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    Clinical Trial Results:
    A Phase III, randomized, open-label, controlled, multicenter study to evaluate immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals’ Infanrix and Hiberix vaccines at 15-18 months of age.

    Summary
    EudraCT number
    		 2013-004304-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2018
    First version publication date
    22 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    117119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02096263
    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 Cente, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Cente, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN)] one month after the third dose of the primary vaccination.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 2014
    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
    United States: 585
    Worldwide total number of subjects
    585
    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)
    585
    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
    		 This study was conducted in 43 centers in the United States of America (USA).

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix hexa Group
    Arm description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as a booster dose at 15-18 months of age.

    Investigational medicinal product name
    Hiberix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as a booster dose at 15-18 months of age.

    Investigational medicinal product name
    Prevnar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    This vaccine was administered as 2 doses at 2 and 4 months of age.

    Arm title
    		 Pediarix Group
    Arm description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as a booster dose at 15-18 months of age.

    Investigational medicinal product name
    Prevnar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    This vaccine was administered as 2 doses at 2 and 4 months of age.

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 primary doses at 2, 4 and 6 months of age and as a booster dose at 15-18 months of age.

    Arm title
    		 Pentacel Group
    Arm description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Prevnar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 doses at 2, 4 and 6 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    This vaccine was administered as 2 doses at 2 and 4 months of age.

    Investigational medicinal product name
    Pentacel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    This vaccine was administered as 3 primary doses at 2, 4 and 6 months of age and as a booster dose at 15 to 18 months of age.

    Number of subjects in period 1
    		Infanrix hexa Group Pediarix Group Pentacel Group
    Started
    195
    194
    196
    Completed
    161
    158
    157
    Not completed
    34
    36
    39
         Consent withdrawn by subject
    5
    7
    8
         Sponsor study termination
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    1
         Unspecified
    7
    9
    6
         Lost to follow-up
    14
    18
    15
         Protocol deviation
    7
    2
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pediarix Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pentacel Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group values
    		 Infanrix hexa Group Pediarix Group Pentacel Group Total
    Number of subjects
    		 195 194 196
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.5 ( 1.0 ) 8.6 ( 1.1 ) 8.6 ( 1.1 ) -
    Gender categorical
    Units: Subjects
        Male
    		 94 114 101 309
        Female
    		 101 80 95 276
    Race/Ethnicity, Customized
    Units: Subjects
        Asian - Japanese Heritage
    		 1 0 1 2
        African Heritage / African American
    		 16 9 20 45
        Asian - East Asian Heritage
    		 3 2 0 5
        White - Caucasian / European Heritage
    		 118 128 115 361
        Asian - Central/South Asian Heritage
    		 2 2 1 5
        White - Arabic / North African Heritage
    		 0 1 0 1
        Unspecified
    		 29 27 32 88
        American Indian or Alaskan Native
    		 15 15 17 47
        Native Hawaiian or Other Pacific Islander
    		 2 1 2 5
        Asian - South East Asian Heritage
    		 9 9 8 26

    End points

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    End points reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pediarix Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pentacel Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Primary: Antibody concentrations for pertussis toxoid (Anti-PT), filamentous hemagglutinin (Anti-FHA) and pertactin (Anti-PRN).

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    End point title
    		 Antibody concentrations for pertussis toxoid (Anti-PT), filamentous hemagglutinin (Anti-FHA) and pertactin (Anti-PRN).
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
    End point type
    Primary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    146
    149
    149
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    43.2 (38.1 to 48.9)
    48.3 (42.7 to 54.5)
    24.2 (21.1 to 27.7)
        Anti-FHA
    106.3 (95.0 to 119.0)
    122.7 (109.9 to 137.0)
    59.9 (51.7 to 69.3)
        Anti-PRN
    57.4 (49.5 to 66.6)
    46.9 (39.9 to 55.3)
    33.0 (27.8 to 39.1)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.
    Comparison groups
    Infanrix hexa Group v Pediarix Group
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.31
    Notes
    [1] - Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.
    Comparison groups
    Infanrix hexa Group v Pediarix Group
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.35
    Notes
    [2] - Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.
    Comparison groups
    Infanrix hexa Group v Pediarix Group
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.99
    Notes
    [3] - Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.

    Secondary: Number of seropositive subjects for Anti-PT, Anti-FHA and Anti-PRN.

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    End point title
    		 Number of seropositive subjects for Anti-PT, Anti-FHA and Anti-PRN.
    End point description
    A seropositve subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    146
    149
    149
    Units: Participants
        Anti-PT
    146
    148
    148
        Anti-FHA
    146
    149
    149
        Anti-PRN
    146
    148
    148
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against diphtheria (D) and tetanus (T).

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    End point title
    		 Number of seroprotected subjects against diphtheria (D) and tetanus (T).
    End point description
    A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    146
    149
    149
    Units: Participants
        Anti-T (N=146;149;149)
    146
    149
    148
        Anti-D (N=142;144;149)
    142
    144
    149
    No statistical analyses for this end point

    Secondary: Antibody concentrations for Anti-D and Anti-T.

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    End point title
    		 Antibody concentrations for Anti-D and Anti-T.
    End point description
    Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    146
    149
    149
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T (N=146;149;149)
    2.458 (2.195 to 2.753)
    2.633 (2.338 to 2.966)
    2.012 (1.768 to 2.290)
        Anti-D (N=142;144;149)
    1.777 (1.551 to 2.036)
    1.648 (1.44 to 1.886)
    1.249 (1.095 to 1.425)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-polio types 1, 2 and 3.

