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    Clinical Trial Results:
    A phase IV, open-label, study to assess the antibody persistence in healthy 5-year-old children, previously vaccinated at 3, 5 and 11 months of age with GSK Biologicals’ DTPa-HBV-IPV/Hib or DTPa-IPV/Hib vaccine, in study 105539 (10PN-PD-DIT-002).

    Summary
    EudraCT number
    		 2011-000943-26
    Trial protocol
    		 SE   NO  
    Global end of trial date
    15 Jul 2011

    Results information
    Results version number
    		 v3(current)
    This version publication date
    13 Dec 2020
    First version publication date
    13 Feb 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    115375
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01358825
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 004 8773793718, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 004 8773793718, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to all vaccine antigens in 5-year-old children.
    Protection of trial subjects
    Since the study does not involve active vaccination, serious adverse events (SAEs) related to study procedures and/or concomitant GSK medication were documented and described in detail.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 May 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
    Norway: 46
    Country: Number of subjects enrolled
    Sweden: 12
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    0
    Children (2-11 years)
    58
    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
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix hexa Group
    Arm description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects from Sweden previously vaccinated with 3 doses of Infanrix hexa vaccine in the primary study (NCT00307034).

    Arm title
    		 Infanrix-IPV/Hib Group
    Arm description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects from Norway previously vaccinated with 3 doses of Infanrix-IPV/Hib vaccine in the primary study (NCT00307034).

    Number of subjects in period 1
    		Infanrix hexa Group Infanrix-IPV/Hib Group
    Started
    12
    46
    Completed
    12
    45
    Not completed
    0
    1
         Blood sample not drawn
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.

    Reporting group title
    Infanrix-IPV/Hib Group
    Reporting group description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.

    Reporting group values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group Total
    Number of subjects
    		 12 46 58
    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: years
        arithmetic mean (standard deviation)
    		 5 ( 0 ) 5 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 14 23
        Male
    		 3 32 35

    End points

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    End points reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.

    Reporting group title
    Infanrix-IPV/Hib Group
    Reporting group description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.

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

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti-T). [1]
    End point description
    A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: subjects
        Anti-D [N=12;45]
    7
    28
        Anti-T [N=12;44]
    10
    34
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against anti-D and anti-T

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    End point title
    		 Concentrations of antibodies against anti-D and anti-T [2]
    End point description
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D [N=12;45]
    0.13 (0.072 to 0.235)
    0.196 (0.114 to 0.338)
        Anti-T [N=12;44]
    0.29 (0.135 to 0.624)
    0.352 (0.207 to 0.599)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥5 ELISA units per milliliter (EL.U/mL).

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    End point title
    		 Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥5 ELISA units per milliliter (EL.U/mL). [3]
    End point description
    Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: subjects
        Anti-PT
    0
    9
        Anti-FHA
    12
    41
        Anti-PRN
    8
    34
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against anti-PT, anti-FHA and anti-PRN.

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    End point title
    		 Concentrations of antibodies against anti-PT, anti-FHA and anti-PRN. [4]
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    2.5 (2.5 to 2.5)
    4.2 (2.9 to 6)
        Anti-FHA
    32.6 (11.5 to 92.5)
    50.7 (30.6 to 84.1)
        Anti-PRN
    6.2 (3.9 to 9.9)
    11.9 (8.4 to 16.8)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-hepatitis B surface antigen (anti-HBs).

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    End point title
    		 Number of seroprotected subjects against anti-hepatitis B surface antigen (anti-HBs). [5] [6]
    End point description
    Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Anti-HBs concentrations assessed only in subjects primed with a HBs-containing vaccine
    End point values
    		 Infanrix hexa Group
    Number of subjects analysed
    12
    Units: subjects
        Anti-HBs
    5
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against anti-HBs.

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    End point title
    		 Concentrations of antibodies against anti-HBs. [7] [8]
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Anti-HBs concentrations assessed only in subjects who previously received a HBs containing vaccine
    End point values
    		 Infanrix hexa Group
    Number of subjects analysed
    12
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    9 (3.9 to 20.9)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-polyribosyl ribitol phosphate (anti-PRP).

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    End point title
    		 Number of seroprotected subjects against anti-polyribosyl ribitol phosphate (anti-PRP). [9]
    End point description
    A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)
    End point type
    Primary
    End point timeframe
    At Day 0
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: subjects
        Anti-PRP
    10
    40
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against anti-PRP.

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    End point title
    		 Concentrations of antibodies against anti-PRP. [10]
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    45
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    0.404 (0.22 to 0.743)
    0.886 (0.558 to 1.407)
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs).

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    End point title
    		 Number of subjects with serious adverse events (SAEs). [11]
    End point description
    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Primary
    End point timeframe
    During the entire study period (up to Day 46)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group Infanrix-IPV/Hib Group
    Number of subjects analysed
    12
    46
    Units: subjects
        SAEs
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL [12] [13]
    End point description
    Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 0
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group
    Number of subjects analysed
    12
    Units: Subjects
        Anti-HBs
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs: during the entire study period (Day 0 to Day 46)
    Adverse event reporting additional description
    As no vaccine was administered during the study, no safety data other than spontaneous SAEs were collected during the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Infanrix-IPV/Hib Group
    Reporting group description
    		 Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Arm group description is missing. Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.

    Serious adverse events
    		 Infanrix-IPV/Hib Group Infanrix hexa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix-IPV/Hib Group Infanrix hexa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 12 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Adverse events were not collected as the study did not involve any vaccination

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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