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    Clinical Trial Results:
    A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

    Summary
    EudraCT number
    		 2014-001120-30
    Trial protocol
    		 ES   CZ   Outside EU/EEA   FI   IT  
    Global end of trial date
    19 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jan 2020
    First version publication date
    12 Jan 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    201334
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02853929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GSKClinicalSupportHD@gsk.com, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2019
    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 booster response* for the pertussis antigens, 1 month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 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
    Australia: 24
    Country: Number of subjects enrolled
    Canada: 141
    Country: Number of subjects enrolled
    Czech Republic: 67
    Country: Number of subjects enrolled
    Finland: 49
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Spain: 262
    Worldwide total number of subjects
    551
    EEA total number of subjects
    386
    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)
    551
    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
    		 Subjects enrolled in the study were infants aged 9 months at the time of enrollment, born to mothers vaccinated with Boostrix in study 116945 BOOSTRIX-047 [NCT02377349] and who received primary vaccination Infanrix hexa co-administered with Prevenar 13 in study 201330 BOOSTRIX-048 [NCT0242264]

    Pre-assignment
    Screening details
    		 551 subjects were enrolled in this trial, out of which 540 received the booster dose of Infanrix hexa co-administered with Prevenar 13. 11 subjects did not receive booster vaccination even though subject number had been allocated.

    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
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects in this group received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization schedule.

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects in this group received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization schedule.

    Arm title
    		 Control Group
    Arm description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
    Arm type
    		 Placebo

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects in this group received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization schedule.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects in this group received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization schedule.

    Number of subjects in period 1
    		dTpa Group Control Group
    Started
    270
    281
    Vaccinated
    263
    277
    Completed
    259
    277
    Not completed
    11
    4
         Consent withdrawn by subject
    1
    -
         Subjects enrolled but not vaccinated
    7
    4
         Lost to follow-up
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    dTpa Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Reporting group title
    Control Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Reporting group values
    		 dTpa Group Control Group Total
    Number of subjects
    		 270 281 551
    Age Categorical
    Units: Participants
        Infants and toddlers (28 days-23 months)
    		 270 281 551
    Sex: Female, Male
    Units: Participants
        Female
    		 127 128 255
        Male
    		 143 153 296
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 4 9 13
        Asian - East Asian Heritage
    		 1 0 1
        Asian - South East Asian Heritage
    		 2 0 2
        White - Arabic / North African Heritage
    		 1 3 4
        White - Caucasian / European Heritage
    		 246 262 508
        Other
    		 16 7 23

    End points

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    End points reporting groups
    Reporting group title
    dTpa Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Reporting group title
    Control Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Primary: Number of seroprotected subjects against anti-diphtheria (Anti-D), anti-tetanus (Anti-T), anti-hepatitis B (Anti-HBs), anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol phosphate (anti-PRP)

