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    Clinical Trial Results:
    A phase III, randomized, controlled, single-blind study to evaluate the non-inferiority of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine compared to the 7-valent pneumococcal conjugate vaccine Prevenar™ when administered as a 3-dose primary immunization course at 2, 4 and 6 months of age, co-administered with GSK Biologicals’ Hiberix™ vaccine.

    Summary
    EudraCT number
    		 2015-001505-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 May 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Mar 2021
    First version publication date
    25 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    110808
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00680914
    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, 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
    31 Aug 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a three-dose primary vac-cination course in Korea is non-inferior to Prevenar for the immune response against at least 7 of the pneumococcal serotypes contained in the 10-valent pneumococcal conjugate vaccine.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 503
    Worldwide total number of subjects
    503
    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)
    503
    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 Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    This study was conducted in a single-blind manner meaning that the investigator and/or his staff were aware of the treatment assignment but the subject’s parent(s)/guardian(s) were not.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix Group
    Arm description
    		 Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal vaccine GSK1024850A (Synflorix)
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly.

    Investigational medicinal product name
    GSK Biologicals’ Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly.

    Arm title
    		 Prevenar Group
    Arm description
    		 Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK Biologicals’ Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly.

    Number of subjects in period 1
    		Synflorix Group Prevenar Group
    Started
    374
    129
    Completed
    364
    125
    Not completed
    10
    4
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    6
    3
         Lost to follow-up
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Group
    Reporting group description
    		 Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

    Reporting group values
    		 Synflorix Group Prevenar Group Total
    Number of subjects
    		 374 129 503
    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)
    		 9.5 ( 1.49 ) 9.5 ( 1.43 ) -
    Gender categorical
    Units: Subjects
        Female
    		 189 71 260
        Male
    		 185 58 243
    Region of enrollment
    Units: Subjects
        East Asia
    		 373 129 502
        Southeast Asia
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Synflorix Group
    Reporting group description
    		 Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

    Primary: Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value

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    End point title
    		 Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
    End point description
    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
    End point type
    Primary
    End point timeframe
    One month after administration of 3rd dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: Subjects
        Anti-1
    344
    7
        Anti-4
    343
    123
        Anti-5
    344
    18
        Anti-6B
    318
    121
        Anti-7F
    344
    4
        Anti-9V
    343
    122
        Anti-14
    342
    123
        Anti-18C
    343
    123
        Anti-19F
    340
    123
        Anti-23F
    331
    121
    Statistical analysis title
    		 Immune response non-inferiority–Anti-4
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.21
         upper limit
    		 1.81
    Notes
    [1] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-6B
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    5.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 9.86
    Notes
    [2] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-9V
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.66
         upper limit
    		 1.1
    Notes
    [3] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-14
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.92
         upper limit
    		 2.28
    Notes
    [4] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-18C
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.21
         upper limit
    		 1.81
    Notes
    [5] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-19F
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 3.15
    Notes
    [6] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-23F
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.65
         upper limit
    		 5.34
    Notes
    [7] - For each of the Prevenar™ vaccine serotypes, non-inferiority was demonstrated if the upper limit of the 2-sided 96.5% confidence interval (CI) (adjusted 1-sided alpha = 0.0175) of the difference between groups (Prevenar Group minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-1
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.18
    Notes
    [8] - For each of the 3 non-Prevenar™ vaccine serotypes (i.e., 1, 5 and 7F), non-inferiority was demonstrated if the upper limit of the 96.5% CI of the difference between the aggregate response for the Prevenar™ vaccine serotypes and responses to 1, 5 and 7F in Synflorix Group, (Aggregate 7Pn [=number of subjects in the Prevenar Group, multiplied by 7] minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-5
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.18
    Notes
    [9] - For each of the 3 non-Prevenar™ vaccine serotypes (i.e., 1, 5 and 7F), non-inferiority was demonstrated if the upper limit of the 96.5% CI of the difference between the aggregate response for the Prevenar™ vaccine serotypes and responses to 1, 5 and 7F in Synflorix Group, (Aggregate 7Pn [=number of subjects in the Prevenar Group, multiplied by 7] minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 mg/mL, was lower than 10%.
    Statistical analysis title
    		 Immune response non-inferiority –Anti-7F
    Statistical analysis description
    To demonstrate that GSK 1024850A vaccine administered as a three-dose primary vaccination course in Korea is non-inferior to Prevenar™ vaccine for the immune response against at least 7 of the pneumococcal serotypes contained in the GSK 1024850A vaccine.
    Comparison groups
    Synflorix Group v Prevenar Group
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.18
    Notes
    [10] - For each of the 3 non-Prevenar™ vaccine serotypes (i.e., 1, 5 and 7F), non-inferiority was demonstrated if the upper limit of the 96.5% CI of the difference between the aggregate response for the Prevenar™ vaccine serotypes and responses to 1, 5 and 7F in Synflorix Group, (Aggregate 7Pn [=number of subjects in the Prevenar Group, multiplied by 7] minus Synflorix Group), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 mg/mL, was lower than 10%.

