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    Clinical Trial Results:
    A phase IIIb, open, multi-country, controlled, randomized study to demonstrate the immunogenicity and safety of GSK Biologicals' meningococcal conjugate vaccine, MenACWY-TT (GSK 134612) in healthy infants, given on a 3+1 primary and booster (2, 4, 6 and 15-18 months of age), a 1+1 primary and booster (6 and 15-18 months of age) or as a single dose at 15-18 months of age

    Summary
    EudraCT number
    		 2013-002537-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    29 Apr 2016
    First version publication date
    29 Apr 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    114858
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01340898
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, 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
    Interim
    Date of interim/final analysis
    12 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Aug 2014
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y one month post-dose 3 of MenACWY-TT at 7 months of age in healthy infants. Criteria for immunogenicity: For each serogroup, one month after dose 3 of MenACWY-TT vaccination, the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Mexico: 351
    Country: Number of subjects enrolled
    Lebanon: 402
    Worldwide total number of subjects
    753
    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)
    753
    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
    		 -

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

    Period 1
    Period 1 title
    Primary Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 3+1 Group
    Arm description
    		 Subjects who received 3 doses of Nimenrix™ vaccine at 3 doses at 2, 4 and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT vaccine, GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The 3 vaccine doses were administered in the anterolateral region of the thigh at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Arm title
    		 Nimenrix 1+1 Group
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine 1 dose at 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT vaccine, GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered in the anterolateral region of the thigh at 6 months of age.

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Arm title
    		 Nimenrix 1 Group
    Arm description
    		 Subjects who received routine administration of Infanrix-IPV, Hiberix and Synflorix at 2, 4 and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Number of subjects in period 1 [1]
    		Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Started
    376
    187
    187
    Completed
    360
    178
    181
    Not completed
    16
    9
    6
         Consent withdrawn by subject
    8
    7
    5
         Migrated/moved from study area
    4
    1
    -
         Serious adverse event
    -
    -
    1
         Lost to follow-up
    4
    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: Not all subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.
    Period 2
    Period 2 title
    Booster Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 3+1 Group
    Arm description
    		 Subjects who received 1 dose of Nimenrix™ vaccine at 15-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT vaccine, GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Arm title
    		 Nimenrix 1+1 Group
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine 15-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT vaccine, GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Arm title
    		 Nimenrix 1 Group
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine at 15-18 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT vaccine, GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    10Pn vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

    Number of subjects in period 2 [2]
    		Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Started
    342
    166
    170
    Completed
    332
    164
    163
    Not completed
    10
    2
    7
         Consent withdrawn by subject
    3
    -
    4
         Migrated/moved from study area
    3
    -
    -
         Lost to follow-up
    4
    2
    3
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix 3+1 Group
    Reporting group description
    		 Subjects who received 3 doses of Nimenrix™ vaccine at 3 doses at 2, 4 and 6 months of age.

    Reporting group title
    Nimenrix 1+1 Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine 1 dose at 6 months of age.

    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects who received routine administration of Infanrix-IPV, Hiberix and Synflorix at 2, 4 and 6 months of age.

    Reporting group values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group Total
    Number of subjects
    		 376 187 187 750
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 8.1 ± 1.6 8.1 ± 1.7 8.2 ± 1.7 -
    Gender categorical
    Units: Subjects
        Female
    		 182 105 95 382
        Male
    		 194 82 92 368

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix 3+1 Group
    Reporting group description
    		 Subjects who received 3 doses of Nimenrix™ vaccine at 3 doses at 2, 4 and 6 months of age.

    Reporting group title
    Nimenrix 1+1 Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine 1 dose at 6 months of age.

    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects who received routine administration of Infanrix-IPV, Hiberix and Synflorix at 2, 4 and 6 months of age.
    Reporting group title
    Nimenrix 3+1 Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix™ vaccine at 15-18 months of age.

    Reporting group title
    Nimenrix 1+1 Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine 15-18 months of age.

    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 15-18 months of age.

