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    Clinical Trial Results:
    A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age.

    Summary
    EudraCT number
    		 2007-004002-26
    Trial protocol
    		 NL  
    Global end of trial date
    01 Dec 2010

    Results information
    Results version number
    		 v1
    This version publication date
    25 Feb 2016
    First version publication date
    19 Jun 2015
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    110142, 111053
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00652951
    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
    12 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2010
    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 when co-administered with DTPa-IPV-Hib (Pediacel) (10Pn-PDC group) is non-inferior to co-administration with DTPa-HBV-IPV/Hib (Infanrix hexa) (10Pn-Hexa group), in terms of immune response to the 10 pneumococcal vaccine serotypes and to protein D, when administered as a three-dose primary vaccination course. Criteria for non-inferiority: For each of the 10 pneumococcal vaccine serotypes and protein D, non-inferiority will be demonstrated if the upper limit of the 2-sided 95% CI of the GMC ratio between groups (10Pn-Hexa group over 10Pn-PDC group), is lower than 2.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available in case of a rare anaphylactic reaction. 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. Also, all Intramuscular injections were administered into the anterolateral region of the thigh or into the deltoid. The buttock was not used for administration of vaccines because of the potential risk of injury to the sciatic nerve and the risk of decreased immunogenicity because of inadvertent subcutaneous injection or injection into deep fat tissue. For all intramuscular injections, the needle was selected long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue, but not so long as to involve underling nerves and blood vessels or bone. Vaccinators were familiar with the anatomy of the area into which they are injecting vaccine. When appropriate, an individual decision on needle size and site of injection was made for each person on the basis of age, and the size of the muscle. Subjects were followed-up for 31 days after the last vaccination/product administration for adverse events following vaccination. Subjects were also followed during the entire study period for serious adverse events (SAEs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 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
    Netherlands: 780
    Worldwide total number of subjects
    780
    EEA total number of subjects
    780
    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)
    780
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study included a Primary (PRI) Phase, up to Month 3, followed by a Booster (BST) Phase, up to Month 9.

    Pre-assignment
    Screening details
    		 At screening the following was performed: informed consent was obtained and signed from subjects’ parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed as regards to vaccination, and medical history of subjects was collected. Subjects’ pre-vaccination body temperature was evaluated.

    Period 1
    Period 1 title
    Primary Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn-PD-DiT, 10Pn, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    DTPa-HBV-IPV/Hib
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Arm title
    		 10Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn-PD-DiT, 10Pn, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Pediacel
    Investigational medicinal product code
    DTPa-IPV-Hib
    Other name
    DTPa-IPV-Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Arm title
    		 7Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine(Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    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 at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Pediacel
    Investigational medicinal product code
    DTPa-IPV-Hib
    Other name
    DTPa-IPV-Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Number of subjects in period 1
    		10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-HBV-IPV/Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Started
    260
    260
    260
    Completed
    260
    260
    260
    Period 2
    Period 2 title
    Booster Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn-PD-DiT, 10Pn, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    DTPa-HBV-IPV/Hib
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Arm title
    		 10Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn-PD-DiT, 10Pn, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Pediacel
    Investigational medicinal product code
    DTPa-IPV-Hib
    Other name
    DTPa-IPV-Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Arm title
    		 7Pn+DTPa-HBV-IPV/Hib Group
    Arm description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine(Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn; 7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.
    Arm type
    		 Experimental

    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 at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Pediacel
    Investigational medicinal product code
    DTPa-IPV-Hib
    Other name
    DTPa-IPV-Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 2, 3 and 4 months of age (Study Months 0, 1, 2) followed by a booster dose between 11 and 13 months of age (Study Month 9). Vaccine was administered in the left thigh or deltoid.

    Number of subjects in period 2 [1]
    		10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-HBV-IPV/Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Started
    257
    259
    258
    Completed
    256
    258
    258
    Not completed
    1
    1
    0
         Adverse event, non-fatal
    -
    1
    -
         Not specified
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 6 subjects did not join the study for the BST phase, 3 subjects from the 10Pn+DTPa-HBV-IPV/Hib Group, 1 subject from the 10Pn+DTPa-IPV-Hib Group and 2 subjects from the 7Pn+DTPa-IPV-Hib Group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.

    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.

    Reporting group title
    7Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine(Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.

    Reporting group values
    		 10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-HBV-IPV/Hib Group 7Pn+DTPa-HBV-IPV/Hib Group Total
    Number of subjects
    		 260 260 260 780
    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)
    		 7.4 ( 1.2 ) 7.6 ( 1.29 ) 7.6 ( 1.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 118 130 136 384
        Male
    		 142 130 124 396

    End points

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    End points reporting groups
    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.

    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.

    Reporting group title
    7Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine(Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.
    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.

    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.

    Reporting group title
    7Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine(Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn; 7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.

