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    Clinical Trial Results:
    A phase IIIb, open, multi-center study to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals’ MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals’ Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 and 4 years after MenACWY-TT booster vaccination.

    Summary
    EudraCT number
    		 2012-002575-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Apr 2016

    Results information
    Results version number
    		 v1
    This version publication date
    05 Nov 2016
    First version publication date
    05 Nov 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    116727
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01777308
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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
    Interim
    Date of interim/final analysis
    11 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*. *Vaccine response to meningococcal antigens (A, C, W-135 and Y) is defined as: - For initially seronegative subjects (pre-vaccination rSBA titer below 1:8): rSBA antibody titer ≥ 1:32 one month after vaccination, and - For initially seropositive subjects (pre-vaccination rSBA titer ≥ 1:8): at least four-fold increase in rSBA titers from pre-vaccination to one month after vaccination.
    Protection of trial subjects
    The axillary, rectal, oral or tympanic body temperature of all subjects needed to be measured prior to any study vaccine/product administration. The preferred route for recording temperature in this study was oral. If the subject had fever [fever was defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route] on the day of vaccination, the vaccination visit was rescheduled within the allowed interval for this visit. All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 156
    Worldwide total number of subjects
    156
    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)
    156
    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 study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 Healthy male or female subjects who were primed with Menitorix™ vaccine, administered intramuscularly in the deltoid region of the left arm, and Priorix™ vaccine, administered subcutaneously on the upper-right side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine, administered intramuscularly in the deltoid region of the left arm, at Month 72 post primary vaccination (booster visit 1) in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were primed with one dose of vaccine, administered subcutaneously on the upper-right side of the arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Hib-MenC-TT
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were primed with one dose of vaccine, administered intramuscularly in the deltoid region of the left arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).

    Investigational medicinal product name
    GSK134612
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were boosted with one dose of vaccine, intramuscularly in the deltoid region of the left arm, at Month 72, post primary vaccination.

    Arm title
    		 Hiberix + Meningitec Group
    Arm description
    		 Healthy male or female subjects who were primed with Meningitec™ vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, Hiberix™ vaccine, administered intramuscularly on the left side of the thigh, and Priorix™ vaccine, administered subcutaneously on the right-upper side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine at Month 72 post primary vaccination (booster visit 1) in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MCC, MenC
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were primed with one dose of vaccine, intramuscularly in the deltoid region of the non-dominant arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were primed with one dose of vaccine, intramuscularly on the left side of the thigh, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were primed with one dose of vaccine, subcutaneously on the right-upper side of the arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).

    Investigational medicinal product name
    GSK134612
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were boosted with one dose of vaccine, intramuscularly in the deltoid region of the left arm, at Month 72, post primary vaccination.

    Number of subjects in period 1
    		Menitorix Group Hiberix + Meningitec Group
    Started
    119
    37
    Completed
    118
    37
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Menitorix™ vaccine, administered intramuscularly in the deltoid region of the left arm, and Priorix™ vaccine, administered subcutaneously on the upper-right side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine, administered intramuscularly in the deltoid region of the left arm, at Month 72 post primary vaccination (booster visit 1) in the current study.

    Reporting group title
    Hiberix + Meningitec Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Meningitec™ vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, Hiberix™ vaccine, administered intramuscularly on the left side of the thigh, and Priorix™ vaccine, administered subcutaneously on the right-upper side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine at Month 72 post primary vaccination (booster visit 1) in the current study.

    Reporting group values
    		 Menitorix Group Hiberix + Meningitec Group Total
    Number of subjects
    		 119 37 156
    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)
    		 7 ( 0.2 ) 7 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 57 14 71
        Male
    		 62 23 85

    End points

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    End points reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Menitorix™ vaccine, administered intramuscularly in the deltoid region of the left arm, and Priorix™ vaccine, administered subcutaneously on the upper-right side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine, administered intramuscularly in the deltoid region of the left arm, at Month 72 post primary vaccination (booster visit 1) in the current study.

    Reporting group title
    Hiberix + Meningitec Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Meningitec™ vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, Hiberix™ vaccine, administered intramuscularly on the left side of the thigh, and Priorix™ vaccine, administered subcutaneously on the right-upper side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine at Month 72 post primary vaccination (booster visit 1) in the current study.

