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    Clinical Trial Results:
    A Multicenter Post Marketing Surveillance Study to monitor the safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY conjugate vaccine(MenACWY-CRM) administered according to the prescribing information to healthy subjects from 2 months to 55 years of age in the Republic of South Korea.

    Summary
    EudraCT number
    		 2017-000166-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2018
    First version publication date
    05 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205341
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to monitor the safety of MenACWY-CRM vaccine in subjects from 2 months to 55 years of age, as evaluated by: • Local and systemic solicited adverse events reported from study Day 1 (day of vaccination) through study Day 7 post-vaccination; • All unsolicited Adverse Events (AEs) reported from study Day 1 (day of vaccination) through study Day 7 post-vaccination; • Medically attended Adverse Events reported from study Day 1 to study termination (Day 29/early termination). • All Serious Adverse Events (SAEs) reported from study Day 1 to study termination (Day 29/early termination).
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes in the clinic after vaccination, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines. Study vaccines were administered only by personnel qualified to perform that function according to the routine clinical practice and under applicable local laws and regulations for the specific study site.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2013
    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: 3948
    Worldwide total number of subjects
    3948
    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)
    654
    Children (2-11 years)
    955
    Adolescents (12-17 years)
    302
    Adults (18-64 years)
    2035
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy subjects from 2 months to 55 years of age were enrolled in 46 centres in South Korea.

    Pre-assignment
    Screening details
    		 Out of the 3,948 subjects enrolled, only 3,939 subjects were exposed to vaccination as 1 subject did not receive a study vaccination and 8 subjects did not provide post vaccination safety data. Among 3939 subjects, 15 subjects are in the ≥ 56 age category (outside the range defined as per the protocol).

    Pre-assignment period milestones
    Number of subjects started
    		 3948
    Number of subjects completed
    		 3939

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No safety data provided: 8
    Reason: Number of subjects
    		 Did not receive study vaccination: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open- label study. No blinding methods were used

    Arms
    Arm title
    		 MenACWY-CRM Group
    Arm description
    		 Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
    Arm type
    		 Safety surveillance

    Investigational medicinal product name
    MenACWY-CRM conjugate vaccine (Menveo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one intramuscular injection of MenACWY-CRM vaccine at Day 1

    Number of subjects in period 1 [1]
    		MenACWY-CRM Group
    Started
    3939
    Completed
    3888
    Not completed
    51
         Consent withdrawn by subject
    22
         Inappropriate enrollment
    18
         Lost to follow-up
    10
         withdrawal and inappropriate enrollment
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in the baseline period are based on the exposed set (3939). Out of 3948 subjects enrolled, 8 subjects did not report safety data and 1 subject did not receive the study vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-CRM Group
    Reporting group description
    		 Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

    Reporting group values
    		 MenACWY-CRM Group Total
    Number of subjects
    		 3939 3939
    Age categorical
    Units: Subjects
        2- 23 months
    		 654 654
        2-5 years
    		 551 551
        6-10 years
    		 339 339
        11-18 years
    		 433 433
        19-34 years
    		 1286 1286
        35 - 55 years
    		 661 661
        ≥ 56 years
    		 15 15
    Age continuous
    Units: years
        log mean (standard deviation)
    		 18.37 ± 15.40 -
    Gender categorical
    Units: Subjects
        Female
    		 2181 2181
        Male
    		 1758 1758
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 3937 3937
        Caucasian
    		 1 1
        Hispanic
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-CRM Group
    Reporting group description
    		 Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

    Primary: Number of subjects reporting any local and systemic solicited Adverse Events (AEs)

