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    Clinical Trial Results:
    A Phase 3b, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-005133-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Apr 2013

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V59P14E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01148017
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    Sponsor organisation address
    350 Massachusetts Avenue, Cambridge, United States, 02139
    Public contact
    Posting Director, Novartis Vaccines & Diagnostics, Inc, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines & Diagnostics, Inc, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the persistence of the antibody response in children of 40 and 60 months of age previously vaccinated with MenACWY in study V59P14, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
    Protection of trial subjects
    This clinical study was designed, conducted, and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare) and applicable Standard Operating Procedures (SOPs), with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 433
    Worldwide total number of subjects
    433
    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)
    433
    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 who participated at US sites in the V59P14 trial (NCT00474526) were recruited for this extension study, with an aim to reach 400 subjects enrolled. A total of 27 sites in the US participated in the extension study (V59P14E1) at the 40-month timepoint and 18 sites in the US participated at the 60-month timepoint.

    Pre-assignment
    Screening details
    		 Priority for enrollment for both the ACWY-4 and ACWY-2 groups was given to those subjects who were part of the primary per protocol (PP) population, followed by subjects with available hSBA result for at least 1 serogroup and then the subjects without any hSBA data available.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Laboratory personnel were blinded so that vaccine groups would not be identifiable during the testing.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACWY - 4
    Arm description
    		 Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, were administered one booster dose of the same vaccine at 60 months of age.
    Arm type
    		 Experimental

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

    Arm title
    		 ACWY - 2
    Arm description
    		 Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, were administered one booster dose of the same vaccine at 60 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MenACWY IM injection in the left deltoid.

    Arm title
    		 Naïve - 40
    Arm description
    		 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MenACWY IM injection in the left deltoid.

    Arm title
    		 Naïve - 60
    Arm description
    		 Control subjects, age-matched with the intervention groups subjects (60 months of age), were administered one dose of MenACWY-CRM.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MenACWY IM injection in the left deltoid.

    Number of subjects in period 1
    		ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
    Started
    214
    121
    53
    45
    Completed
    134
    87
    53
    45
    Not completed
    80
    34
    0
    0
         Consent withdrawn by subject
    31
    14
    -
    -
         Inappropriate enrollment
    1
    -
    -
    -
         Unable to classify
    3
    1
    -
    -
         Lost to follow-up
    23
    10
    -
    -
         Administrative reason
    22
    9
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACWY - 4
    Reporting group description
    		 Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    ACWY - 2
    Reporting group description
    		 Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    Naïve - 40
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.

    Reporting group title
    Naïve - 60
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (60 months of age), were administered one dose of MenACWY-CRM.

    Reporting group values
    		 ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60 Total
    Number of subjects
    		 214 121 53 45 433
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 39.6 ( 3.4 ) 39.5 ( 2.4 ) 38.7 ( 1.8 ) 60 ( 1.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 97 55 29 26 207
        Male
    		 117 66 24 19 226

    End points

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    End points reporting groups
    Reporting group title
    ACWY - 4
    Reporting group description
    		 Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    ACWY - 2
    Reporting group description
    		 Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    Naïve - 40
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.

    Reporting group title
    Naïve - 60
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (60 months of age), were administered one dose of MenACWY-CRM.

    Subject analysis set title
    Enrolled Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who had signed an informed consent, undergone screening procedures, and were enrolled.

    Subject analysis set title
    PPS 40-Month Persistence
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the 40 Month Persistence FAS population who had no major protocol deviation as defined prior to database lock.

    Subject analysis set title
    PPS 60-Month Persistence
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the 60 Month Persistence FAS population who had no major protocol deviation as defined prior to database lock.

    Subject analysis set title
    PPS Post-MenACWY-CRM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.

    Subject analysis set title
    Safety Solicited AEs from 6 Hour to Day 7
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.

    Subject analysis set title
    Post MenACWY at 60 months safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received a vaccination at 60 months and were assessed for postvaccination safety

    Primary: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W, and Y at 40 months of age

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    End point title
    		 Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W, and Y at 40 months of age [1] [2]
    End point description
    The persistence of the antibody response in subjects at 40 months of age, previously vaccinated with two or four doses of MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, was measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W, and Y. Analysis was done on the 40-month persistence Per Protocol Set (40-month persistence PPS), i.e, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviations.
    End point type
    Primary
    End point timeframe
    Visit 9 (continuation from the parent study), 40-month visit
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    [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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 40
    Number of subjects analysed
    206
    117
    51
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    10 (6 to 15)
    35 (26 to 44)
    2 (0.05 to 10)
        Men C (N=206, 116, 51)
    34 (28 to 41)
    51 (41 to 60)
    12 (4 to 24)
        Men W (N=204, 115, 51)
    76 (70 to 82)
    83 (74 to 89)
    47 (33 to 62)
        Men Y (N=205, 116, 51)
    67 (60 to 73)
    71 (62 to 79)
    22 (11 to 35)
    No statistical analyses for this end point

    Primary: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W, and Y at 60 months of age

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    End point title
    		 Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W, and Y at 60 months of age [3] [4]
    End point description
    The persistence of the antibody response in subjects of 60 months of age previously vaccinated with two or four doses of MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, was measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W, and Y. Analysis was done on the 60-Month persistence Per Protocol Set (60-month persistence PPS), i.e, all subjects in the enrolled population who provided an evaluable serum sample at the 60-months of age visit and had no major protocol deviations.
    End point type
    Primary
    End point timeframe
    Visit 10 (continuation from the parent study), 60 months of age
    Notes
    [3] - 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: There was no statistical null hypothesis associated with this immunogenicity objective.
    [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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    123
    80
    45
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    6 (2 to 11)
    25 (16 to 36)
    2 (0.056 to 12)
        Men C
    27 (19 to 36)
    43 (32 to 54)
    22 (11 to 37)
        Men W (N=121, 78, 45)
    69 (60 to 77)
    74 (63 to 84)
    40 (26 to 56)
        Men Y (N=122, 80, 44)
    56 (46 to 65)
    69 (57 to 79)
    25 (13 to 40)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W, and Y at 40 Months of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W, and Y at 40 Months of Age [5]
    End point description
    The persistence of the antibody response in subjects of 40 months of age previously vaccinated with two or four doses of MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, was measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W, and Y. Analysis was done on the PPS 40-month persistence.
    End point type
    Secondary
    End point timeframe
    Visit 9 (continuation from the parent study), 40 months of age.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 40
    Number of subjects analysed
    206
    117
    51
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    13 (9 to 18)
    40 (31 to 50)
    2 (0.05 to 10)
        Men C (N=206, 116, 51)
    43 (36 to 50)
    61 (52 to 70)
    16 (7 to 29)
        Men W (N=204, 115, 51)
    81 (75 to 86)
    88 (80 to 93)
    49 (35 to 63)
        Men Y (N=205, 116, 51)
    76 (69 to 81)
    80 (72 to 87)
    24 (13 to 37)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W, and Y at 60 Months of Age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W, and Y at 60 Months of Age [6]
    End point description
    The persistence of the antibody response in subjects of 60 months of age previously vaccinated with two or four doses of MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, was measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W, and Y. Analysis was done on the 60-Month persistence PPS.
    End point type
    Secondary
    End point timeframe
    Visit 10 (continuation from the parent study), 60 months of age.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    123
    80
    45
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    9 (5 to 15)
    33 (22 to 44)
    2 (0.056 to 12)
        Men C
    46 (37 to 55)
    60 (48 to 71)
    33 (20 to 49)
        Men W (N=121, 78, 45)
    74 (66 to 82)
    83 (73 to 91)
    42 (28 to 58)
        Men Y (N=122, 80, 44)
    65 (56 to 73)
    74 (63 to 83)
    25 (13 to 40)
    No statistical analyses for this end point

    Secondary: hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W, and Y at 40 Months of Age

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    End point title
    		 hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W, and Y at 40 Months of Age [7]
    End point description
    The persistence of the antibody response in children of 40 months of age previously vaccinated with two or four doses of MenACWY-CRM in study V59P14, and baseline antibody levels in age-matched naive subjects, was measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y. Analysis was done on the 40-month persistence PPS.
    End point type
    Secondary
    End point timeframe
    Visit 9 (continuation from the parent study), 40-months of age.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 40
    Number of subjects analysed
    206
    117
    51
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A
    2.54 (2.23 to 2.9)
    4.81 (4.06 to 5.69)
    2.02 (1.57 to 2.61)
        Men C (N=206, 116, 51)
    6.14 (4.98 to 7.59)
    9.24 (7.05 to 12)
    2.52 (1.68 to 3.78)
        Men W (N=204, 115, 51)
    26 (21 to 32)
    29 (22 to 39)
    8.25 (5.47 to 12)
        Men Y (N=205, 116, 51)
    16 (13 to 20)
    18 (14 to 24)
    3.69 (2.44 to 5.57)
    No statistical analyses for this end point