    Primary: Number of subjects with meningococcal polysaccharide A serum bactericidal assay using baby rabbit complement (rSBA-MenA) titers ≥ 1:8

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    End point title
    		 Number of subjects with meningococcal polysaccharide A serum bactericidal assay using baby rabbit complement (rSBA-MenA) titers ≥ 1:8 [1]
    End point description
    End point type
    Primary
    End point timeframe
    One month following Dose 3
    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: Results will be updated when they become available.
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Subjects
        rSBA-MenA, D3
    Notes
    [2] - Immunogenicity results will be updated when they become available.
    [3] - Immunogenicity results will be updated when they become available.
    [4] - Immunogenicity results will be updated when they become available.
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms (PRI)

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    End point title
    		 Number of subjects with solicited local symptoms (PRI)
    End point description
    End point type
    Secondary
    End point timeframe
    Withing 8 days (Day 0-7) post primary vaccination
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    369
    182
    184
    Units: Subjects
        Any Pain Dose 1 [N=369;182;184]
    220
    115
    108
        Grade 3 Pain Dose 1 [N=369;182;184]
    38
    25
    14
        Any Redness Dose 1 [N=369;182;184]
    94
    39
    43
        Grade 3 Redness Dose 1 [N=369;182;184]
    1
    0
    0
        Any Swelling Dose 1 [N=369;182;184]
    84
    31
    34
        Grade 3 Swelling Dose 1 [N=369;182;184]
    0
    3
    0
        Any Pain Dose 2 [N=363;181;181]
    177
    92
    101
        Grade 3 Pain Dose 2 [N=363;181;181]
    33
    11
    16
        Any Redness Dose 2 [N=363;181;181]
    93
    51
    48
        Grade 3 Redness Dose 2 [N=363;181;181]
    2
    0
    1
        Any Swelling Dose 2 [N=363;181;181]
    76
    47
    42
        Grade 3 Swelling Dose 2 [N=363;181;181]
    2
    2
    0
        Any Pain Dose 3 [N=359;177;180]
    148
    73
    93
        Grade 3 Pain Dose 3 [N=359;177;180]
    16
    18
    9
        Any Redness Dose 3 [N=359;177;180]
    74
    46
    42
        Grade 3 Redness Dose 3 [N=359;177;180]
    1
    1
    1
        Any Swelling Dose 3 [N=359;177;180]
    66
    46
    37
        Grade 3 Swelling Dose 3 [N=359;177;180]
    1
    0
    0
        Any Pain Across Doses [N=369;182;184]
    262
    135
    142
        Grade 3 Pain Across Doses [N=369;182;184]
    65
    36
    33
        Any Redness Across Doses [N=369;182;184]
    160
    79
    78
        Grade 3 Redness Across Doses [N=369;182;184]
    4
    1
    2
        Any Swelling Across Doses [N=369;182;184]
    147
    74
    70
        Grade 3 Swelling Across Doses [N=369;182;184]
    3
    4
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms (BST)

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    End point title
    		 Number of subjects with solicited local symptoms (BST)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 days (Day 0-7) post booster vaccination
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    338
    165
    167
    Units: Subjects
        Any Pain
    139
    71
    77
        Grade 3 Pain
    21
    19
    14
        Any Redness
    74
    32
    39
        Grade 3 Redness
    1
    1
    3
        Any Swelling
    55
    29
    33
        Grade 3 Swelling
    2
    1
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms (PRI)