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    End point title
    		 Number of seroprotected subjects against anti-polio types 1, 2 and 3.
    End point description
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    137
    134
    136
    Units: Participants
        Anti-polio 1 (N=137;134;136)
    137
    134
    135
        Anti-polio 2 (N=133;131;134)
    133
    131
    134
        Anti-polio 3 (N=129;132;126)
    129
    132
    124
    No statistical analyses for this end point

    Secondary: Antibody titres for anti-polio types 1, 2 and 3.

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    End point title
    		 Antibody titres for anti-polio types 1, 2 and 3.
    End point description
    Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    137
    134
    136
    Units: titres
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N=137;134;1136)
    546.9 (447.7 to 668.0)
    604.1 (495.9 to 736.0)
    319.5 (256.8 to 397.5)
        Anti-polio 2 (N=133;131;134)
    483.5 (394.2 to 593.0)
    567.7 (448.8 to 718.1)
    283.0 (229.4 to 349.2)
        Anti-polio 3 (N=129;132;126)
    722.2 (577.4 to 903.4)
    927.0 (740.7 to 1160.3)
    294.6 (221.6 to 391.7)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against polyribosyl ribitol phosphate (Anti-PRP).

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    End point title
    		 Number of seroprotected subjects against polyribosyl ribitol phosphate (Anti-PRP).
    End point description
    A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    154
    154
    156
    Units: Participants
        Participants
    146
    151
    154
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-PRP antibody concentrations ≥ 1 µg/mL.

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    End point title
    		 Number of subjects with Anti-PRP antibody concentrations ≥ 1 µg/mL.
    End point description
    The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    154
    154
    156
    Units: Participants
        Participants
    85
    145
    130
    No statistical analyses for this end point

    Secondary: Antibody concentrations for Anti-PRP.

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    End point title
    		 Antibody concentrations for Anti-PRP.
    End point description
    Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    154
    154
    156
    Units: µg/mL
    geometric mean (confidence interval 95%)
        µg/mL
    1.348 (1.076 to 1.688)
    9.258 (7.362 to 11.642)
    5.717 (4.363 to 7.492)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against hepatitis B (Anti-HBs).

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    End point title
    		 Number of seroprotected subjects against hepatitis B (Anti-HBs).
    End point description
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    134
    138
    136
    Units: Participants
        Participants
    134
    138
    133
    No statistical analyses for this end point

    Secondary: Antibody concentrations for Anti-HBs.