    Primary: Number of subjects with vaccine response to the serum bactericidal assay meningococcal serogroup A, C, W-135 and Y using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)

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    End point title
    		 Number of subjects with vaccine response to the serum bactericidal assay meningococcal serogroup A, C, W-135 and Y using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) [1]
    End point description
    Vaccine response was defined as : - For initially seronegative subjects, antibody titer ≥ 1:32 at post-vaccination, and - For initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
    End point type
    Primary
    End point timeframe
    At one month post booster vaccination (Month 73)
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    104
    34
    Units: Subjects
        rSBA-MenA (N=104;34)
    102
    33
        rSBA-MenC (N=104;34)
    101
    33
        rSBA-MenW-135 (N=104;34)
    102
    33
        rSBA-MenY (N=104;34)
    101
    33
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers greater than or equal to (≥) the predefined cut-off values of 1:8 and 1:128

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    End point title
    		 Number of subjects with anti-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers greater than or equal to (≥) the predefined cut-off values of 1:8 and 1:128
    End point description
    End point type
    Secondary
    End point timeframe
    At one month post booster vaccination (Month 73)
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    104
    35
    Units: Subjects
        rSBA-MenA, ≥ 1:8 (N=104;35)
    102
    35
        rSBA-MenA, ≥ 1:128 (N=104;35)
    102
    35
        rSBA-MenC, ≥ 1:8 (N=104;35)
    102
    35
        rSBA-MenC, ≥ 1:128 (N=104;35)
    102
    34
        rSBA-MenW-135, ≥ 1:8 (N=104;35)
    102
    35
        rSBA-MenW-135, ≥ 1:128 (N=104;35)
    102
    35
        rSBA-MenY, ≥ 1:8 (N=104;35)
    103
    34
        rSBA-MenY, ≥ 1:128 (N=104;35)
    103
    34
    No statistical analyses for this end point

    Secondary: Anti-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers

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    End point title
    		 Anti-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    At one month post booster vaccination (Month 73)
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    104
    35
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (N=104;35)
    3421.4 (2659.3 to 4402)
    2925.1 (1949.5 to 4389)
        rSBA-MenC (N=104;35)
    11819.2 (9026.4 to 15476.1)
    7419.7 (4543.2 to 12117.3)
        rSBA-MenW-135 (N=104;35)
    17166.5 (12745.9 to 23120.3)
    15747.7 (10033 to 24717.7)
        rSBA-MenY (N=104;35)
    4871 (3932.7 to 6033.1)
    3495.9 (2126.6 to 5746.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local and solicited general symptoms

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    End point title
    		 Number of subjects with solicited local and solicited general symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4 days (Day 0-3), post booster vaccination
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    118
    37
    Units: Subjects
        Any Pain (N=118;37)
    69
    15
        Any Redness (N=118;37)
    56
    19
        Any Swelling (N=118;37)
    30
    8
        Any Fatigue (N=118;37)
    31
    10
        Any Gastrointestinal symptoms (N=118;37)
    29
    5
        Any Headache (N=118;37)
    29
    6
        Any Fever (Oral) (N=118;37)
    6
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset chronic illnesses (NOCIs)

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    End point title
    		 Number of subjects reporting new onset chronic illnesses (NOCIs)
    End point description
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    During the 31 days period (Day 0-30), post booster vaccination
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    119
    37
    Units: Subjects
        Any NOCIs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31 days period (Day 0-30), post booster vaccination
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    119
    37
    Units: Subjects
        Any AEs
    36
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with 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 or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the 31 days period (Day 0-30), post booster vaccination
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    119
    37
    Units: Subjects
        Any SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited and unsolicited symptoms at least once

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    End point title
    		 Number of subjects reporting solicited and unsolicited symptoms at least once
    End point description
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post booster vaccination
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    119
    37
    Units: Subjects
        Any solicited/unsolicited symptoms
    97
    28
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs

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    End point title
    		 Number of subjects with SAEs
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Month 72 until Data Lock Point (DLP) August 30th 2016
    End point values
    		 Menitorix Group Hiberix + Meningitec Group
    Number of subjects analysed
    119
    37
    Units: Subjects
        Any SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and solicited general symptoms: during the 4-day post-vaccination period; Solicited and unsolicited symptoms: during the 31-day post-vaccination period; SAEs: during the 31-day post-vaccination period and up to DLP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Menitorix™ vaccine, administered intramuscularly in the deltoid region of the left arm, and Priorix™ vaccine, administered subcutaneously on the upper-right side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine, administered intramuscularly in the deltoid region of the left arm, at Month 72 post primary vaccination (booster visit 1) in the current study.

