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    Clinical Trial Results:
    A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of Infanrix hexa? administered as primary vaccination in healthy infants born to mothers given Boostrix? during pregnancy or post-delivery in 116945 [DTPA (BOOSTRIX)-047].

    Summary
    EudraCT number
    		 2014-001117-41
    Trial protocol
    		 ES   CZ   Outside EU/EEA   FI   IT  
    Global end of trial date
    07 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2019
    First version publication date
    06 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    201330
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02422264
    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 Response Center, GlaxoSmithKline, 044 8664357343, 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
    26 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunological response to Infanrix hexa in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and Hib antigens, and in terms of vaccine response for the pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Canada: 144
    Country: Number of subjects enrolled
    Czech Republic: 71
    Country: Number of subjects enrolled
    Finland: 52
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Spain: 282
    Worldwide total number of subjects
    601
    EEA total number of subjects
    419
    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)
    601
    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
    		 Out of 601 subjects enrolled in the study, only 592 were vaccinated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 dTpa Group
    Arm description
    		 Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects received Infanrix hexa co-administered with Prevnar 13 at 2, 4 and 6 months or 2, 3 and 4 months, depending on the immunization schedule of the country. In some countries/regions, Prevnar 13 was given as a 2-dose schedule at 2 and 4 months of age.

    Arm title
    		 Control Group
    Arm description
    		 Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects received Infanrix hexa co-administered with Prevnar 13 at 2, 4 and 6 months or 2, 3 and 4 months, depending on the immunization schedule of the country. In some countries/regions, Prevnar 13 was given as a 2-dose schedule at 2 and 4 months of age.

    Number of subjects in period 1
    		dTpa Group Control Group
    Started
    296
    305
    Completed
    291
    301
    Not completed
    5
    4
         Consent withdrawn by subject
    1
    2
         Migrated/moved from study area
    3
    1
         Subject vaccinated outside of the study
    -
    1
         Serious Adverse Event
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    dTpa Group
    Reporting group description
    		 Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Reporting group title
    Control Group
    Reporting group description
    		 Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Reporting group values
    		 dTpa Group Control Group Total
    Number of subjects
    		 296 305 601
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 296 305 601
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Age at Dose 1
    Units: Weeks
        arithmetic mean (standard deviation)
    		 8.7 ± 1.6 8.9 ± 1.8 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 141 144 285
        Male
    		 155 161 316
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 4 9 13
        Asian - East Asian Heritage
    		 2 0 2
        Asian - South East Asian Heritage
    		 3 0 3
        White - Arabic / North African Heritage
    		 1 3 4
        White - Caucasian / European Heritage
    		 268 285 553
        Mixed origin
    		 18 8 26

    End points

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    End points reporting groups
    Reporting group title
    dTpa Group
    Reporting group description
    		 Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Reporting group title
    Control Group
    Reporting group description
    		 Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Primary: Number of subjects with vaccine response against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) antigens

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    End point title
    		 Number of subjects with vaccine response against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) antigens [1]
    End point description
    Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
    End point type
    Primary
    End point timeframe
    1 month after the last dose of the 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    240
    251
    Units: Participants
        anti-PT antibody
    185
    249
        anti-FHA antibody
    95
    238
        anti-PRN antibody
    90
    225
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentration above or equal to the assay cut-off

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    End point title
    		 Number of seroprotected subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentration above or equal to the assay cut-off [2]
    End point description
    A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    1 month after the last dose of the 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: Participants
        anti-D antibody
    264
    271
        anti-T antibody
    266
    271
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects with anti Hepatitis B (anti-HBs) antibody concentration above or equal to the assay cut-off

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    End point title
    		 Number of seroprotected subjects with anti Hepatitis B (anti-HBs) antibody concentration above or equal to the assay cut-off [3]
    End point description
    A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    1 month after the last dose of the 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    253
    263
    Units: Participants
    251
    259
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects with anti-poliovirus type 1, 2 and 3 antibody concentration above or equal to 8

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    End point title
    		 Number of seroprotected subjects with anti-poliovirus type 1, 2 and 3 antibody concentration above or equal to 8 [4]
    End point description
    A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.
    End point type
    Primary
    End point timeframe
    1 month after the last dose of the 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    241
    245
    Units: Participants
        anti-Polio 1 antibody
    233
    242
        anti-Polio 2 antibody
    239
    235
        anti-Polio 3 antibody
    228
    236
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration above or equal to the assay cut-off

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    End point title
    		 Number of seroprotected subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration above or equal to the assay cut-off [5]
    End point description
    A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
    End point type
    Primary
    End point timeframe
    1 month after the last dose of the primary vaccination
    Notes
    [5] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: Participants
    255
    256
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations.