    Primary: Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F)

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    End point title
    		 Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F)
    End point description
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measure by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA) Assay; calculated, expressed as geometric mean concentrations (GMCs) and tabulated. The seropositivity cut-off for the assay was >= 0.05 microgram per millilitre (microg/mL).
    End point type
    Primary
    End point timeframe
    At Month 3, aka one month after the administration of the third dose of pneumococcal conjugate vaccine
    End point values
    		 10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-HBV-IPV/Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    194
    189
    192
    Units: microg/mL
    geometric mean (confidence interval 95%)
        Anti-1 (N=181;178;178)
    1.17 (1.02 to 1.33)
    1.31 (1.16 to 1.48)
    0.03 (0.03 to 0.03)
        Anti-4 (N=192;185;191)
    1.61 (1.41 to 1.84)
    1.59 (1.38 to 1.83)
    2.44 (2.19 to 2.73)
        Anti-5 (N=187;181;178)
    2.11 (1.88 to 2.37)
    2.16 (1.92 to 2.43)
    0.03 (0.03 to 0.03)
        Anti-6B (N=177;174;180)
    0.33 (0.26 to 0.4)
    0.35 (0.28 to 0.43)
    0.41 (0.34 to 0.51)
        Anti-7F (N=192;187;183)
    1.7 (1.52 to 1.9)
    1.77 (1.57 to 1.99)
    0.04 (0.03 to 0.04)
        Anti-9V (N=185;186;187)
    1.4 (1.2 to 1.63)
    1.47 (1.29 to 1.68)
    2.14 (1.91 to 2.4)
        Anti-14 (N=192;187;192)
    3.38 (2.99 to 3.81)
    3.33 (2.93 to 3.78)
    3.64 (3.24 to 4.1)
        Anti-18C (N=194;189;191)
    1.73 (1.45 to 2.05)
    1.07 (0.92 to 1.25)
    2.1 (1.83 to 2.4)
        Anti-19F (N=189;183;189)
    2.07 (1.73 to 2.48)
    1.96 (1.64 to 2.34)
    3.04 (2.71 to 3.42)
        Anti-23F (N=179;175;184)
    0.5 (0.41 to 0.6)
    0.54 (0.44 to 0.66)
    1.24 (1.04 to 1.47)
    Statistical analysis title
    		 Immune response non-inferiority - serotype 1
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.07
    Notes
    [1] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 4
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.23
    Notes
    [2] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 5
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.15
    Notes
    [3] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 6B
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.26
    Notes
    [4] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 7F
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.13
    Statistical analysis title
    		 Immune response non-inferiority - serotype 9V
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.16
    Notes
    [5] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 14
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.21
    Notes
    [6] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 18C
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    		 Regression, Cox
    Parameter type
    		 GMC ratio
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 2.03
    Notes
    [7] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 19F
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.23
    Notes
    [8] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.
    Statistical analysis title
    		 Immune response non-inferiority - serotype 23F
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    383
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.23
    Notes
    [9] - The non-inferiority objective was reached if the upper limit of the 2-sided 95% CI of the GMC ratio for between groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), was lower than 2, for each of the 10 pneumococcal serotypes and protein D.

    Primary: Antibody concentration against protein D (PD).

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    End point title
    		 Antibody concentration against protein D (PD).
    End point description
    Anti-PD antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs) and tabulated. The seropositivity cut-off for the assay was >= 100 Enzyme-Linked ImmunoSobent Assay (ELISA) units per millilitre (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Month 3, aka one month after the administration of the third dose of pneumococcal conjugate vaccine
    End point values
    		 10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-HBV-IPV/Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects analysed
    195
    189
    182
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD
    1580 (1409.5 to 1771.1)
    1743 (1560.2 to 1947.2)
    69.7 (63 to 77.1)
    Statistical analysis title
    		 Immune response non-inferiority - protein D
    Statistical analysis description
    The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the 10Pn+DTPa-HBV-IPV/Hib and 10Pn+DTPa-IPV-Hib groups (10Pn+DTPa-HBV-IPV/Hib Group over 10Pn+DTPa-IPV-Hib Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.
    Comparison groups
    10Pn+DTPa-HBV-IPV/Hib Group v 10Pn+DTPa-HBV-IPV/Hib Group
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.06

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms & Unsolicited AEs: During the 4-and 31-days period(s) post primary (PRI) or booster (BST) vaccinations, respectively; SAEs: from study start to study end
    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
    14.0
    Reporting groups
    Reporting group title
    10Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-HBV-IPV/Hib vaccine (Infanrix hexa by GSK Biologicals) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-HBV-IPV/Hib) thigh or deltoid.

    Reporting group title
    10Pn+DTPa-IPV-Hib Group
    Reporting group description
    		 Subjects received 3 doses of 10Pn-PD-DiT (or GSK1024850A) vaccine co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (10Pn-PD-DiT) or left (DTPa-IPV/Hib) thigh or deltoid.

    Reporting group title
    7Pn+DTPa-HBV-IPV/Hib Group
    Reporting group description
    		 Subjects received 3 doses of 7Pn vaccine (or Prevenar by Pfizer [formerly Wyeth Lederle Vaccines S.A.]) co-administered with DTPa-IPV-Hib vaccine (Pediacel by Sanofi Pasteur MSD) at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (7Pn) or left (DTPa-IPV-Hib; DTPa-HBV-IPV/Hib) thigh or deltoid.