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    End point title
    		 Number of subjects with solicited general symptoms (PRI)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 days (Day 0-7) post primary vaccination
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    369
    182
    184
    Units: Subjects
        Any Drowsiness Dose 1 [N=369;182;184]
    177
    93
    84
        Grade 3 Drowsiness Dose 1 [N=369;182;184]
    18
    10
    2
        Related Drowsiness Dose 1 [N=369;182;184]
    160
    84
    79
        Any Irritability Dose 1 [N=369;182;184]
    200
    107
    99
        Grade 3 Irritability Dose 1 [N=369;182;184]
    19
    9
    10
        Related Irritability Dose 1 [N=369;182;184]
    188
    96
    89
        Any Loss of appetite Dose 1 [N=369;182;184]
    109
    62
    42
        Grade 3 Loss of appetite Dose 1 [N=369;182;184]
    7
    5
    3
        Related Loss of appetite Dose 1 [N=369;182;184]
    99
    55
    35
        Any Temperature Dose 1 [N=369;182;184]
    126
    62
    58
        Grade 3 Temperature Dose 1 [N=369;182;184]
    0
    0
    1
        Related Temperature Dose 1 [N=369;182;184]
    109
    56
    53
        Any Drowsiness Dose 2 [N=363;181;181]
    116
    72
    67
        Grade 3 Drowsiness Dose 2 [N=363;181;181]
    9
    8
    8
        Related Drowsiness Dose 2 [N=363;181;181]
    109
    69
    62
        Any Irritability Dose 2 [N=363;181;181]
    163
    82
    90
        Grade 3 Irritability Dose 2 [N=363;181;181]
    20
    14
    10
        Related Irritability Dose 2 [N=363;181;181]
    158
    77
    85
        Any Loss of appetite Dose 2 [N=363;181;181]
    89
    50
    44
        Grade 3 Loss of appetite Dose 2 [N=363;181;181]
    6
    5
    6
        Related Loss of appetite Dose 2 [N=363;181;181]
    80
    48
    39
        Any Temperature Dose 2 [N=363;181;181]
    119
    64
    63
        Grade 3 Temperature Dose 2 [N=363;181;181]
    0
    0
    0
        Related Temperature Dose 2 [N=363;181;181]
    116
    59
    54
        Any Drowsiness Dose 3 [N=359;177;180]
    102
    54
    64
        Grade 3 Drowsiness Dose 3 [N=359;177;180]
    11
    8
    4
        Related Drowsiness Dose 3 [N=359;177;180]
    95
    54
    60
        Any Irritability Dose 3 [N=359;177;180]
    140
    73
    73
        Grade 3 Irritability Dose 3 [N=359;177;180]
    14
    14
    3
        Related Irritability Dose 3 [N=359;177;180]
    132
    72
    69
        Any Loss of appetite Dose 3 [N=359;177;180]
    76
    43
    50
        Grade 3 Loss of appetite Dose 3 [N=359;177;180]
    7
    6
    3
        Related Loss of appetite Dose 3 [N=359;177;180]
    63
    41
    46
        Any Temperature Dose 3 [N=359;177;180]
    109
    51
    41
        Grade 3 Temperature Dose 3 [N=359;177;180]
    2
    0
    0
        Related Temperature Dose 3 [N=359;177;180]
    96
    46
    36
        Any Drowsiness Across Doses [N=369;182;184]
    217
    121
    118
        Grade 3 Drowsiness Across Doses [N=369;182;184]
    30
    19
    13
        Related Drowsiness Across Doses [N=369;182;184]
    205
    116
    114
        Any Irritability Across Doses [N=369;182;184]
    254
    128
    126
        Grade 3 Irritability Across Doses [N=369;182;184]
    42
    27
    18
        Related Irritability Across Doses [N=369;182;184]
    246
    125
    121
        Any Loss of appetite Across [N=369;182;184]
    165
    89
    82
        Grade 3 Loss of appetite Across [N=369;182;184]
    17
    13
    10
        Related Loss of appetite Across [N=369;182;184]
    151
    84
    77
        Any Temperature Across Doses [N=369;182;184]
    203
    102
    101
        Grade 3 Temperature Across Doses [N=369;182;184]
    2
    0
    1
        Related Temperature Across Doses [N=369;182;184]
    193
    97
    93
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms (BST)