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    End point title
    		 Anti-D and anti-T antibody concentrations.
    End point description
    Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before the first dose of Infanrix hexa
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    242
    253
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-D antibody, before dose 1
    0.423 (0.354 to 0.506)
    0.089 (0.076 to 0.103)
        anti-T antibody, before dose 1
    2.152 (1.925 to 2.406)
    0.378 (0.330 to 0.434)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations.

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations.
    End point description
    Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before the first dose of Infanrix hexa
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    242
    253
    Units: IU/ml
    geometric mean (confidence interval 95%)
        anti-PT antibody
    11.9 (10.3 to 13.6)
    2.2 (2.0 to 2.5)
        anti-FHA antibody
    88.3 (77.7 to 100.4)
    6.6 (5.7 to 7.7)
        anti-PRN antibody
    70.5 (56.1 to 88.5)
    4.5 (3.7 to 5.4)
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations

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    End point title
    		 Anti-D and anti-T antibody concentrations
    End point description
    Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: IU/ml
    geometric mean (confidence interval 95%)
        anti-Diphtheria antibody
    1.747 (1.598 to 1.910)
    2.746 (2.502 to 3.015)
        anti-Tetanus antibody
    2.347 (2.135 to 2.582)
    2.278 (2.069 to 2.508)
    No statistical analyses for this end point

    Secondary: Anti-Polio type 1, 2 and 3 antibody titers

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    End point title
    		 Anti-Polio type 1, 2 and 3 antibody titers
    End point description
    Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    241
    245
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-Polio 1 antibody
    432.1 (351.8 to 530.9)
    489.9 (402.6 to 596.0)
        anti-Polio 2 antibody
    424.6 (342.7 to 526.2)
    388.4 (306.3 to 492.6)
        anti-Polio 3 antibody
    730.6 (596.5 to 894.9)
    775.6 (645.9 to 931.3)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: µg/mL
        geometric mean (confidence interval 95%)
    1.862 (1.554 to 2.231)
    1.717 (1.428 to 2.064)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA, anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA, anti-PRN antibody concentrations
    End point description
    Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-PT antibody
    32.7 (30.2 to 35.3)
    54.7 (51.0 to 58.6)
        anti-FHA antibody
    68.5 (63.5 to 73.9)
    103.5 (95.6 to 112.1)
        anti-PRN antibody
    60.5 (54.2 to 67.6)
    92.0 (81.6 to 103.6)
    No statistical analyses for this end point

    Secondary: Anti-pneumococcal antibody concentrations

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    End point title
    		 Anti-pneumococcal antibody concentrations
    End point description
    Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    232
    237
    Units: µg/mL
    geometric mean (confidence interval 95%)
        anti-PnPS 1 antibody
    1.61 (1.43 to 1.80)
    1.92 (1.73 to 2.14)
        anti-PnPS 3 antibody
    0.54 (0.49 to 0.60)
    0.60 (0.55 to 0.67)
        anti-PnPS 4 antibody
    1.20 (1.07 to 1.35)
    1.56 (1.40 to 1.75)
        anti-PnPS 5 antibody
    1.09 (0.96 to 1.24)
    1.27 (1.13 to 1.43)
        anti-PnPS 6A antibody
    2.16 (1.89 to 2.47)
    2.59 (2.27 to 2.95)
        anti-PnPS 6B antibody
    1.37 (1.12 to 1.68)
    1.44 (1.20 to 1.73)
        anti-PnPS 7F antibody
    2.39 (2.15 to 2.65)
    2.67 (2.43 to 2.93)
        anti-PnPS 9V antibody
    1.33 (1.19 to 1.50)
    1.64 (1.47 to 1.83)
        anti-PnPS 14 antibody
    5.70 (4.99 to 6.52)
    6.57 (5.71 to 7.56)
        anti-PnPS 18C antibody
    1.61 (1.42 to 1.82)
    1.79 (1.59 to 2.01)
        anti-PnPS 19A antibody
    1.61 (1.43 to 1.82)
    2.01 (1.78 to 2.27)
        anti-PnPS 19F antibody
    2.57 (2.35 to 2.82)
    3.24 (2.92 to 3.60)
        anti-PnPS 23F antibody
    0.86 (0.74 to 0.99)
    1.02 (0.88 to 1.17)
    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
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after each vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    294
    303
    Units: Participants
        Any Pain, Dose 1
    120
    120
        Any Redness, Dose 1
    128
    116
        Any Swelling, Dose 1
    81
    87
        Any Pain, Dose 2
    109
    101
        Any Redness, Dose 2
    139
    139
        Any Swelling, Dose 2
    98
    95
        Any Pain, Dose 3
    85
    94
        Any Redness, Dose 3
    122
    134
        Any Swelling, Dose 3
    77
    109
        Any Pain, Across Doses
    175
    184
        Any Redness, Across Doses
    205
    203
        Any Swelling, Across Doses
    157
    168
    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
    Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after each vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    294
    303
    Units: Participants
        Any Drowsiness, Dose 1
    166
    174
        Any Irritability / Fussiness, Dose 1
    187
    191
        Any Loss of Appetite, Dose 1
    85
    94
        Any Temperature/(Axillary) (≥37.5°C), Dose 1
    64
    69
        Any Drowsiness, Dose 2
    142
    149
        Any Irritability / Fussiness, Dose 2
    182
    194
        Any Loss of Appetite, Dose 2
    69
    94
        Any Temperature/(Axillary) (≥37.5°C), Dose 2
    62
    76
        Any Drowsiness, Dose 3
    99
    104
        Any Irritability / Fussiness, Dose 3
    142
    161
        Any Loss of Appetite, Dose 3
    64
    63
        Any Temperature/(Axillary) (≥37.5°C), Dose 3
    52
    47
        Any Drowsiness, Across Doses
    216
    232
        Any Irritability/Fussiness, Across Doses
    255
    257
        Any Loss of appetite, Across Doses
    142
    157
        Any Temperature/(Axillary) (≥37.5°C), Across Doses
    125
    126
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events

