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    Clinical Trial Results:
    A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004617-82
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Mar 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V59_50
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01725217
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics SRL
    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)
    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
    13 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with human serum bactericidal assay (hSBA)seroresponse, directed against N meningitidis serogroups A, C, W, and Y.
    Protection of trial subjects
    Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision were readily available in case of anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine, or locally approved medications were available in case of any anaphylactic reactions. This clinical study was designed and implemented and reported in accordance with the ICH (International Conference on Harmozination) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2012
    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
    Russian Federation: 198
    Worldwide total number of subjects
    198
    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)
    76
    Adolescents (12-17 years)
    56
    Adults (18-64 years)
    63
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 4 centres in Russia.

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

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ≥2 to ≤10 Years
    Arm description
    		 Subjects ≥2 to ≤10 years of age who received one vaccination 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
    Single dose 0.5 mL of injectable solution was administered intramuscularly

    Arm title
    		 ≥11 to ≤17 Years
    Arm description
    		 Subjects ≥11 to ≤17 years of age who received one vaccination 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
    Single dose 0.5 mL of injectable solution was administered intramuscularly

    Arm title
    		 ≥18 years
    Arm description
    		 Subjects ≥18 years of age who received one vaccination 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
    Single dose 0.5 mL of injectable solution was administered intramuscularly

    Arm title
    		 Overall (≥2 years)
    Arm description
    		 All subjects ≥2 years of age who received one vaccination 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
    Single dose 0.5 mL of injectable solution was administered intramuscularly

    Number of subjects in period 1
    		≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Started
    66
    66
    66
    198
    Completed
    65
    66
    66
    197
    Not completed
    1
    0
    0
    1
         Consent withdrawn by subject
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ≥2 to ≤10 Years
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥11 to ≤17 Years
    Reporting group description
    		 Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥18 years
    Reporting group description
    		 Subjects ≥18 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    Overall (≥2 years)
    Reporting group description
    		 All subjects ≥2 years of age who received one vaccination of MenACWY-CRM

    Reporting group values
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years) Total
    Number of subjects
    		 66 66 66 198
    Age categorical
    Units: Subjects
    Age continuous
    Analysis was done on the all enrolled set
    Units: years
        arithmetic mean (standard deviation)
    		 6 ( 2.7 ) 13.8 ( 2.1 ) 38.8 ( 12.5 ) 19.6 ( 15.9 ) -
    Gender categorical
    Analysis was done on the all enrolled set
    Units: Subjects
        Female
    		 35 29 44 108 108
        Male
    		 31 37 22 90 90

    End points

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    End points reporting groups
    Reporting group title
    ≥2 to ≤10 Years
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥11 to ≤17 Years
    Reporting group description
    		 Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥18 years
    Reporting group description
    		 Subjects ≥18 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    Overall (≥2 years)
    Reporting group description
    		 All subjects ≥2 years of age who received one vaccination of MenACWY-CRM

    Subject analysis set title
    All enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who have signed an informed consent, undergone screening procedure(s), and have a subject number assigned.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the exposed population who provided evaluable serum samples whose assay results are available for at least one serogroup on day 1 and/or day 29

    Subject analysis set title
    Exposed Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who actually received study vaccination

    Subject analysis set title
    Safety Set ( >2 - <3 years of age)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population between 2 and 3 years of age who provided any post-baseline safety data

    Subject analysis set title
    Safety Set ( >2 - <5 years of age)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population between 2 and 5 years of age who provided any post-baseline safety data

    Subject analysis set title
    Safety Set ( >2 years of age)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population who provided any post-baseline safety data

    Subject analysis set title
    Safety Set ( >6 - <10 years of age)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population between 6 and 10 years of age who provided any post-baseline safety data

    Subject analysis set title
    Safety Set ( >6 years of age)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population older than 6 years of age who provided any post-baseline safety data

