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    Clinical Trial Results:
    A phase III, open-label study to assess the immunogenicity and reactogenicity of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age in healthy infants in Russia

    Summary
    EudraCT number
    		 2013-005577-43
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    27 Oct 2018
    First version publication date
    27 Oct 2018
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    116194
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02858440
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, (44) 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, (44) 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    24 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Oct 2017
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response to the study vaccine in terms of seroprotection status for diphtheria, tetanus, Hib and poliovirus types 1, 2 and 3 antigens, and in terms of seropositivity to the pertussis antigens, one month after the third dose of primary vaccination.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccine, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2016
    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
    Russian Federation: 235
    Worldwide total number of subjects
    235
    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)
    235
    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
    		 Results for Booster Epoch are not yet available

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 235
    Number of subjects completed
    		 235

    Period 1
    Period 1 title
    Primary Epoch (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DTPa-IPV/Hib Group
    Arm description
    		 All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

    Number of subjects in period 1
    		DTPa-IPV/Hib Group
    Started
    235
    Completed
    229
    Not completed
    6
         The child left for another region
    1
         Consent withdrawal
    3
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTPa-IPV/Hib Group
    Reporting group description
    		 All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

    Reporting group values
    		 DTPa-IPV/Hib Group Total
    Number of subjects
    		 235
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristics are reported only for the Primary Epoch; results for Booster Epoch are not yet available.
    Units: weeks
        arithmetic mean (standard deviation)
    		 14.1 ± 1.2 -
    Gender categorical
    Baseline characteristics are reported only for the Primary Epoch; results for Booster Epoch are not yet available.
    Units: Subjects
        Male
    		 124 124
        Female
    		 111 111
    Race/Ethnicity, Customized
    Baseline characteristics are reported only for the Primary Epoch; results for Booster Epoch are not yet available.
    Units: Subjects
        White - Caucasian / European Heritage
    		 235 235

    End points

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    End points reporting groups
    Reporting group title
    DTPa-IPV/Hib Group
    Reporting group description
    		 All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

    Primary: Percentage of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T), post primary vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T), post primary vaccination [1]
    End point description
    A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-D antibody ≥ 0.1 IU/mL
    100 (97.9 to 100)
        Anti-T antibody ≥ 0.1 IU/mL
    100 (97.9 to 100)
    No statistical analyses for this end point

    Primary: Percentage of seroprotected subjects for anti-poliovirus types 1, 2 and 3, post primary vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-poliovirus types 1, 2 and 3, post primary vaccination [2]
    End point description
    A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
    End point type
    Primary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    151
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-Polio 1 antibody ≥ 8 ED50
    100 (97.6 to 100)
        Anti-Polio 2 antibody ≥ 8 ED50
    100 (97.6 to 100)
        Anti-Polio 3 antibody ≥ 8 ED50
    99.3 (96.4 to 100)
    No statistical analyses for this end point

    Primary: Percentage of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP), post primary vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP), post primary vaccination [3]
    End point description
    A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.
    End point type
    Primary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    182
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-PRP antibody ≥ 0.15 µg/mL
    98.4 (95.3 to 99.7)
    No statistical analyses for this end point

    Primary: Percentage of seropositive subjects for anti-pertussis (anti- PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN), post primary vaccination

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    End point title
    		 Percentage of seropositive subjects for anti-pertussis (anti- PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN), post primary vaccination [4]
    End point description
    A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
    End point type
    Primary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-FHA antibody ≥ 2.046 IU/mL
    99.4 (96.9 to 100)
        Anti-PRN antibody ≥ 2.187 IU/mL
    99.4 (96.9 to 100)
        Anti-PT antibody ≥ 2.693 IU/mL
    98.9 (96.0 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of seroprotected subjects for anti-D and anti-T, post booster vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-D and anti-T, post booster vaccination
    End point description
    A seroprotected subject is a subject whose anti-D and anti-T antibody concentration is ≥ 0.1 IU/mL. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [5]
    Units: Percentage of subjects
    Notes
    [5] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Percentage of seroprotected subjects for anti-poliovirus types 1, 2 and 3, post booster vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-poliovirus types 1, 2 and 3, post booster vaccination
    End point description
    A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer is ≥ 8 ED50. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [6]
    Units: Percentage of subjects
    Notes
    [6] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Percentage of seroprotected subjects for anti-PRP, post booster vaccination