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    End point title
    		 Number of subjects reporting any local and systemic solicited Adverse Events (AEs) [1]
    End point description
    Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. “Any” is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data, excluding 19 subjects from safety set with protocol violations.
    End point type
    Primary
    End point timeframe
    From Day 1 (day of vaccination) to Day 7 post 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 descriptive analysis. Therefore, no statistical analyses have been specified for this endpoint.
    End point values
    		 MenACWY-CRM Group
    Number of subjects analysed
    3920
    Units: Participants
        Any injection site tenderness,2 - 23 months(N-653)
    67
        Any injection site erythema, 2 - 23 months(N-653)
    32
        Any injection site induration,2 - 23 months(N-653)
    28
        Any change in eating habbits, 2 - 23 months(N-653)
    110
        Any sleepiness, 2 - 23 months(N-653)
    126
        Any irritability, 2 - 23 months(N-653)
    219
        Any vomiting, 2 - 23 months(N-653)
    66
        Any diarrhea, 2 - 23 months(N-653)
    82
        Any rash, 2 - 23 months(N-653)
    20
        Any fever, 2 - 23 months(N-653)
    57
        Any injection site tenderness, 2 - 5 years(N-551)
    135
        Any injection site erythema, 2 - 5 years(N-551)
    71
        Any injection site induration, 2 - 5 years(N-551)
    49
        Any change in eating habits, 2 - 5 years(N-551)
    22
        Any sleepiness, 2 - 5 years(N-551)
    17
        Any irritability, 2 - 5 years(N-551)
    35
        Any vomiting, 2 - 5 years(N-551)
    4
        Any diarrhea, 2 - 5 years(N-551)
    7
        Any rash, 2 - 5 years(N-551)
    18
        Any fever, 2 - 5 years(N-551)
    12
        Any injection site tenderness, 6 - 10 years(N-338)
    108
        Any injection site erythema, 6 - 10 years(N-338)
    53
        Any injection site induration, 6 - 10 years(N-338)
    45
        Any chills, 6 - 10 years(N-338)
    7
        Any nausea, 6 - 10 years(N-338)
    7
        Any malaise, 6 - 10 years(N-338)
    5
        Any myalgia, 6 - 10 years(N-338)
    6
        Any arthralgia, 6 - 10 years(N-338)
    6
        Any headache, 6 - 10 years(N-338)
    11
        Any rash, 6 - 10 years(N-338)
    10
        Any fever, 6 - 10 years(N-338)
    9
        Any injection site tenderness, 11-18 years(N-431)
    91
        Any injection site erythema, 11 - 18 years(N-431)
    17
        Any injection site induration, 11- 18 years(N-431)
    21
        Any chills, 11 - 18 years(N-431)
    9
        Any nausea, 11 - 18 years(N-431)
    4
        Any malaise, 11 - 18 years(N-431)
    9
        Any myalgia, 11 - 18 years(N-431)
    12
        Any arthralgia, 11 - 18 years(N-431)
    5
        Any headache, 11 - 18 years(N-431)
    12
        Any rash, 11 - 18 years(N-431)
    6
        Any fever, 11 - 18 years(N-431)
    4
        Any injenction site tenderness,19-34 years(N-1286)
    214
        Any injection site erythema, 19 - 34 years(N-1286)
    14
        Any injection site induration,19 - 34 years(N-1286
    9
        Any chills, 19 - 34 years(N-1286)
    7
        Any nausea, 19 - 34 years(N-1286)
    6
        Any malaise, 19 - 34 years(N-1286)
    20
        Any myalgia, 19 - 34 years(N-1286)
    21
        Any arthralgia, 19 - 34 years(N-1286)
    8
        Any headache, 19 - 34 years(N-1286)
    29
        Any rash, 19 - 34 years(N-1286)
    13
        Any fever, 19 - 34 years(N-1286)
    3
        Any injection site tenderness, 35-55 years(N-661)
    174
        Any injection site erythema, 35 - 55 years(N-661)
    7
        Any injection site induration, 35 -55 years(N-661)
    6
        Any chills, 35 - 55 years(N-661)
    7
        Any nausea, 35 - 55 years(N-661)
    9
        Any malaise, 35 - 55 years(N-661)
    16
        Any myalgia, 35 - 55 years(N-661)
    23
        Any arthralgia, 35 - 55 years(N-661)
    15
        Any headache, 35 - 55 years(N-661)
    19
        Any rash, 35 - 55 years(N-661)
    6
        Any fever, 35 - 55 years(N-661)
    2
    No statistical analyses for this end point