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    End point title
    		 Number of subjects with solicited general symptoms (BST)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 days (Day 0-7) post booster vaccination
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    338
    165
    167
    Units: Subjects
        Any Drowsiness
    79
    46
    43
        Grade 3 Drowsiness
    4
    7
    5
        Related Drowsiness
    75
    42
    43
        Any Irritability
    112
    54
    61
        Grade 3 Irritability
    9
    12
    10
        Related Irritability
    106
    52
    60
        Any Loss of appetite
    69
    37
    39
        Grade 3 Loss of appetite
    5
    5
    1
        Related Loss of appetite
    60
    34
    37
        Any Temperature
    68
    35
    27
        Grade 3 Temperature
    2
    1
    0
        Related Temperature
    62
    32
    24
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs) (PRI)
    End point description
    End point type
    Secondary
    End point timeframe
    Withing 31 days (Day 0-30) post each primary vaccine dose
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    376
    187
    187
    Units: Subjects
        Any AE(s) Dose 1 [N=376;187;187]
    67
    36
    34
        Any AE(s) Dose 2 [N=368;182;182]
    70
    34
    28
        Any AE(s) Dose 3 [N=362;179;181]
    97
    49
    45
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs) (BST)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0-30) post booster vaccination
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    342
    166
    170
    Units: Subjects
        Any AE(s)
    58
    32
    36
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    376
    187
    187
    Units: Subjects
        Any SAE(s)
    35
    14
    14
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with new onset of chronic illnesses (NOCIs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Number of subjects analysed
    376
    187
    187
    Units: Subjects
        Any NOCI(s)
    16
    8
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: within 8 days (Day 0-Day 7), AEs: within 31 days (Day 0 – Day 30), SAEs: throughout the study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Nimenrix 3+1 Group
    Reporting group description
    		 Subjects who receive 3 primary doses of the investigational vaccine at 2, 4 and 6 months of age and 1 booster dose at 15-18 months of age

    Reporting group title
    Nimenrix 1+1 Group
    Reporting group description
    		 Subjects received 1 primary vaccination dose of the investigational vaccine at 6 months of age and 1 booster dose at 15-18 months of age

    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects received 1 dose of the investigational vaccine at 15-18 months of age

