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    Clinical Trial Results:
    A phase IV, non-randomised, open-label, multicentre study with two parallel groups to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2, 4 and 6 months of age in healthy infants in Canada.

    Summary
    EudraCT number
    		 2013-003428-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Mar 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Aug 2022
    First version publication date
    30 May 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

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    Trial identification
    Sponsor protocol code
    103506
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00753649
    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 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    28 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response to the Hib component of GSK Biologicals’ combined DTPa-HBV-IPV/Hib preservative-free vaccine in terms of seroprotection rates one month after the three-dose primary vaccination course in “Aboriginal infants” and “Other Non-Aboriginal infants”.
    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
    23 Sep 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
    Canada: 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

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    Recruitment
    Recruitment details
    		 Study started on 23-Sep-2008 and enrolled 224 subjects from Canada.

    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 Aboriginal Group
    Arm description
    		 Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
    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 vaccine were administered by injection, intramuscularly in the right side of the tight, at 2, 4 and 6 months of age. All subjects were offered co-administrated vaccines: a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses of Rotarix vaccine were administered concomitantly with the first two doses of Infanrix Hexa vaccine. Rotarix was given orally at 2 and 4 months of age, according to the immunization schedule.

    Arm title
    		 Infanrix Hexa Non-Aboriginal Group
    Arm description
    		 Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
    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 vaccine were administered by injection, intramuscularly in the right side of the tight, at 2, 4 and 6 months of age. All subjects were offered co-administrated vaccines: a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses of Rotarix vaccine were administered concomitantly with the first two doses of Infanrix Hexa vaccine. Rotarix was given orally at 2 and 4 months of age, according to the immunization schedule.

    Number of subjects in period 1
    		Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Started
    112
    112
    Completed
    105
    112
    Not completed
    7
    0
         Lost to follow-up (subjects with complete vaccinat
    1
    -
         Protocol Violation
    2
    -
         Lost to follow-up (subjects with incomplete vaccin
    3
    -
         Migrated/moved from study area
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix Hexa Aboriginal Group
    Reporting group description
    		 Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

    Reporting group title
    Infanrix Hexa Non-Aboriginal Group
    Reporting group description
    		 Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

    Reporting group values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal 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)
    		 9.3 ± 1.38 9.2 ± 1.3 -
    Gender categorical
    Units: Subjects
        Female
    		 62 52 114
        Male
    		 50 60 110

    End points

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    End points reporting groups
    Reporting group title
    Infanrix Hexa Aboriginal Group
    Reporting group description
    		 Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

    Reporting group title
    Infanrix Hexa Non-Aboriginal Group
    Reporting group description
    		 Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

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

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    End point title
    		 Number of seroprotected subjects against Polyribosyl-ribitol phosphate (anti-PRP) [1]
    End point description
    A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL). The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    One month after (POST) Dose 3.
    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, hence no statistical hypothesis test was performed.
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    94
    107
    Units: Subjects
        Anti-PRP, POST-M1 [N=94,107]
    92
    106
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-Polyribosyl-ribitol phosphate (anti-PRP) antibodies with concentrations ≥1µg/mL

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    End point title
    		 Number of subjects with anti-Polyribosyl-ribitol phosphate (anti-PRP) antibodies with concentrations ≥1µg/mL
    End point description
    For this assay, 1 μg/mL was considered as the seropositivity cut-off. The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Secondary
    End point timeframe
    One month after (POST) Dose 3
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    94
    107
    Units: Subjects
        Anti-PRP, POST-M1 [N=94,107]
    83
    91
    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
    Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL). The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Secondary
    End point timeframe
    One month after (POST) Dose 3
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    94
    107
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, POST-M1 [N=94,107]
    6.123 (4.498 to 8.334)
    3.51 (2.745 to 4.488)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Hepatitis B (anti-HBs)

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    End point title
    		 Number of seroprotected subjects against Hepatitis B (anti-HBs)
    End point description
    A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA. The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Secondary
    End point timeframe
    One month after (POST) Dose 3.
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    91
    103
    Units: Subjects
        Anti-HBs, POST-M1 [N=91,103]
    91
    103
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-HBs antibody concentrations ≥100 mIU/mL

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    End point title
    		 Number of subjects with Anti-HBs antibody concentrations ≥100 mIU/mL
    End point description
    The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay. The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Secondary
    End point timeframe
    One month after (POST) Dose 3
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    91
    103
    Units: Subjects
        Anti-HBs, POST-M1 [N=91,103]
    89
    100
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Secondary
    End point timeframe
    One month after (POST) Dose 3
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    91
    103
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, POST-M1 [N=91,103]
    1797.9 (1375.1 to 2350.7)
    1544.4 (1210.4 to 1970.5)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.
    End point type
    Secondary
    End point timeframe
    During the 31 day (Days 0-30) post vaccination
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any AEs, [N=112,112]
    26
    19
    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
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.
    End point type
    Secondary
    End point timeframe
    During the entire study period up to Last subject last visit on 03/12/2013
    End point values
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any SAEs, [N=112,112]
    6
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
    Adverse event reporting additional description
    During this study, no solicited adverse events were collected, therefore none are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Infanrix Hexa Aboriginal Group
    Reporting group description
    		 Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

    Reporting group title
    Infanrix Hexa Non-Aboriginal Group
    Reporting group description
    		 Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.

    Serious adverse events
    		 Infanrix Hexa Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 112 (5.36%)
    0 / 112 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
    alternative assessment type: Non-systematic
         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
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
    alternative assessment type: Non-systematic
         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
    Pneumonia bacterial
    alternative assessment type: Non-systematic
         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
    Respiratory syncytial virus infection
    alternative assessment type: Non-systematic
         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 Aboriginal Group Infanrix Hexa Non-Aboriginal Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 112 (5.36%)
    0 / 112 (0.00%)
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 112 (5.36%)
    0 / 112 (0.00%)
         occurrences all number
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2010
    Amendment 2 The protocol was originally designed for sites in British Columbia (BC) and therefore the vaccines that the subject may receive outside of the study were recommended according to the BC vaccination schedule. New sites were selected in provinces where the recommended schedule for vaccine co-administration is different from BC, therefore the protocol is being amended to allow vaccine coadministration according to the provincial schedule rather than the BC schedules. • Some formatting errors have been corrected in the protocol.

    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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