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    Clinical Trial Results:
    A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea.

    Summary
    EudraCT number
    		 2014-005392-90
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2018
    First version publication date
    31 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205336
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02446691
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l'Institu 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, sss42438@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, sss42438@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?
    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
    29 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the persistence of the antibody response against N. meningitidis serogroups A, C, W and Y at approximately 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by hSBA titers ≥8. 2. To evaluate the persistence of the antibody response against N. meningitidis serogroups A, C, W and Y at approximately 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and and 12 months of age) of MenACWY vaccine as measured by rSBA titers ≥8 and ≥128.
    Protection of trial subjects
    All subjects were supervised/observed for 30 minutes after 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/products.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2015
    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
    Korea, Republic of: 128
    Worldwide total number of subjects
    128
    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)
    128
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 6 centers in South Korea.

    Pre-assignment
    Screening details
    		 All enrolled subjects were vaccinated

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label study. No blinding methods were used.

    Arms
    Arm title
    		 MenACWY Group
    Arm description
    		 Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Infants received 4 doses of the Meningococcal Vaccine intramuscularly.

    Number of subjects in period 1
    		MenACWY Group
    Started
    128
    Completed
    117
    Not completed
    11
         Consent withdrawn by subject
    2
         Lost to follow-up
    8
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY Group
    Reporting group description
    		 Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.

    Reporting group values
    		 MenACWY Group Total
    Number of subjects
    		 128 128
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 128 128
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: Days
        arithmetic mean (standard deviation)
    		 71.7 ± 8.09 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 59 59
        Male
    		 69 69
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 127 127
        Unspecified
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    MenACWY Group
    Reporting group description
    		 Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.

    Primary: Number of subjects with any solicited Adverse Events (AEs) within 30 minutes after each vaccination.

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    End point title
    		 Number of subjects with any solicited Adverse Events (AEs) within 30 minutes after each vaccination. [1]
    End point description
    Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None [<10mm], Any[>=10 mm]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever[ body temperature >=38°C measured preferably via tympanic route]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis.Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
    End point type
    Primary
    End point timeframe
    Within 30 minutes of each vaccination
    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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    128
    Units: Participants
        Injection site erythema,Vaccination 1,Any
    0
        Injection site erythema,Vaccination 2,Any
    0
        Injection site erythema, Vaccination 3,Any
    0
        Injection site erythema,Vaccination 4,Any(N-124)
    1
        Injection site induration,Vaccination 1, Any
    0
        Injection site induration,Vaccination 2, Any
    0
        Injection site induration,Vaccination 3, Any
    0
        Injection site induration,Vaccination 4,Any(N-124)
    1
        Injection site tenderness,Vaccination 1, Any
    0
        Injection site tenderness,Vaccination 2, Any
    0
        Injection site tenderness,Vaccination 3, Any
    0
        Injection site tenderness,Vaccination 4,Any(N-124)
    0
        Change in eating habits,Vaccination 1,Any
    0
        Change in eating habits,Vaccination 2,Any
    0
        Change in eating habits,Vaccination 3,Any
    0
        Change in eating habits,Vaccination 4,Any(N-124)
    0
        Diarrhea, Vaccination 1, Any
    0
        Diarrhea, Vaccination 2, Any
    0
        Diarrhea, Vaccination 3, Any
    0
        Diarrhea,Vaccination 4,Any (N-124)
    0
        Irritability, Vaccination 1, Any
    0
        Irritability, Vaccination 2, Any
    0
        Irritability, Vaccination 3, Any
    0
        Irritability,Vaccination 4,Any(N-124)
    0
        Sleepiness, Vaccination 1, Any
    0
        Sleepiness, Vaccination 2, Any
    0
        Sleepiness, Vaccination 3, Any
    0
        Sleepiness,Vaccination 4,Any(N-124)
    0
        Vomiting, Vaccination 1, Any
    0
        Vomiting, Vaccination 2, Any
    0
        Vomiting, Vaccination 3, Any
    0
        Vomiting,Vaccination 4,Any(N-124)
    1
        Fever, Vaccination 1, Yes
    0
        Fever, Vaccination 1, No
    128
        Fever, Vaccination 2, Yes
    0
        Fever, Vaccination 2, No
    128
        Fever, Vaccination 3, Yes
    0
        Fever, Vaccination 3, No
    128
        Fever, Vaccination 4, Yes
    0
        Fever, Vaccination 4, No(N-124)
    124
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited local AEs from Day 1 to Day 7 after each vaccination

