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    Clinical Trial Results:
    A phase III, open, randomized, controlled, primary vaccination study to demonstrate non-inferiority of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate vaccine compared to licensed MenC-CRM197 conjugate vaccine when administered to healthy subjects aged 2 through 10 years.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2007-007837-38
    Trial protocol
    DE   FR  
    Global end of trial date
    08 Jan 2009

    Results information
    Results version number
    v2(current)
    This version publication date
    08 Jun 2016
    First version publication date
    04 Apr 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results.

    Trial information

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    Trial identification
    Sponsor protocol code
    111414
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00674583
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals , 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals , 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000429-PIP01-01
    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
    14 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Sep 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: •To demonstrate non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed conjugate vaccine (MenC-CRM197) in terms of serum bactericidal antibody vaccine response to N. meningitidis serogroup C (MenC). Criterion for assessment of non-inferiority for serogroup C: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT Group minus MenC-CRM Group) in the percentages of subjects with vaccine response to meningococcal polysaccharide C serum based on a bactericidal assay using baby rabbit complement (rSBA-MenC) is greater than or equal to the pre-defined clinical limit of –10%. The vaccine response to MenC is defined as post-vaccination rSBA-MenC titer ≥ 1:32 for initially seronegative subjects (i.e. rSBA-MenC titer < 1:8) and at least a 4-fold increase in rSBA-MenC titers from pre to post-vaccination for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8) subjects.
    Protection of trial subjects
    Written informed consent was obtained from each subject’s parent/guardian prior to the performance of any study-specific procedures.The investigator was required to notify GSK Biologicals’ Study Contact for Serious Adverse Event by fax, within 24 hours of his/her becoming aware of the SAE. After the initial AE/SAE report, the investigator was required to proactively follow each subject and provide further information to GSK Biologicals on the subject’s condition. All AEs and SAEs documented at a previous visit/contact and designated as not recovered/not resolved or recovering/resolving were reviewed at subsequent visits/contacts.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 May 2008
    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
    Germany: 259
    Country: Number of subjects enrolled
    France: 155
    Worldwide total number of subjects
    414
    EEA total number of subjects
    414
    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)
    414
    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
    -

    Pre-assignment
    Screening details
    During the screening the following steps occurred: check for inclusion/exclusion criteria,contraindications/precautions, medical history of the subjects and signing informed consent forms

    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
    Yes

    Arm title
    Nimenrix Group
    Arm description
    Subjects received 1 dose of Nimenrix vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    MenACWY-TT, Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose by intramuscular administration in the non-dominant deltoid/thigh region at Day 0.

    Arm title
    Menjugate Group
    Arm description
    Subjects received 1 dose of Menjugate vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    Menjugate
    Investigational medicinal product code
    Other name
    MenC-CRM197
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose by intramuscular administration in the non-dominant deltoid/thigh region at Day 0.

    Number of subjects in period 1
    Nimenrix Group Menjugate Group
    Started
    311
    103
    Completed
    311
    103

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    Subjects received 1 dose of Nimenrix vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Reporting group title
    Menjugate Group
    Reporting group description
    Subjects received 1 dose of Menjugate vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Reporting group values
    Nimenrix Group Menjugate Group Total
    Number of subjects
    311 103 414
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    5.6 ± 2.52 5.6 ± 2.32 -
    Gender categorical
    Units: Subjects
        Female
    163 51 214
        Male
    148 52 200

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    Subjects received 1 dose of Nimenrix vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Reporting group title
    Menjugate Group
    Reporting group description
    Subjects received 1 dose of Menjugate vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Primary: Number of subjects with vaccine response to rSBA-MenC antibody

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    End point title
    Number of subjects with vaccine response to rSBA-MenC antibody
    End point description
    Vaccine response to MenC was defined as the number of subjects with post-vaccination rSBA-MenC titer ≥ 1:32 for initially seronegative subjects (i.e. rSBA-MenC titer < 1:8) and at least a 4-fold increase in rSBA-MenC titers from pre to post-vaccination for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8) subjects.
    End point type
    Primary
    End point timeframe
    One month after the vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    268
    92
    Units: Subjects
        rSBA-MenC
    254
    88
    Statistical analysis title
    Difference in % of subjects with vaccine response
    Statistical analysis description
    To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% CI for the groups difference [Nimenrix group minus Menjugate group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.
    Comparison groups
    Nimenrix Group v Menjugate Group
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    -0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.25
         upper limit
    5.75
    Notes
    [1] - For MenC serogroup, the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with bactericidal vaccine response was computed.