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    End point title
    		 Number of subjects with unsolicited adverse events
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (days 0-30) follow-up period after each vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    296
    305
    Units: Participants
    161
    173
    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 included 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 Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    296
    305
    Units: Participants
    7
    17
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against diphtheria (anti-D) and tetanus (anti-T) antibody concentration above or equal to the assay cut-off.

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    End point title
    		 Number of seroprotected subjects against diphtheria (anti-D) and tetanus (anti-T) antibody concentration above or equal to the assay cut-off.
    End point description
    A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before the first dose of Infanrix hexa
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    242
    253
    Units: Participants
        anti-D antibody
    200
    110
        anti-T antibody
    240
    225
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentration above or equal to the assay cut-off.

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentration above or equal to the assay cut-off.
    End point description
    A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
    End point type
    Secondary
    End point timeframe
    Before the first dose of Infanrix hexa
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    242
    253
    Units: Participants
        anti-PT antibody
    218
    88
        anti-FHA antibody
    242
    210
        anti-PRN antibody
    231
    151
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    253
    263
    Units: mIU/ml
        geometric mean (confidence interval 95%)
    1322.8 (1116.7 to 1567.0)
    1339.2 (1132.8 to 1583.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA, anti-PRN antibody concentration above or equal to the assay cut-off.

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    End point title
    		 Number of subjects with anti-PT, anti-FHA, anti-PRN antibody concentration above or equal to the assay cut-off.
    End point description
    A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
    End point type
    Secondary
    End point timeframe
    1 month after the last dose of the primary vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    266
    271
    Units: Participants
        anti-PT antibody
    266
    271
        anti-FHA antibody
    266
    271
        anti-PRN antibody
    266
    269
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms were collected during the 4-day (Day 0-Day 3) and unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 until the study end (Month 3 or 5).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Infants born to mothers belonging to the Control group in study NCT02377349 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Reporting group title
    dTpa Group
    Reporting group description
    		 Infants born to mothers belonging to the Boostrix Group in study NCT02377349 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.