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    End point title
    		 Number of subjects with any solicited local AEs from Day 1 to Day 7 after each vaccination [2]
    End point description
    Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration:Type II None (<10 mm), Any (>=10 mm).Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after each vaccination
    Notes
    [2] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    128
    Units: Participants
        Injection site erythema, Vaccination 1, Any
    4
        Injection site erythema, Vaccination 2, Any
    6
        Injection site erythema,Vaccination 3, Any(N-127)
    6
        Injection site erythema,Vaccination 4, Any(N-124)
    6
        Injection site induration,Vaccination 1,Any
    4
        Injection site induration,Vaccination 2,Any
    9
        Injection site induration,Vaccination 3,Any(N-127)
    3
        Injection site induration,Vaccination 4,Any(N-124)
    6
        Injection site tenderness,Vaccination 1,Any
    17
        Injection site tenderness,Vaccination 2,Any
    21
        Injection site tenderness,Vaccination 3,Any(N-127)
    14
        Injection site tenderness,Vaccination 4,Any(N-124)
    20
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited systemic AEs from Day 1 to Day 7 after each vaccination.

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    End point title
    		 Number of subjects with any solicited systemic AEs from Day 1 to Day 7 after each vaccination. [3]
    End point description
    Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after each vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    128
    Units: Participants
        Change in eating habits,Vaccination 1,Any
    29
        Change in eating habits,Vaccination 2,Any
    21
        Change in eating habits,Vaccination 3,Any(N-127)
    21
        Change in eating habits,Vaccination 4,Any(N-124)
    24
        Diarrhea,Vaccination 1,Any
    15
        Diarrhea, Vaccination 2, Any
    13
        Diarrhea, Vaccination 3, Any(N-127)
    15
        Diarrhea, Vaccination 4, Any(N-124)
    17
        Irritability, Vaccination 1, Any
    58
        Irritability, Vaccination 2, Any
    49
        Irritability,Vaccination 3,Any(N-127)
    47
        Irritability,Vaccination 4,Any(N-124)
    45
        Sleepiness,Vaccination 1,Any
    52
        Sleepiness, Vaccination 2, Any
    31
        Sleepiness,Vaccination 3,Any(N-127)
    28
        Sleepiness,Vaccination 4,Any(N-124)
    20
        Vomiting, Vaccination 1, Any
    26
        Vomiting, Vaccination 2, Any
    20
        Vomiting,Vaccination 3,Any(N-127)
    15
        Vomiting,Vaccination 4,Any(N-124)
    5
        Fever, Vaccination 1, Yes
    4
        Fever, Vaccination 1, No
    124
        Fever, Vaccination 2, Yes
    10
        Fever, Vaccination 2, No
    118
        Fever, Vaccination 3, Yes(N-127)
    6
        Fever, Vaccination 3, No(N-127)
    121
        Fever, Vaccination 4, Yes(N-124)
    15
        Fever, Vaccination 4, No(N-124)
    109
    No statistical analyses for this end point

    Primary: Number of subjects with any medically attended unsolicited AEs and AEs leading to premature withdrawal

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    End point title
    		 Number of subjects with any medically attended unsolicited AEs and AEs leading to premature withdrawal [4]
    End point description
    An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.Analysis was performed on the unsolicited safety set, which included all subjects who received a study vaccination and reported any unsolicited adverse event data.
    End point type
    Primary
    End point timeframe
    From Day 1 to Visit 6 (at 24 Months of age)
    Notes
    [4] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    128
    Units: Participants
        Any Medically Attended Unsolicited AEs
    85
        AEs leading to premature withdrawal
    0
    No statistical analyses for this end point

    Primary: Number of subjects with Serious AEs (SAEs)

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    End point title
    		 Number of subjects with Serious AEs (SAEs) [5]
    End point description
    Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.Analysis was performed on the overall safety set, which included all subjects who received a study vaccination and reported any solicited/unsolicited adverse event data.
    End point type
    Primary
    End point timeframe
    From Day 1 to Visit 6 (At 24 months of age)
    Notes
    [5] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    128
    Units: Participants
    26
    No statistical analyses for this end point

    Primary: Percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 8 against each N.meningitidis serogroup A,C,W and Y at 24 months of age.

