nine to six.
    06 Dec 2004
    1) changed the study design in order to evaluate the responses to the non-adjuvanted formulation of Novartis MenACWY. 2) evaluated the responses to the non-adjuvanted formulation in response to a request from FDA. 3) investigated the immunogenicity of a 2nd dose of Novartis MenACWY either with or without adjuvant at different time points as well as the persistence of antibodies at either 6 or 12 months after the 1st or 2nd dose of vaccine.
    09 Jun 2005
    1)specified that sponsor did not request the original of the SAE form and that submission of SAE to EC/IRB was to be perforemed forrlowing EC/IRB and local law requirements. 2) added hSBA >= 8 3) defined the collection of AEs at 6 months after any vaccination or subject's withdrawal 4) changed the local reactions (erythema, induration) categorization.

    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
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