    Primary: 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) [2]
    End point description
    An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. “Any” is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data, excluding 19 subjects from safety set with protocol violations.
    End point type
    Primary
    End point timeframe
    From Day 1 (day of vaccination) to Day 7 post 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 descriptive analysis. Therefore, no statistical analyses have been specified for this endpoint.
    End point values
    		 MenACWY-CRM Group
    Number of subjects analysed
    3920
    Units: Participants
        2 - 23 Months(N-653)
    82
        2 - 5 Years(N-551)
    56
        6 - 10 Years(N-338)
    18
        11 - 18 Years(N-431)
    8
        19 - 34 Years(N-1286)
    17
        35 - 55 Years(N-661)
    5
    No statistical analyses for this end point

    Primary: Number of subjects reporting medically attended AEs (MAAEs)

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    End point title
    		 Number of subjects reporting medically attended AEs (MAAEs) [3]
    End point description
    MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data, excluding 19 subjects from safety set with protocol violations.
    End point type
    Primary
    End point timeframe
    From Day 1 (day of vaccination) to study termination (Day 29/early termination)
    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 descriptive analysis. Therefore, no statistical analyses have been specified for this endpoint.
    End point values
    		 MenACWY-CRM Group
    Number of subjects analysed
    3920
    Units: Participants
        2 - 23 Months(N-653)
    238
        2 - 5 Years(N-551)
    120
        6 - 10 Years(N-338)
    28
        11 - 18 Years(N-431)
    20
        19 - 34 Years(N-1286)
    16
        35 - 55 Years(N-661)
    5
    No statistical analyses for this end point

    Primary: Number of subjects reporting serious AEs (SAEs)

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    End point title
    		 Number of subjects reporting serious AEs (SAEs) [4]
    End point description
    SAE is defined as any untoward medical occurrence that at any dose results in death,is life-threatening;it doesnot refer to an event which hypothetically might have caused death if it were more severe,requires or prolongs subject’s hospitalization,results in persistent/significant disability/incapacity,results in congenital anomaly/birth defect,is an important and significant medical event that may not be immediately life threatening/resulting in death/hospitalization but,based upon appropriate medical judgment,may jeopardize the subject/may require intervention to prevent one of the other outcomes listed above.Subjects from 2 months to 55 years of age were evaluated for the outcome measure. This analysis was performed on the Safety per protocol set,which included all enrolled subjects who signed an informed consent,underwent screening,received a subject number,received a study vaccination & provided post vaccination data,excluding 19 subjects from safety set with protocol violation
    End point type
    Primary
    End point timeframe
    From Day 1 (day of vaccination) to study termination (Day 29/early termination)
    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 descriptive analysis. Therefore, no statistical analyses have been specified for this endpoint.
    End point values
    		 MenACWY-CRM Group
    Number of subjects analysed
    3920
    Units: Participants
        2 - 23 Months(N-653)
    3
        2 - 5 Years(N-551)
    3
        6 - 10 Years(N-338)
    0
        11 - 18 Years(N-431)
    2
        19 - 34 Years(N-1286)
    0
        35 - 55 Years(N-661)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
    Adverse event reporting additional description
    Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    MenACWY-CRM Group
    Reporting group description
    		 Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