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    End point title
    		 Percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 8 against each N.meningitidis serogroup A,C,W and Y at 24 months of age. [6]
    End point description
    To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received at least one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
    End point type
    Primary
    End point timeframe
    At 24 months of age (Visit 6)
    Notes
    [6] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    114
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    39 (30.4 to 49.1)
        Serogroup C (N-110)
    61 (51.1 to 70.1)
        Serogroup W (N-113)
    88 (80.1 to 93.1)
        Serogroup Y
    89 (81.3 to 93.8)
    No statistical analyses for this end point

    Primary: Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 8, against each N.meningitidis serogroup at 24 months of age

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    End point title
    		 Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 8, against each N.meningitidis serogroup at 24 months of age [7]
    End point description
    To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
    End point type
    Primary
    End point timeframe
    At 24 months of age (Visit 6)
    Notes
    [7] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    108
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    99 (94.9 to 99.98)
        Serogroup C
    54 (43.8 to 63.3)
        Serogroup W
    69 (59.8 to 77.9)
        Serogroup Y(N-107)
    90 (82.3 to 94.8)
    No statistical analyses for this end point

    Primary: Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 128 against each N.meningitidis serogroup at 24 months of age

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    End point title
    		 Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 128 against each N.meningitidis serogroup at 24 months of age [8]
    End point description
    To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
    End point type
    Primary
    End point timeframe
    At 24 months of age (Visit 6)
    Notes
    [8] - 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 endpoint was descrpitive analysis. No statistical analyses were performed.
    End point values
    		 MenACWY Group
    Number of subjects analysed
    108
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    98 (93.5 to 99.77)
        Serogroup C
    30 (21.2 to 39.2)
        Serogroup W
    62 (52.2 to 71.2)
        Serogroup Y(N-107)
    80 (71.6 to 87.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with hSBA ≥8 against each N. meningitidis serogroups A, C, W and Y at 13 months of age

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    End point title
    		 Percentage of Subjects with hSBA ≥8 against each N. meningitidis serogroups A, C, W and Y at 13 months of age
    End point description
    To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received at least one study vaccination and who provided evaluable hSBA immunogenicity data at 1 month after last vaccination for at least one serogroup.
    End point type
    Secondary
    End point timeframe
    At 13 months of age (Visit 5)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    122
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    94 (88.5 to 97.7)
        Serogroup C
    98 (94.2 to 99.80)
        Serogroup W
    100 (97.0 to 100.0)
        Serogroup Y(N-120)
    100 (97.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with rSBA titers ≥ 8 against each N. meningitidis serogroups A, C, W and Y at 13 months of age

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    End point title
    		 Percentage of Subjects with rSBA titers ≥ 8 against each N. meningitidis serogroups A, C, W and Y at 13 months of age
    End point description
    To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 13 months of age (Visit 5)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    116
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A (N-115)
    100 (96.8 to 100.0)
        Serogroup C(N-115)
    99 (95.3 to 99.98)
        Serogroup W(N-115)
    100 (96.8 to 100.0)
        Serogroup Y
    100 (96.9 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with rSBA titers ≥ 128 against each N. meningitidis serogroups A, C, W and Y at 13 months of age

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    End point title
    		 Percentage of Subjects with rSBA titers ≥ 128 against each N. meningitidis serogroups A, C, W and Y at 13 months of age
    End point description
    To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 13 months of age (Visit 5)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    116
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A(N-115)
    100 (96.8 to 100.0)
        Serogroup C(N-115)
    92 (85.7 to 96.4)
        Serogroup W(N-115)
    98 (93.9 to 99.79)
        Serogroup Y
    98 (93.9 to 99.79)
    No statistical analyses for this end point

    Secondary: hSBA Geometric Mean Titers (GMTs) against each N. meningitidis serogroups A, C, W and Y at 24 months of age

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    End point title
    		 hSBA Geometric Mean Titers (GMTs) against each N. meningitidis serogroups A, C, W and Y at 24 months of age
    End point description
    To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 24 months of age (Visit 6)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    114
    Units: Titers
    geometric mean (confidence interval 95%)
        Serogroup A
    6.80 (5.19 to 8.93)
        Serogroup C(N-110)
    13.04 (9.65 to 17.63)
        Serogroup W(N-113)
    53.56 (40.42 to 70.97)
        Serogroup Y
    50.75 (38.76 to 66.45)
    No statistical analyses for this end point

    Secondary: rSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 24 months of age

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    End point title
    		 rSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 24 months of age
    End point description
    To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 24 months of age (Visit 6)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    108
    Units: Titers
    geometric mean (confidence interval 95%)
        Serogroup A
    2269.48 (1761.12 to 2924.59)
        Serogroup C
    17.17 (11.28 to 26.14)
        Serogroup W
    114.04 (65.22 to 199.39)
        Serogroup Y(N-107)
    310.91 (203.23 to 475.65)
    No statistical analyses for this end point

    Secondary: hSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 13 months of age

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    End point title
    		 hSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 13 months of age
    End point description
    To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable hSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 13 months of age (Visit 5)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    122
    Units: Titers
    geometric mean (confidence interval 95%)
        Serogroup A
    107.90 (85.73 to 135.81)
        Serogroup C
    201.04 (157.90 to 255.96)
        Serogroup W
    426.74 (338.34 to 538.24)
        Serogroup Y(N-120)
    359.39 (280.59 to 460.31)
    No statistical analyses for this end point

    Secondary: rSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 13 months of age.