    Reporting group title
    Hiberix + Meningitec Group
    Reporting group description
    		 Healthy male or female subjects who were primed with Meningitec™ vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, Hiberix™ vaccine, administered intramuscularly on the left side of the thigh, and Priorix™ vaccine, administered subcutaneously on the right-upper side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine at Month 72 post primary vaccination (booster visit 1) in the current study.

    Serious adverse events
    		 Menitorix Group Hiberix + Meningitec Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Menitorix Group Hiberix + Meningitec Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 119 (57.98%)
    19 / 37 (51.35%)
    Nervous system disorders
    Headache (unsolicited)
         subjects affected / exposed
    30 / 119 (25.21%)
    7 / 37 (18.92%)
         occurrences all number
    30
    9
    General disorders and administration site conditions
    Fatigue (unsolicited)
         subjects affected / exposed
    31 / 119 (26.05%)
    10 / 37 (27.03%)
         occurrences all number
    31
    10
    Pain (unsolicited)
         subjects affected / exposed
    69 / 119 (57.98%)
    15 / 37 (40.54%)
         occurrences all number
    69
    15
    Pyrexia
         subjects affected / exposed
    6 / 119 (5.04%)
    2 / 37 (5.41%)
         occurrences all number
    6
    2
    Swelling (unsolicited)
         subjects affected / exposed
    30 / 119 (25.21%)
    8 / 37 (21.62%)
         occurrences all number
    30
    8
    Pain (solicited)
         subjects affected / exposed [1]
    69 / 118 (58.47%)
    15 / 37 (40.54%)
         occurrences all number
    69
    15
    Redness
         subjects affected / exposed [2]
    56 / 118 (47.46%)
    19 / 37 (51.35%)
         occurrences all number
    56
    19
    Swelling (solicited)
         subjects affected / exposed [3]
    30 / 118 (25.42%)
    8 / 37 (21.62%)
         occurrences all number
    30
    8
    Fatigue (solicited)
         subjects affected / exposed [4]
    31 / 118 (26.27%)
    10 / 37 (27.03%)
         occurrences all number
    31
    10
    Gastrointestinal symptoms
         subjects affected / exposed [5]
    29 / 118 (24.58%)
    5 / 37 (13.51%)
         occurrences all number
    29
    5
    Headache (solicited)
         subjects affected / exposed [6]
    29 / 118 (24.58%)
    6 / 37 (16.22%)
         occurrences all number
    29
    6
    Fever (Oral)
         subjects affected / exposed [7]
    6 / 118 (5.08%)
    1 / 37 (2.70%)
         occurrences all number
    6
    1
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    29 / 119 (24.37%)
    5 / 37 (13.51%)
         occurrences all number
    29
    5
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    56 / 119 (47.06%)
    19 / 37 (51.35%)
         occurrences all number
    56
    19
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 119 (5.88%)
    2 / 37 (5.41%)
         occurrences all number
    7
    2
    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.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2013
    This protocol amendment has been done to remove the recording of any antipyretic administered in the period starting 6 hours before vaccination and ending 12 hours after vaccination in the protocol, since the collection of this information is not needed for the study, is not included in the eCRF and also involves a complex collection process. In addition: • Table 5 has been corrected with an error with respect to the allowed interval at Year 4. • The authors list has been updated according to changes in the clinical study team. • The Sponsor Information section now mentions that the Sponsor Information Sheet will be used instead of the local study contact information document for details of the Medical Expert and Study Monitor. • The duration of the study of approximately four years for each subject has been mentioned for more clarity. • The introduction has been updated with the current licensing status of GSK Biologicals’ MenACWY-TT conjugate vaccine. • The recording of subjects’ non-participation in the booster study in the eCRF has been removed. • The name of the HPA (Health Protection Agency) laboratory is now changed to PHE (Public Health England) laboratory. • The manner in which the investigators will be provided with the immunogenicity results has been updated. • The preparation of an annex report after the Year 2 persistence analysis has been removed since this analysis will be included in the Year 4 persistence CSR only.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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