    Secondary: hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W, and Y at 60 Months of Age

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    End point title
    		 hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W, and Y at 60 Months of Age [8]
    End point description
    The persistence of the antibody response in children of 60 months of age previously vaccinated with two or four doses of MenACWY-CRM in study V59P14, and baseline antibody levels in age-matched naive subjects was measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y.
    End point type
    Secondary
    End point timeframe
    Visit 10 (continuation from the parent study), 60 months of age.
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    123
    80
    45
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A
    2.27 (1.95 to 2.63)
    3.74 (3.12 to 4.48)
    2.14 (1.68 to 2.74)
        Men C
    5.17 (3.96 to 6.75)
    9.26 (6.71 to 13)
    3.87 (2.5 to 5.98)
        Men W (N=121, 78, 45)
    17 (13 to 22)
    20 (14 to 28)
    6.63 (4.25 to 10)
        Men Y (N=122, 80, 44)
    11 (8.1 to 14)
    14 (9.94 to 19)
    4.1 (2.61 to 6.45)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W, and Y, at 1 Month Post-vaccination with MenACWY-CRM at 60 months of age

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W, and Y, at 1 Month Post-vaccination with MenACWY-CRM at 60 months of age [9]
    End point description
    The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, was measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W, and Y, at 1 month post-vaccination. Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM.
    End point type
    Secondary
    End point timeframe
    Visit 11, 1 month after vaccination.
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    116
    76
    45
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A (≥1:8)
    97 (91 to 99)
    97 (91 to 100)
    87 (73 to 95)
        Men C (≥1:8; N=115, 75, 45)
    96 (90 to 99)
    99 (93 to 100)
    84 (71 to 94)
        Men W (≥1:8; N=104, 70, 44)
    100 (97 to 100)
    100 (95 to 100)
    89 (75 to 96)
        Men Y (≥1:8; N=111, 74, 44)
    100 (97 to 100)
    100 (95 to 100)
    73 (57 to 85)
        Men A (≥1:4)
    97 (91 to 99)
    97 (91 to 100)
    89 (76 to 96)
        Men C (≥1:4; N=115, 75, 45)
    97 (93 to 99)
    100 (95 to 100)
    87 (73 to 95)
        Men W (≥1:4; N=104, 70, 44)
    100 (97 to 100)
    100 (95 to 100)
    91 (78 to 97)
        Men Y (≥1:4; N=111, 74, 44)
    100 (97 to 100)
    100 (95 to 100)
    80 (65 to 90)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroresponse at 1 Month Post-vaccination

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    End point title
    		 Percentage of Subjects With Seroresponse at 1 Month Post-vaccination [10]
    End point description
    The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, was measured by the percentage of subjects with seroresponse at 1 month post-vaccination. Analysis was done on the PPS Post-MenACWY-CRM.
    End point type
    Secondary
    End point timeframe
    Visit 11, 1 month after vaccination.
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    116
    76
    45
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    97 (91 to 99)
    96 (89 to 99)
    87 (73 to 95)
        Men C (N=115, 75, 45)
    87 (79 to 93)
    87 (77 to 93)
    73 (58 to 85)
        Men W (N=104, 70, 44)
    99 (95 to 100)
    100 (95 to 100)
    57 (41 to 72)
        Men Y (N=111, 74, 44)
    98 (94 to 100)
    99 (93 to 100)
    52 (37 to 68)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity

