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    Clinical Trial Results:
    A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given in healthy infants at 3, 5 and 11 months of age.

    Summary
    EudraCT number
    		 2008-006365-91
    Trial protocol
    		 SK  
    Global end of trial date
    25 Jun 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Apr 2023
    First version publication date
    04 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    111761
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00871741
    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
    Final
    Date of interim/final analysis
    26 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine (Combo group) is non-inferior to GSK Biologicals’ DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine co-administered with Novartis’ meningococcal serogroup C vaccine (Menjugate) (Control group), in terms of immune response to Hib and MenC antigens, one month after the second vaccine dose. Criteria for non-inferiority:  Non-inferiority in terms of response to PRP will be demonstrated if the upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Control minus Combo] in percentage of subjects with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 µg/ml is lesser than or equal to (≤) 10%. Non-inferiority in terms of response to MenC will be demonstrated if the upper limit of the standardized asymptotic 95% CI on the group difference [Control minus Combo] in percentage of subjects with rSBA-MenC titres ≥ 8 is ≤ 10%.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2009
    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
    Slovakia: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    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
    		 The number of actual participants that completed is 0 (due to study termination no subjects completed the study), however due to a system constraint (0 in an invalid value), the value of 7 and respectively 9 has been entered in the Completed field.

    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.

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2202083A Group
    Arm description
    		 Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2202083A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection in the anterolateral quadrant of the right thigh, three doses at 3, 5 and 11 months of age.

    Arm title
    		 Infanrix + Menjugate Group
    Arm description
    		 Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection in the left anterolateral thigh, three doses at 3, 5 and 11 months of age.

    Investigational medicinal product name
    Menjugate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection in the right anterolateral thigh, 2 doses at 3 and 5 months of age.

    Number of subjects in period 1
    		GSK2202083A Group Infanrix + Menjugate Group
    Started
    9
    7
    Vaccinated
    0 [1]
    0 [2]
    Completed
    9
    7
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of actual participants that completed is 0 (due to study termination no subjects completed the study), however due to a system constraint (0 in an invalid value), the value of 7 and respectively 9 has been entered in the Completed field.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of actual participants that completed is 0 (due to study termination no subjects completed the study), however due to a system constraint (0 in an invalid value), the value of 7 and respectively 9 has been entered in the Completed field.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2202083A Group
    Reporting group description
    		 Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

    Reporting group title
    Infanrix + Menjugate Group
    Reporting group description
    		 Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

    Reporting group values
    		 GSK2202083A Group Infanrix + Menjugate Group Total
    Number of subjects
    		 9 7 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 9 7 16
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 12.8 ± 2.28 13.9 ± 1.57 -
    Gender categorical
    Units: Subjects
        Female
    		 2 5 7
        Male
    		 7 2 9

    End points

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    End points reporting groups
    Reporting group title
    GSK2202083A Group
    Reporting group description
    		 Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

    Reporting group title
    Infanrix + Menjugate Group
    Reporting group description
    		 Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