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria (Anti-D), anti-tetanus (Anti-T), anti-hepatitis B (Anti-HBs), anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol phosphate (anti-PRP) [1]
    End point description
    Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB’s, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination
    End point type
    Primary
    End point timeframe
    At one month after the booster dose (Day 30)
    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: Statistical analysis is not applicable for this endpoint, as this is not a confirmatory analysis.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    221
    247
    Units: Participants
        Anti-D (N-221, 247)
    221
    247
        Anti-T (N-221, 247)
    221
    247
        Anti-HBs (N-216, 241)
    215
    239
        Anti-polio 1 (N-204, 228)
    204
    228
        Anti-polio 2 (N-201, 227)
    201
    227
        Anti-polio 3 (N-188, 210)
    188
    210
        Anti-PRP (N-221, 247)
    221
    246
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with a booster response to Pertussis antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) [2]
    End point description
    Booster response to PT, FHA and PRN antigens was defined as: - for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥4 times the assay cut-off, - for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥4 times the pre-vaccination antibody concentration, and - for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN.Analysis was performed on the According to Protocol cohort for immunogenicity
    End point type
    Primary
    End point timeframe
    At one month after the booster dose (Day 30)
    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: Statistical analysis is not applicable for this endpoint, as this is not a confirmatory analysis.
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    215
    241
    Units: Participants
        Anti-PT, S- (N-67, 42)
    62
    40
        Anti-PT, S+ (< 4*assay cut-off) (N-108,126)
    98
    124
        Anti-PT, S+ (≥ 4*assay cut-off) (N-40, 73)
    38
    71
        Anti-PT, Overall (N-215, 241)
    198
    235
        Anti-FHA, S- (N-8, 3)
    8
    3
        Anti-FHA, S+ (< 4*assay cut-off) (N-84, 58)
    83
    58
        Anti-FHA, S+ (≥ 4*assay cut-off) (N-123,180)
    117
    172
        Anti-FHA, Overall (N-215, 241)
    208
    233
        Anti-PRN, S- (N-35, 31)
    34
    31
        Anti-PRN, S+ (< 4*assay cut-off) (N-90, 77)
    90
    76
        Anti-PRN, S+ (≥ 4*assay cut-off) (N-89,133)
    86
    133
        Anti-PRN, Overall (N-214, 241)
    210
    240
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-PRP.

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-PRP.
    End point description
    Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB’s, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    223
    244
    Units: Participants
        Anti-D (N-223, 244)
    181
    220
        Anti-T (N-223, 244)
    215
    232
        Anti-HBs (N-219, 243)
    206
    229
        Anti-polio 1 (N- 213, 247)
    188
    212
        Anti-polio 2 (N-210, 236)
    188
    215
        Anti-polio 3 (N-205, 226)
    188
    215
        Anti-PRP (N-222, 244)
    161
    166
    No statistical analyses for this end point

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

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    End point title
    		 Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN
    End point description
    Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    223
    244
    Units: Participants
        Anti-PT (N-223, 244)
    153
    201
        Anti-FHA (N-223, 244)
    215
    241
        Anti-PRN (N-223, 244)
    187
    213
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)

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    End point title
    		 Number of seropositive subjects for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
    End point description
    Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    211
    232
    Units: Participants
        Anti-pneumococcal serotype 1 (N-211, 232)
    196
    214
        Anti-pneumococcal serotype 3 (N-211, 232)
    122
    147
        Anti-pneumococcal serotype 4 (N-209, 232)
    189
    215
        Anti-pneumococcal serotype 5 (N-211, 229)
    163
    182
        Anti-pneumococcal serotype 6A (N-211, 232)
    196
    219
        Anti-pneumococcal serotype 6B (N-211, 232)
    175
    205
        Anti-pneumococcal serotype 7F (N-211, 232)
    210
    232
        Anti-pneumococcal serotype 9V (N-211, 232)
    203
    225
        Anti-pneumococcal serotype 14 (N-211, 232)
    201
    223
        Anti-pneumococcal serotype 18C (N-211, 232)
    168
    190
        Anti-pneumococcal serotype 19A (N-211, 232)
    148
    172
        Anti-pneumococcal serotype 19F (N-211, 232)
    183
    202
        Anti-pneumococcal serotype 23F (N-210, 229)
    160
    191
    No statistical analyses for this end point