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    End point title
    		 rSBA GMTs against each N. meningitidis serogroups A, C, W and Y at 13 months of age.
    End point description
    To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
    End point type
    Secondary
    End point timeframe
    At 13 months of age (Visit 5)
    End point values
    		 MenACWY Group
    Number of subjects analysed
    116
    Units: Titers
    geometric mean (confidence interval 95%)
        Serogroup A(N-115)
    7394.18 (6057.42 to 9025.93)
        Serogroup C(N-115)
    735.07 (545.22 to 991.03)
        Serogroup W(N-115)
    2718.69 (2031.77 to 3637.85)
        Serogroup Y
    2226.70 (1731.21 to 2863.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, Serious AEs (SAEs): From Day 1 to study end (visit 6).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    MenACWY Group
    Reporting group description
    		 Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.

    Serious adverse events
    		 MenACWY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 128 (20.31%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Buried penis syndrome
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    5 / 128 (3.91%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 128 (3.13%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MenACWY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 128 (87.50%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    41 / 128 (32.03%)
         occurrences all number
    136
    Pyrexia
         subjects affected / exposed
    33 / 128 (25.78%)
         occurrences all number
    68
    Injection site induration
         subjects affected / exposed
    22 / 128 (17.19%)
         occurrences all number
    67
    Injection site erythema
         subjects affected / exposed
    16 / 128 (12.50%)
         occurrences all number
    40
    Immune system disorders
    Atopy
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 128 (4.69%)
         occurrences all number
    7
    Rhinorrhoea
         subjects affected / exposed
    4 / 128 (3.13%)
         occurrences all number
    9
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    86 / 128 (67.19%)
         occurrences all number
    461
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    4 / 128 (3.13%)
         occurrences all number
    4
    Contusion
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Ear canal injury
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Eye contusion
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Lip injury
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences all number
    2
    Radial head dislocation
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    2
    Skin abrasion
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Skull fracture
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    67 / 128 (52.34%)
         occurrences all number
    265
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Eye disorders
    Eye discharge
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences all number
    2
    Retinal disorder
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    41 / 128 (32.03%)
         occurrences all number
    178
    Enteritis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences all number
    2
    Mouth ulceration
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    42 / 128 (32.81%)
         occurrences all number
    168
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    3
    Dry skin
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    4 / 128 (3.13%)
         occurrences all number
    4
    Pityriasis alba
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    3
    Urticaria
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    4
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Bronchiolitis
         subjects affected / exposed
    11 / 128 (8.59%)
         occurrences all number
    14
    Bronchitis
         subjects affected / exposed
    11 / 128 (8.59%)
         occurrences all number
    21
    Cellulitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Croup infectious
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    3
    Ear infection
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Enterovirus infection
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    4
    Exanthema subitum
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    9 / 128 (7.03%)
         occurrences all number
    10
    Gastroenteritis viral
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Gianotti-Crosti syndrome
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    6 / 128 (4.69%)
         occurrences all number
    6
    Herpangina
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Impetigo
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    15 / 128 (11.72%)
         occurrences all number
    18
    Oral candidiasis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Otitis externa
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    5 / 128 (3.91%)
         occurrences all number
    5
    Otitis media acute
         subjects affected / exposed
    11 / 128 (8.59%)
         occurrences all number
    13
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences all number
    3
    Pharyngotonsillitis
         subjects affected / exposed
    6 / 128 (4.69%)
         occurrences all number
    6
    Pneumonia
         subjects affected / exposed
    5 / 128 (3.91%)
         occurrences all number
    7
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    6 / 128 (4.69%)
         occurrences all number
    7
    Sinusitis
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences all number
    3
    Tonsillitis
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 128 (25.00%)
         occurrences all number
    52
    Viral infection
         subjects affected / exposed
    4 / 128 (3.13%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences all number
    2
    Hypophagia
         subjects affected / exposed
    59 / 128 (46.09%)
         occurrences all number
    230

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2015
    Due to change in Market Authorization Holder from Novartis to GSK Vaccines, the protocol was revised to change name of sponsor

    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
    For support, Contact us.
    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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