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    Clinical Trial Results:
    An open-label study to assess the immune persistence in healthy Chinese toddlers primed in infancy with three doses of GSK Biologicals’ DTPa-IPV/Hib vaccine, and to assess the safety and immunogenicity of a booster dose of IPV and DTPa/Hib administered at 18 to 24 months of age.

    Summary
    EudraCT number
    		 2012-003324-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Jan 2012

    Results information
    Results version number
    		 v2
    This version publication date
    23 Apr 2016
    First version publication date
    10 Jul 2015
    Other versions
    		 v1 , v3
    Version creation reason
    • New data added to full data set
    Data for secondary endpoints have been added.

    Trial information

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    Trial identification
    Sponsor protocol code
    114386
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01449812
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2989904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2989904466, 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
    16 Jan 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To assess the persistence of antibodies to all vaccine antigens before the booster dose. •To assess the immune response to the study vaccines in terms of seroprotection to diphtheria, tetanus, Haemophilus influenzae type b and poliovirus types 1, 2 and 3, and in terms of vaccine response to the pertussis antigens, one month after booster vaccination. •To assess the immune response to the study vaccines in terms of antibody concentrations or titres for all antigens, one month after the booster dose.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2011
    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
    China: 825
    Worldwide total number of subjects
    825
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    825
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix+Hib/Poliorix 1 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix+Hib™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Arm title
    		 Infanrix+Hib/Poliorix 2 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix+Hib™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4, 5 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4, 5 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Arm title
    		 Control Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix+Hib™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix+Hib™ vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects primed with 3 doses of the Infanrix+Hib™ vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines at 18-24 months of age. The Poliorix™ and Infanrix+Hib™ vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.

    Number of subjects in period 1
    		Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Started
    272
    273
    280
    Completed
    270
    273
    279
    Not completed
    2
    0
    1
         Consent withdrawn by subject
    -
    -
    1
         Migrated/moved from study area
    1
    -
    -
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix+Hib/Poliorix 1 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix+Hib/Poliorix 2 Group
    Reporting group description
    		 -

    Reporting group title
    Control Group
    Reporting group description
    		 -

    Reporting group values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group Total
    Number of subjects
    		 272 273 280 825
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 19.5 ( 0.93 ) 19.4 ( 0.91 ) 19.5 ( 0.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 131 126 120 377
        Male
    		 141 147 160 448

    End points

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    End points reporting groups
    Reporting group title
    Infanrix+Hib/Poliorix 1 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix+Hib/Poliorix 2 Group
    Reporting group description
    		 -

    Reporting group title
    Control Group
    Reporting group description
    		 -

    Primary: Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T)

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) [1]
    End point description
    A seroprotected subject was defined as a vaccinated subject with Anti-D and Anti-T antibody concentrations ≥0.1 international units per milliliter (IU/mL)
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    279
    Units: subjects
        Anti-diphtheria [N=271;272;279]
    241
    250
    234
        Anti-tetanus [N=272;273;278]
    269
    271
    275
    No statistical analyses for this end point

    Primary: Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations [2]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    279
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria [N=271;272;279]
    0.175 (0.163 to 0.188)
    0.189 (0.176 to 0.202)
    0.154 (0.142 to 0.166)
        Anti-tetanus [N=272;273;278]
    0.45 (0.423 to 0.478)
    0.509 (0.481 to 0.54)
    0.38 (0.359 to 0.404)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP)

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    End point title
    		 Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP) [3]
    End point description
    A seroprotected subject was defined as a vaccinated subject with Anti-PRP antibody concentration ≥0.15 microgram per milliliter (µg/mL)
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: Subjects
        Anti-PRP [N=272;273;280]
    226
    234
    241
    No statistical analyses for this end point

    Primary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations [4]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥0.15 µg/mL
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP [N=272;273;280]
    2.275 (1.856 to 2.788)
    2.674 (2.193 to 3.26)
    2.413 (2.006 to 2.904)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-polio type 1, 2 and 3