    Serious adverse events
    		 MenACWY-CRM Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 3939 (0.20%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         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-CRM Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1379 / 3939 (35.01%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Orthostatic hypotension-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site pain-Solicited Local AE
    Additional description: This symptom was assessed as a solicited local AE.
         subjects affected / exposed
    592 / 3939 (15.03%)
         occurrences all number
    592
    Injection site tenderness-Solicited local AE
    Additional description: This symptom was assessed as a solicited local AE.
         subjects affected / exposed
    202 / 3939 (5.13%)
         occurrences all number
    202
    Injection site erythema-Solicited local AE
    Additional description: This symptom was assessed as a solicited local AE.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    195 / 3939 (4.95%)
         occurrences all number
    195
    Injection site induration-solicited local AE
    Additional description: This symptom was assessed as a solicited local AE.
         subjects affected / exposed
    158 / 3939 (4.01%)
         occurrences all number
    158
    Diarrhea-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    89 / 3939 (2.26%)
         occurrences all number
    89
    Chills-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    31 / 3939 (0.79%)
         occurrences all number
    31
    Nausea-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    28 / 3939 (0.71%)
         occurrences all number
    28
    Myalgia-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    64 / 3939 (1.62%)
         occurrences all number
    64
    Malaise-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE,
         subjects affected / exposed
    53 / 3939 (1.35%)
         occurrences all number
    53
    Arthralgia-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    34 / 3939 (0.86%)
         occurrences all number
    34
    Fever-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    87 / 3939 (2.21%)
         occurrences all number
    87
    Pyrexia
         subjects affected / exposed
    8 / 3939 (0.20%)
         occurrences all number
    8
    Injection site erythema
         subjects affected / exposed
    9 / 3939 (0.23%)
         occurrences all number
    9
    Injection site induration
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Injection site pruritus
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Injection site pain
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Injection site warmth
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injection site bruising
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injection site swelling
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Pyrexia-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    15 / 3939 (0.38%)
         occurrences all number
    17
    Injection site erythema-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injection site pruritus-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Oedema peripheral-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Chest pain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injection site rash-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injection site swelling-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Immune system disorders
    Atopy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Prostatic cyst
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Prostatic cyst-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Asthma
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Rhinorrhoea
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Rhinitis allergic-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    18 / 3939 (0.46%)
         occurrences all number
    18
    Asthma-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    8 / 3939 (0.20%)
         occurrences all number
    8
    Cough-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Rhinorrhoea-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Nasal congestion-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Productive cough-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Psychiatric disorders
    Eating disorder-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    132 / 3939 (3.35%)
         occurrences all number
    132
    Irritability-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    254 / 3939 (6.45%)
         occurrences all number
    254
    Eating disorder
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Irritability
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Eating disorder-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Irritability-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    2
    Nail injury
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Arthropod bite-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Contusion-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Laceration-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    2
    Ligament sprain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Muscle strain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Skin abrasion-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Nervous system disorders
    Sleepiness-Solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    143 / 3939 (3.63%)
         occurrences all number
    143
    Headache-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    73 / 3939 (1.85%)
         occurrences all number
    73
    Headache
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Burning sensation
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dizziness-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    sleepiness
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphadentitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Anaemia-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Iron deficiency anaemia-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Lymphadenitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Eye discharge
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Conjunctivitis allergic-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Keratitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    70 / 3939 (1.78%)
         occurrences all number
    70
    Enteritis
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Colitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dental caries
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastritis erosive
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Enteritis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    22 / 3939 (0.56%)
         occurrences all number
    23
    Diarrhoea-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Vomiting-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    8 / 3939 (0.20%)
         occurrences all number
    8
    Constipation-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Stomatitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Gastritis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Abdominal pain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Colitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Chronic gastritis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dental caries-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastritis erosive-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastrooesophageal reflux disease-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Irritable bowel syndrome-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash-solicited general AE
    Additional description: This symptom was assessed as a solicited general AE.
         subjects affected / exposed
    74 / 3939 (1.88%)
         occurrences all number
    74
    Dermatitis atopic
         subjects affected / exposed
    7 / 3939 (0.18%)
         occurrences all number
    7
    Dermatitis
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Urticaria
