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    Clinical Trial Results:
    A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with that of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-003514-91
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Mar 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Jun 2016
    First version publication date
    20 Nov 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00329849
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sample data: Sample data
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics s.r.l
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000032-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the percentage of subjects presenting at least one severe (solicited) systemic reaction to the Novartis MenACWY conjugate vaccine with the percentage presenting at least one severe systemic reaction to the licensed meningococcal ACWY polysaccharide (PS) vaccine (Menomune) during the first 7 days (day 1 to 7) following a single injection administered to healthy children 2 to 10 years of age To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine with the immunogenicity of a single injection of PS vaccine (Menomune), defined as the percentage of subjects with seroresponse in human serum bactericidal assay against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. 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
    24 May 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1500
    Worldwide total number of subjects
    1500
    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)
    1500
    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 3 study centers in Argentina.

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Men ACWY-PS
    Arm description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menomune (MenACWY PS vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One 0.5 mL injection of PS vaccine was administered by SC injection

    Arm title
    		 Men ACWY- CRM
    Arm description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis MenACWY conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL injection of the MenACWY conjugate vaccine was administered by IM injection

    Number of subjects in period 1
    		Men ACWY-PS Men ACWY- CRM
    Started
    550
    950
    Completed
    546
    944
    Not completed
    4
    6
         Consent withdrawn by subject
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Men ACWY-PS
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine

    Reporting group title
    Men ACWY- CRM
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine

    Reporting group values
    		 Men ACWY-PS Men ACWY- CRM Total
    Number of subjects
    		 550 950 1500
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.7 ( 2.5 ) 5.8 ( 2.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 288 482 770
        Male
    		 262 468 730

    End points

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    End points reporting groups
    Reporting group title
    Men ACWY-PS
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine

    Reporting group title
    Men ACWY- CRM
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine

    Subject analysis set title
    Per Protocol-primary -Men ACWY-CRM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT (Modified Intention to treat) population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.

    Subject analysis set title
    Per Protocol-primary -Men ACWY-PS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.

    Subject analysis set title
    Per Protocol-Persistence-Men ACWY-CRM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.

    Subject analysis set title
    Per Protocol-persistence-Men ACWY-PS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.

    Subject analysis set title
    Safety-MenACWY-CRM_2 to 5 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Subject analysis set title
    Safety-MenACWY-PS_2 to 5 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Subject analysis set title
    Safety-MenACWY-CRM_6 to 10 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Subject analysis set title
    Safety-MenACWY-PS_6 to 10 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Subject analysis set title
    Safety-MenACWY-CRM_2 to 10 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Subject analysis set title
    Safety-MenACWY-PS_2 to 10 Years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who have received a study vaccine and have post-baseline safety data.

    Primary: Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

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    End point title
    		 Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
    End point description
    Immunogenicity was measured as the percentage of subjects with hSBA Seroresponse, directed against each of meningococcal Serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29) with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: for subjects with a prevaccination hSBA titer <1:4, a post vaccination hSBA titer ≥1:8; For subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of atleast four times the prevaccination titer.
    End point type
    Primary
    End point timeframe
    1 month after vaccination (day 29)
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    148
    148
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Serogroup A
    55 (46 to 63)
    93 (87 to 96)
        Serogroup C (N=144,147)
    52 (44 to 60)
    82 (74 to 88)
        Serogroup W (N=142, 143)
    46 (37 to 54)
    74 (66 to 81)
        Serogroup Y(N=146, 146)
    63 (55 to 71)
    82 (74 to 87)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison of hSBA Seroresponse for the Serogroups A one month after vaccination of MenACWYCRM and MenACWY-PS
    Comparison groups
    Men ACWY-PS v Men ACWY- CRM
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Chi-squared
    Parameter type
    		 Group Difference
    Point estimate
    38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29
         upper limit
    		 47
    Variability estimate
    Standard deviation
    Notes
    [1] - The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS
    Comparison groups
    Men ACWY- CRM v Men ACWY-PS
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 Chi-squared corrected
    Parameter type
    		 Group Difference
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19
         upper limit
    		 40
    Notes
    [2] - The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWYCRM and MenACWY-PS
    Comparison groups
    Men ACWY- CRM v Men ACWY-PS
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 Chi-squared
    Parameter type
    		 Group Difference
    Point estimate
    28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17
         upper limit
    		 39
    Notes
    [3] - The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month post vaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWYCRM and MenACWY-PS
    Comparison groups
    Men ACWY- CRM v Men ACWY-PS
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 Chi-squared
    Parameter type
    		 Group Difference
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 28
    Notes
    [4] - The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.