    Secondary: Meningococcal serogroups rSBA antibody titers

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    End point title
    Meningococcal serogroups rSBA antibody titers
    End point description
    Antibody titers were expressed as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    296
    97
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, Month 0 [N=227;76]
    31.5 (23.3 to 42.5)
    25.9 (15.6 to 43)
        rSBA-MenA, Month 1 [N=294;82]
    6236.1 (5574.5 to 6976.3)
    27.2 (15.6 to 47.4)
        rSBA-MenC, Month 0 [N=270;94]
    22.7 (18.1 to 28.4)
    19.4 (13.1 to 28.8)
        rSBA-MenC, Month 1 [N=293;97]
    2794.8 (2393.5 to 3263.3)
    5291.6 (3814.6 to 7340.5)
        rSBA-MenW-135, Month 0 [N=282;92]
    83.2 (67.9 to 102)
    70.2 (48.5 to 101.6)
        rSBA-MenW-135, Month 1 [N=296;95]
    8549.5 (7618.5 to 9594.3)
    87.3 (58.5 to 130.4)
        rSBA-MenY, Month 0 [N=285;90]
    153.6 (125.3 to 188.3)
    107.4 (71.4 to 161.6)
        rSBA-MenY, Month 1 [N=295;95]
    8360.7 (7447.3 to 9386.1)
    128.2 (83.8 to 196.2)
    No statistical analyses for this end point

    Secondary: Anti-meningococcal serotype polysaccharide (anti-PS) antibody concentrations

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    End point title
    Anti-meningococcal serotype polysaccharide (anti-PS) antibody concentrations
    End point description
    Antibody concentrations were expressed as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    149
    52
    Units: concentration
    geometric mean (confidence interval 95%)
        Anti-PSA, Month 0 [N=148;52]
    0.2 (0.17 to 0.22)
    0.22 (0.17 to 0.29)
        Anti-PSA, Month 1 [N=149;50]
    32.45 (26.57 to 39.63)
    0.31 (0.19 to 0.49)
        Anti-PSc, Month 0 [N=147;52]
    0.18 (0.16 to 0.2)
    0.2 (0.16 to 0.25)
        Anti-PSC, Month 1 [N=149;52]
    14.95 (12.89 to 17.34)
    18.07 (13.88 to 23.51)
        Anti-PSW-135, Month 0 [N=144;47]
    0.17 (0.15 to 0.18)
    0.17 (0.14 to 0.2)
        Anti-PSW-135, Month 1 [N=144;47]
    6.96 (5.72 to 8.47)
    0.18 (0.15 to 0.22)
        Anti-PSY, Month 0 [N=147;47]
    0.16 (0.15 to 0.17)
    0.16 (0.15 to 0.17)
        Anti-PSY, Month 1 [N=144;47]
    14.15 (11.66 to 17.17)
    0.17 (0.15 to 0.19)
    No statistical analyses for this end point

    Secondary: Number of subjects between 2 and 5 years of age with any solicited local symptoms

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    End point title
    Number of subjects between 2 and 5 years of age with any solicited local symptoms
    End point description
    Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    162
    53
    Units: Subjects
        Pain
    45
    15
        Redness
    57
    21
        Swelling
    43
    13
    No statistical analyses for this end point

    Secondary: Number of subjects between 6 and 10 years of age with any solicited local symptoms

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    End point title
    Number of subjects between 6 and 10 years of age with any solicited local symptoms
    End point description
    Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    148
    50
    Units: Subjects
        Pain
    65
    27
        Redness
    58
    19
        Swelling
    44
    15
    No statistical analyses for this end point

    Secondary: Number of subjects between 2 and 5 years of age with any solicited general symptoms