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

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    End point title
    		 Anti-D, anti-T, anti-PT, anti-FHA, anti-PRN antibody concentrations
    End point description
    Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0) and One month after the booster dose (Day 30)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    223
    247
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Anti-D at Day 0 (N-223, 244)
    0.207 (0.184 to 0.234)
    0.322 (0.285 to 0.363)
        Anti-D at Day 30 (N-221, 247)
    6.114 (5.577 to 6.703)
    8.402 (7.694 to 9.174)
        Anti-T at Day 0 (N-223, 244)
    0.753 (0.646 to 0.878)
    0.578 (0.506 to 0.659)
        Anti-T at Day 30 (N-221, 247)
    8.200 (7.324 to 9.180)
    6.758 (6.143 to 7.433)
        Anti-PT at Day 0 (N-223, 244)
    4.4 (3.8 to 5.0)
    6.3 (5.5 to 7.1)
        Anti-PT at Day 30 (N-221, 247)
    52.4 (46.9 to 58.4)
    80.3 (73.3 to 88.1)
        Anti-FHA at Day 0 (N-223, 244)
    11.2 (9.6 to 13.1)
    16.5 (14.4 to 18.8)
        Anti-FHA at Day 30 (N-221, 247)
    152.5 (136.3 to 170.6)
    187.2 (172.7 to 202.9)
        Anti-PRN at Day 0 (N-223, 244)
    6.9 (5.8 to 8.2)
    9.6 (8.3 to 11.2)
        Anti-PRN at Day 30 (N-220, 247)
    333.9 (285.4 to 390.7)
    262.3 (230.9 to 298.1)
    No statistical analyses for this end point

    Secondary: Anti-poliovirus type 1, 2, 3 antibody titres

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    End point title
    		 Anti-poliovirus type 1, 2, 3 antibody titres
    End point description
    Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT). Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0) and One month after the booster dose (Day 30)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    213
    237
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 at Day 0 (N-213, 237)
    64.9 (52.0 to 80.9)
    83.3 (67.7 to 102.5)
        Anti-polio 1 at Day 30 (N-204, 228)
    1611.7 (1381.2 to 1880.6)
    1532.1 (1322.2 to 1775.3)
        Anti-polio 2 at Day 0 (N-210, 236)
    71.7 (57.6 to 89.4)
    79.2 (64.4 to 97.5)
        Anti-polio 2 at Day 30 (N-201, 227)
    2232.4 (1931.2 to 2580.5)
    2371.2 (2097.9 to 2680.1)
        Anti-polio 3 at Day 0 (N-205, 226)
    106.0 (84.1 to 133.4)
    118.4 (97.0 to 144.5)
        Anti-polio 3 at Day 30 (N-188, 210)
    2944.6 (2529.4 to 3427.9)
    2891.8 (2496.2 to 3350.2)
    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
    Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0) and One month after the booster dose (Day 30)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    219
    243
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs at Day 0 (N-219, 243)
    158.7 (129.9 to 194.0)
    193.4 (158.4 to 236.1)
        Anti-HBs at Day 30 (N-216, 241)
    4858.3 (3918.4 to 6023.7)
    5031.2 (4072.7 to 6215.4)
    No statistical analyses for this end point

    Secondary: Anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and anti-PRP antibody concentrations

