Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) administered to Indian infants according to a 6-10-14 weeks.

    Summary
    EudraCT number
    		 2013-003427-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    13 Apr 2016
    First version publication date
    30 May 2015
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111157
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01353703
    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, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    25 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2013
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunological response to the study vaccine in terms of seroprotection status for diphtheria, tetanus, polio, hepatitis B and Hib antigens, and in terms of vaccine response for the pertussis, one month after the third dose of the primary vaccination.
    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
    12 Apr 2012
    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
    India: 224
    Worldwide total number of subjects
    224
    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)
    224
    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

    		 Close Top of page
    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 Hexa 6-10-14 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of Infanrix hexa™ were administered by injection intramuscularly into the right side of the thight, at 6, 10 and 14 weeks of age.

    Arm title
    		 Infanrix Hexa 2-4-6 Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of Infanrix hexa™ were administered by injection intramuscularly into the right side of the thight, at 2, 4 and 6 months of age.

    Number of subjects in period 1
    		Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Started
    112
    112
    Completed
    111
    112
    Not completed
    1
    0
         'Migrated/moved from study area '
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Reporting group values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group Total
    Number of subjects
    		 112 112 224
    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: weeks
        arithmetic mean (standard deviation)
    		 6.7 ± 1.04 6.8 ± 1.13 -
    Gender categorical
    Units: Subjects
        Female
    		 52 52 104
        Male
    		 60 60 120

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Primary: Immunogenicity with respect to components of the study vaccine

    		 Close Top of page
    End point title
    		 Immunogenicity with respect to components of the study vaccine [1]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of primary 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 Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: subjects
    Notes
    [2] - At the time of posting, immunogenicity data were not available.
    [3] - At the time of posting, immunogenicity data were not available.
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

    		 Close Top of page
    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, after each dose
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    111
    112
    Units: Subjects
        Any Pain, D1 [N=111,112]
    23
    11
        Any Redness, D1 [N=111,112]
    3
    1
        Any Swelling, D1 [N=111,112]
    7
    4
        Any Pain, D2 [N=111,112]
    13
    3
        Any Redness, D2 [N=111,112]
    0
    1
        Any Swelling, D2 [N=111,112]
    2
    2
        Any Pain, D3 [N=111,112]
    10
    6
        Any Redness, D3 [N=111,112]
    3
    0
        Any Swelling, D3 [N=111,112]
    2
    3
        Any Pain, Across [N=111,112]
    28
    15
        Any Redness, Across [N=111,112]
    6
    2
        Any Swelling, Across [N=111,112]
    8
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

    		 Close Top of page
    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, after each dose
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    111
    112
    Units: Subjects
        Any Drowsiness, D1 [N=111,112]
    0
    2
        Any Irritability/fussiness, D1 [N=111,112]
    8
    5
        Any Loss of appetite, D1 [N=111,112]
    1
    3
        Any Temperature/(Axillary), D1 [N=111,112]
    10
    7
        Any Drowsiness, D2 [N=111,112]
    0
    0
        Any Irritability/fussiness, D2 [N=111,112]
    2
    5
        Any Loss of appetite, D2 [N=111,112]
    0
    1
        Any Temperature/(Axillary), D2 [N=111,112]
    5
    7
        Any Drowsiness, D3 [N=111,112]
    0
    0
        Any Irritability/fussiness, D3 [N=111,112]
    3
    3
        Any Loss of appetite, D3 [N=111,112]
    1
    1
        Any Temperature/(Axillary), D3 [N=111,112]
    3
    6
        Any Drowsiness, Across [N=111,112]
    0
    2
        Any Irritability/fussiness, Across [N=111,112]
    13
    10
        Any Loss of appetite, Across [N=111,112]
    2
    5
        Any Temperature/(Axillary), Across [N=111,112]
    17
    17
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post vaccination
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any AEs [N=112,112]
    40
    25
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any SAEs [N=112,112]
    2
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 112 (1.79%)
    3 / 112 (2.68%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 112 (35.71%)
    25 / 112 (22.32%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 112 (25.00%)
    15 / 112 (13.39%)
         occurrences all number
    28
    15
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 112 (5.36%)
    2 / 112 (1.79%)
         occurrences all number
    6
    2
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 112 (7.14%)
    9 / 112 (8.04%)
         occurrences all number
    8
    9
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 112 (1.79%)
         occurrences all number
    0
    2
    Irritability/fussiness
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 112 (11.61%)
    10 / 112 (8.93%)
         occurrences all number
    13
    10
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 112 (1.79%)
    5 / 112 (4.46%)
         occurrences all number
    2
    5
    Temperature/Axillary
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 112 (15.18%)
    17 / 112 (15.18%)
         occurrences all number
    17
    17
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 112 (16.07%)
    11 / 112 (9.82%)
         occurrences all number
    18
    11
    Rhinitis
         subjects affected / exposed
    4 / 112 (3.57%)
    6 / 112 (5.36%)
         occurrences all number
    4
    6

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2012
    As per the request of the regulatory authorities in India, sub-group analyses will be performed based on the hepatitis B status of the mother and number of OPV doses given to the subject since birth. Also, an analysis based on the prevaccination status of anti-HBs antibodies will be performed. As these exploratory analyses are not powered to draw conclusions, the analyses will be performed for information only. • The secondary objectives and endpoints have been updated to include analysis of anti-HBs antibody concentrations before the first dose of primary vaccination. • The outline of study procedures table has been updated to include the information about the hepatitis B status of the mother based on medical history. • The names of the contributing authors have been updated in the title page. The name of the sponsor signatory has also been updated in the protocol amendment 1 sponsor signatory approval page.

    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.

    European Medicines Agency © 1995-Thu May 02 08:38:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA