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    Clinical Trial Results:
    A phase IIIb, open-label, multicentre study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa)- Haemophilus influenzae type b (Hib) vaccine (DTPa/Hib) compared with GSK Biologicals’ DTPa and Hib vaccines co-administered at different injection sites, when administered as booster vaccination to healthy Chinese subjects aged 18 to 24 months previously primed with the same vaccines in study DTPa-131 (104567)

    Summary
    EudraCT number
    		 2015-001507-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2018
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    111535
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00696423
    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 Trails Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trails Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    20 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immune response to all vaccine antigens, i.e. diphtheria and tetanus toxoids, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and polyribosyl-ribitol-phosphate (PRP), one month after booster vaccination with the DTPa/Hib vaccine or with the DTPa and Hib vaccines administered separately.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2008
    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: 467
    Worldwide total number of subjects
    467
    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)
    467
    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
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix/Hib Group
    Arm description
    		 Subjects who had received Infanrix/Hib vaccine administered in one injection in the primary study received a booster dose of the same vaccine in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™
    Investigational medicinal product code
    Other name
    DTPa
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.The vaccine was administered intramuscularly into the left anterolateral thigh.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the left anterolateral thigh, one dose, mixed extemporaneously with the Infanrix™ (DTPa) vaccine.

    Arm title
    		 Infanrix + Hiberix Group
    Arm description
    		 Subjects who had received Infanrix (DTPa) and Hiberix (Hib) vaccines, co-administered at separate injection sites in the primary study received a booster dose of the same vaccines in this study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™
    Investigational medicinal product code
    Other name
    DTPa
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.The Infanrix™ vaccine was administered intramuscularly into the left anterolateral thigh.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the right anterolateral thigh.

    Number of subjects in period 1
    		Infanrix/Hib Group Infanrix + Hiberix Group
    Started
    244
    223
    Completed
    244
    218
    Not completed
    0
    5
         Migrated/moved from study area
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix/Hib Group
    Reporting group description
    		 Subjects who had received Infanrix/Hib vaccine administered in one injection in the primary study received a booster dose of the same vaccine in this study.

    Reporting group title
    Infanrix + Hiberix Group
    Reporting group description
    		 Subjects who had received Infanrix (DTPa) and Hiberix (Hib) vaccines, co-administered at separate injection sites in the primary study received a booster dose of the same vaccines in this study.

    Reporting group values
    		 Infanrix/Hib Group Infanrix + Hiberix Group Total
    Number of subjects
    		 244 223 467
    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)
    		 19.2 ± 0.79 19.2 ± 0.75 -
    Gender categorical
    Units: Subjects
        Female
    		 113 111 224
        Male
    		 131 112 243

    End points

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    End points reporting groups
    Reporting group title
    Infanrix/Hib Group
    Reporting group description
    		 Subjects who had received Infanrix/Hib vaccine administered in one injection in the primary study received a booster dose of the same vaccine in this study.

    Reporting group title
    Infanrix + Hiberix Group
    Reporting group description
    		 Subjects who had received Infanrix (DTPa) and Hiberix (Hib) vaccines, co-administered at separate injection sites in the primary study received a booster dose of the same vaccines in this study.

    Primary: Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentrations

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    End point title
    		 Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentrations [1]
    End point description
    Geometric mean concentrations are given in microgram per milliliter (μg/mL).
    End point type
    Primary
    End point timeframe
    One month after 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 Group Infanrix + Hiberix Group
    Number of subjects analysed
    238
    216
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-polyribosyl-ribitol-phosphate (PRP) antibody
    34.428 (29.452 to 40.244)
    132.075 (112.563 to 154.97)
    No statistical analyses for this end point

    Primary: Anti-diphtheria toxoid antibody concentrations

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    End point title
    		 Anti-diphtheria toxoid antibody concentrations [2]
    End point description
    Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    One month after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    237
    214
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria toxoid antibody concentrations
    0.945 (0.905 to 0.987)
    0.926 (0.887 to 0.966)
    No statistical analyses for this end point

    Primary: Anti-tetanus toxoid antibody concentrations

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    End point title
    		 Anti-tetanus toxoid antibody concentrations [3]
    End point description
    Geometric mean concentrations are given in IU/mL.
    End point type
    Primary
    End point timeframe
    One month after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    237
    214
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-tetanus toxoid antibody concentrations
    7.455 (6.881 to 8.077)
    10.104 (9.08 to 11.242)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations [4]
    End point description
    Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    One month after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    239
    216
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    52.2 (48.1 to 56.7)
    55.8 (51.7 to 60.3)
        Anti-FHA
    93.3 (82.6 to 105.4)
    92.8 (83.3 to 103.4)
        Anti-PRN
    235.9 (208.7 to 266.5)
    241.6 (213.6 to 273.2)
    No statistical analyses for this end point