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    End point title
    		 Anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and anti-PRP antibody concentrations
    End point description
    Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
    End point type
    Secondary
    End point timeframe
    Before the booster dose (Day 0) and One month after the booster dose (Day 30)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    222
    247
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PnPS 1 at Day 0 (N-211, 232)
    0.22 (0.19 to 0.24)
    0.27 (0.24 to 0.30)
        Anti-PnPS 1 at Day 30 (N-208, 236)
    3.22 (2.88 to 3.60)
    3.64 (3.28 to 4.04)
        Anti-PnPS 3 at Day 0 (N-211, 232)
    0.08 (0.07 to 0.09)
    0.10 (0.09 to 0.11)
        Anti-PnPS 3 at Day 30 (N-208, 235)
    0.59 (0.53 to 0.65)
    0.62 (0.57 to 0.69)
        Anti-PnPS 4 at Day 0 (N-209, 232)
    0.15 (0.13 to 0.16)
    0.19 (0.17 to 0.22)
        Anti-PnPS 4 at Day 30 (N-208, 234)
    2.91 (2.54 to 3.33)
    3.28 (2.89 to 3.72)
        Anti-PnPS 5 at Day 0 (N-211, 229)
    0.33 (0.29 to 0.37)
    0.34 (0.31 to 0.38)
        Anti-PnPS 5 at Day 30 (N-204, 229)
    2.66 (2.39 to 2.97)
    2.81 (2.52 to 3.14)
        Anti-PnPS 6A at Day 0 (N-211, 232)
    0.38 (0.33 to 0.43)
    0.44 (0.39 to 0.50)
        Anti-PnPS 6A at Day 30 (N-208, 236)
    9.07 (8.05 to 10.22)
    9.49 (8.45 to 10.67)
        Anti-PnPS 6B at Day 0 (N-211, 232)
    0.29 (0.25 to 0.33)
    0.33 (0.29 to 0.38)
        Anti-PnPS 6B at Day 30 (N-208, 236)
    7.83 (6.82 to 8.98)
    8.00 (7.06 to 9.06)
        Anti-PnPS 7F at Day 0 (N-211, 232)
    0.49 (0.44 to 0.54)
    0.56 (0.51 to 0.61)
        Anti-PnPS 7F at Day 30 (N-208, 235)
    5.00 (4.55 to 5.50)
    4.96 (4.50 to 5.48)
        Anti-PnPS 9V at Day 0 (N-211, 232)
    0.26 (0.23 to 0.29)
    0.32 (0.28 to 0.36)
        Anti-PnPS 9V at Day 30 (N-208, 235)
    3.74 (3.35 to 4.16)
    3.91 (3.52 to 4.35)
        Anti-PnPS 14 at Day 0 (N-211, 232)
    0.97 (0.85 to 1.11)
    1.19 (1.04 to 1.37)
        Anti-PnPS 14 at Day 30 (N-208, 236)
    10.36 (9.22 to 11.64)
    11.62 (10.34 to 13.06)
        Anti-PnPS 18C at Day 0 (N-211, 232)
    0.19 (0.17 to 0.21)
    0.23 (0.21 to 0.26)
        Anti-PnPS 18C at Day 30 (N-208, 236)
    3.23 (2.86 to 3.65)
    3.57 (3.21 to 3.98)
        Anti-PnPS 19A at Day 0 (N-211, 232)
    0.32 (0.27 to 0.37)
    0.37 (0.32 to 0.43)
        Anti-PnPS 19A at Day 30 (N-208, 236)
    7.90 (7.06 to 8.83)
    8.68 (7.82 to 9.63)
        Anti-PnPS 19F at Day 0 (N-211, 232)
    0.37 (0.32 to 0.43)
    0.47 (0.41 to 0.55)
        Anti-PnPS 19F at Day 30 (N-208, 236)
    7.66 (6.84 to 8.57)
    8.63 (7.75 to 9.62)
        Anti-PnPS 23F at Day 0 (N-210, 229)
    0.14 (0.12 to 0.16)
    0.19 (0.16 to 0.22)
        Anti-PnPS 23F at Day 30 (N-207, 235)
    2.07 (1.83 to 2.34)
    2.38 (2.10 to 2.69)
        Anti-PRP at Day 0 (N-222, 244)
    0.371 (0.303 to 0.453)
    0.292 (0.244 to 0.349)
        Anti-PRP at Day 30 (N-221, 247)
    26.186 (22.610 to 30.327)
    19.714 (16.891 to 23.010)
    No statistical analyses for this end point

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

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    End point title
    		 Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
    End point description
    Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN. Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination.
    End point type
    Secondary
    End point timeframe
    At one month after the booster dose (Day 30)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    221
    247
    Units: Participants
        Anti-PT (N-221, 247)
    220
    247
        Anti-FHA (N-221, 247)
    221
    247
        Anti-PRN (N-220, 247)
    220
    247
    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, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter. The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    257
    275
    Units: Participants
        Pain (N-257, 275)
    134
    154
        Redness (N-257, 275)
    143
    169
        Swelling (N-257, 275)
    119
    122
    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, Fever, Irritability/Fussiness and Loss of appetite. Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route. The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    258
    275
    Units: Participants
        Drowsiness (N-258, 275)
    128
    138
        Irritability (N-258, 275)
    163
    188
        Loss of Appetite (N-258, 275)
    104
    116
        Fever (N-258, 275)
    73
    85
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    263
    277
    Units: Participants
        Any AEs (N-263, 277)
    94
    111
    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
    SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity. The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available
    End point type
    Secondary
    End point timeframe
    From booster dose up to study end (approximately 6 or 7 months, per subject)
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    263
    277
    Units: Participants
        Any SAEs (N-263, 277)
    0
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with an ASQ-3 score (Ages & Stages Questionnaires, third edition) in the black zone

