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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
    		 v1
    This version publication date
    01 Apr 2016
    First version publication date
    10 Jul 2015
    Other versions
    		 v2 , v3

    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 seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-diphtheria (anti-D).

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-diphtheria (anti-D). [1]
    End point description
    End point type
    Primary
    End point timeframe
    Before 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: subjects
    Notes
    [2] - The record will be updated when the results become available.
    [3] - The record will be updated when the results become available.
    [4] - The record will be updated when the results become available.
    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
    Infanrix+Hib/Poliorix 2 Group
    Reporting group description
    		 -

    Reporting group title
    Control Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix+Hib/Poliorix 1 Group Infanrix+Hib/Poliorix 2 Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 280 (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 / 273 (0.00%)
    0 / 280 (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 / 273 (0.00%)
    0 / 280 (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 Infanrix+Hib/Poliorix 2 Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 272 (37.50%)
    105 / 273 (38.46%)
    91 / 280 (32.50%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    73 / 270 (27.04%)
    74 / 273 (27.11%)
    76 / 279 (27.24%)
         occurrences all number
    73
    74
    76
    Redness
         subjects affected / exposed [2]
    19 / 270 (7.04%)
    15 / 273 (5.49%)
    16 / 279 (5.73%)
         occurrences all number
    19
    15
    16
    Swelling
         subjects affected / exposed [3]
    16 / 270 (5.93%)
    10 / 273 (3.66%)
    14 / 279 (5.02%)
         occurrences all number
    16
    10
    14
    Drowsiness
         subjects affected / exposed [4]
    38 / 270 (14.07%)
    50 / 273 (18.32%)
    38 / 279 (13.62%)
         occurrences all number
    38
    50
    38
    Irritability
         subjects affected / exposed [5]
    78 / 270 (28.89%)
    81 / 273 (29.67%)
    72 / 279 (25.81%)
         occurrences all number
    78
    81
    72
    Loss of appetite
         subjects affected / exposed [6]
    67 / 270 (24.81%)
    73 / 273 (26.74%)
    69 / 279 (24.73%)
         occurrences all number
    67
    73
    69
    Fever
         subjects affected / exposed [7]
    102 / 270 (37.78%)
    105 / 273 (38.46%)
    91 / 279 (32.62%)
         occurrences all number
    102
    105
    91
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 272 (2.94%)
    6 / 273 (2.20%)
    13 / 280 (4.64%)
         occurrences all number
    8
    6
    13
    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 and general symptoms were only reported 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 and general symptoms were only reported 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 and general symptoms were only reported 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 and general symptoms were only reported 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 and general symptoms were only reported 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 and general symptoms were only reported 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 and general symptoms were only reported 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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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