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    End point title
    		 Antibody concentrations for Anti-HBs.
    End point description
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 5, one month after the third dose of the primary vaccination
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    134
    138
    136
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    2258.8 (1910.7 to 2670.4)
    1886.0 (1565.6 to 2271.9)
    1053.4 (780.2 to 1422.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA; Inf hexa = Infanrix hexa, Ped = Pediarix, Pen = Pentacel. Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 1
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    185
    189
    188
    Units: Participants
        Any Pain, ActHIB/Engerix (N=0;189;188)
    0
    123
    100
        ≥ G 2 Pain, ActHIB/Engerix (N=0;189;188)
    0
    66
    45
        G 3 Pain, ActHIB/Engerix (N=0;189;188)
    0
    22
    10
        MA Pain, ActHIB/Engerix (N=0;189;188)
    0
    1
    0
        Any Pain, Inf hexa/Ped/Pen (N=185;189;188)
    94
    113
    115
        ≥ G 2 Pain, Inf hexa/Ped/Pen (N=185;189;188)
    40
    65
    51
        G 3 Pain, Inf hexa/Ped/Pen (N=185;189;188)
    8
    17
    12
        MA Pain, Inf hexa/Ped/Pen (N=185;189;188)
    1
    0
    0
        Any Redness, ActHIB/Engerix (N=0;189;188)
    0
    63
    55
        ≥ G 2 Redness, ActHIB/Engerix (N=0;189;188)
    0
    19
    12
        G 3 Redness, ActHIB/Engerix (N=0;189;188)
    0
    8
    1
        MA Redness, ActHIB/Engerix (N=0;189;188)
    0
    1
    0
        Any Redness, Inf hexa/Ped/Pen (N=185;189;188)
    47
    56
    57
        ≥ G 2 Redness, Inf hexa/Ped/Pen (N=185;189;188)
    15
    15
    20
        G 3 Redness,Inf hexa/Ped/Pen (N=185;189;188)
    3
    4
    3
        MA Redness, Inf hexa/Ped/Pen (N=185;189;188)
    0
    0
    0
        Any Swelling, ActHIB/Engerix (N=0;189;188)
    0
    41
    39
        ≥ G 2 Swelling, ActHIB/Engerix (N=0;189;188)
    0
    14
    14
        G 3 Swelling, ActHIB/Engerix (N=0;189;188)
    0
    6
    3
        MA Swelling, ActHIB/Engerix (N=0;189;188)
    0
    1
    0
        Any Swelling, Inf hexa/Ped/Pen (N=185;189;188)
    31
    35
    45
        ≥ G 2 Swelling, Inf hexa/Ped/Pen (N=185;189;188)
    10
    14
    24
        G 3 Swelling, Inf hexa/Ped/Pen (N=185;189;188)
    2
    3
    11
        MA Swelling, Inf hexa/Ped/Pen (N=185;189;188)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA; Inf hexa = Infanrix hexa, Ped = Pediarix, Pen = Pentacel. Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 2
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    182
    184
    180
    Units: Participants
        Any Pain, ActHIB/Engerix (N=0;184;13)
    0
    104
    6
        ≥ G 2 Pain, ActHIB/Engerix (N=0;184;13)
    0
    47
    2
        G 3 Pain, ActHIB/Engerix (N=0;184;13)
    0
    9
    0
        MA Pain, ActHIB/Engerix (N=0;184;13)
    0
    0
    0
        Any Pain, Inf hexa/Ped/Pen (N=182;184;180)
    84
    108
    93
        ≥G2 Pain, Inf hexa/Ped/Pen (N=182;184;180)
    25
    44
    31
        G3 Pain, Inf hexa/Ped/Pen (N=182;184;180)
    1
    7
    6
        MA Pain, Inf hexa/Ped/Pen (N=182;184;180)
    0
    0
    0
        Any Redness, ActHIB/Engerix (N=0;184;13)
    0
    66
    5
        ≥ G 2 Redness, ActHIB/Engerix (N=0;184;13)
    0
    17
    1
        G 3 Redness, ActHIB/Engerix (N=0;184;13)
    0
    1
    0
        MA Redness, ActHIB/Engerix (N=0;184;13)
    0
    0
    0
        Any Red, Inf hexa/Ped/Pen (N=182;184;180)
    59
    61
    64
        ≥G2 Red,Inf hexa/Ped/Pen (N=182;184;180)
    15
    12
    15
        G 3 Red, Inf hexa/Ped/Pen (N=182;184;180)
    3
    3
    2
        MA Red, Inf hexa/Ped/Pen (N=182;184;180)
    0
    0
    0
        Any Swelling, ActHIB/Engerix (N=0;184;13)
    0
    40
    3
        ≥ G 2 Swelling, ActHIB/Engerix (N=0;184;13)
    0
    11
    0
        G 3 Swelling, ActHIB/Engerix (N=0;184;13)
    0
    1
    0
        MA Swelling, ActHIB/Engerix (N=0;184;13)
    0
    0
    0
        Any Swe, Inf hexa/Ped/Pen (N=182;184;180)
    41
    40
    42
        ≥G2 Swe, Inf hexa/Ped/Pen (N=182;184;180)
    10
    12
    7
        G 3 Swe, Inf hexa/Ped/Pen (N=182;184;180)
    2
    2
    3
        MA Swe, Inf hexa/Ped/Pen (N=182;184;180)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA; Inf hexa = Infanrix hexa, Ped = Pediarix, Pen = Pentacel. Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 3
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    172
    175
    171
    Units: Participants
        Any Pain, ActHIB/Engerix (N=0;175;169)
    0
    93
    75
        ≥ G 2 Pain, ActHIB/Engerix (N=0;175;169)
    0
    41
    25
        G 3 Pain, ActHIB/Engerix (N=0;175;169)
    0
    7
    5
        MA Pain, ActHIB/Engerix (N=0;175;169)
    0
    1
    0
        Any Pain, Inf hexa/Ped/Pen (N=172;175;170)
    67
    90
    76
        ≥ G2 Pain, Inf hexa/Ped/Pen (N=172;175;170)
    18
    39
    20
        G3 Pain, Inf hexa/Ped/Pen (N=172;175;170)
    0
    7
    7
        MA Pain, Inf hexa/Ped/Pen (N=172;175;170)
    0
    1
    0
        Any Red, ActHIB/Engerix (N=0;175;169)
    0
    69
    51
        ≥ G 2 Red, ActHIB/Engerix (N=0;175;169)
    0
    7
    9
        G 3 Red, ActHIB/Engerix (N=0;175;169)
    0
    1
    2
        MA Red, ActHIB/Engerix (N=0;175;169)
    0
    0
    0
        Any Red, Inf hexa/Ped/Pen (N=172;175;170)
    63
    66
    56
        ≥G2 Red, Inf hexa/Ped/Pen (N=172;175;170)
    7
    12
    11
        G3 Red, Inf hexa/Ped/Pen (N=172;175;170)
    1
    3
    0
        MA Red, Inf hexa/Ped/Pen (N=172;175;170)
    0
    1
    0
        Any Swe, ActHIB/Engerix (N=0;175;169)
    0
    42
    37
        ≥ G 2 Swe, ActHIB/Engerix (N=0;175;169)
    0
    7
    7
        G 3 Swe, ActHIB/Engerix (N=0;175;169)
    0
    1
    0
        MA Swe, ActHIB/Engerix (N=0;175;169)
    0
    0
    0
        Any Swe, Inf hexa/Ped/Pen (N=172;175;170)
    43
    44
    35
        ≥ G2 Swe, Inf hexa/Ped/Pen (N=172;175;170)
    7
    10
    4
        G3 Swe, Inf hexa/Ped/Pen (N=172;175;170)
    1
    3
    0
        MA Swe, Inf hexa/Ped/Pen (N=172;175;170)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA; Inf hexa = Infanrix hexa, Ped = Pediarix, Pen = Pentacel. Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following any dose.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    187
    189
    188
    Units: Participants
        Any Pain, ActHIB/Engerix (N=0;189;188)
    0
    148
    127
        ≥ G 2 Pain, ActHIB/Engerix (N=0;189;188)
    0
    96
    62
        G 3 Pain, ActHIB/Engerix (N=0;189;188)
    0