    Serious adverse events
    		 Control Group dTpa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 305 (5.57%)
    7 / 296 (2.36%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cytomegalovirus infection
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniosynostosis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dandy-walker syndrome
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear malformation
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcephaly
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    4 / 305 (1.31%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Group dTpa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    294 / 305 (96.39%)
    292 / 296 (98.65%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Infantile haemangioma
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Vascular disorders
    Pallor
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 305 (0.00%)
    3 / 296 (1.01%)
         occurrences all number
    0
    3
    Injection site bruising
         subjects affected / exposed
    2 / 305 (0.66%)
    2 / 296 (0.68%)
         occurrences all number
    2
    2
    Injection site mass
         subjects affected / exposed
    1 / 305 (0.33%)
    3 / 296 (1.01%)
         occurrences all number
    2
    4
    Injection site induration
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Injection site swelling
         subjects affected / exposed
    169 / 305 (55.41%)
    157 / 296 (53.04%)
         occurrences all number
    292
    256
    Injection site nodule
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    139 / 305 (45.57%)
    133 / 296 (44.93%)
         occurrences all number
    208
    203
    Thirst
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Vaccination site erythema
         subjects affected / exposed
    2 / 305 (0.66%)
    0 / 296 (0.00%)
         occurrences all number
    2
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Vaccination site swelling
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Vessel puncture site bruise
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Injection site erythema
         subjects affected / exposed
    203 / 305 (66.56%)
    205 / 296 (69.26%)
         occurrences all number
    389
    389
    Injection site pain
         subjects affected / exposed
    184 / 305 (60.33%)
    175 / 296 (59.12%)
         occurrences all number
    315
    314
    Irritability postvaccinal
         subjects affected / exposed
    257 / 305 (84.26%)
    255 / 296 (86.15%)
         occurrences all number
    546
    511
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    2 / 305 (0.66%)
    1 / 296 (0.34%)
         occurrences all number
    2
    1
    Reproductive system and breast disorders
    Genital labial adhesions
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 305 (4.26%)
    6 / 296 (2.03%)
         occurrences all number
    14
    6
    Choking
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    6 / 305 (1.97%)
    0 / 296 (0.00%)
         occurrences all number
    6
    0
    Rhinorrhoea
         subjects affected / exposed
    5 / 305 (1.64%)
    3 / 296 (1.01%)
         occurrences all number
    5
    3
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Irritability
         subjects affected / exposed
    3 / 305 (0.98%)
    2 / 296 (0.68%)
         occurrences all number
    3
    2
    Investigations
    Body temperature increased
         subjects affected / exposed
    2 / 305 (0.66%)
    2 / 296 (0.68%)
         occurrences all number
    2
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Bite
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Injury
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Road traffic accident
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    0 / 305 (0.00%)
    2 / 296 (0.68%)
         occurrences all number
    0
    2
    Congenital, familial and genetic disorders
    Congenital torticollis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Phimosis
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    External hydrocephalus
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    232 / 305 (76.07%)
    216 / 296 (72.97%)
         occurrences all number
    427
    407
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    2 / 305 (0.66%)
    1 / 296 (0.34%)
         occurrences all number
    2
    1
    Eye discharge
         subjects affected / exposed
    2 / 305 (0.66%)
    0 / 296 (0.00%)
         occurrences all number
    2
    0
    Eye irritation
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Eye swelling
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Pupils unequal
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Abnormal faeces
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Change of bowel habit
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    9 / 305 (2.95%)
    8 / 296 (2.70%)
         occurrences all number
    10
    9
    Diarrhoea
         subjects affected / exposed
    2 / 305 (0.66%)
    8 / 296 (2.70%)
         occurrences all number
    2
    8
    Flatulence
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Enteritis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Gastric disorder
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 305 (1.97%)
    8 / 296 (2.70%)
         occurrences all number
    6
    8
    Gingival pain
         subjects affected / exposed
    1 / 305 (0.33%)
    4 / 296 (1.35%)
         occurrences all number
    1
    5
    Haematochezia
         subjects affected / exposed
    3 / 305 (0.98%)
    0 / 296 (0.00%)
         occurrences all number
    3
    0
    Infantile colic
         subjects affected / exposed
    2 / 305 (0.66%)
    2 / 296 (0.68%)
         occurrences all number
    2
    2
    Infrequent bowel movements
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Mucous stools
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Oral mucosal erythema
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Regurgitation
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Sandifer’s syndrome
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Teething
         subjects affected / exposed
    14 / 305 (4.59%)
    14 / 296 (4.73%)
         occurrences all number
    16
    21
    Toothache
         subjects affected / exposed
    1 / 305 (0.33%)
    2 / 296 (0.68%)
         occurrences all number
    1
    2
    Umbilical hernia
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 305 (1.31%)
    6 / 296 (2.03%)
         occurrences all number
    4
    6
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    8 / 305 (2.62%)