    Secondary: Number of subjects with a seropositivity status against protein D and defined pneumococcal serotypes

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    End point title
    		 Number of subjects with a seropositivity status against protein D and defined pneumococcal serotypes
    End point description
    Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units (EL.U/mL). Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: Subjects
        Anti-PD
    343
    123
        Anti-1
    344
    44
        Anti-4
    344
    123
        Anti-5
    344
    85
        Anti-6B
    337
    122
        Anti-7F
    344
    22
        Anti-9V
    343
    123
        Anti-14
    344
    123
        Anti-18C
    344
    123
        Anti-19F
    344
    123
        Anti-23F
    340
    122
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against pneumococcal serotypes contained in the vaccine above the cut-off value

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    End point title
    		 Number of subjects with opsonophagocytic activity against pneumococcal serotypes contained in the vaccine above the cut-off value
    End point description
    The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    165
    63
    Units: Subjects
        Opsono-1 (N=162; 62)
    150
    8
        Opsono-4 (N=161; 63)
    158
    63
        Opsono-5 (N=165; 62)
    161
    6
        Opsono-6B (N=162; 63)
    152
    63
        Opsono-7F (N=164; 59)
    164
    40
        Opsono-9V (N= 165; 63)
    164
    62
        Opsono-14 (N= 165; 63)
    163
    62
        Opsono-18C (N= 159; 63)
    142
    61
        Opsono-19F (N=164; 61)
    159
    55
        Opsono-23F (N= 164; 63)
    160
    62
    No statistical analyses for this end point

    Secondary: Number of Subjects With cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

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    End point title
    		 Number of Subjects With cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
    End point description
    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: Subjects
        Anti-6A
    232
    85
        Anti-19A
    203
    33
    No statistical analyses for this end point

    Secondary: Antibody concentrations against Pneumococal serotypes contained in the vaccine

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    End point title
    		 Antibody concentrations against Pneumococal serotypes contained in the vaccine
    End point description
    Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1
    3.41 (3.14 to 3.71)
    0.04 (0.04 to 0.05)
        Anti-4
    4 (3.67 to 4.35)
    5.35 (4.66 to 6.15)
        Anti-5
    4.52 (4.24 to 4.83)
    0.07 (0.06 to 0.08)
        Anti-6B
    1.4 (1.24 to 1.58)
    2.07 (1.75 to 2.44)
        Anti-7F
    4.08 (3.77 to 4.41)
    0.03 (0.03 to 0.04)
        Anti-9V
    3.39 (3.09 to 3.71)
    5.09 (4.34 to 5.96)
        Anti-14
    5.54 (5.02 to 6.12)
    8.51 (7.27 to 9.95)
        Anti-18C
    5.8 (5.17 to 6.52)
    5.13 (4.31 to 6.11)
        Anti-19F
    7.41 (6.67 to 8.23)
    2.77 (2.45 to 3.13)
        Anti-23F
    1.96 (1.75 to 2.19)
    3.94 (3.26 to 4.77)
    No statistical analyses for this end point

    Secondary: Anti-PD Antibody Concentration

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    End point title
    		 Anti-PD Antibody Concentration
    End point description
    Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: EL.U/mL.
        geometric mean (confidence interval 95%)
    1622.4 (1500.8 to 1754)
    88.2 (74.7 to 104)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal cross-reactive serotypes

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    End point title
    		 Antibody concentrations against pneumococcal cross-reactive serotypes
    End point description
    Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    344
    123
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A
    0.38 (0.33 to 0.44)
    0.48 (0.36 to 0.63)
        Anti-19A
    0.29 (0.25 to 0.33)
    0.12 (0.1 to 0.14)
    No statistical analyses for this end point