    30
    14
        MA Pain, ActHIB/Engerix (N=0;189;188)
    0
    2
    0
        Any Pain, Inf hexa/Ped/Pen (N=187;189;188)
    127
    151
    147
        ≥ G2 Pain,Inf hexa/Ped/Pen (N=187;189;188)
    58
    93
    80
        G3 Pain, Inf hexa/Ped/Pen (N=187;189;188)
    8
    27
    22
        MA Pain, Inf hexa/Ped/Pen (N=187;189;188)
    1
    1
    0
        Any Red, ActHIB/Engerix (N=0;189;188)
    0
    108
    77
        ≥ G 2 Red, ActHIB/Engerix (N=0;189;188)
    0
    38
    20
        G 3 Red, ActHIB/Engerix (N=0;189;188)
    0
    10
    3
        MA Red, ActHIB/Engerix (N=0;189;188)
    0
    1
    0
        Any Red, Inf hexa/Ped/Pen (N=187;189;188)
    94
    98
    87
        ≥ G2 Red, Inf hexa/Ped/Pen (N=187;189;188)
    27
    32
    37
        G3 Red, Inf hexa/Ped/Pen (N=187;189;188)
    7
    9
    5
        MA Red, Inf hexa/Ped/Pen (N=187;189;188)
    0
    1
    0
        Any Swe, ActHIB/Engerix (N=0;189;188)
    0
    78
    64
        ≥ G 2 Swe, ActHIB/Engerix (N=0;189;188)
    0
    25
    18
        G 3 Swe, ActHIB/Engerix (N=0;189;188)
    0
    7
    3
        MA Swe, ActHIB/Engerix (N=0;189;188)
    0
    1
    0
        Any Swe, Inf hexa/Ped/Pen (N=187;189;188)
    73
    70
    72
        ≥ G2 Swe, Inf hexa/Ped/Pen (N=187;189;188)
    20
    26
    26
        G3 Swe, Inf hexa/Ped/Pen (N=187;189;188)
    4
    7
    12
        MA Swe, Inf hexa/Ped/Pen (N=187;189;188)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 1.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    185
    189
    188
    Units: Participants
        Any Drowsiness
    114
    143
    149
        ≥ G 2 Drowsiness
    36
    56
    53
        G 3 Drowsiness
    3
    8
    12
        Rel Drowsiness
    112
    136
    141
        G3 Rel Drowsiness
    3
    7
    12
        MA Drowsiness
    1
    0
    0
        Any Irritability / Fussiness
    115
    165
    153
        ≥ G 2 Irritability / Fussiness
    42
    79
    68
        G 3 Irritability / Fussiness
    9
    17
    15
        Rel Irritability / Fussiness
    113
    163
    147
        G3 Rel Irritability / Fussiness
    9
    17
    15
        MA Irritability / Fussiness
    1
    0
    0
        Any Loss of appetite
    53
    76
    80
        ≥ G 2 Loss of appetite
    8
    13
    26
        G 3 Loss of appetite
    0
    1
    4
        Rel Loss of appetite
    48
    73
    77
        G3 Rel Loss of appetite
    0
    1
    4
        MA Loss of appetite
    0
    0
    0
        Any Fever
    22
    34
    29
        ≥ G 2 Fever
    0
    0
    2
        G 3 Fever
    0
    0
    0
        Rel Fever
    15
    31
    27
        G3 Rel Fever
    0
    0
    0
        MA Fever
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 2.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    182
    184
    179
    Units: Participants
        Any Drowsiness
    97
    132
    109
        ≥ G 2 Drowsiness
    31
    43
    39
        G 3 Drowsiness
    8
    7
    4
        Rel Drowsiness
    94
    126
    108
        G3 Rel Drowsiness
    7
    7
    3
        MA Drowsiness
    0
    0
    0
        Any Irritability / Fussiness
    128
    147
    136
        ≥ G 2 Irritability / Fussiness
    53
    70
    61
        G 3 Irritability / Fussiness
    6
    14
    11
        Rel Irritability / Fussiness
    125
    143
    133
        G3 Rel Irritability / Fussiness
    6
    13
    11
        MA Irritability / Fussiness
    0
    0
    2
        Any Loss of appetite
    56
    55
    56
        ≥ G 2 Loss of appetite
    17
    15
    15
        G 3 Loss of appetite
    1
    1
    2
        Rel Loss of appetite
    52
    51
    55
        G3 Rel Loss of appetite
    1
    1
    2
        MA Loss of appetite
    0
    0
    1
        Any Fever
    47
    36
    35
        ≥ G 2 Fever
    2
    3
    2
        G 3 Fever
    0
    0
    0
        Rel Fever
    37
    32
    33
        G3 Rel Fever
    0
    0
    0
        MA Fever
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following Dose 3.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    172
    175
    170
    Units: Participants
        Any Drowsiness
    85
    108
    88
        ≥ G 2 Drowsiness
    23
    37
    25
        G 3 Drowsiness
    3
    5
    9
        Rel Drowsiness
    81
    105
    86
        G3 Rel Drowsiness
    3
    5
    9
        MA Drowsiness
    0
    2
    1
        Any Irritability / Fussiness
    126
    135
    122
        ≥ G 2 Irritability / Fussiness
    46
    58
    58
        G 3 Irritability / Fussiness
    6
    15
    11
        Rel Irritability / Fussiness
    121
    129
    120
        G3 Rel Irritability / Fussiness
    6
    13
    11
        MA Irritability / Fussiness
    0
    3
    1
        Any Loss of appetite
    45
    58
    53
        ≥ G 2 Loss of appetite
    11
    13
    15
        G 3 Loss of appetite
    1
    2
    2
        Rel Loss of appetite
    44
    56
    52
        G3 Rel Loss of appetite
    1
    2
    2
        MA Loss of appetite
    0
    1
    0
        Any Fever
    40
    45
    37
        ≥ G 2 Fever
    4
    11
    7
        G 3 Fever
    0
    2
    0
        Rel Fever
    35
    39
    35
        G3 Rel Fever
    0
    2
    0
        MA Fever
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following any dose.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    187
    189
    188
    Units: Participants
        Any Drowsiness
    147
    172
    168
        ≥ G 2 Drowsiness
    67
    88
    81
        G 3 Drowsiness
    11
    19
    22
        Rel Drowsiness
    144
    169
    166
        G3 Rel Drowsiness
    11
    18
    21
        MA Drowsiness
    1
    2
    1
        Any Irritability / Fussiness
    164
    182
    177
        ≥ G 2 Irritability / Fussiness
    96
    128
    120
        G 3 Irritability / Fussiness
    18
    35
    30
        Rel Irritability / Fussiness
    161
    180
    175
        G3 Rel Irritability / Fussiness
    18
    34
    30
        MA Irritability / Fussiness
    1
    3
    3
        Any Loss of appetite
    95
    111
    117
        ≥ G 2 Loss of appetite
    28
    32
    39
        G 3 Loss of appetite
    2
    3
    6
        Rel Loss of appetite
    91
    108
    116
        G3 Rel Loss of appetite
    2
    3
    6
        MA Loss of appetite
    0
    1
    1
        Any Fever
    72
    78
    72
        ≥ G 2 Fever
    6
    14
    10
        G 3 Fever
    0
    2
    0
        Rel Fever
    61
    74
    69
        G3 Rel Fever
    0
    2
    0
        MA Fever
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with specific adverse events (AEs).

