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    Clinical Trial Results:
    A phase III, open, randomized, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ conjugate Hib-MenC vaccine co-administered with GSK Biologicals’ measles-mumps-rubella vaccine, Priorix™, versus MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ Hib vaccine, Hiberix™, and Priorix™ in 12- to 18-month-old toddlers primed in infancy with a Hib vaccine but not with a meningococcal serogroup C vaccine; and to evaluate the long-term antibody persistence up to 5 years after the administration of the Hib-MenC vaccine.

    Summary
    EudraCT number
    		 2011-005032-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Nov 2007

    Results information
    Results version number
    		 v3(current)
    This version publication date
    26 May 2022
    First version publication date
    29 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    106445
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00326118
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 106446: eTrack number, 106449: eTrack number, 106450: eTrack number, 106452: eTrack number, 106454: eTrack number
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials 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
    08 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: To demonstrate the non-inferiority of the meningococcal serogroup C and Hib responses induced by Hib-MenC vaccine, compared to separately administered MCC and Hib vaccines (with MMR co-administered in each group), when given as a single dose to toddlers 12-18 months of age primed with routine infant vaccines including Hib, but no MenC vaccine, in terms of: -Percentage of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer ≥ 1:8. -Percentage of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL
    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
    01 Jun 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 433
    Worldwide total number of subjects
    433
    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)
    433
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 Subjects received a single dose of Menitorix vaccine co-administered with Priorix vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Hib-MenC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular dose at 12-18 months of age, administered in the left deltoid region.

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One subcutaneous dose at 12-18 months of age, administered in the right upper arm.

    Arm title
    		 Meningitec + Hiberix Group
    Arm description
    		 Subjects received a single dose of Meningitec vaccine co-administered with Hiberix and Priorix vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MCC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular dose at 12-18 months of age, administered in the left deltoid region.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular dose at 12-18 months of age, administered in the left tight region.

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One subcutaneous dose at 12-18 months of age, administered in the right upper arm.

    Number of subjects in period 1
    		Menitorix Group Meningitec + Hiberix Group
    Started
    324
    109
    Completed
    320
    108
    Not completed
    4
    1
         Consent withdrawn by subject
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 Subjects received a single dose of Menitorix vaccine co-administered with Priorix vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.

    Reporting group title
    Meningitec + Hiberix Group
    Reporting group description
    		 Subjects received a single dose of Meningitec vaccine co-administered with Hiberix and Priorix vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

    Reporting group values
    		 Menitorix Group Meningitec + Hiberix Group Total
    Number of subjects
    		 324 109 433
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.5 ( 0.94 ) 12.5 ( 0.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 150 42 192
        Male
    		 174 67 241

    End points

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    End points reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 Subjects received a single dose of Menitorix vaccine co-administered with Priorix vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.

    Reporting group title
    Meningitec + Hiberix Group
    Reporting group description
    		 Subjects received a single dose of Meningitec vaccine co-administered with Hiberix and Priorix vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

    Primary: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer

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    End point title
    		 Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
    End point description
    rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
    End point type
    Primary
    End point timeframe
    One month after vaccination.
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    281
    98
    Units: Subjects
        rSBA-MenC, M1(N=281; 98)
    280
    98
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenC ≥ 1:8
    Statistical analysis description
    To demonstrate the non-inferiority of the meningococcal serogroup C and Hib responses induced by Hib-MenC vaccine, compared to separately administered MCC and Hib vaccines (with MMR co-administered in each group), when given as a single dose to toddlers 12-18 months of age primed with routine infant vaccines including Hib, but no MenC vaccine, in terms of percentage of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer ≥ 1:8.
    Comparison groups
    Meningitec + Hiberix Group v Menitorix Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.99
         upper limit
    		 3.43
    Notes
    [1] - Criterion for achieving the co-primary objectives: One month after vaccination, the lower limit of the standardized asymptotic 95% confidence interval on the difference between the study vaccine group and (minus) the control group was above -10%.

    Primary: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)

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    End point title
    		 Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
    End point description
    Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
    End point type
    Primary
    End point timeframe
    One month after vaccination.
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    292
    100
    Units: Subjects
        Anti-PRP, M1, >=0.15μg/mL (N=292; 100)
    292
    100
    Statistical analysis title
    		 Difference in % subjects with anti-PRP ≥0.15 μg/mL
    Statistical analysis description
    To demonstrate the non-inferiority of the meningococcal serogroup C and Hib responses induced by Hib-MenC vaccine, compared to separately administered MCC and Hib vaccines (with MMR co-administered in each group), when given as a single dose to toddlers 12-18 months of age primed with routine infant vaccines including Hib, but no MenC vaccine, in terms of percentage of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 μg/mL.
    Comparison groups
    Menitorix Group v Meningitec + Hiberix Group
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 3.71
    Notes
    [2] - Criterion for achieving the co-primary objectives: One month after vaccination, the lower limit of the standardized asymptotic 95% confidence interval on the difference between the study vaccine group and (minus) the control group was above -10%.