    Primary: Anti- PRP antibody concentrations ≥ 0.15 mg/mL

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    End point title
    		 Anti- PRP antibody concentrations ≥ 0.15 mg/mL [1]
    End point description
    As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
    End point type
    Primary
    End point timeframe
    At Month 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 i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2202083A Group Infanrix + Menjugate Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Subjects
        Anti-PRP
    Notes
    [2] - As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done
    [3] - As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited local symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited local symptoms
    End point description
    The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
    End point values
    		 GSK2202083A Group Infanrix + Menjugate Group
    Number of subjects analysed
    9
    7
    Units: Subjects
        Any pain, Dose 1
    2
    2
        Grade 3 pain, Dose 1
    0
    0
        Any redness, Dose 1
    4
    4
        Grade 3 redness, Dose 1
    0
    0
        Any swelling, Dose 1
    3
    1
        Grade 3 swelling, Dose 1
    1
    1
        Any pain, Dose 2
    0
    0
        Grade 3 pain, Dose 2
    0
    0
        Any redness, Dose 2
    0
    0
        Grade 3 redness, Dose 2
    0
    0
        Any swelling, Dose 2
    0
    0
        Grade 3 swelling, Dose 2
    0
    0
        Any pain, Across doses
    2
    2
        Grade 3 pain, Across doses
    0
    0
        Any redness, Across doses
    4
    4
        Grade 3 redness, Across doses
    0
    0
        Any swelling, Across doses
    3
    1
        Grade 3 swelling, Across doses
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
    End point values
    		 GSK2202083A Group Infanrix + Menjugate Group
    Number of subjects analysed
    9
    7
    Units: Subjects
        Any drowsiness, Dose 1
    1
    1
        Grade 3 drowsiness, Dose 1
    0
    0
        Related drowsiness, Dose 1
    1
    0
        Any irritability, Dose 1
    4
    4
        Grade 3 irritability, Dose 1
    0
    0
        Related irritability, Dose 1
    4
    3
        Any loss of appetite, Dose 1
    2
    1
        Grade 3 loss of appetite, Dose 1
    0
    0
        Related loss of appetite, Dose 1
    2
    1
        Any temperature, Dose 1
    4
    1
        Grade 3 temperature (>39.0°C), Dose 1
    0
    0
        Related temperature, Dose 1
    4
    1
        Any drowsiness, Dose 2
    0
    0
        Grade 3 drowsiness, Dose 2
    0
    0
        Related drowsiness, Dose 2
    0
    0
        Any irritability, Dose 2
    0
    0
        Grade 3 irritability, Dose 2
    0
    0
        Related irritability, Dose 2
    0
    0
        Any loss of appetite, Dose 2
    0
    0
        Grade 3 loss of appetite, Dose 2
    0
    0
        Related loss of appetite, Dose 2
    0
    0
        Any temperature, Dose 2
    1
    0
        Grade 3 temperature (>39.0°C), Dose 2
    0
    0
        Related temperature, Dose 2
    1
    0
        Any drowsiness, Across doses
    1
    1
        Grade 3 drowsiness, Across doses
    0
    0
        Related drowsiness, Across doses
    1
    0
        Any irritability, Across doses
    4
    4
        Grade 3 irritability, Across doses
    0
    0
        Related irritability, Across doses
    4
    3
        Any loss of appetite, Across doses
    2
    1
        Grade 3 loss of appetite, Across doses
    0
    0
        Related loss of appetite, Across doses
    2
    1
        Any temperature, Across doses
    4
    1
        Grade 3 temperature (>39.0°C), Across doses
    0
    0
        Related temperature, Across doses
    4
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events AE(s)

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    End point title
    		 Number of subjects with unsolicited adverse events AE(s)
    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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-vaccination period
    End point values
    		 GSK2202083A Group Infanrix + Menjugate Group
    Number of subjects analysed
    9
    7
    Units: Subjects
        Any AE(s)
    2
    3
    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.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 to Month 9)
    End point values
    		 GSK2202083A Group Infanrix + Menjugate Group
    Number of subjects analysed
    9
    7
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period.
    Adverse event reporting additional description
    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
    12.0
    Reporting groups
    Reporting group title
    Infanrix + Menjugate Group
    Reporting group description
    		 -

    Reporting group title
    GSK2202083A Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix + Menjugate Group GSK2202083A Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix + Menjugate Group GSK2202083A Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    5 / 9 (55.56%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 9 (22.22%)
         occurrences all number
    2
    2
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 7 (57.14%)
    4 / 9 (44.44%)
         occurrences all number
    4
    4
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 7 (57.14%)
    4 / 9 (44.44%)
         occurrences all number
    4
    4
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Temperature
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    4 / 9 (44.44%)
         occurrences all number
    1
    4
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Feb 2009
    Amendment 1 This protocol amendment is being prepared to allow the analysis of data pertaining to the primary vaccination phase (up to and including Visit 3) as soon as they are available. Additionally the participation of Italy was cancelled before study start hence the protocol has been updated to reflect this. Some bullets related to collection and transcription of diary cards, were misplaced in the list of procedures table which have been corrected.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 May 2009
    The study was terminated early due to discrepancies between the initial participating countries and the actual participating one. It was deemed that in a single country design there was insufficient justification of using Menjugate and that the incidence of meningococcal type C disease in children up to 2 years was too low in Slovakia. Following this decision of the Ethics Committee, the study was prematurely terminated after enrolling and vaccinating 16 subjects.
    -

    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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