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    End point title
    Number of subjects between 2 and 5 years of age with any solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 37.5°C.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    162
    53
    Units: Subjects
        Drowsiness
    23
    6
        Fever
    9
    3
        Irritability
    25
    6
        Loss of appetite
    17
    5
    No statistical analyses for this end point

    Secondary: Number of subjects between 6 and 10 years of age with any solicited general symptoms

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    End point title
    Number of subjects between 6 and 10 years of age with any solicited general symptoms
    End point description
    Solicited general symptoms assessed were fatigue, fever, gastrointestinal and headache. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 37.5°C
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    148
    50
    Units: Subjects
        Fatigue
    33
    11
        Fever
    10
    1
        Gastrointestinal
    22
    4
        Headache
    30
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting specific adverse events

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    End point title
    Number of subjects reporting specific adverse events
    End point description
    Specific AEs include: − rash (hives, idiopathic thrombocytopenic purpura, petechiae), − new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), and/or − conditions prompting emergency room (ER) visits.
    End point type
    Secondary
    End point timeframe
    Up to 6 months after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    311
    103
    Units: Subjects
        Rash(es)
    8
    1
        NOCI (s)
    1
    1
        ER visit(s)
    11
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Up to one month (Day 0-Day 30) after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    311
    103
    Units: Subjects
        Unsolicited symptom (s)
    55
    20
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    Number of subjects reporting any serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months after vaccination
    End point values
    Nimenrix Group Menjugate Group
    Number of subjects analysed
    311
    103
    Units: Subjects
        SAE (s)
    6
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination. Unsolicited adverse events: Up to one month (Day 0-Day 30) after vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Menjugate Group
    Reporting group description
    Subjects received 1 dose of Menjugate vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Reporting group title
    Nimenrix Group
    Reporting group description
    Subjects received 1 dose of Nimenrix vaccine administered intramuscularly in the non-dominant deltoid/thigh region at Day 0.

    Serious adverse events
    Menjugate Group Nimenrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 103 (0.97%)
    6 / 311 (1.93%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental poisoning
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         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 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 311 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 311 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Menjugate Group Nimenrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 103 (26.21%)
    65 / 311 (20.90%)
    General disorders and administration site conditions
    Pain (1)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    15 / 53 (28.30%)
    45 / 162 (27.78%)
         occurrences all number
    53
    162
    Redness (1)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    21 / 53 (39.62%)
    57 / 162 (35.19%)
         occurrences all number
    53
    162
    Swelling (1)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    13 / 53 (24.53%)
    43 / 162 (26.54%)
         occurrences all number
    53
    162
    Pain (2)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    27 / 50 (54.00%)
    65 / 148 (43.92%)
         occurrences all number
    50
    148
    Redness (2)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    19 / 50 (38.00%)
    58 / 148 (39.19%)
         occurrences all number
    50
    148
    Swelling (2)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    15 / 50 (30.00%)
    44 / 148 (29.73%)
         occurrences all number
    50
    148
    Drowsiness
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    6 / 53 (11.32%)
    23 / 162 (14.20%)
         occurrences all number
    53
    162
    Fever (Orally) (1)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    3 / 53 (5.66%)
    9 / 162 (5.56%)
         occurrences all number
    53
    162
    Irritability
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    6 / 53 (11.32%)
    25 / 162 (15.43%)
         occurrences all number
    53
    162
    Loss of appetite
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    5 / 53 (9.43%)
    17 / 162 (10.49%)
         occurrences all number
    53
    162
    Fatigue
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    11 / 50 (22.00%)
    33 / 148 (22.30%)
         occurrences all number
    50
    148
    Fever (Orally) (2)
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    1 / 50 (2.00%)
    10 / 148 (6.76%)
         occurrences all number
    50
    148
    Gastrointestinal
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    4 / 50 (8.00%)
    22 / 148 (14.86%)
         occurrences all number
    50
    148
    Headache
    Additional description: Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 6-10 years of age
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    4 / 50 (8.00%)
    30 / 148 (20.27%)
         occurrences all number
    50
    148
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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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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