    Primary: 1) Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination

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    End point title
    		 1) Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination [1] [2]
    End point description
    Immunogenicity was measured as the percentages of overall subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in hSBA from day 1 in subjects with a baseline hSBA ≥1:4. Analysis was done on Full Analysis Set (FAS).
    End point type
    Primary
    End point timeframe
    Day 29
    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 analysis for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: there was no statistical analysis for this endpoint.
    End point values
    		 Overall (≥2 years)
    Number of subjects analysed
    193 [3]
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A
    85 (79 to 90)
        Men C
    74 (67 to 80)
        Men W
    60 (53 to 67)
        Men Y
    83 (77 to 88)
    Notes
    [3] - Men C, N= 192 Men W, N=192 Men Y, N= 191
    No statistical analyses for this end point

    Secondary: 2) Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group

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    End point title
    		 2) Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group [4]
    End point description
    Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N. meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 29
    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: there was no statistical analysis for this endpoint.
    End point values
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years
    Number of subjects analysed
    63 [5]
    65
    65
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A
    89 (78 to 95)
    89 (79 to 96)
    77 (65 to 86)
        Men C
    69 (56 to 80)
    82 (70 to 90)
    71 (58 to 81)
        Men W
    73 (60 to 83)
    51 (38 to 63)
    57 (44 to 69)
        Men Y
    77 (65 to 87)
    88 (77 to 95)
    85 (74 to 92)
    Notes
    [5] - Men C, N= 62,65,65 Men W, N= 62,65,65 Men Y, N= 61,65,65
    No statistical analyses for this end point

    Secondary: 3) Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination

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    End point title
    		 3) Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
    End point description
    Immunogenicity was measured as hSBA GMTs, against N. meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Number of subjects analysed
    63 [6]
    65
    65
    193
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A (Day 1)
    2.17 (1.79 to 2.62)
    2.43 (2.01 to 2.93)
    2.61 (2.11 to 3.23)
    2.35 (2.17 to 2.55)
        Men A (Day 29)
    67 (38 to 119)
    134 (77 to 233)
    76 (41 to 143)
    93 (73 to 119)
        Men C (Day 1)
    3.16 (2.18 to 4.57)
    3.59 (2.5 to 5.15)
    6.68 (4.43 to 10)
    4.07 (3.45 to 4.8)
        Men C (Day 29)
    28 (14 to 56)
    47 (24 to 92)
    112 (52 to 243)
    59 (43 to 81)
        Men W (Day 1)
    7.93 (4.69 to 13)
    21 (13 to 36)
    13 (7.16 to 23)
    12 (9.42 to 15)
        Men W (Day 29)
    94 (56 to 155)
    117 (72 to 191)
    143 (83 to 248)
    111 (89 to 139)
        Men Y (Day 1)
    3.02 (2.33 to 3.92)
    3.73 (2.89 to 4.82)
    2.74 (2.05 to 3.66)
    2.93 (2.61 to 3.28)
        Men Y (Day 29)
    32 (18 to 56)
    67 (39 to 115)
    80 (43 to 147)
    58 (46 to 74)
    Notes
    [6] - Men C (Day 29), N=62,65,65,192 Men C (Day 29), N=62,65,65,192
    No statistical analyses for this end point

    Secondary: 4) Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination

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    End point title
    		 4) Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
    End point description
    Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and bye age group. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Days 1 and 29
    End point values
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Number of subjects analysed
    63 [7]
    65
    65
    193
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Men A (Day 1)
    2 (0.04 to 9)
    5 (1 to 13)
    11 (4 to 21)
    6 (3 to 10)
        Men A (Day 29)
    89 (78 to 95)
    92 (83 to 97)
    85 (74 to 92)
    89 (83 to 93)
        Men C (Day 1)
    13 (6 to 23)
    17 (9 to 28)
    49 (37 to 62)
    26 (20 to 33)
        Men C (Day 29)
    76 (63 to 86)
    86 (75 to 93)
    89 (79 to 96)
    84 (78 to 89)
        Men W (Day 1)
    30 (19 to 43)
    71 (58 to 81)
    69 (57 to 80)
    57 (50 to 64)
        Men W (Day 29)
    95 (87 to 99)
    98 (92 to 100)
    97 (89 to 100)
    97 (93 to 99)
        Men Y (Day 1)
    10 (4 to 20)
    15 (8 to 26)
    22 (12 to 33)
    16 (11 to 22)
        Men Y (Day 29)
    79 (67 to 88)
    94 (85 to 98)
    89 (79 to 96)
    88 (82 to 92)
    Notes
    [7] - Day29 Men C,N=62,65,65,192 Men W,N=62,65,65,192 Men Y,N=62,65,65,192 Day 1 MenY,N= 62,65,65,192
    No statistical analyses for this end point