    1 / 296 (0.34%)
         occurrences all number
    8
    1
    Dermatitis atopic
         subjects affected / exposed
    6 / 305 (1.97%)
    4 / 296 (1.35%)
         occurrences all number
    7
    4
    Dermatitis diaper
         subjects affected / exposed
    4 / 305 (1.31%)
    3 / 296 (1.01%)
         occurrences all number
    4
    3
    Dry skin
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    5 / 305 (1.64%)
    5 / 296 (1.69%)
         occurrences all number
    5
    5
    Erythema
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    9 / 305 (2.95%)
    4 / 296 (1.35%)
         occurrences all number
    9
    4
    Rash erythematous
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Rash macular
         subjects affected / exposed
    2 / 305 (0.66%)
    0 / 296 (0.00%)
         occurrences all number
    2
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 305 (0.66%)
    2 / 296 (0.68%)
         occurrences all number
    2
    2
    Urticaria
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Head deformity
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Positional plagiocephaly
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Posture abnormal
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Torticollis
         subjects affected / exposed
    0 / 305 (0.00%)
    2 / 296 (0.68%)
         occurrences all number
    0
    2
    Epiphysiolysis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Adenoiditis
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Bronchiolitis
         subjects affected / exposed
    11 / 305 (3.61%)
    5 / 296 (1.69%)
         occurrences all number
    12
    5
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    5 / 305 (1.64%)
    4 / 296 (1.35%)
         occurrences all number
    6
    4
    Candida nappy rash
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 305 (0.00%)
    2 / 296 (0.68%)
         occurrences all number
    0
    2
    Conjunctivitis
         subjects affected / exposed
    13 / 305 (4.26%)
    6 / 296 (2.03%)
         occurrences all number
    14
    6
    Croup infectious
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    10 / 305 (3.28%)
    6 / 296 (2.03%)
         occurrences all number
    12
    6
    Enterovirus infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Erythema infectiosum
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Exanthema subitum
         subjects affected / exposed
    3 / 305 (0.98%)
    1 / 296 (0.34%)
         occurrences all number
    3
    1
    Eye infection
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    2
    Fungal skin infection
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    8 / 305 (2.62%)
    5 / 296 (1.69%)
         occurrences all number
    8
    5
    Gastroenteritis viral
         subjects affected / exposed
    1 / 305 (0.33%)
    3 / 296 (1.01%)
         occurrences all number
    1
    3
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 305 (0.66%)
    0 / 296 (0.00%)
         occurrences all number
    2
    0
    Impetigo
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    3 / 305 (0.98%)
    3 / 296 (1.01%)
         occurrences all number
    3
    3
    Nail infection
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    15 / 305 (4.92%)
    20 / 296 (6.76%)
         occurrences all number
    17
    21
    Oral candidiasis
         subjects affected / exposed
    2 / 305 (0.66%)
    4 / 296 (1.35%)
         occurrences all number
    2
    4
    Oral fungal infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    3 / 305 (0.98%)
    0 / 296 (0.00%)
         occurrences all number
    3
    0
    Pharyngitis
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Otitis media acute
         subjects affected / exposed
    2 / 305 (0.66%)
    3 / 296 (1.01%)
         occurrences all number
    3
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    9 / 305 (2.95%)
    4 / 296 (1.35%)
         occurrences all number
    12
    5
    Respiratory tract infection viral
         subjects affected / exposed
    8 / 305 (2.62%)
    4 / 296 (1.35%)
         occurrences all number
    8
    4
    Rhinitis
         subjects affected / exposed
    8 / 305 (2.62%)
    2 / 296 (0.68%)
         occurrences all number
    8
    2
    Tonsillitis
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 296 (0.34%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 305 (10.49%)
    36 / 296 (12.16%)
         occurrences all number
    38
    41
    Urinary tract infection
         subjects affected / exposed
    2 / 305 (0.66%)
    3 / 296 (1.01%)
         occurrences all number
    2
    3
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 296 (0.34%)
         occurrences all number
    1
    1
    Viral rash
         subjects affected / exposed
    2 / 305 (0.66%)
    0 / 296 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 296 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    157 / 305 (51.48%)
    142 / 296 (47.97%)
         occurrences all number
    252
    219

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2016
    Given the fact that only infants born from mothers vaccinated in the previous study (116945 [DTPA (BOOSTRIX)-047) can be enrolled in the current study, the enrolment in DTPA (BOOSTRIX)-047 study has an impact on this current study (e.g. cohorts to be investigated). Initially, the DTPA (BOOSTRIX)-047 study was opened only in countries using 3-dose primary vaccination series against diphtheria, tetanus and pertussis in infants. Nevertheless, the 2-dose primary vaccination schedule in infants is also meaningful for different regions in the world (e.g. Europe). It was therefore decided to open the DTPA (BOOSTRIX)-047, and therefore the current study to countries using 2-dose primary vaccination series in infants with the aim to increase the scientific value of the study and generate clinical data in diverse infant vaccination schedules. The notion of end of study was added and Section 11.5 describing the posting of information on public registry was revised accordingly. The names and functions of the contributing authors have been updated. The name of GSK Biologicals’ Global Vaccines Clinical Laboratories (GVCL) department has been updated to Clinical Laboratory Sciences (CLS) and the name of outsourced laboratory (Quest Diagnostic laboratory is now called Q² Solutions) has also been updated. In addition, minor updates including typos, abbreviations, clarifications of wording were done throughout the document.

    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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