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    End point title
    		 Number of seroprotected subjects for anti-polio type 1, 2 and 3 [5]
    End point description
    The Anti-Polivirus cut-off value was defined as greater than or equal to 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection, by 50%
    End point type
    Primary
    End point timeframe
    Before (PRE) booster 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: Subjects
        Anti-Polio 1
    259
    267
    270
        Anti-Polio 2
    248
    261
    250
        Anti-Polio 3
    254
    259
    257
    No statistical analyses for this end point

    Primary: 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 [6]
    End point description
    Titers were expressed as Geometric Mean Titers (GMTs) for the seroprotection cut-off of ≥ 8
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1
    72.3 (62.4 to 83.7)
    95.7 (82.5 to 111)
    77.2 (67 to 89)
        Anti-Polio 2
    57.3 (47 to 70)
    63.6 (53.5 to 75.5)
    42.6 (35.7 to 50.8)
        Anti-Polio 3
    71.3 (60.1 to 84.7)
    79.9 (66.4 to 96.2)
    60.6 (51.2 to 71.8)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [7]
    End point description
    A seropositive subject was defined as a vaccinated subject with Anti-PT, Anti-FHA and Anti-PRN antibody concentration ≥ 5 (ELISA) units per milliliter (EL.U/ml)
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: Subjects
        Anti-PT
    260
    263
    260
        Anti-FHA
    262
    267
    262
        Anti-PRN
    260
    265
    267
    No statistical analyses for this end point

    Primary: Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [8]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/ml
    End point type
    Primary
    End point timeframe
    Before (PRE) booster vaccination
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: EL.U/ml
    geometric mean (confidence interval 95%)
        Anti-PT
    10.3 (9.6 to 11.1)
    12.2 (11.3 to 13.1)
    10.4 (9.6 to 11.2)
        Anti-FHA
    12.8 (11.9 to 13.7)
    14.3 (13.4 to 15.2)
    12.4 (11.5 to 13.4)
        Anti-PRN
    9.2 (8.8 to 9.7)
    9.7 (9.2 to 10.1)
    9 (8.5 to 9.5)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T)

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) [9]
    End point description
    A seroprotected subject was defined as a vaccinated subject with Anti-D and Anti-T antibody concentrations ≥0.1 international units per milliliter (IU/mL)
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST) for immunogenicity
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    272
    Units: Subjects
        Anti-diphtheria, PRE [N=265;267;272]
    235
    245
    228
        Anti-diphtheria, POST [N=265;268;270]
    265
    268
    270
        Anti-tetanus, PRE [N=266;268;271]
    264
    266
    268
        Anti-tetanus, POST [N=266;268;272]
    266
    268
    272
    No statistical analyses for this end point

    Primary: Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations [10]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST) for immunogenicity
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    272
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria, PRE [N=265;267;272]
    0.174 (0.162 to 0.187)
    0.189 (0.176 to 0.202)
    0.154 (0.142 to 0.166)
        Anti-diphtheria, POST [N=265;268;270]
    1.341 (1.239 to 1.451)
    1.504 (1.377 to 1.643)
    1.227 (1.134 to 1.326)
        Anti-tetanus, PRE [N=266;268;271]
    0.455 (0.429 to 0.483)
    0.511 (0.482 to 0.542)
    0.38 (0.357 to 0.403)
        Anti-tetanus, POST [N=266;268;272]
    4.862 (4.614 to 5.124)
    4.927 (4.693 to 5.173)
    4.371 (4.161 to 4.591)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP)

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    End point title
    		 Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP) [11]
    End point description
    A seroprotected subject was defined as a vaccinated subject with Anti-PRP antibody concentration ≥0.15 microgram per milliliter (µg/mL)
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST) for immunogenicity
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: Subjects
        Anti-PRP, PRE
    221
    229
    234
        Anti-PRP, POST
    264
    268
    271
    No statistical analyses for this end point