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    End point title
    		 Number of subjects with specific adverse events (AEs).
    End point description
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
    End point type
    Secondary
    End point timeframe
    From Month 0 up to 6 months post primary-vaccination (Month 10)
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    195
    194
    196
    Units: Participants
        Participants
    7
    11
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs.

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    End point title
    		 Number of subjects with unsolicited AEs.
    End point description
    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-primary vaccination period.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    195
    194
    196
    Units: Participants
        Participants
    113
    108
    96
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs).
    End point description
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Month 0 up to 6 months post-primary vaccination (Month 10)
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    195
    194
    196
    Units: Participants
        Participants
    7
    1
    7
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Anti-D and Anti-T.

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    End point title
    		 Number of seroprotected subjects against Anti-D and Anti-T.
    End point description
    A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    136
    126
    Units: Participants
        Anti-T at Visit 5 (N=131;132;121)
    118
    123
    107
        Anti-T at Visit 6 (N=138;136;126)
    138
    136
    125
        Anti-D at Visit 5 (N=131;132;121)
    128
    123
    115
        Anti-D at Visit 6 (N=138;136;126)
    138
    136
    126
    No statistical analyses for this end point

    Secondary: Antibody concentrations for Anti-D and Anti-T.

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    End point title
    		 Antibody concentrations for Anti-D and Anti-T.
    End point description
    Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    136
    126
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T at Visit 5 (N=131;132;121)
    0.327 (0.281 to 0.380)
    0.402 (0.340 to 0.474)
    0.340 (0.281 to 0.410)
        Anti-T at Visit 6 (N=138;136;126)
    9.212 (7.863 to 10.793)
    8.870 (7.668 to 10.261)
    6.880 (5.905 to 8.015)
        Anti-D at Visit 5 (N=131;132;121)
    0.701 (0.597 to 0.825)
    0.622 (0.514 to 0.753)
    0.764 (0.629 to 0.928)
        Anti-D at Visit 6 (N=138;136;126)
    8.334 (7.479 to 9.286)
    7.886 (6.972 to 8.92)
    8.537 (7.524 to 9.687)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for Anti-PT, Anti-FHA and Anti-PRN.

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    End point title
    		 Number of seropositive subjects for Anti-PT, Anti-FHA and Anti-PRN.
    End point description
    A seropositve subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    136
    126
    Units: Participants
        Anti-PT at Visit 5 (N=131;132;121)
    107
    114
    63
        Anti-FHA at Visit 5 (N=131;132;121)
    130
    130
    113
        Anti-PRN at Visit 5 (N=131;132;120)
    110
    104
    91
        Anti-PT at Visit 6 (N=138;136;126)
    138
    136
    126
        Anti-FHA at Visit 6 (N=138;136;126)
    138
    136
    126
        Anti-PRN at Visit 6 (N=137;136;125)
    136
    136
    124
    No statistical analyses for this end point

    Secondary: Antibody concentrations for Anti-PT, Anti-FHA and Anti-PRN.

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    End point title
    		 Antibody concentrations for Anti-PT, Anti-FHA and Anti-PRN.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    136
    126
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT Visit 5 (N=131;132;121)
    5.3 (4.6 to 6.2)
    6.5 (5.6 to 7.7)
    3.1 (2.6 to 3.7)
        Anti-FHA Visit 5 (N=131;132;121)
    17.1 (14.7 to 19.9)
    21.8 (18.3 to 26.1)
    8.1 (6.6 to 9.9)
        Anti-PRN Visit 5 (N=131;132;120)
    6.8 (5.5 to 8.3)
    5.5 (4.5 to 6.6)
    6.0 (4.8 to 7.5)
        Anti-PT Visit 6 (N=138;136;126)
    71.4 (62.6 to 81.5)
    87.6 (76.6 to 100.2)
    55.5 (47.4 to 65.1)
        Anti-FHA Visit 6 (N=138;136;126)
    186.9 (165.1 to 211.5)
    250.4 (220.4 to 284.6)
    101.0 (86.2 to 118.3)
        Anti-PRN Visit 6 (N=137;136;125)
    208.0 (172.3 to 251.1)
    215.6 (176.1 to 263.8)
    130.5 (105.9 to 160.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response for anti-PT, anti-FHA and anti-PRN.

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    End point title
    		 Number of subjects with a booster response for anti-PT, anti-FHA and anti-PRN.
    End point description
    Booster response to PT, FHA and PRN antigens was defined as: - For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration = 4 times the assay cut-off, - For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration. The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
    End point type
    Secondary
    End point timeframe
    At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    131
    130
    116
    Units: Participants
        Anti-PT (N=131;130;116)
    126
    121
    111
        Anti-FHA (N=131;130;116)
    130
    127
    114
        Anti-PRN (N=130;130;115)
    128
    128
    112
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Anti-PRP.