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    End point title
    		 Percentage of seroprotected subjects for anti-PRP, post booster vaccination
    End point description
    A seroprotected subject is a subject whose anti-PRP antibody concentration is ≥ 0.15 µg/mL. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [7]
    Units: Percentage of subjects
    Notes
    [7] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Percentage of seropositive subjects for anti- PT, anti-FHA and anti-PRN, post booster vaccination

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    End point title
    		 Percentage of seropositive subjects for anti- PT, anti-FHA and anti-PRN, post booster vaccination
    End point description
    A seropositive subject is a subject whose antibody concentration is ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [8]
    Units: Percentage of subjects
    Notes
    [8] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-D and anti-T, post primary vaccination

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    End point title
    		 Antibody concentrations for anti-D and anti-T, post primary vaccination
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). GMCs were expressed as International Units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D antibody
    3.24 (2.84 to 3.68)
        Anti-T antibody
    3.14 (2.81 to 3.51)
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-D and anti-T, post booster vaccination

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    End point title
    		 Antibody concentrations for anti-D and anti-T, post booster vaccination
    End point description
    Concentrations are expressed as GMCs. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [9]
    Units: IU/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [9] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Antibody titers for anti-polio types 1, 2 and 3, post primary vaccination

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    End point title
    		 Antibody titers for anti-polio types 1, 2 and 3, post primary vaccination
    End point description
    Titers were expressed as geometric mean titres (GMTs).
    End point type
    Secondary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    151
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 antibody
    613.9 (505.5 to 745.5)
        Anti-Polio 2 antibody
    591.6 (487.3 to 718.3)
        Anti-Polio 3 antibody
    827.4 (674.7 to 1014.6)
    No statistical analyses for this end point

    Secondary: Antibody titers for anti-polio types 1, 2 and 3, post booster vaccination

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    End point title
    		 Antibody titers for anti-polio types 1, 2 and 3, post booster vaccination
    End point description
    Titers are expressed as GMTs. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [10]
    Units: Titers
        geometric mean (confidence interval 99%)
    ( to )
    Notes
    [10] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Antibody concentration for anti-PRP, post primary vaccination

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    End point title
    		 Antibody concentration for anti-PRP, post primary vaccination
    End point description
    Concentration was expressed as GMC. GMC was expressed as micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    182
    Units: µg/mL
    geometric mean (confidence interval 95%)
        µg/mL
    2.97 (2.48 to 3.54)
    No statistical analyses for this end point

    Secondary: Antibody concentration for anti-PRP, post booster vaccination

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    End point title
    		 Antibody concentration for anti-PRP, post booster vaccination
    End point description
    Concentration is expressed as GMC. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [11]
    Units: µg/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [11] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-PT, anti-FHA and anti-PRN, post primary vaccination

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    End point title
    		 Antibody concentrations for anti-PT, anti-FHA and anti-PRN, post primary vaccination
    End point description
    Concentrations were expressed as GMCs.
    End point type
    Secondary
    End point timeframe
    At Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-FHA antibody
    120.2 (107.0 to 135.1)
        Anti-PRN antibody
    166.1 (146.8 to 187.8)
        Anti-PT antibody
    65.0 (57.7 to 73.2)
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-PT, anti-FHA and anti-PRN, post booster vaccination

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    End point title
    		 Antibody concentrations for anti-PT, anti-FHA and anti-PRN, post booster vaccination
    End point description
    Concentrations are expressed as GMCs. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    At Visit 6 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [12]
    Units: IU/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [12] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local adverse events (AEs) following each dose of primary vaccination

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    End point title
    		 Number of subjects with any solicited local adverse events (AEs) following each dose of primary vaccination
    End point description
    Assessed solicited local AEs were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after each primary vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    232
    Units: Participants
        Any Pain, Dose 1
    58
        Any Redness, Dose 1
    83
        Any Swelling, Dose 1
    45
        Any Pain, Dose 2 (N=229)
    47
        Any Redness, Dose 2 (N=229)
    89
        Any Swelling, Dose 2 (N=229)
    58
        Any Pain, Dose 3 (N=226)
    50
        Any Redness, Dose 3 (N=226)
    96
        Any Swelling, Dose 3 (N=226)
    63
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local AEs following booster vaccination