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    End point title
    		 Number of subjects with an ASQ-3 score (Ages & Stages Questionnaires, third edition) in the black zone
    End point description
    Neurodevelopmental status was measured by ASQ-3 score scale [ASQ-3, 2016] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III [BSID-III]). The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.
    End point type
    Secondary
    End point timeframe
    At 9 months of age, 18 months of age, and 9 or 18 months of age
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    269
    281
    Units: Participants
        Any domain at Month 9 (N-269, 281)
    27
    28
        Communication at Month 9 (N-269, 281)
    1
    3
        Gross motor skills at Month 9 (N-269, 281)
    14
    19
        Fine motor at Month 9 (N-269, 281)
    8
    3
        Problem solving at Month 9 (N-269, 281)
    7
    6
        Personal- Social at Month 9 (N-269, 281)
    2
    2
        Any domain at Month 18 (N-257, 274)
    6
    5
        Communication at Month 18 (N-257, 274)
    1
    0
        Gross motor skills at Month 18 (N-257, 274)
    3
    2
        Fine motor at Month 18 (N-257, 274)
    1
    1
        Problem solving at Month 18 (N-257, 274)
    1
    3
        Personal- Social at Month 18 (N-257, 274)
    0
    0
        Any domain at Month 9 or 18 (N-269, 281)
    31
    31
        Communication at Month 9 or 18 (N-269, 281)
    2
    3
        Gross motor skills at Month 9 or 18 (N-269, 281)
    16
    20
        Fine motor at Month 9 or 18 (N-269, 281)
    9
    4
        Problem solving at Month 9 or 18 (N-269, 281)
    8
    8
        Personal- Social at Month 9 or 18 (N-269, 281)
    2
    2
    No statistical analyses for this end point

    Secondary: Number of subjects referred for formal neurodevelopmental evaluation using BSID-III (Bayley Scale for Infant Development, Version III)

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    End point title
    		 Number of subjects referred for formal neurodevelopmental evaluation using BSID-III (Bayley Scale for Infant Development, Version III)
    End point description
    Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III). The analysis was performed on subjects from the Total enrolled cohort, who scored, below the defined cut-off in any of the 5 domains, when using the ASQ-3 score scale.
    End point type
    Secondary
    End point timeframe
    At 9 months of age, 18 months of age, and 9 or 18 months of age
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    31
    31
    Units: Participants
        Any Domain at Month 9 (N-27, 28)
    16
    14
        Any Domain at Month 18 (N-6, 5)
    6
    3
        Any Domain at Month 9 or 18 (N-31, 31)
    20
    17
    No statistical analyses for this end point

    Secondary: Estimated proportion of infants with at least one of the indicators of neurodevelopmental impairment using BSID-III (Bayley Scale for Infant Development, Version III)

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    End point title
    		 Estimated proportion of infants with at least one of the indicators of neurodevelopmental impairment using BSID-III (Bayley Scale for Infant Development, Version III)
    End point description
    The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 * (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) * (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation), The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.
    End point type
    Secondary
    End point timeframe
    At 9 months of age, 18 months of age, and 9 or 18 months of age
    End point values
    		 dTpa Group Control Group
    Number of subjects analysed
    269
    281
    Units: Percentage of Infants
    number (confidence interval 95%)
        Any domain at Month 9 (N-269, 281)
    4.39 (2.1 to 8.0)
    5.69 (3.0 to 9.6)
        Any domain at Month 18 (N-257, 274)
    1.17 (0.2 to 3.4)
    0.61 (0.1 to 2.8)
        Any domain at Month 9 or 18 (N-269, 281)
    4.61 (2.3 to 8.2)
    5.84 (3.2 to 9.7)
    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 4-day (Day 0-Day 3) and Unsolicited AEs were collected during 31-day (Day 0-Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approx. 6/7 months, per subject)
    Adverse event reporting additional description
    Safety analysis has been performed on the vaccinated subjects
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Reporting group title
    dTpa Group
    Reporting group description
    		 This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