    Secondary: Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values

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    End point title
    		 Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
    End point description
    The cut-off values assessed were greater than or equal to (≥) 1:8.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    255
    83
    Units: Subjects
        rSBA-MenC, PRE, (N=255; 83)
    37
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values

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    End point title
    		 Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
    End point description
    Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection)
    End point type
    Secondary
    End point timeframe
    Prior to vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    285
    98
    Units: Subjects
        Anti-PRP, PRE, (N=285; 98)
    219
    82
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:128 titer

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    End point title
    		 Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:128 titer
    End point description
    rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    281
    98
    Units: Subjects
        rSBA-MenC, PRE, (N=255; 83)
    15
    3
        rSBA-MenC, M1, (N=281; 98)
    247
    89
    No statistical analyses for this end point

    Secondary: Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers

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    End point title
    		 Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
    End point description
    Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    281
    98
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenC, PRE, (N=255; 83)
    6.3 (5.5 to 7.3)
    5.5 (4.3 to 7.2)
        rSBA-MenC, M1, (N=281; 98)
    482.8 (420.7 to 554.2)
    621 (480.3 to 802.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values

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    End point title
    		 Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
    End point description
    Anti-PRP antibody concentration cut-off values assessed include 1.0 µg/mL (indicative of long-term protection).
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    292
    100
    Units: Subjects
        Anti-PRP, PRE, (N=285; 98)
    77
    22
        Anti-PRP, M1, (N=292; 100)
    286
    100
    No statistical analyses for this end point

    Secondary: Anti-polyribosylribitol Phosphate (Anti-PRP) antibody concentrations

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    End point title
    		 Anti-polyribosylribitol Phosphate (Anti-PRP) antibody concentrations
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    292
    100
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, PRE, (N=285; 98)
    0.438 (0.374 to 0.512)
    0.472 (0.364 to 0.611)
        Anti-PRP, M1, (N=292; 100)
    46.652 (38.929 to 55.907)
    73.976 (57.624 to 94.968)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentrations above the Cut-off Values

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    End point title
    		 Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentrations above the Cut-off Values
    End point description
    Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    290
    100
    Units: Subjects
        Anti-PSC, PRE, >=0.3μg/mL (N=283; 96)
    2
    1
        Anti-PSC, M1, >=0.3μg/mL (N=290; 100)
    290
    100
        Anti-PSC, PRE, >=2.0μg/mL (N=283; 96)
    0
    0
        Anti-PSC, M1, >=2.0μg/mL (N=290; 100)
    289
    96
    No statistical analyses for this end point

    Secondary: Anti-polysaccharide C (anti-PSC) antibody concentrations

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    End point title
    		 Anti-polysaccharide C (anti-PSC) antibody concentrations
    End point description
    Concentrations given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to vaccination and one month after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    290
    100
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC, PRE, (N=283; 96)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.16)
        Anti-PSC, M1, (N=290; 100)
    18.69 (17.1 to 20.42)
    7.95 (6.95 to 9.08)
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values

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    End point title
    		 Number of subjects with meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
    End point description
    rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titers were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titers were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
    End point type
    Secondary
    End point timeframe
    At 1, 2, 3, 4, and 5 years after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    249
    89
    Units: Subjects
        rSBA, M12, ≥ 1:8 (N=249;89)
    216
    68
        rSBA, M12, ≥ 1:128 (N=249;89)
    117
    37
        rSBA, M24, ≥ 1:8 (N=235;86)
    164
    52
        rSBA, M24, ≥ 1:128 (N=235;86)
    76
    26
        rSBA, M36, ≥ 1:8 (N=226;77)
    145
    41
        rSBA, M36, ≥ 1:128 (N=226;77)
    58
    22
        rSBA, M48, ≥ 1:8 (N=208;73)
    26
    9
        rSBA, M48, ≥ 1:128 (N=208;73)
    7
    4
        rSBA, M60, ≥ 1:8 (N=195;68)
    37
    17
        rSBA, M60, ≥ 1:128 (N=195;68)
    12
    7
    No statistical analyses for this end point

    Secondary: Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers

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    End point title
    		 Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
    End point description
    Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titers were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titers were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
    End point type
    Secondary
    End point timeframe
    At 1, 2, 3, 4, and 5 years after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    249
    89
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA, M12, (N=249;89)
    91.7 (75.6 to 111.3)
    63.8 (43.3 to 94.1)
        rSBA, M24, (N=235;86)
    39.3 (31.3 to 49.3)
    30.6 (20.1 to 46.7)
        rSBA, M36, (N=226;77)
    29.8 (23.6 to 37.6)
    21.8 (14.2 to 33.5)
        rSBA, M48, (N=208;73)
    5.3 (4.7 to 6)
    6 (4.5 to 8)
        rSBA, M60, (N=195;68)
    6.6 (5.6 to 7.8)
    8.5 (5.9 to 12.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values