    Secondary: Number of subjects with Opsonophagocytic activity against pneumococcal cross-reactive serotypes

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    End point title
    		 Number of subjects with Opsonophagocytic activity against pneumococcal cross-reactive serotypes
    End point description
    The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    162
    60
    Units: Subjects
        Opsono-6A (N=158; 60)
    134
    54
        Opsono-19A (N= 162; 60)
    53
    7
    No statistical analyses for this end point

    Secondary: Anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentrations

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    End point title
    		 Anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentrations
    End point description
    Concentration of anti-PRP antibody given as GMC in ug/mL.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    175
    60
    Units: µg/mL
        geometric mean (confidence interval 95%)
    20.131 (16.775 to 24.158)
    11.844 (8.542 to 16.424)
    No statistical analyses for this end point

    Secondary: Number of subjects with Seroprotection status against PRP

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    End point title
    		 Number of subjects with Seroprotection status against PRP
    End point description
    Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    175
    60
    Units: Subjects
        Above 0.15
    175
    60
        Above 1.0
    173
    58
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    Within 4 days after each vaccination
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    371
    129
    Units: Subjects
        Pain
    210
    72
        Redness
    252
    84
        Swelling
    182
    69
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature >= 37.5 degrees Celsius.
    End point type
    Secondary
    End point timeframe
    Within 4 days after each vaccination
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    371
    129
    Units: Subjects
        Drowsiness
    212
    65
        Fever
    113
    33
        Irritability
    293
    99
        Loss of Appetite
    177
    66
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events

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    End point title
    		 Number of subjects reporting unsolicited adverse events
    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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 31 days after each vaccination
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    374
    129
    Units: Subjects
    213
    62
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAE)
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    374
    129
    Units: Subjects
    56
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to study Month 5
    Adverse event reporting additional description
    Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. 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
    Synflorix Group
    Reporting group description
    		 Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

    Serious adverse events
    		 Synflorix Group Prevenar Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    56 / 374 (14.97%)
    9 / 129 (6.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
         subjects affected / exposed
    2 / 374 (0.53%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 374 (0.27%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    22 / 374 (5.88%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 374 (2.14%)
    3 / 129 (2.33%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    9 / 374 (2.41%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 374 (1.07%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infections
         subjects affected / exposed
    2 / 374 (0.53%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    2 / 374 (0.53%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    3 / 374 (0.80%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    2 / 374 (0.53%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site abscess
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 374 (0.27%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 129 (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 bronchiolitis
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 374 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix Group Prevenar Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    357 / 374 (95.45%)
    124 / 129 (96.12%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    210 / 374 (56.15%)
    72 / 129 (55.81%)
         occurrences all number
    210
    72
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    252 / 374 (67.38%)
    84 / 129 (65.12%)
         occurrences all number
    252
    84
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    182 / 374 (48.66%)
    69 / 129 (53.49%)
         occurrences all number
    182
    69
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    212 / 374 (56.68%)
    65 / 129 (50.39%)
         occurrences all number
    212
    65
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    113 / 374 (30.21%)
    33 / 129 (25.58%)
         occurrences all number
    113
    33
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    293 / 374 (78.34%)
    99 / 129 (76.74%)
         occurrences all number
    293
    99
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    177 / 374 (47.33%)
    66 / 129 (51.16%)
         occurrences all number
    177
    66
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    44 / 374 (11.76%)
    16 / 129 (12.40%)
         occurrences all number
    44
    16
    Nasopharyngitis
         subjects affected / exposed
    42 / 374 (11.23%)
    16 / 129 (12.40%)
         occurrences all number
    42
    16
    Bronchiolitis
         subjects affected / exposed
    36 / 374 (9.63%)
    4 / 129 (3.10%)
         occurrences all number
    36
    4
    Pharyngitis
         subjects affected / exposed
    26 / 374 (6.95%)
    6 / 129 (4.65%)
         occurrences all number
    26
    6
    Bronchitis
         subjects affected / exposed
    14 / 374 (3.74%)
    7 / 129 (5.43%)
         occurrences all number
    14
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Feb 2008
    The protocol has been amended according to comments received from the Korean FDA. In addition, the Detailed Study Title has been corrected.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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