    Primary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations [12]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥0.15 µg/mL
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST) for immunogenicity
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, PRE
    2.308 (1.878 to 2.836)
    2.743 (2.245 to 3.352)
    2.407 (1.993 to 2.908)
        Anti-PRP, POST
    35.178 (30.617 to 40.418)
    49.023 (43.649 to 55.058)
    27.682 (24.251 to 31.598)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-polio type 1, 2 and 3

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    End point title
    		 Number of seroprotected subjects for anti-polio type 1, 2 and 3 [13]
    End point description
    The Anti-Polivirus cut-off value was defined as greater than or equal to 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection, by 50%
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: Subjects
        Anti-Polio 1, PRE [N=266;268;273]
    253
    262
    263
        Anti-Polio 1, POST [N=265;268;273]
    265
    268
    273
        Anti-Polio 2, PRE [N=266;268;273]
    243
    256
    244
        Anti-Polio 2, POST [N=265;268;273]
    265
    268
    273
        Anti-Polio 3, PRE [N=266;268;273]
    249
    254
    250
        Anti-Polio 3, POST [N=265;268;273]
    265
    268
    273
    No statistical analyses for this end point

    Primary: 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 [14]
    End point description
    Titers were expressed as Geometric Mean Titers (GMTs) for the seroprotection cut-off of ≥ 8
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, PRE [N=266;268;273]
    72 (62 to 83.7)
    96.3 (82.8 to 112)
    75.9 (65.7 to 87.6)
        Anti-Polio 1, POST [N=265;268;273]
    3512.2 (3159.7 to 3904.1)
    3410.9 (3081.7 to 3775.4)
    3386.8 (3078 to 3726.6)
        Anti-Polio 2, PRE [N=266;268;273]
    56.5 (46.2 to 69)
    64.1 (53.8 to 76.4)
    41.9 (35 to 50)
        Anti-Polio 2, POST [N=265;268;273]
    1931.2 (1721.7 to 2166.2)
    2237.9 (2001.6 to 2502.1)
    1886.1 (1679.6 to 2117.9)
        Anti-Polio 3, PRE [N=266;268;273]
    72.6 (61.1 to 86.3)
    79.4 (65.8 to 95.8)
    60.3 (50.8 to 71.6)
        Anti-Polio 3, POST [N=265;268;273]
    5237.8 (4671.8 to 5872.3)
    5438.5 (4846.8 to 6102.4)
    5141.2 (4650.1 to 5684.2)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [15]
    End point description
    A seropositive subject was defined as a vaccinated subject with Anti-PT, Anti-FHA and Anti-PRN antibody concentration ≥ 5 (ELISA) units per millilitre (EL.U/ml)
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: Subjects
        Anti-PT, PRE [N=266;268;273]
    254
    258
    253
        Anti-PT, POST [N=266;268;273]
    266
    268
    273
        Anti-FHA, PRE [N=266;268;273]
    256
    262
    255
        Anti-FHA, POST [N=266;268;273]
    266
    268
    273
        Anti-PRN, PRE [N=266;268;273]
    254
    260
    260
        Anti-PRN, POST [N=266;268;273]
    266
    268
    273
    No statistical analyses for this end point

    Primary: Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [16]
    End point description
    Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/ml
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after booster vaccination (POST)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: EL.U/ml
    geometric mean (confidence interval 95%)
        Anti-PT, PRE [N=266;268;273]
    10.3 (9.5 to 11.1)
    12.2 (11.3 to 13.1)
    10.3 (9.5 to 11.2)
        Anti-PT, POST [N=266;268;273]
    138.5 (132 to 145.3)
    146.2 (139.7 to 153)
    126.8 (120.4 to 133.5)
        Anti-FHA, PRE [N=266;268;273]
    12.7 (11.8 to 13.6)
    14.3 (13.4 to 15.2)
    12.3 (11.4 to 13.3)
        Anti-FHA, POST [N=266;268;273]
    124.6 (119.2 to 130.2)
    124 (119.2 to 129)
    120.8 (115.3 to 126.6)
        Anti-PRN, PRE [N=266;268;273]
    9.2 (8.7 to 9.6)
    9.7 (9.2 to 10.2)
    9 (8.5 to 9.5)
        Anti-PRN, POST [N=266;268;273]
    57.3 (55.6 to 59.1)
    59.9 (58.1 to 61.8)
    57.2 (55.3 to 59.1)
    No statistical analyses for this end point