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    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity [11]
    End point description
    Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination. Note: Solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs. Analysis was done on the Solicited Safety Set (from 6 hours to day 7)
    End point type
    Secondary
    End point timeframe
    From day 1 to 7 after vaccination.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 60
    Number of subjects analysed
    129
    83
    45 [12]
    Units: Percentages of subjects
    number (not applicable)
        Any local
    67
    44
    29
        Injection site pain
    54
    33
    24
        Injection site erythema
    26
    20
    13
        Injection site induration
    18
    14
    10
        Any systemic
    45
    26
    23
        Change in eating habits
    14
    5
    4
        Sleepiness
    20
    9
    7
        Irritability
    24
    14
    8
        Vomiting
    4
    0
    3
        Diarrhea
    7
    1
    1
        Arthralgia
    2
    4
    0
        Headache
    6
    6
    2
        Rash
    4
    2
    3
        Fever
    4
    2
    2
        Any other
    18
    11
    7
        Stayed home due to reaction
    5
    0
    0
        Use of analgesics/antipyretics
    18
    11
    7
    Notes
    [12] - Actual number of subjects analyzed was 49.
    No statistical analyses for this end point

    Secondary: Percentages of Subjects Reporting Unsolicited AEs and SAEs

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    End point title
    		 Percentages of Subjects Reporting Unsolicited AEs and SAEs
    End point description
    Percentages of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination. Analysis was done on the Post MenACWY at 40 and 60 months safety set
    End point type
    Secondary
    End point timeframe
    Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).
    End point values
    		 ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
    Number of subjects analysed
    132
    87
    11 [13]
    45 [14]
    Units: Percentages of subjects
        Any unsolicited AE
    7
    8
    0
    12
        Possibly related AE
    4
    6
    0
    6
        Medically attended AEs
    0
    0
    27
    0
        Any SAE
    0
    0
    0
    0
    Notes
    [13] - Unsolicated AEs were not recorded for this group
    [14] - Actual number of subjects analyzed was 50.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination.
    Adverse event reporting additional description
    Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    ACWY - 4
    Reporting group description
    		 Subjects who previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    ACWY - 2
    Reporting group description
    		 Subjects who previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, were administered one booster dose of the same vaccine at 60 months of age.

    Reporting group title
    Naïve - 40
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.

    Reporting group title
    Naïve - 60
    Reporting group description
    		 Control subjects, age-matched with the intervention groups subjects (60 months of age), were administered one dose of MenACWY-CRM.

    Serious adverse events
    		 ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 87 (0.00%)
    0 / 11 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 132 (65.91%)
    57 / 87 (65.52%)
    3 / 11 (27.27%)
    39 / 50 (78.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 132 (4.55%)
    7 / 87 (8.05%)
    0 / 11 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    6
    9
    0
    2
    Somnolence
         subjects affected / exposed
    21 / 132 (15.91%)
    9 / 87 (10.34%)
    0 / 11 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    25
    9
    0
    7
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    26 / 132 (19.70%)
    22 / 87 (25.29%)
    0 / 11 (0.00%)
    13 / 50 (26.00%)
         occurrences all number
    26
    23
    0
    13
    Injection site induration
         subjects affected / exposed
    21 / 132 (15.91%)
    15 / 87 (17.24%)
    0 / 11 (0.00%)
    11 / 50 (22.00%)
         occurrences all number
    22
    16
    0
    12
    Injection site pain
         subjects affected / exposed
    59 / 132 (44.70%)
    37 / 87 (42.53%)
    0 / 11 (0.00%)
    24 / 50 (48.00%)
         occurrences all number
    60
    38
    0
    25
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 132 (5.30%)
    2 / 87 (2.30%)
    0 / 11 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    8
    3
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 132 (3.03%)
    0 / 87 (0.00%)
    0 / 11 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    4
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 87 (0.00%)
    1 / 11 (9.09%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    4 / 132 (3.03%)
    2 / 87 (2.30%)
    0 / 11 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    4
    2
    0
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    24 / 132 (18.18%)
    14 / 87 (16.09%)
    0 / 11 (0.00%)
    9 / 50 (18.00%)
         occurrences all number
    27
    15
    0
    9
    Eating disorders
         subjects affected / exposed
    14 / 132 (10.61%)
    5 / 87 (5.75%)
    0 / 11 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    17
    5
    0
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 132 (1.52%)
    4 / 87 (4.60%)
    1 / 11 (9.09%)
    1 / 50 (2.00%)
         occurrences all number
    2
    5
    1
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 87 (1.15%)
    0 / 11 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    1
    0
    4
    Otitis media acute
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 87 (0.00%)
    1 / 11 (9.09%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 87 (0.00%)
    1 / 11 (9.09%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    2
    Viral pharyngitis
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 87 (0.00%)
    1 / 11 (9.09%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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