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Dermatitis contact
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Dermatitis allergic
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Cold sweat
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Generalised erythema
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dermatitis atopic-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    20 / 3939 (0.51%)
         occurrences all number
    20
    Dermatitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    11 / 3939 (0.28%)
         occurrences all number
    11
    Urticaria-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    10 / 3939 (0.25%)
         occurrences all number
    12
    Dermatitis contact-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    8 / 3939 (0.20%)
         occurrences all number
    8
    Blister-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Dermatitis allergic-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Dermatitis diaper-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Eczema-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Generalised erythema-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Miliaria-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Seborrhoeic dermatitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Renal cyst
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Haematuria-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Renal cyst-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Tubulointerstitial nephritis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Arthralgia-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Neck pain-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    21 / 3939 (0.53%)
         occurrences all number
    21
    Nasopharyngitis
         subjects affected / exposed
    31 / 3939 (0.79%)
         occurrences all number
    31
    Pharyngitis
         subjects affected / exposed
    13 / 3939 (0.33%)
         occurrences all number
    13
    Gastroenteritis
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Bronchiolitis
         subjects affected / exposed
    11 / 3939 (0.28%)
         occurrences all number
    11
    Otitis media
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Pneumonia
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Conjunctivitis
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Tonsillitis
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Influenza
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Cellulitis
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Acute sinusitis
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Herpangina
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Laryngitis
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Viral pharyngitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Periodontitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Bronchitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    94 / 3939 (2.39%)
         occurrences all number
    100
    Nasopharyngitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    82 / 3939 (2.08%)
         occurrences all number
    93
    Pharyngitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    40 / 3939 (1.02%)
         occurrences all number
    42
    Gastroenteritis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    30 / 3939 (0.76%)
         occurrences all number
    31
    Bronchiolitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    28 / 3939 (0.71%)
         occurrences all number
    29
    Otitis media-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    22 / 3939 (0.56%)
         occurrences all number
    22
    Pneumonia-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    15 / 3939 (0.38%)
         occurrences all number
    16
    Rhinitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    13 / 3939 (0.33%)
         occurrences all number
    13
    Conjunctivitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    12 / 3939 (0.30%)
         occurrences all number
    12
    Tonsillitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    17 / 3939 (0.43%)
         occurrences all number
    17
    Upper respiratory tract infection-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    11 / 3939 (0.28%)
         occurrences all number
    11
    Influenza-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    8 / 3939 (0.20%)
         occurrences all number
    8
    Cellulitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    6 / 3939 (0.15%)
         occurrences all number
    6
    Acute sinusitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Impetigo-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    5 / 3939 (0.13%)
         occurrences all number
    5
    Herpes dermatitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Otitis media acute-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    4 / 3939 (0.10%)
         occurrences all number
    4
    Hand-foot-and-mouth disease-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Herpangina-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Laryngitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Oral candidiasis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Viral pharyngitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    3 / 3939 (0.08%)
         occurrences all number
    3
    Cystitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Oral herpes-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Pharyngitis bacterial-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Pharyngotonsillitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Tracheitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    2 / 3939 (0.05%)
         occurrences all number
    2
    Bacterial infection-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Croup infectious-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Exanthema subitum-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Gastrointestinal infection-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Hordeolum-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Periodontitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Pharyngitis streptococcal-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Sinusitis-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Urinary tract infection-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1
    Vitamin D deficiency-MAAE
    Additional description: This symptom was assessed as a MAAE.
         subjects affected / exposed
    1 / 3939 (0.03%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2013
    Rationale for change: Change in target population from 11-55 years of age to 2-55 years of age. Allow Assent Form provided to minors when requested by IRBs. Change in the solicited local and systemic events description. Exclusion criteria numbered. Change of Korea Food and Drug Administration (KFDA) to Ministry of Food and Drug Safety (MFDS)
    22 Oct 2014
    Rationale for change: Change in the location of the injection including infants. Change in the study population, adding infants from 2 to 23 months. Text added to clarify the procedure of infant vaccination. Inclusion of infants in standard temperature measurement. Text included to ensure that infants were not enrolled more than once. Spontaneous reporting applied to this PMS studies. Procedure correction involving the CRO instead of NVD. Clarification that additional SAP will be performed to follow ICH requirements.
    12 May 2015
    Rationale for change: Text included- For subjects 2-23 months of age, the parents will also be asked to consent for surveillance after subsequent vaccinations. Some texts changed to align with Korean Heath Authorities. Study time and events table was modified to include infant subjects. Clarification of study participation duration.
    25 Aug 2015
    Rationale for change: Due to change of Marketing Authorization Holder from Novartis Vaccines to GSK Vaccines, the document 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
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