    Serious adverse events
    		 Control Group dTpa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 277 (1.08%)
    0 / 263 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (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
    Periorbital cellulitis
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (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
    257 / 277 (92.78%)
    232 / 263 (88.21%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Mastocytoma
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Discomfort
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    2
    Crying
         subjects affected / exposed
    0 / 277 (0.00%)
    2 / 263 (0.76%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    169 / 277 (61.01%)
    143 / 263 (54.37%)
         occurrences all number
    169
    143
    Injection site induration
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    1
    1
    Injection site mass
         subjects affected / exposed
    2 / 277 (0.72%)
    0 / 263 (0.00%)
         occurrences all number
    2
    0
    Injection site pain
         subjects affected / exposed
    154 / 277 (55.60%)
    134 / 263 (50.95%)
         occurrences all number
    154
    134
    Pyrexia
         subjects affected / exposed
    101 / 277 (36.46%)
    81 / 263 (30.80%)
         occurrences all number
    109
    85
    Injection site swelling
         subjects affected / exposed
    122 / 277 (44.04%)
    119 / 263 (45.25%)
         occurrences all number
    122
    119
    Vaccination site irritation
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Vaccination site pain
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital erythema
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    2 / 277 (0.72%)
    1 / 263 (0.38%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    5 / 277 (1.81%)
    1 / 263 (0.38%)
         occurrences all number
    5
    1
    Dyspnoea
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 277 (0.72%)
    0 / 263 (0.00%)
         occurrences all number
    2
    0
    Sinus congestion
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Irritability
         subjects affected / exposed
    189 / 277 (68.23%)
    163 / 263 (61.98%)
         occurrences all number
    191
    164
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Arthropod sting
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Mouth injury
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Scratch
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Phimosis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    138 / 277 (49.82%)
    128 / 263 (48.67%)
         occurrences all number
    138
    128
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    6 / 277 (2.17%)
    6 / 263 (2.28%)
         occurrences all number
    6
    7
    Toothache
         subjects affected / exposed
    1 / 277 (0.36%)
    2 / 263 (0.76%)
         occurrences all number
    1
    2
    Teething
         subjects affected / exposed
    2 / 277 (0.72%)
    4 / 263 (1.52%)
         occurrences all number
    2
    4
    Vomiting
         subjects affected / exposed
    8 / 277 (2.89%)
    10 / 263 (3.80%)
         occurrences all number
    8
    11
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    1
    1
    Dermatitis diaper
         subjects affected / exposed
    2 / 277 (0.72%)
    3 / 263 (1.14%)
         occurrences all number
    2
    3
    Eczema
         subjects affected / exposed
    2 / 277 (0.72%)
    1 / 263 (0.38%)
         occurrences all number
    2
    1
    Pruritus
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    6 / 277 (2.17%)
    2 / 263 (0.76%)
         occurrences all number
    6
    2
    Urticaria
         subjects affected / exposed
    2 / 277 (0.72%)
    0 / 263 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    6 / 277 (2.17%)
    5 / 263 (1.90%)
         occurrences all number
    6
    5
    Candida infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Candida nappy
         subjects affected / exposed
    0 / 277 (0.00%)
    2 / 263 (0.76%)
         occurrences all number
    0
    2
    Cellulitis
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Croup infectious
         subjects affected / exposed
    0 / 277 (0.00%)
    2 / 263 (0.76%)
         occurrences all number
    0
    2
    Conjunctivitis
         subjects affected / exposed
    5 / 277 (1.81%)
    9 / 263 (3.42%)
         occurrences all number
    5
    9
    Ear infection
         subjects affected / exposed
    12 / 277 (4.33%)
    9 / 263 (3.42%)
         occurrences all number
    13
    9
    Cystitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Exanthema subitum