    Secondary: 5) Percentages of Subjects Reporting Solicited local and systemic Adverse Events (AEs) After MenACWY-CRM Vaccination

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    End point title
    		 5) Percentages of Subjects Reporting Solicited local and systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
    End point description
    Safety was assessed in terms of percentages of subjects who reported solicited local and systemic Adverse Events (AEs) after MenACWY-CRM vaccination, overall and by age group. Analysis was done on safety set
    End point type
    Secondary
    End point timeframe
    Within days 1 through 7 postvaccination
    End point values
    		 Safety Set ( >2 - <3 years of age) Safety Set ( >2 - <5 years of age)
    Number of subjects analysed
    18
    27
    Units: Percentages of Subjects
    number (not applicable)
        Tenderness
    7
    11
        Erythema
    5
    7
        Induration
    3
    5
        Change in Eating Habits
    1
    1
        Sleepiness
    5
    9
        Irritability
    3
    7
        Vomiting
    0
    1
        Diarrhea
    2
    3
        Rash
    1
    1
        Fever (≥38 °C)
    1
    1
        Use of analgesic/antipyretics
    0
    2
    No statistical analyses for this end point

    Secondary: 6) Percentages of Subjects Reporting Solicited local and systemic Adverse Events (AEs) After MenACWY-CRM Vaccination

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    End point title
    		 6) Percentages of Subjects Reporting Solicited local and systemic Adverse Events (AEs) After MenACWY-CRM Vaccination [8]
    End point description
    Safety was assessed in terms of percentages of subjects who reported solicited local and systemic Adverse Events (AEs) after MenACWY-CRM vaccination, overall and by age group. Analysis was done on safety set.
    End point type
    Secondary
    End point timeframe
    Within days 1 through 7 postvaccination
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: there was no statistical analysis for this endpoint.
    End point values
    		 ≥11 to ≤17 Years ≥18 years Safety Set ( >6 - <10 years of age) Safety Set ( >6 years of age)
    Number of subjects analysed
    66
    66
    38
    170
    Units: Percentages of Subjects
    number (not applicable)
        Pain
    33
    33
    16
    82
        Erythema
    12
    11
    7
    30
        Induration
    11
    8
    4
    23
        Chills
    5
    8
    3
    16
        Nausea
    7
    5
    1
    13
        Malaise
    15
    13
    6
    34
        Myalgia
    11
    9
    5
    33
        Arthralgia
    7
    7
    1
    15
        Headache
    18
    18
    7
    43
        Rash
    0
    3
    1
    4
        Fever (≥38 °C)
    2
    1
    2
    5
        Use of analgesic/antipyretics
    6
    6
    7
    19
    No statistical analyses for this end point

