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    Clinical Trial Results:
    Immunogenicity and safety of GSK Biologicals’ DTPa-IPV/Hib (Infanrix™-IPV/Hib) combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b (DTPa-IPV/Hib) conjugate vaccine (Infanrix™-IPV/Hib) [213503 (DTPA-IPV)] vaccine in healthy Russian infants.

    Summary
    EudraCT number
    		 2013-005577-43
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Nov 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2019
    First version publication date
    27 Oct 2018
    Other versions
    		 v1
    Version creation reason

    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
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Clinical Trials, GlaxoSmithKline, 044 8773793718, 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
    22 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2018
    Was the trial ended prematurely?
    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 will be 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
    		 -

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

    Period 1
    Period 1 title
    Overall study (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
    DTPa-IPV/Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Patients received four doses of Infanrix-IPV/Hib vaccine, at day 0, month 1.5, month 3 and month 15.

    Number of subjects in period 1
    		DTPa-IPV/Hib Group
    Started
    235
    Completed
    223
    Not completed
    12
         Consent withdrawn by subject
    3
         Migrated/moved from study area
    4
         Lost to follow-up
    3
         Protocol deviation
    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
    		 235 235
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 235 235
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: Weeks
        arithmetic mean (standard deviation)
    		 14.1 ± 1.2 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 111 111
        Male
    		 124 124
    Race/Ethnicity, Customized
    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: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T), post primary vaccination

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    End point title
    		 Number 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 International Units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At Month 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: No formal statistical hypothesis testing was planned, results were summarized as descriptive statistics only.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: Participants
        Anti-D antibody ≥ 0.1 IU/mL
    176
        Anti-T antibody ≥ 0.1 IU/mL
    176
    No statistical analyses for this end point

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

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    End point title
    		 Number 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 Month 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: No formal statistical hypothesis testing was planned, results were summarized as descriptive statistics only.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    151
    Units: Participants
        Anti-Polio 1 antibody ≥ 8 ED50
    151
        Anti-Polio 2 antibody ≥ 8 ED50
    151
        Anti-Polio 3 antibody ≥ 8 ED50
    150
    No statistical analyses for this end point

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

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    End point title
    		 Number 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 micrograms per milliliters (µg/mL).
    End point type
    Primary
    End point timeframe
    At Month 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: No formal statistical hypothesis testing was planned, results were summarized as descriptive statistics only.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    182
    Units: Participants
        Anti-PRP
    179
    No statistical analyses for this end point

    Primary: Number 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
    		 Number 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 Month 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: No formal statistical hypothesis testing was planned, results were summarized as descriptive statistics only.
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176
    Units: Participants
        Anti-FHA antibody ≥ 2.046 IU/mL
    175
        Anti-PRN antibody ≥ 2.187 IU/mL
    175
        Anti-PT antibody ≥ 2.693 IU/mL
    174
    No statistical analyses for this end point

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

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    End point title
    		 Number 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.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188
    Units: Participants
        anti-D antibody
    188
        anti-T antibody
    188
    No statistical analyses for this end point

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

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    End point title
    		 Number 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.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176 [5]
    Units: Participants
        anti-Polio 1 antibody
    176
        anti-Polio 2 antibody
    169
        anti-Polio 3 antibody
    167
    Notes
    [5] - The number of subjects analysed was different for the 3 serotypes (176, 169 and 167, respectively).
    No statistical analyses for this end point

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

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    End point title
    		 Number 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.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188
    Units: Participants
        Anti-PRP
    188
    No statistical analyses for this end point