    Serious adverse events
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 376 (9.31%)
    14 / 187 (7.49%)
    14 / 187 (7.49%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 376 (0.00%)
    2 / 187 (1.07%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns first degree
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 376 (0.27%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemic seizure
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 376 (0.53%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 376 (0.27%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Milk allergy
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 376 (0.53%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    13 / 376 (3.46%)
    2 / 187 (1.07%)
    3 / 187 (1.60%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    5 / 376 (1.33%)
    1 / 187 (0.53%)
    3 / 187 (1.60%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 376 (1.06%)
    1 / 187 (0.53%)
    3 / 187 (1.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 376 (0.80%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 376 (0.53%)
    2 / 187 (1.07%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 376 (0.27%)
    2 / 187 (1.07%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 376 (0.53%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    2 / 187 (1.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 376 (0.27%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 376 (0.27%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 376 (0.00%)
    0 / 187 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurological infection
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Roseola
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 376 (0.00%)
    1 / 187 (0.53%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 376 (0.27%)
    0 / 187 (0.00%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 376 (0.53%)
    1 / 187 (0.53%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix 3+1 Group Nimenrix 1+1 Group Nimenrix 1 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    262 / 376 (69.68%)
    135 / 187 (72.19%)
    142 / 187 (75.94%)
    General disorders and administration site conditions
    Pain (Primary)
         subjects affected / exposed [1]
    262 / 369 (71.00%)
    135 / 182 (74.18%)
    142 / 184 (77.17%)
         occurrences all number
    262
    135
    142
    Redness (Primary)
         subjects affected / exposed [2]
    160 / 369 (43.36%)
    79 / 182 (43.41%)
    78 / 184 (42.39%)
         occurrences all number
    160
    79
    78
    Swelling (Primary)
         subjects affected / exposed [3]
    147 / 369 (39.84%)
    74 / 182 (40.66%)
    70 / 184 (38.04%)
         occurrences all number
    147
    74
    70
    Pain (Booster)
         subjects affected / exposed [4]
    139 / 338 (41.12%)
    71 / 165 (43.03%)
    77 / 167 (46.11%)
         occurrences all number
    139
    71
    77
    Redness (Booster)
         subjects affected / exposed [5]
    74 / 338 (21.89%)
    32 / 165 (19.39%)
    39 / 167 (23.35%)
         occurrences all number
    74
    32
    39
    Swelling (Booster)
         subjects affected / exposed [6]
    55 / 338 (16.27%)
    29 / 165 (17.58%)
    33 / 167 (19.76%)
         occurrences all number
    55
    29
    33
    Drowsiness (Primary)
         subjects affected / exposed [7]
    217 / 369 (58.81%)
    121 / 182 (66.48%)
    118 / 184 (64.13%)
         occurrences all number
    217
    121
    118
    Irritability (Primary)
         subjects affected / exposed [8]
    254 / 369 (68.83%)
    128 / 182 (70.33%)
    126 / 184 (68.48%)
         occurrences all number
    254
    128
    126
    Loss of appetite (Primary)
         subjects affected / exposed [9]
    165 / 369 (44.72%)
    89 / 182 (48.90%)
    82 / 184 (44.57%)
         occurrences all number
    165
    89
    82
    Temperature(Rectally) (Primary)
         subjects affected / exposed [10]
    203 / 369 (55.01%)
    102 / 182 (56.04%)
    101 / 184 (54.89%)
         occurrences all number
    203
    102
    101
    Drowsiness (Booster)
         subjects affected / exposed [11]
    79 / 338 (23.37%)
    46 / 165 (27.88%)
    43 / 167 (25.75%)
         occurrences all number
    79
    46
    43
    Irritability (Booster)
         subjects affected / exposed [12]
    112 / 338 (33.14%)
    54 / 165 (32.73%)
    61 / 167 (36.53%)
         occurrences all number
    112
    54
    61
    Loss of appetite (Booster)
         subjects affected / exposed [13]
    69 / 338 (20.41%)
    37 / 165 (22.42%)
    39 / 167 (23.35%)
         occurrences all number
    69
    37
    39
    Temperature(Rectally) (Booster)
         subjects affected / exposed [14]
    68 / 338 (20.12%)
    35 / 165 (21.21%)
    27 / 167 (16.17%)
         occurrences all number
    68
    35
    27
    Infections and infestations
    Nasopharyngitis (Booster)
         subjects affected / exposed [15]
    17 / 342 (4.97%)
    12 / 166 (7.23%)
    7 / 170 (4.12%)
         occurrences all number
    17
    12
    7
    Nasopharyngitis (Primary)
         subjects affected / exposed [16]
    31 / 362 (8.56%)
    14 / 179 (7.82%)
    10 / 181 (5.52%)
         occurrences all number
    31
    14
    10
    Pharyngitis
         subjects affected / exposed [17]
    17 / 362 (4.70%)
    13 / 179 (7.26%)
    12 / 181 (6.63%)
         occurrences all number
    17
    13
    12
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jul 2011
    Amendment 1 One of the participating countries has requested that the subjects enrolled in that country be vaccinated with acellualr pertussis vaccine instead of whole cell pertussis vaccine in order to align with the national recommendation. On account of this request the following changes have been made in the protocol as part of this amendment. • All subjects will be co-administrated with Infanrix-IPV/Hiberix instead of Tritanrix-HepB/Hiberix that was foreseen in the original protocol. Consequently, changes have been made in the exclusion and elimination criteria, assays, secondary endpoints and the statistical analysis section. - HepB, and whole cell pertussis assays have been removed and assays for the evaluation of acellular pertussis and polio type 1, 2 and 3 have been included. - Secondary endpoints and the statistical analysis sections have been modified to remove whole cell pertussis and HepB analysis and to include acellular pertussis and polio type 1, 2 and 3 analysis. - Exclusion and elimination criteria have been revised based on the change in the co-administered vaccines • Subjects will receive both primary and booster doses of Infanrix-IPV/Hiberix • Interval during which concomitant vaccinations are allowed has been clarified in the exclusion and elimination criteria to ensure that no concomitant vaccination is given during the period between a study vaccine administration and the subsequent blood sampling visit, if applicable.

    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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