    Secondary: 7) Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination

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    End point title
    		 7) Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
    End point description
    Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs,SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group. Analysis was done on safety set.
    End point type
    Secondary
    End point timeframe
    AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29
    End point values
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Number of subjects analysed
    65
    66
    66
    197
    Units: Percentages of Subjects
    number (not applicable)
        Any AEs (days 1 through 7)
    13
    8
    12
    33
        At least possibly related AEs (days 1 through 7)
    2
    6
    12
    20
        Any SAE (days 1 through 29)
    0
    0
    0
    0
        At least possibly related SAE (days 1 through 29)
    0
    0
    0
    0
        Medically attended AE (days 1 through 29)
    5
    1
    2
    8
        Premature withdrawal due to AE (days 1 through 29)
    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
    From day 1 through day 29
    Adverse event reporting additional description
    Solicited local and systemic AEs were collected within days 1 through 7 postvaccination. All unsolicited AEs from days 1 through 7, SAEs from days 1 through 29.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ≥2 to ≤10 Years
    Reporting group description
    		 Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥11 to ≤17 Years
    Reporting group description
    		 Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    ≥18 years
    Reporting group description
    		 Subjects ≥18 years of age who received one vaccination of MenACWY-CRM

    Reporting group title
    Overall (≥2 years)
    Reporting group description
    		 All subjects ≥2 years of age who received one vaccination of MenACWY-CRM

    Serious adverse events
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 66 (0.00%)
    0 / 197 (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
    		 ≥2 to ≤10 Years ≥11 to ≤17 Years ≥18 years Overall (≥2 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 65 (64.62%)
    42 / 66 (63.64%)
    44 / 66 (66.67%)
    128 / 197 (64.97%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 65 (12.31%)
    18 / 66 (27.27%)
    18 / 66 (27.27%)
    44 / 197 (22.34%)
         occurrences all number
    10
    21
    19
    50
    Somnolence
         subjects affected / exposed
    9 / 65 (13.85%)
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    10 / 197 (5.08%)
         occurrences all number
    9
    1
    0
    10
    General disorders and administration site conditions
    Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 65 (4.62%)
    5 / 66 (7.58%)
    8 / 66 (12.12%)
    16 / 197 (8.12%)
         occurrences all number
    3
    6
    8
    17
    Injection site erythema
         subjects affected / exposed
    12 / 65 (18.46%)
    13 / 66 (19.70%)
    10 / 66 (15.15%)
    35 / 197 (17.77%)
         occurrences all number
    13
    14
    13
    40
    Injection site induration
         subjects affected / exposed
    8 / 65 (12.31%)
    11 / 66 (16.67%)
    8 / 66 (12.12%)
    27 / 197 (13.71%)
         occurrences all number
    9
    12
    10
    31
    Injection site pain
         subjects affected / exposed
    27 / 65 (41.54%)
    33 / 66 (50.00%)
    33 / 66 (50.00%)
    93 / 197 (47.21%)
         occurrences all number
    28
    35
    35
    98
    Malaise
         subjects affected / exposed
    6 / 65 (9.23%)
    15 / 66 (22.73%)
    13 / 66 (19.70%)
    34 / 197 (17.26%)
         occurrences all number
    7
    17
    15
    39
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 65 (1.54%)
    7 / 66 (10.61%)
    5 / 66 (7.58%)
    13 / 197 (6.60%)
         occurrences all number
    2
    7
    5
    14
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    7 / 65 (10.77%)
    0 / 66 (0.00%)
    0 / 66 (0.00%)
    7 / 197 (3.55%)
         occurrences all number
    7
    0
    0
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 65 (1.54%)
    7 / 66 (10.61%)
    7 / 66 (10.61%)
    15 / 197 (7.61%)
         occurrences all number
    1
    8
    7
    16
    Myalgia
         subjects affected / exposed
    5 / 65 (7.69%)
    19 / 66 (28.79%)
    9 / 66 (13.64%)
    33 / 197 (16.75%)
         occurrences all number
    5
    20
    9
    34
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    6 / 65 (9.23%)
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    7 / 197 (3.55%)
         occurrences all number
    6
    0
    1
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2012
    Indicate the number of children aged 2-3 y.o within the group of 66 children aged 2-10 y.o.; state vaccination timeframe in the section “Methodology”; state that the interval between blood draw is the same for all vaccinated subjects; list all contraindications listed in the annotation for use in the exclusion criteria; exclude possibility of IMP use which was stored in terms of temperature deviations; indicate the difference of systemic reactions amongst different age groups.

    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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