    Primary: Number of subjects with a booster response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of subjects with a booster response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [17]
    End point description
    Booster response defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations >= cut-off value), taking into consideration the decreasing maternal antibodies.
    End point type
    Primary
    End point timeframe
    One month after booster vaccination (POST)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    266
    268
    273
    Units: Subjects
        Anti-PT, POST
    266
    268
    272
        Anti-FHA, POST
    266
    268
    272
        Anti-PRN, POST
    239
    230
    244
    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
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    270
    273
    279
    Units: subjects
        Any Pain
    73
    74
    76
        Any Redness
    19
    15
    19
        Any Swelling
    16
    10
    14
    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
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    270
    273
    279
    Units: subjects
        Any Drowsiness
    38
    50
    38
        Any Irritability
    78
    81
    72
        Any Loss of appetite
    67
    73
    69
        Any Fever
    102
    105
    91
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs

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    End point title
    		 Number of subjects with unsolicited AEs
    End point description
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) period following booster vaccination
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: subjects
        Any AEs
    16
    13
    21
    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
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    272
    273
    280
    Units: subjects
        Any SAEs
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Infanrix+Hib/Poliorix 1 Group
    Reporting group description
    		 -

    Reporting group title
    Control Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix+Hib/Poliorix 2 Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix+Hib/Poliorix 1 Group Control Group Infanrix+Hib/Poliorix 2 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 280 (0.00%)
    0 / 273 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 280 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 280 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix+Hib/Poliorix 1 Group Control Group Infanrix+Hib/Poliorix 2 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 272 (37.50%)
    91 / 280 (32.50%)
    105 / 273 (38.46%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    73 / 270 (27.04%)
    76 / 279 (27.24%)
    74 / 273 (27.11%)
         occurrences all number
    73
    76
    74
    Redness
         subjects affected / exposed [2]
    19 / 270 (7.04%)
    16 / 279 (5.73%)
    15 / 273 (5.49%)
         occurrences all number
    19
    16
    15
    Swelling
         subjects affected / exposed [3]
    16 / 270 (5.93%)
    14 / 279 (5.02%)
    10 / 273 (3.66%)
         occurrences all number
    16
    14
    10
    Drowsiness
         subjects affected / exposed [4]
    38 / 270 (14.07%)
    38 / 279 (13.62%)
    50 / 273 (18.32%)
         occurrences all number
    38
    38
    50
    Irritability
         subjects affected / exposed [5]
    78 / 270 (28.89%)
    72 / 279 (25.81%)
    81 / 273 (29.67%)
         occurrences all number
    78
    72
    81
    Loss of appetite
         subjects affected / exposed [6]
    67 / 270 (24.81%)
    69 / 279 (24.73%)
    73 / 273 (26.74%)
         occurrences all number
    67
    69
    73
    Fever
         subjects affected / exposed [7]
    102 / 270 (37.78%)
    91 / 279 (32.62%)
    105 / 273 (38.46%)
         occurrences all number
    102
    91
    105
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 272 (2.94%)
    13 / 280 (4.64%)
    6 / 273 (2.20%)
         occurrences all number
    8
    13
    6
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were only tabulated for subjects with a symptom sheet completed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2011
    Due to significant revisions to the Chinese Pharmacopeia, the DTPa-IPV/Hib vaccine can currently not be locally retested and released in that country. The study design is therefore being modified to boost all subjects with the DTPa/Hib (Infanrix Hib) and IPV (Poliorix) vaccines.

    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
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