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    End point title
    		 Number of seroprotected subjects against Anti-PRP.
    End point description
    A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    139
    131
    Units: Participants
        Anti-PRP at Visit 5 (N=131;132;121)
    91
    122
    94
        Anti-PRP at Visit 6 (N=138;139;131)
    138
    139
    129
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-PRP antibody concentrations ≥ 1 µg/mL.

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    End point title
    		 Number of subjects with Anti-PRP antibody concentrations ≥ 1 µg/mL.
    End point description
    The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    139
    131
    Units: Participants
        Anti-PRP at Visit 5 (N=131;132;121)
    23
    71
    47
        Anti-PRP at Visit 6 (N=138;139;131)
    136
    138
    128
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-PRP.

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    End point title
    		 Antibody concentrations for anti-PRP.
    End point description
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    138
    139
    131
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP at Visit 5 (N=131;132;121)
    0.301 (0.242 to 0.373)
    0.987 (0.775 to 1.256)
    0.614 (0.458 to 0.822)
        Anti-PRP at Visit 6 (N=138;139;131)
    39.365 (31.520 to 49.164)
    51.140 (41.954 to 62.339)
    27.318 (21.140 to 35.302)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-polio types 1, 2 and 3.

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    End point title
    		 Number of seroprotected subjects against anti-polio types 1, 2 and 3.
    End point description
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    128
    129
    117
    Units: Participants
        Anti-polio 1 (N=128;128;116)
    124
    121
    100
        Anti-polio 2 (N=128;128;117)
    119
    122
    109
        Anti-polio 3 (N=127;129;117)
    123
    126
    80
    No statistical analyses for this end point

    Secondary: Antibody titres for anti-polio types 1, 2 and 3.

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    End point title
    		 Antibody titres for anti-polio types 1, 2 and 3.
    End point description
    Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    128
    129
    117
    Units: titres
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N=128;128;116)
    99.5 (79.4 to 124.8)
    107.4 (83.7 to 137.9)
    42.2 (32.6 to 54.6)
        Anti-polio 2 (N=128;128;117)
    94.9 (73.2 to 123.1)
    111.9 (88.0 to 142.4)
    51.2 (40.8 to 64.3)
        Anti-polio 3 (N=127;129;117)
    122.1 (95.1 to 156.9)
    160.4 (125.8 to 204.6)
    28.4 (20.6 to 39.1)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Anti-HBs.

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    End point title
    		 Number of seroprotected subjects against Anti-HBs.
    End point description
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    133
    131
    121
    Units: Participants
        Participants
    131
    128
    105
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-HBs.

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    End point title
    		 Antibody concentrations for anti-HBs.
    End point description
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    133
    131
    121
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    328.7 (261.5 to 413.2)
    235.8 (188.2 to 295.5)
    149.4 (100.5 to 222.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA. Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    154
    151
    150
    Units: Participants
        Any Pain, ActHIB/Hiberix (N=153;151;0)
    61
    64
    0
        ≥ G 2 Pain, ActHIB/Hiberix (N=153;151;0)
    11
    15
    0
        G 3 Pain, ActHIB/Hiberix (N=153;151;0)
    1
    2
    0
        MA Pain, ActHIB/Hiberix (N=153;151;0)
    0
    0
    0
        Any Pain, Infanrix/Pentacel (N=154;151;150)
    62
    74
    59
        ≥ G2 Pain, Infanrix/Pentacel (N=154;151;150)
    12
    19
    16
        G3 Pain, Infanrix/Pentacel (N=154;151;150)
    2
    3
    2
        MA Pain, Infanrix/Pentacel (N=154;151;150)
    1
    0
    0
        Any Red, ActHIB/Hiberix (N=153;151;0)
    42
    49
    0
        ≥ G 2 Red, ActHIB/Hiberix (N=153;151;0)
    7
    4
    0
        G 3 Red, ActHIB/Hiberix (N=153;151;0)
    0
    2
    0
        MA Red, ActHIB/Hiberix (N=153;151;0)
    0
    0
    0
        Any Red, Infanrix/Pentacel (N=154;151;150)
    49
    60
    47
        ≥ G2 Red, Infanrix/Pentacel (N=154;151;150)
    17
    14
    13
        G3 Red, Infanrix/Pentacel (N=154;151;150)
    8
    4
    2
        MA Red, Infanrix/Pentacel (N=154;151;150)
    2
    0
    0
        Any Swe, ActHIB/Hiberix (N=153;151;0)
    29
    29
    0
        ≥ G 2 Swe, ActHIB/Hiberix (N=153;151;0)
    7
    6
    0
        G 3 Swe, ActHIB/Hiberix (N=153;151;0)
    0
    2
    0
        MA Swe, ActHIB/Hiberix (N=153;151;0)
    0
    0
    0
        Any Swe, Infanrix/Pentacel (N=154;151;150)
    42
    44
    35
        ≥ G2 Swe, Infanrix/Pentacel (N=154;151;150)
    13
    17
    14
        G3 Swe, Infanrix/Pentacel (N=154;151;150)
    5
    7
    4
        MA Swe, Infanrix/Pentacel (N=154;151;150)
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    153
    150
    151
    Units: Participants
        Any Drowsiness
    59
    67
    65
        ≥ G 2 Drowsiness
    18
    20
    17
        G 3 Drowsiness
    1
    3
    2
        Rel Drowsiness
    55
    65
    61
        G3 Rel Drowsiness
    1
    3
    2
        MA Drowsiness
    0
    0
    0
        Any Irritability / Fussiness
    86
    94
    76
        ≥ G 2 Irritability / Fussiness
    26
    35
    23
        G 3 Irritability / Fussiness
    3
    4
    4
        Rel Irritability / Fussiness
    85
    92
    68
        G3 Rel Irritability / Fussiness
    3
    4
    4
        MA Irritability / Fussiness
    0
    0
    1
        Any Loss of appetite
    47
    47
    46
        ≥ G 2 Loss of appetite
    8
    9
    11
        G 3 Loss of appetite
    1
    2
    2
        Rel Loss of appetite
    44
    44
    41
        G3 Rel Loss of appetite
    1
    2
    2
        MA Loss of appetite
    0
    0
    0
        Any Fever
    4
    10
    11
        ≥ G 2 Fever
    1
    1
    1
        G 3 Fever
    0
    0
    0
        Rel Fever
    2
    10
    9
        G3 Rel Fever
    0
    0
    0
        MA Fever
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with specific AEs.