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

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    End point title
    		 Number 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.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188 [6]
    Units: Participants
        anti-PT antibody
    188
        anti-FHA antibody
    188
        anti-PRN antibody
    187
    Notes
    [6] - The number of subjects analysed was different for the 3 antibodies (188, 188 and 187, respectively).
    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
    The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 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
    The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-D antibody
    12.11 (10.82 to 13.56)
        anti-T antibody
    8.18 (7.35 to 9.11)
    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
    The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At Month 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
    The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    176 [7]
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-Polio 1 antibody
    2185.4 (1901.1 to 2512.3)
        anti-Polio 2 antibody
    2944.1 (2601.3 to 3332.2)
        anti-Polio 3 antibody
    3684.6 (3225.3 to 4209.3)
    Notes
    [7] - The number of subjects analysed was different for the 3 serotypes (176, 169 and 167, respectively).
    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
    The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 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%)
        Anti-PRP
    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
    The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    28.72 (24.70 to 33.40)
    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
    The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 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
    The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 16 (i.e. one month after booster vaccination)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    188 [8]
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-FHA antibody
    268.4 (242.4 to 297.2)
        anti-PRN antibody
    563.4 (495.6 to 640.5)
        anti-PT antibody
    107.9 (96.5 to 120.7)
    Notes
    [8] - The number of subjects analysed was different for the 3 antibodies (188, 188 and 187, respectively).
    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
    The solicited local AEs assessed were pain, redness and swelling at the injection site. Any = Occurrence of the AE regardless of the intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    232 [9]
    Units: Participants
        Any Pain, Dose 1
    58
        Any Redness, Dose 1
    83
        Any Swelling, Dose 1
    45
        Any Pain, Dose 2
    47
        Any Redness, Dose 2
    89
        Any Swelling, Dose 2
    58
        Any Pain, Dose 3
    50
        Any Redness, Dose 3
    96
        Any Swelling, Dose 3
    63
    Notes
    [9] - The number of subjects analysed for dose 1, dose 2 and dose 3 was 232, 229 and 226, respectively.
    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
    The solicited local AEs assessed were pain, redness, and swelling at the injection site. Any = Occurrence of the AE regardless of the intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    225
    Units: Participants
        Any Pain
    71
        Any Redness
    101
        Any Swelling
    73
    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
    The solicited general AEs assessed 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 (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    232 [10]
    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
    69
        Any Irritability / Fussiness, Dose 2
    104
        Any Loss Of Appetite, Dose 2
    34
        Any Temperature/(Axillary) (°C), Dose 2
    32
        Any Drowsiness, Dose 3
    65
        Any Irritability / Fussiness, Dose 3
    106
        Any Loss Of Appetite, Dose 3
    43
        Any Temperature/(Axillary) (°C), Dose 3
    28
    Notes
    [10] - The number of subjects analysed for dose 1, dose 2 and dose 3 was 232, 229 and 226, respectively.
    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
    The solicited general AEs assessed 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 (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    225
    Units: Participants
        Any Drowsiness
    54
        Any Irritability / Fussiness
    88
        Any Loss Of Appetite
    40
        Any Temperature/(Axillary) (°C)
    26
    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
    An 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 (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    235
    Units: Participants
        Any AEs
    48
    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
    An 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 (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    225
    Units: Participants
        Any AEs
    13
    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
    The SAEs assessed included 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.
    End point type
    Secondary
    End point timeframe
    During the entire study period (i.e. from Day 0 until Month 16)
    End point values
    		 DTPa-IPV/Hib Group
    Number of subjects analysed
    235
    Units: Participants
        Any SAEs
    3
    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 (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16
    Adverse event reporting additional description
    Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
    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
    3 / 235 (1.28%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Congenital, familial and genetic disorders
    Heart disease congenital
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastric infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DTPa-IPV/Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    201 / 235 (85.53%)
    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
    131 / 235 (55.74%)
         occurrences all number
    270
    Tremor
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    140 / 235 (59.57%)
         occurrences all number
    369
    Injection site pain
         subjects affected / exposed
    103 / 235 (43.83%)
         occurrences all number
    226
    Injection site swelling
         subjects affected / exposed
    102 / 235 (43.40%)
         occurrences all number
    239
    Pyrexia
         subjects affected / exposed
    67 / 235 (28.51%)
         occurrences all number
    104
    Irritability postvaccinal
         subjects affected / exposed
    157 / 235 (66.81%)
         occurrences all number
    398
    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
    2 / 235 (0.85%)
         occurrences all number
    2
    Diarrhoea
         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
    Rhinorrhoea
         subjects affected / exposed
    4 / 235 (1.70%)
         occurrences all number
    4
    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
    5 / 235 (2.13%)
         occurrences all number
    5
    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
    Erythema
         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
    Nightmare
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 235 (1.28%)
         occurrences all number
    3
    Ear infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 235 (1.28%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Respiratory tract infection viral
         subjects affected / exposed
    5 / 235 (2.13%)
         occurrences all number
    6
    Rhinitis
         subjects affected / exposed
    15 / 235 (6.38%)
         occurrences all number
    18
    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
    4 / 235 (1.70%)
         occurrences all number
    7
    Urinary tract infection
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    2 / 235 (0.85%)
         occurrences all number
    2
    Enteritis infectious
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    93 / 235 (39.57%)
         occurrences all number
    150
    Iron deficiency
         subjects affected / exposed
    1 / 235 (0.43%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2016
    Amendment 1 was assessed to: as per Russian legislation, only parents or adoptive parents can give consent for the enrolment of their child in a clinical trial. No other persons are allowed to give consent on behalf of a minor to participate in a clinical trial. Therefore the wording “parents/Legally Acceptable Representative(s) (LAR[s])” should be replaced by the wording “parents/adoptive parents”. This change was implemented by the local team in the Russian translation of the protocol and informed consent form after obtaining approval from competent authorities and ethics committees in order to meet Russian legislation requirements. The purpose of this amendment is to replace “parents/LAR(s)” by “parents/adoptive parents” in order to ensure consistency in wording between local protocol and central protocol; in addition, the list of study personnel and the function names have been updated.

    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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