    Primary: The number of subjects seroprotected for anti-PRP, anti-diphtheria and anti-tetanus antibodies and seropositive for anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    		 The number of subjects seroprotected for anti-PRP, anti-diphtheria and anti-tetanus antibodies and seropositive for anti-PT, anti-FHA and anti-PRN antibodies [5]
    End point description
    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
    End point type
    Primary
    End point timeframe
    One month after 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    239
    216
    Units: Subjects
        Seroprotection against PRP (n=238, 216)
    238
    216
        Seroprotection against diphtheria (n=237, 214)
    237
    214
        Seroprotection against tetanus (n=237, 214)
    237
    214
        Seropositivity for anti-PT (n=239, 216)
    226
    213
        Seropositivity for anti-FHA (n=239, 216)
    238
    216
        Seropositivity for anti-PRN (n=239, 216)
    239
    215
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    Geometric mean concentrations are given in μg/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    237
    216
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP antibody concentrations
    1.24 (1.085 to 1.418)
    2.461 (2.136 to 2.837)
    No statistical analyses for this end point

    Secondary: Anti-diphtheria toxoid antibody concentrations

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    End point title
    		 Anti-diphtheria toxoid antibody concentrations
    End point description
    Geometric mean concentrations are given in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    237
    214
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria toxoid antibody concentrations
    0.055 (0.053 to 0.058)
    0.054 (0.052 to 0.057)
    No statistical analyses for this end point

    Secondary: Anti-tetanus toxoid antibody concentrations

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    End point title
    		 Anti-tetanus toxoid antibody concentrations
    End point description
    Geometric mean concentrations are given in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    237
    214
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-tetanus toxoid antibody concentrations
    0.219 (0.195 to 0.247)
    0.311 (0.274 to 0.353)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    Geometric mean concentrations are given in EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    239
    216
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    10 (10 to 10)
    10 (10 to 10.1)
        Anti-FHA
    10.1 (10 to 10.2)
    10.3 (9.9 to 10.7)
        Anti-PRN
    10.2 (10 to 10.4)
    10.3 (10 to 10.5)
    No statistical analyses for this end point

    Secondary: The number of subjects seroprotected for anti-PRP, anti-diphtheria and anti-tetanus antibodies and seropositive for anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    		 The number of subjects seroprotected for anti-PRP, anti-diphtheria and anti-tetanus antibodies and seropositive for anti-PT, anti-FHA and anti-PRN antibodies
    End point description
    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    239
    216
    Units: Subjects
        Seroprotection against PRP (n= 237, 216)
    236
    216
        Seroprotection against diphtheria (n= 237, 214)
    21
    16
        Seroprotection against tetanus (n= 237, 214)
    209
    198
        Seropositivity for anti-PT (n= 239, 216)
    0
    1
        Seropositivity for anti-FHA (n= 239, 216)
    2
    3
        Seropositivity for anti-PRN (n= 239, 216)
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local and general symptoms

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    End point title
    		 Number of subjects reporting solicited local and general symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    244
    220
    Units: Subjects
        Pain
    26
    26
        Redness
    16
    8
        Swelling
    9
    1
        Drowsiness
    26
    20
        Fever
    73
    93
        Irritability
    43
    46
        Loss of appetite
    40
    39
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AE)

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    244
    223
    Units: Subjects
        Any AEs
    66
    56
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAE)

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    End point title
    		 Number of Subjects Reporting Serious Adverse Events (SAE)
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after booster vaccination
    End point values
    		 Infanrix/Hib Group Infanrix + Hiberix Group
    Number of subjects analysed
    244
    223
    Units: Subjects
        Any SAEs
    1
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Infanrix/Hib Single Injection Group
    Reporting group description
    		 Subjects who had received Infanrix/Hib vaccine administered in one injection in the primary study received a booster dose of the same vaccine in this study.

    Reporting group title
    Infanrix + Hiberix Group
    Reporting group description
    		 Subjects who had received Infanrix (DTPa) and Hiberix (Hib) vaccines, co-administered at separate injection sites in the primary study received a booster dose of the same vaccines in this study.

    Serious adverse events
    		 Infanrix/Hib Single Injection Group Infanrix + Hiberix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 223 (1.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 223 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 223 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix/Hib Single Injection Group Infanrix + Hiberix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    244 / 244 (100.00%)
    223 / 223 (100.00%)
    General disorders and administration site conditions
    Pain at injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 244 (10.66%)
    26 / 223 (11.66%)
         occurrences all number
    26
    26
    Redness at injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 244 (6.56%)
    8 / 223 (3.59%)
         occurrences all number
    16
    8
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 244 (10.66%)
    20 / 223 (8.97%)
         occurrences all number
    26
    20
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    73 / 244 (29.92%)
    93 / 223 (41.70%)
         occurrences all number
    73
    93
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 244 (17.62%)
    46 / 223 (20.63%)
         occurrences all number
    43
    46
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 244 (16.39%)
    39 / 223 (17.49%)
         occurrences all number
    40
    39
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    39 / 244 (15.98%)
    24 / 223 (10.76%)
         occurrences all number
    39
    24

    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
    For support, Contact us.
    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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