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    End point title
    		 Number of subjects with specific AEs.
    End point description
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-booster vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    167
    158
    161
    Units: Participants
        Participants
    4
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs.

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    End point title
    		 Number of subjects with unsolicited AEs.
    End point description
    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-booster vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    167
    158
    161
    Units: Participants
        Participants
    37
    35
    41
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs.

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    End point title
    		 Number of subjects with SAEs.
    End point description
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-booster vaccination.
    End point values
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Number of subjects analysed
    167
    158
    161
    Units: Participants
        Participants
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pediarix Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Reporting group title
    Pentacel Group
    Reporting group description
    		 Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.

    Serious adverse events
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 195 (4.10%)
    1 / 194 (0.52%)
    8 / 196 (4.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Near drowning
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Road traffic accident
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         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
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Seizure like phenomena
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         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
    Leukocytosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Apparent life threatening event
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choking
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Hypoxia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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 distress
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (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
    Meningitis viral
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    2 / 196 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Infanrix hexa Group Pediarix Group Pentacel Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    188 / 195 (96.41%)
    190 / 194 (97.94%)
    187 / 196 (95.41%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Crying
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Ill-defined disorder
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site bruising
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 194 (1.03%)
    5 / 196 (2.55%)
         occurrences all number
    2
    2
    5
    Injection site erythema
         subjects affected / exposed
    112 / 195 (57.44%)
    129 / 194 (66.49%)
    116 / 196 (59.18%)
         occurrences all number
    228
    299
    248
    Injection site induration
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    4
    1
    0
    Injection site mass
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site nodule
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    141 / 195 (72.31%)
    162 / 194 (83.51%)
    152 / 196 (77.55%)
         occurrences all number
    322
    423
    361
    Injection site pruritus
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site rash
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    2 / 196 (1.02%)
         occurrences all number
    1
    0
    3
    Injection site scab
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Injection site swelling
         subjects affected / exposed
    92 / 195 (47.18%)
    103 / 194 (53.09%)
    90 / 196 (45.92%)
         occurrences all number
    166
    201
    180
    Injection site warmth
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    0
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 194 (1.55%)
    0 / 196 (0.00%)
         occurrences all number
    0
    3
    0
    Pyrexia
         subjects affected / exposed
    82 / 195 (42.05%)
    85 / 194 (43.81%)
    82 / 196 (41.84%)
         occurrences all number
    133
    136
    130
    Swelling
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site bruising
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    1 / 196 (0.51%)
         occurrences all number
    0
    3
    1
    Vaccination site erythema
         subjects affected / exposed
    2 / 195 (1.03%)
    5 / 194 (2.58%)
    3 / 196 (1.53%)
         occurrences all number
    2
    5
    3
    Vaccination site induration
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site pain
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    3 / 196 (1.53%)
         occurrences all number
    2
    1
    3
    Vaccination site swelling
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 194 (0.52%)
    2 / 196 (1.02%)
         occurrences all number
    3
    1
    2
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Food allergy
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    0
    1
    1
    Milk allergy
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    3
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    2
    0
    0
    Genital labial adhesions
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    0
    2
    0
    Penile adhesion
         subjects affected / exposed
    3 / 195 (1.54%)
    3 / 194 (1.55%)
    0 / 196 (0.00%)
         occurrences all number
    3
    3
    0
    Penile erythema
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    3 / 196 (1.53%)
         occurrences all number
    0
    0
    3
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    2
    1
    0
    Cough
         subjects affected / exposed
    17 / 195 (8.72%)
    8 / 194 (4.12%)
    7 / 196 (3.57%)
         occurrences all number
    20
    8
    7
    Dysphonia
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    3 / 195 (1.54%)
    6 / 194 (3.09%)
    2 / 196 (1.02%)
         occurrences all number
    3
    7
    2
    Respiratory arrest
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 194 (1.03%)
    1 / 196 (0.51%)
         occurrences all number
    1
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    1
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    5 / 195 (2.56%)
    4 / 194 (2.06%)
    5 / 196 (2.55%)
         occurrences all number
    5
    5
    6
    Sinus congestion
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Wheezing
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 194 (0.00%)
    3 / 196 (1.53%)
         occurrences all number
    3
    0
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    167 / 195 (85.64%)
    183 / 194 (94.33%)
    180 / 196 (91.84%)
         occurrences all number
    461
    544
    488
    Screaming
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Cardiac murmur
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    2
    1
    1
    Arthropod sting
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Concussion
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Corneal abrasion
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Foreign body
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    0
    1
    1
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    1 / 196 (0.51%)
         occurrences all number
    0
    2
    1
    Head injury
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    3 / 196 (1.53%)
         occurrences all number
    1
    0
    3
    Mouth injury
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Nasal injury
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Congenital skin dimples
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 194 (1.55%)
    1 / 196 (0.51%)
         occurrences all number
    0
    3
    1
    Dacryostenosis congenital
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Dermoid cyst