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    End point title
    		 Number of subjects with anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
    End point description
    Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
    End point type
    Secondary
    End point timeframe
    At 1, 2, 3, 4, and 5 years after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    255
    91
    Units: Subjects
        Anti-PRP, M12, ≥ 0.15 μg/mL (N=255;91)
    252
    91
        Anti-PRP, M12, ≥ 1.0 μg/mL (N=255;91)
    209
    80
        Anti-PRP, M24, ≥ 0.15 μg/mL (N=237;84)
    235
    84
        Anti-PRP, M24, ≥ 1.0 μg/mL (N=237;84)
    174
    72
        Anti-PRP, M36, ≥ 0.15 μg/mL (N=233;78)
    231
    77
        Anti-PRP, M36, ≥ 1.0 μg/mL (N=233;78)
    164
    64
        Anti-PRP, M48, ≥ 0.15 μg/mL (N=204;73)
    202
    73
        Anti-PRP, M48, ≥ 1.0 μg/mL (N=204;73)
    144
    57
        Anti-PRP, M60, ≥ 0.15 μg/mL (N=191;67)
    191
    67
        Anti-PRP, M60, ≥ 1.0 μg/mL (N=191;67)
    129
    47
    No statistical analyses for this end point

    Secondary: Anti-polyribosylribitol Phosphate (Anti-PRP) antibody concentrations

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    End point title
    		 Anti-polyribosylribitol Phosphate (Anti-PRP) antibody concentrations
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    At 1, 2, 3, 4, and 5 years after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    255
    91
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, M12, (N=255; 91)
    3.55 (2.988 to 4.218)
    4.802 (3.708 to 6.218)
        Anti-PRP, M24, (N=237; 84)
    2.5 (2.1 to 3)
    3.3 (2.5 to 4.2)
        Anti-PRP, M36, (N=233; 78)
    2.234 (1.886 to 2.647)
    2.751 (2.113 to 3.582)
        Anti-PRP, M48, (N=204; 73)
    2.116 (1.773 to 2.524)
    2.964 (2.215 to 3.966)
        Anti-PRP, M60, (N=191; 67)
    2.131 (1.752 to 2.592)
    2.537 (1.815 to 3.546)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values

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    End point title
    		 Number of subjects with anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
    End point description
    Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    At 1, 2 and 3 years after vaccination.
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    250
    91
    Units: Subjects
        Anti-PSC, M12, ≥ 0.3 μg/mL (N=250;91)
    95
    33
        Anti-PSC, M12, ≥ 2.0 μg/mL (N=250;91)
    6
    0
        Anti-PSC, M24, ≥ 0.3 μg/mL (N=233;84)
    47
    17
        Anti-PSC, M24, ≥ 2.0 μg/mL (N=233;84)
    1
    1
        Anti-PSC, M36, ≥ 0.3 μg/mL (N=230;79)
    24
    8
        Anti-PSC, M36, ≥ 2.0 μg/mL (N=230;79)
    1
    1
    No statistical analyses for this end point

    Secondary: Anti-polysaccharide C (Anti-PSC) antibody concentrations

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    End point title
    		 Anti-polysaccharide C (Anti-PSC) antibody concentrations
    End point description
    Concentrations given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    At 1, 2 and 3 years after vaccination.
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    250 [3]
    91 [4]
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC, M12, (N=250; 91)
    0.27 (0.24 to 0.3)
    0.25 (0.21 to 0.29)
        Anti-PSC, M24, (N=233; 84)
    0.2 (0.2 to 0.2)
    0.2 (0.2 to 0.2)
        Anti-PSC, M36, (N=230; 79)
    0.17 (0.16 to 0.19)
    0.17 (0.16 to 0.19)
    Notes
    [3] - Lower and Upper limits of 95% confidence interval not reliable because of deviation from log normal
    [4] - Lower and Upper limits of 95% confidence interval not reliable because of deviation from log normal
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms

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    End point title
    		 Number of subjects reporting any solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Occurrence of any solicited local symptom regardless of their intensity grade.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0-3) after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    324
    109
    Units: Subjects
        Any pain
    91
    42
        Any redness
    146
    64
        Any swelling
    78
    41
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms