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    5 / 277 (1.81%)
    3 / 263 (1.14%)
         occurrences all number
    5
    3
    Gastroenteritis viral
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 277 (0.72%)
    2 / 263 (0.76%)
         occurrences all number
    2
    2
    Herpangina
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    1
    1
    Injection site cellulitis
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 277 (0.00%)
    2 / 263 (0.76%)
         occurrences all number
    0
    2
    Laryngitis
         subjects affected / exposed
    2 / 277 (0.72%)
    4 / 263 (1.52%)
         occurrences all number
    2
    4
    Lung infection
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    10 / 277 (3.61%)
    12 / 263 (4.56%)
         occurrences all number
    11
    13
    Oral candidiasis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 277 (0.36%)
    2 / 263 (0.76%)
         occurrences all number
    1
    3
    Oral herpes
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Otitis media acute
         subjects affected / exposed
    2 / 277 (0.72%)
    2 / 263 (0.76%)
         occurrences all number
    2
    2
    Pharyngitis
         subjects affected / exposed
    4 / 277 (1.44%)
    3 / 263 (1.14%)
         occurrences all number
    4
    4
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 277 (0.72%)
    0 / 263 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    5 / 277 (1.81%)
    5 / 263 (1.90%)
         occurrences all number
    6
    5
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    3 / 277 (1.08%)
    2 / 263 (0.76%)
         occurrences all number
    3
    2
    Skin infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Roseola
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    4 / 277 (1.44%)
    4 / 263 (1.52%)
         occurrences all number
    4
    4
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 277 (3.25%)
    9 / 263 (3.42%)
         occurrences all number
    9
    9
    Urinary tract infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Vaginal infection
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Viral rash
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    3 / 277 (1.08%)
    1 / 263 (0.38%)
         occurrences all number
    3
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 277 (0.36%)
    1 / 263 (0.38%)
         occurrences all number
    2
    1
    Vulvovaginitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 263 (0.38%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    116 / 277 (41.88%)
    104 / 263 (39.54%)
         occurrences all number
    116
    104
    Iron deficiency
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0
    Lactose intolerance
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 263 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2016
    • Given the fact that only infants born from mothers vaccinated in the study (116945[DTPA (BOOSTRIX)-047) and vaccinated in the previous study 201330 DTPA(BOOSTRIX)-048 PRI] can be enrolled in the current study, the enrolment in these studies has an impact on this current study (e.g. cohorts to be investigated). Initially, the DTPA (BOOSTRIX)-047 and DTPA (BOOSTRIX)-048 PRI studies were opened only in countries using 3-dose primary vaccination series plus a booster vaccination at 12 to 18 months of age against diphtheria, tetanus and pertussis in infants. Nevertheless, the 2-dose primary vaccination schedule with a booster vaccination at 11 to 13 months of age 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 DTPA (BOOSTRIX)-048 PRI, and therefore the current booster study to countries using 2-dose primary vaccination series with a booster vaccination at 11 to 13 months of age with the aim to increase the scientific value of the study and generate clinical data in diverse infant vaccination schedules. This protocol is amended to include the possibility to administered the booster vaccine dose at 11 to 13 months of age, in addition to the 12 to 18 months of age initially planned. • An inclusion criterion was updated to specify that only infant having received the full vaccination series as per protocol requirement in the study DTPA (BOOSTRIX)-048 PRI can be enrolled in the current study (and not only infant born from mother vaccinated in the DTPA (BOOSTRIX)-047). • The vaccination sites were updated to allow vaccination either in the thigh or deltoid, according to the national recommendation, to comply with the Australian recommendations. • Other minor changes have been made to correct typos and improve clarity and alignment within 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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