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    End point title
    		 Number of subjects with any solicited local AEs following booster vaccination
    End point description
    Assessed solicited local AEs are pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after booster vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [13]
    Units: Participants
    Notes
    [13] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general AEs following each dose of primary vaccination

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    End point title
    		 Number of subjects with any solicited general AEs following each dose of primary vaccination
    End point description
    Assessed solicited general AEs were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after each primary vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    232
    Units: Participants
        Any Drowsiness, Dose 1
    82
        Any Irritability / Fussiness, Dose 1
    100
        Any Loss Of Appetite, Dose 1
    33
        Any Temperature/(Axillary) (°C), Dose 1
    14
        Any Drowsiness, Dose 2 (N=230)
    69
        Any Irritability / Fussiness, Dose 2 (N=230)
    104
        Any Loss Of Appetite, Dose 2 (N=230)
    34
        Any Temperature/(Axillary) (°C), Dose 2 (N=230)
    32
        Any Drowsiness, Dose 3 (N=225)
    65
        Any Irritability / Fussiness, Dose 3 (N=225)
    106
        Any Loss Of Appetite, Dose 3 (N=225)
    43
        Any Temperature/(Axillary) (°C), Dose 3 (N=225)
    28
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general AEs following booster vaccination

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    End point title
    		 Number of subjects with any solicited general AEs following booster vaccination
    End point description
    Assessed solicited general AEs are drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after booster vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [14]
    Units: Participants
    Notes
    [14] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs following each dose of primary vaccination

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    End point title
    		 Number of subjects with unsolicited AEs following each dose of primary vaccination
    End point description
    Unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after each primary vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    235
    Units: Participants
        Participants
    41
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs following booster vaccination

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    End point title
    		 Number of subjects with unsolicited AEs following booster vaccination
    End point description
    Unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. Results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after booster vaccination dose
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    0 [15]
    Units: Participants
    Notes
    [15] - Results for Booster Epoch are not yet available.
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    SAEs assessed include any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade. SAEs are reported only for the Primary Epoch; results for Booster Epoch are not yet available.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Visit 4 (i.e. one month after 3rd dose of primary vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    235
    Units: Participants
        Participants
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local & general AEs: during the 4-day follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day follow-up period after each primary & booster vaccination. SAEs: from Day 0 up to Visit 4.
    Adverse event reporting additional description
    Solicited local and general AEs, unsolicited AEs and SAEs are reported only for the Primary Epoch; results for Booster Epoch are not yet available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    DTPa-IPV/Hib Group
    Reporting group description
    		 All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

    Serious adverse events
    		 DTPa-IPV/Hib Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 235 (0.43%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Proctitis
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DTPa-IPV/Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    190 / 235 (80.85%)
    Congenital, familial and genetic disorders
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Nervous system disorders
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Dystonia
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Hydrocephalus
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Motor dysfunction
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Poor quality sleep
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    122 / 235 (51.91%)
         occurrences all number
    216
    Tremor
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    122 / 235 (51.91%)
         occurrences all number
    268
    Injection site pain
         subjects affected / exposed
    77 / 235 (32.77%)
         occurrences all number
    155
    Injection site swelling
         subjects affected / exposed
    83 / 235 (35.32%)
         occurrences all number
    166
    Pyrexia
         subjects affected / exposed
    55 / 235 (23.40%)
         occurrences all number
    78
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Hypersensitivity
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    2
    Flatulence
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Infantile colic
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    2
    Regurgitation
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    4 / 235 (1.70%)
         occurrences all number
    4
    Rash papular
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    150 / 235 (63.83%)
         occurrences all number
    310
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Ear infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 235 (1.28%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    9 / 235 (3.83%)
         occurrences all number
    10
    Tracheitis
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Tracheobronchitis
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 235 (1.28%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    3 / 235 (1.28%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    74 / 235 (31.49%)
         occurrences all number
    110

    More information

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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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