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    End point title
    		 Number of subjects reporting any solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite. Any = Occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C).
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0-3) after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    324
    109
    Units: Subjects
        Any drowsiness
    102
    40
        Any fever
    76
    30
        Any irritability/fussiness
    154
    69
        Any loss of appetite
    102
    40
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited symptoms

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    End point title
    		 Number of subjects reporting any unsolicited symptoms
    End point description
    Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0–30) after vaccination
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    324
    109
    Units: Subjects
        Any AE(s)
    217
    81
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any 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 or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the Active Phase of the study
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    324
    109
    Units: Subjects
        Any SAE(s)
    4
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any solicited 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 or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    At each visit of the long-term persistence phase (at 1 year up to 5 years after vaccination)
    End point values
    		 Menitorix Group Meningitec + Hiberix Group
    Number of subjects analysed
    295
    100
    Units: Subjects
        Any SAE(s), Y1
    0
    0
        Any SAE(s), Y2
    0
    0
        Any SAE(s), Y3
    0
    0
        Any SAE(s), Y4
    0
    0
        Any SAE(s), Y5
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    klUp to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
    Adverse event reporting additional description
    For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec + Hiberix Group
    Reporting group description
    		 -

    Serious adverse events
    		 Menitorix Group Meningitec + Hiberix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 324 (1.23%)
    2 / 109 (1.83%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Traumatic brain injury
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 109 (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
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 324 (0.31%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 324 (0.00%)
    1 / 109 (0.92%)
         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
    		 Menitorix Group Meningitec + Hiberix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    293 / 324 (90.43%)
    104 / 109 (95.41%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    91 / 324 (28.09%)
    42 / 109 (38.53%)
         occurrences all number
    91
    42
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    146 / 324 (45.06%)
    64 / 109 (58.72%)
         occurrences all number
    146
    64
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    78 / 324 (24.07%)
    41 / 109 (37.61%)
         occurrences all number
    78
    41
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 324 (31.48%)
    40 / 109 (36.70%)
         occurrences all number
    102
    40
    Fever (Rectally)
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 324 (23.46%)
    30 / 109 (27.52%)
         occurrences all number
    76
    30
    Irritability/Fussiness (unsolicited general symptom)
    alternative assessment type: Systematic
         subjects affected / exposed
    154 / 324 (47.53%)
    69 / 109 (63.30%)
         occurrences all number
    154
    69
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 324 (31.48%)
    40 / 109 (36.70%)
         occurrences all number
    102
    40
    Injection site reaction
         subjects affected / exposed
    7 / 324 (2.16%)
    10 / 109 (9.17%)
         occurrences all number
    7
    10
    Irritability
         subjects affected / exposed
    0 / 324 (0.00%)
    9 / 109 (8.26%)
         occurrences all number
    0
    9
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    25 / 324 (7.72%)
    8 / 109 (7.34%)
         occurrences all number
    25
    8
    Vomiting
         subjects affected / exposed
    22 / 324 (6.79%)
    9 / 109 (8.26%)
         occurrences all number
    22
    9
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    17 / 324 (5.25%)
    3 / 109 (2.75%)
         occurrences all number
    17
    3
    Skin and subcutaneous tissue disorders
    Pyrexia (unsolicited symptom)
         subjects affected / exposed
    37 / 324 (11.42%)
    13 / 109 (11.93%)
         occurrences all number
    37
    13
    Rash (unsolicited symptom)
         subjects affected / exposed
    24 / 324 (7.41%)
    17 / 109 (15.60%)
         occurrences all number
    24
    17
    Dermatitis diaper
         subjects affected / exposed
    9 / 324 (2.78%)
    9 / 109 (8.26%)
         occurrences all number
    9
    9
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    54 / 324 (16.67%)
    13 / 109 (11.93%)
         occurrences all number
    54
    13
    Teething
         subjects affected / exposed
    40 / 324 (12.35%)
    15 / 109 (13.76%)
         occurrences all number
    40
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jul 2006
    The primary vaccination calendar in Australia was modified since the release of the present protocol, ie Hib-TT combined with DTPa containing vaccine are now routinely given to infants in some regions. As a result, the inclusion criteria and the statistical section have been amended to take into account these changes.
    26 Feb 2007
    In order to improve the enrolment of subjects in the study, some sites may perform home visits. At the first home visit, the parents/guardians will be asked to sign a preinformed consent to allow the sites to collect some personal identifying information. This information will be recorded on a register which will help GSK and the study staff better prepare for and manage the first study visit if the parent/guardian subsequently decide to have their child/ward participate in the study. In order to be consistent throughout all study visits, the physical examinations during the persistence phase of the study do not need to be performed by the investigator. In protocol amendment 1, it was planned to perform all laboratory assays at Rixensart. The protocol was amended to allow for other validated laboratories designated by GSK Biologicals to perform the assays, if needed.

    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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