    Primary: Percentages of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Post vaccination

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    End point title
    		 Percentages of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Post vaccination
    End point description
    Safety was assessed in terms of the percentage of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination. * Value for MenACWY-PS is >1 as it is not possible to add the symbols
    End point type
    Primary
    End point timeframe
    Day 1 to 7 post vaccination
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    550
    950
    Units: Percenatges of Subjects
        number (not applicable)
    1
    1
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Men ACWY- CRM v Men ACWY-PS
    Number of subjects included in analysis
    1500
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 [Risk ratio(MenACWY-CRM/MenACWY-PS)]
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    6.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 49.2
    Notes
    [5] - Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.

    Secondary: Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

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    End point title
    		 Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
    End point type
    Secondary
    End point timeframe
    Day 1 and 29
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    148
    148
    Units: Percentages of subjects
    number (confidence interval 95%)
        Serogroup A (hSBA ≥1:4)- Day 1
    3 (1 to 8)
    5 (2 to 10)
        Serogroup A (hSBA ≥1:4)- Day 29
    55 (47 to 64)
    95 (90 to 98)
        Serogroup C (hSBA ≥1:4)- Day 1 (N=144,147)
    31 (23 to 39)
    26 (19 to 34)
        Serogroup C (hSBA ≥1:4)- Day 29 (N=144,147)
    80 (72 to 86)
    91 (85 to 95)
        Serogroup W (hSBA ≥1:4)- Day 1 (N=142,143)
    37 (29 to 46)
    40 (32 to 48)
        Serogroup W (hSBA ≥1:4)- Day 29 (N=142,143)
    78 (70 to 85)
    99 (96 to 100)
        Serogroup Y (hSBA ≥1:4)- Day 1 (N=146,146)
    15 (10 to 22)
    17 (11 to 24)
        Serogroup Y (hSBA ≥1:4)- Day 29 (N=146,146)
    77 (69 to 83)
    90 (84 to 95)
        Serogroup A (hSBA ≥1:8)- Day 1
    2 (0 to 6)
    4 (2 to 9)
        Serogroup A (hSBA ≥1:8)- Day 29
    55 (47 to 64)
    95 (90 to 98)
        Serogroup C (hSBA ≥1:8)- Day 1 (N=147,144)
    20 (14 to 28)
    16 (10 to 23)
        Serogroup C (hSBA ≥1:8)- Day 29 (N=147,144)
    70 (62 to 77)
    88 (82 to 93)
        Serogroup W (hSBA ≥1:8)- Day 1 (N=143,142)
    35 (27 to 43)
    38 (30 to 46)
        Serogroup W (hSBA ≥1:8)- Day 29 (N=143,142)
    73 (64 to 80)
    99 (96 to 100)
        Serogroup Y (hSBA ≥1:8)- Day 1 (N=146,146)
    11 (6 to 17)
    14 (9 to 21)
        Serogroup Y (hSBA ≥1:8)- Day 29 (N=146,146)
    66 (58 to 74)
    89 (83 to 94)
    No statistical analyses for this end point

    Secondary: The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month after Vaccination With MenACWY-CRM or MenACWY-PS

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    End point title
    		 The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month after Vaccination With MenACWY-CRM or MenACWY-PS
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
    End point type
    Secondary
    End point timeframe
    Day 1 and 29
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    148
    148
    Units: GMT
    geometric mean (confidence interval 95%)
        Serogroup A - Day 1
    2.09 (1.95 to 2.24)
    2.25 (2.1 to 2.41)
        Serogroup A - Day 29
    11 (8.66 to 14)
    65 (51 to 82)
        Serogroup C (N=144,147) - Day 1
    3.27 (2.85 to 3.75)
    3.09 (2.69 to 3.53)
        Serogroup C (N=144,147) - Day 29
    20 (15 to 26)
    42 (32 to 54)
        Serogroup W (N=143,142) - Day 1
    5.4 (4.25 to 6.87)
    6.22 (4.9 to 7.9)
        Serogroup W (N=142,143) - Day 29
    20 (16 to 26)
    72 (56 to 92)
        Serogroup Y (N=146,146) - Day 1
    2.64 (2.33 to 2.99)
    2.81 (2.48 to 3.19)
        Serogroup Y (N=146,146) - Day 29
    25 (19 to 34)
    47 (35 to 63)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS

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    End point title
    		 Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
    End point description
    The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
    End point type
    Secondary
    End point timeframe
    Day 181
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    144
    145
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serogroup A(≥1:4)-Day 29
    54 (46 to 62)
    96 (91 to 98)
        Serogroup A(≥1:4)-Day 181
    41 (33 to 49)
    39 (31 to 47)
        Serogroup C (hSBA ≥1:4) - Day 29 (N=139,141)
    79 (71 to 86)
    91 (85 to 95)
        Serogroup C (hSBA ≥1:4) - Day 181 (N=139,141)
    71 (63 to 79)
    87 (81 to 92)
        Serogroup W (hSBA ≥1:4) - Day 29 (N=137,137)
    78 (70 to 85)
    99 (96 to 100)
        Serogroup W (hSBA ≥1:4) - Day 181 (N=137,137)
    69 (60 to 76)
    97 (93 to 99)
        Serogroup Y (hSBA ≥1:4) - Day 29 (N=141,140)
    77 (69 to 83)
    90 (84 to 94)
        Serogroup Y (hSBA ≥1:4) - Day 181 (N=141,140)
    65 (56 to 72)
    94 (88 to 97)
        Serogroup A (hSBA ≥1:8) - Day 29
    54 (46 to 62)
    95 (90 to 98)
        Serogroup A (hSBA ≥1:8) - Day 181
    38 (30 to 47)
    35 (27 to 44)
        Serogroup C (hSBA ≥1:8) - Day 29 (N=139,141)
    70 (61 to 77)
    88 (81 to 93)
        Serogroup C (hSBA ≥1:8) - Day 181 (N=139,141)
    55 (47 to 64)
    81 (73 to 87)
        Serogroup W (hSBA ≥1:8) - Day 29 (N=137,137)
    72 (64 to 80)
    99 (96 to 100)
        Serogroup W (hSBA ≥1:8) - Day 181 (N=137,137)
    66 (57 to 74)
    96 (92 to 99)
        Serogroup Y (hSBA ≥1:8) - Day 29 (N=141,140)
    67 (59 to 75)
    89 (82 to 93)
        Serogroup Y (hSBA ≥1:8) - Day 181 (N=141,140)
    59 (50 to 67)
    89 (83 to 94)
    No statistical analyses for this end point

    Secondary: The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWYPS

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    End point title
    		 The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWYPS
    End point description
    The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
    End point type
    Secondary
    End point timeframe
    Day 181
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    144
    145
    Units: GMT
    geometric mean (confidence interval 95%)
        Serogroup A - Day 29
    11 (8.33 to 13)
    66 (52 to 83)
        Serogroup A - Day 181
    5.85 (4.68 to 7.32)
    5.06 (4.05 to 6.33)
        Serogroup C (N=141,139) - Day 29
    20 (15 to 27)
    41 (31 to 54)
        Serogroup C (N=141,139) - Day 181
    11 (8.84 to 14)
    22 (17 to 28)
        Serogroup W (N=137,137) - Day 29
    21 (16 to 27)
    74 (58 to 95)
        Serogroup W (N=137,137) - Day 181
    16 (13 to 21)
    69 (54 to 89)
        Serogroup Y (N=141, 140)- Day 29
    26 (19 to 35)
    47 (35 to 64)
        Serogroup Y (N=141, 140)- Day 181
    14 (11 to 19)
    39 (29 to 51)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS

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    End point title
    		 Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
    End point description
    Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
    End point type
    Secondary
    End point timeframe
    Day 1 to 7 post vaccination
    End point values
    		 Safety-MenACWY-CRM_2 to 5 Years Safety-MenACWY-PS_2 to 5 Years Safety-MenACWY-CRM_6 to 10 Years Safety-MenACWY-PS_6 to 10 Years
    Number of subjects analysed
    452
    264
    498
    286
    Units: Number of Subjects
        Any local reaction
    138
    99
    189
    125
        Injection site pain
    89
    68
    132
    100
        Injection site erythema
    75
    34
    91
    37
        Injection site induration
    59
    23
    84
    38
        Any systemic reaction
    130
    73
    119
    69
        Change in Eating Habits
    36
    24
    0
    0
        Sleepiness
    29
    13
    0
    0
        Irritability
    36
    18
    0
    0
        Vomiting
    21
    9
    0
    0
        Diarrhea
    31
    20
    0
    0
        Arthralgia
    26
    11
    18
    15
        Headache
    46
    22
    74
    46
        Chills
    0
    0
    18
    17
        Nausea
    0
    0
    16
    11
        Malaise
    0
    0
    50
    28
        Myalgia
    0
    0
    35
    25
        Any other AE
    69
    42
    69
    47
        Axillary Temperature ≥38 °C
    35
    18
    20
    16
        Analgesic/Antipyretic medicine
    69
    42
    69
    47
    No statistical analyses for this end point

    Secondary: Overview of SAEs

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    End point title
    		 Overview of SAEs
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    		 Men ACWY-PS Men ACWY- CRM
    Number of subjects analysed
    550
    950
    Units: Numbers
        Any Serious Adverse Events
    1
    9
        Adverse Events Leading to Premature Withdrawal
    0
    0
        Deaths
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events (AEs) were collected from Day 1 through 7,serious AEs were collected from day 1 to day 181 after vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    MenACWY-PS
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine

    Reporting group title
    MenACWYCRM
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine

    Serious adverse events
    		 MenACWY-PS MenACWYCRM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 550 (0.18%)
    9 / 950 (0.95%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 950 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 950 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic Convulsion
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 950 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic Crisis
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 950 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 550 (0.00%)
    2 / 950 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 950 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 550 (0.00%)
    3 / 950 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACWY-PS MenACWYCRM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    292 / 550 (53.09%)
    459 / 950 (48.32%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    72 / 550 (13.09%)
    125 / 950 (13.16%)
         occurrences all number
    81
    141
    Somnolence
         subjects affected / exposed
    14 / 550 (2.55%)
    30 / 950 (3.16%)
         occurrences all number
    15
    32
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    71 / 550 (12.91%)
    166 / 950 (17.47%)
         occurrences all number
    73
    174
    Injection site pain
         subjects affected / exposed
    168 / 550 (30.55%)
    221 / 950 (23.26%)
         occurrences all number
    169
    223
    Injection site induration
         subjects affected / exposed
    61 / 550 (11.09%)
    143 / 950 (15.05%)
         occurrences all number
    62
    146
    Malaise
         subjects affected / exposed
    28 / 550 (5.09%)
    50 / 950 (5.26%)
         occurrences all number
    30
    58
    Pyrexia
         subjects affected / exposed
    49 / 550 (8.91%)
    75 / 950 (7.89%)
         occurrences all number
    51
    84
    Chills
         subjects affected / exposed
    18 / 550 (3.27%)
    18 / 950 (1.89%)
         occurrences all number
    19
    18
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    21 / 550 (3.82%)
    36 / 950 (3.79%)
         occurrences all number
    24
    43
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    24 / 550 (4.36%)
    36 / 950 (3.79%)
         occurrences all number
    27
    40
    Irritability
         subjects affected / exposed
    18 / 550 (3.27%)
    18 / 950 (1.89%)
         occurrences all number
    36
    41
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    26 / 550 (4.73%)
    44 / 950 (4.63%)
         occurrences all number
    27
    45
    Myalgia
         subjects affected / exposed
    26 / 550 (4.73%)
    30 / 950 (3.16%)
         occurrences all number
    35
    37
    Infections and infestations
    Varicella
         subjects affected / exposed
    23 / 550 (4.18%)
    43 / 950 (4.53%)
         occurrences all number
    23
    43

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2007
    To modify study endpoints and expand analyses to address regulatory concerns

    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.
    NA

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/19895922
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