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Hydrocele
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Hypospadias
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    0
    2
    0
    Macrocephaly
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    2
    1
    0
    Phimosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Plagiocephaly
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    2 / 196 (1.02%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Hyperreflexia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Poor quality sleep
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    152 / 195 (77.95%)
    173 / 194 (89.18%)
    173 / 196 (88.27%)
         occurrences all number
    355
    450
    411
    Speech disorder developmental
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Tremor
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    2
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    2 / 196 (1.02%)
         occurrences all number
    0
    1
    2
    Ear disorder
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    2 / 196 (1.02%)
         occurrences all number
    0
    0
    2
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    2
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fistula
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 194 (1.03%)
    5 / 196 (2.55%)
         occurrences all number
    1
    3
    5
    Diarrhoea
         subjects affected / exposed
    6 / 195 (3.08%)
    7 / 194 (3.61%)
    13 / 196 (6.63%)
         occurrences all number
    7
    7
    14
    Flatulence
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 195 (0.00%)
    8 / 194 (4.12%)
    1 / 196 (0.51%)
         occurrences all number
    0
    8
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Teething
         subjects affected / exposed
    8 / 195 (4.10%)
    10 / 194 (5.15%)
    11 / 196 (5.61%)
         occurrences all number
    10
    11
    12
    Vomiting
         subjects affected / exposed
    13 / 195 (6.67%)
    10 / 194 (5.15%)
    12 / 196 (6.12%)
         occurrences all number
    13
    11
    12
    Vomiting projectile
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    4 / 195 (2.05%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    4
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    5 / 195 (2.56%)
    8 / 194 (4.12%)
    7 / 196 (3.57%)
         occurrences all number
    5
    8
    7
    Dermatitis contact
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    2
    2
    0
    Dermatitis diaper
         subjects affected / exposed
    4 / 195 (2.05%)
    4 / 194 (2.06%)
    10 / 196 (5.10%)
         occurrences all number
    4
    4
    11
    Dry skin
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Eczema
         subjects affected / exposed
    5 / 195 (2.56%)
    5 / 194 (2.58%)
    4 / 196 (2.04%)
         occurrences all number
    5
    5
    4
    Erythema
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 194 (1.55%)
    0 / 196 (0.00%)
         occurrences all number
    0
    3
    0
    Hair growth abnormal
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertrichosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Post inflammatory pigmentation change
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    6 / 195 (3.08%)
    8 / 194 (4.12%)
    6 / 196 (3.06%)
         occurrences all number
    6
    8
    6
    Rash erythematous
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Rash generalised
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Seborrhoea
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    1
    1
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    3
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 194 (1.55%)
    0 / 196 (0.00%)
         occurrences all number
    0
    3
    0
    Renal and urinary disorders
    Urethral meatus stenosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Asymmetric gluteal fold
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    2
    0
    1
    Positional plagiocephaly
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Anal abscess
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchiolitis
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    3
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Candida infection
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 194 (1.03%)
    0 / 196 (0.00%)
         occurrences all number
    2
    2
    0
    Candida nappy rash
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    1
    1
    1
    Conjunctivitis
         subjects affected / exposed
    10 / 195 (5.13%)
    9 / 194 (4.64%)
    1 / 196 (0.51%)
         occurrences all number
    10
    10
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    0
    1
    1
    Conjunctivitis viral
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Croup infectious
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 194 (1.03%)
    2 / 196 (1.02%)
         occurrences all number
    2
    2
    2
    Ear infection
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Eczema herpeticum
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Exanthema subitum
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Eye infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    1
    1
    0
    Gastric infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 194 (1.03%)
    1 / 196 (0.51%)
         occurrences all number
    2
    2
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 194 (1.03%)
    2 / 196 (1.02%)
         occurrences all number
    1
    2
    2
    Herpangina
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    2
    0
    1
    Hordeolum
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    2
    1
    1
    Impetigo
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    2 / 196 (1.02%)
         occurrences all number
    1
    0
    3
    Influenza
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 195 (2.05%)
    1 / 194 (0.52%)
    4 / 196 (2.04%)
         occurrences all number
    5
    1
    4
    Oral candidiasis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    1 / 196 (0.51%)
         occurrences all number
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    10 / 195 (5.13%)
    11 / 194 (5.67%)
    12 / 196 (6.12%)
         occurrences all number
    10
    13
    12
    Otitis media acute
         subjects affected / exposed
    2 / 195 (1.03%)
    3 / 194 (1.55%)
    0 / 196 (0.00%)
         occurrences all number
    2
    3
    0
    Otitis media chronic
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Pertussis
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    2
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    3 / 196 (1.53%)
         occurrences all number
    0
    0
    3
    Roseola
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 194 (0.52%)
    0 / 196 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Skin candida
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    1
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 196 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 195 (16.41%)
    26 / 194 (13.40%)
    32 / 196 (16.33%)
         occurrences all number
    35
    31
    35
    Urinary tract infection
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 194 (1.03%)
    1 / 196 (0.51%)
         occurrences all number
    0
    2
    1
    Viraemia
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    1 / 196 (0.51%)
         occurrences all number
    0
    0
    1
    Viral infection
         subjects affected / exposed
    4 / 195 (2.05%)
    3 / 194 (1.55%)
    8 / 196 (4.08%)
         occurrences all number
    4
    3
    8
    Viral rash
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 194 (0.00%)
    4 / 196 (2.04%)
         occurrences all number
    3
    0
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 194 (0.00%)
    3 / 196 (1.53%)
         occurrences all number
    0
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    112 / 195 (57.44%)
    126 / 194 (64.95%)
    127 / 196 (64.80%)
         occurrences all number
    201
    236
    235

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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