    Serious adverse events
    		 10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-IPV-Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 260 (13.46%)
    26 / 260 (10.00%)
    35 / 260 (13.46%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    3 / 260 (1.15%)
    2 / 260 (0.77%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Greenstick fracture
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Velo-cardio-facial syndrome
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adhesion
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 260 (0.38%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Coeliac disease
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal stenosis
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 260 (0.00%)
    2 / 260 (0.77%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apparent life threatening event
         subjects affected / exposed
    2 / 260 (0.77%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 260 (0.77%)
    1 / 260 (0.38%)
    4 / 260 (1.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    3 / 260 (1.15%)
    1 / 260 (0.38%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 260 (3.08%)
    4 / 260 (1.54%)
    5 / 260 (1.92%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 260 (0.38%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 260 (0.38%)
    2 / 260 (0.77%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    3 / 260 (1.15%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 260 (0.38%)
    2 / 260 (0.77%)
    3 / 260 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    3 / 260 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    5 / 260 (1.92%)
    2 / 260 (0.77%)
    5 / 260 (1.92%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 260 (0.38%)
    0 / 260 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 260 (0.38%)
    1 / 260 (0.38%)
    4 / 260 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 260 (0.00%)
    2 / 260 (0.77%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 260 (0.00%)
    0 / 260 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Feeding disorder neonatal
         subjects affected / exposed
    0 / 260 (0.00%)
    1 / 260 (0.38%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10Pn+DTPa-HBV-IPV/Hib Group 10Pn+DTPa-IPV-Hib Group 7Pn+DTPa-HBV-IPV/Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    241 / 260 (92.69%)
    230 / 260 (88.46%)
    235 / 260 (90.38%)
    General disorders and administration site conditions
    Pyrexia - BST
         subjects affected / exposed [1]
    16 / 257 (6.23%)
    13 / 259 (5.02%)
    21 / 258 (8.14%)
         occurrences all number
    16
    13
    21
    Pain - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    205 / 260 (78.85%)
    193 / 260 (74.23%)
    178 / 260 (68.46%)
         occurrences all number
    205
    193
    178
    Redness - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    197 / 260 (75.77%)
    193 / 260 (74.23%)
    184 / 260 (70.77%)
         occurrences all number
    197
    193
    184
    Swelling - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    205 / 260 (78.85%)
    199 / 260 (76.54%)
    179 / 260 (68.85%)
         occurrences all number
    205
    199
    179
    Pain - BST
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    174 / 257 (67.70%)
    161 / 259 (62.16%)
    145 / 258 (56.20%)
         occurrences all number
    174
    161
    145
    Redness – BST
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    175 / 257 (68.09%)
    144 / 259 (55.60%)
    180 / 258 (69.77%)
         occurrences all number
    175
    144
    180
    Swelling - BST
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    185 / 257 (71.98%)
    146 / 259 (56.37%)
    160 / 258 (62.02%)
         occurrences all number
    185
    146
    160
    Drowsiness - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    231 / 260 (88.85%)
    220 / 260 (84.62%)
    215 / 260 (82.69%)
         occurrences all number
    231
    220
    215
    Rectal Temperature >=38.0°C - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    153 / 260 (58.85%)
    124 / 260 (47.69%)
    110 / 260 (42.31%)
         occurrences all number
    153
    124
    110
    Irritability - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    241 / 260 (92.69%)
    230 / 260 (88.46%)
    235 / 260 (90.38%)
         occurrences all number
    241
    230
    235
    Loss of appetite - PRI
    alternative dictionary used: MedDRA 12.1
    alternative assessment type: Systematic
         subjects affected / exposed
    155 / 260 (59.62%)
    145 / 260 (55.77%)
    153 / 260 (58.85%)
         occurrences all number
    155
    145
    153
    Drowsiness – BST
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    131 / 257 (50.97%)
    118 / 259 (45.56%)
    128 / 258 (49.61%)
         occurrences all number
    131
    118
    128
    Rectal Temperature >=38.0°C – BST
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    100 / 257 (38.91%)
    100 / 259 (38.61%)
    103 / 258 (39.92%)
         occurrences all number
    100
    100
    103
    Irritability – BST
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    167 / 257 (64.98%)
    161 / 259 (62.16%)
    166 / 258 (64.34%)
         occurrences all number
    167
    161
    166
    Loss of appetite - BST
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    93 / 257 (36.19%)
    83 / 259 (32.05%)
    111 / 258 (43.02%)
         occurrences all number
    93
    83
    111
    Gastrointestinal disorders
    Diarrhoea - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    15 / 260 (5.77%)
    14 / 260 (5.38%)
    12 / 260 (4.62%)
         occurrences all number
    15
    14
    12
    Vomiting - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    11 / 260 (4.23%)
    13 / 260 (5.00%)
    0 / 260 (0.00%)
         occurrences all number
    11
    13
    0
    Respiratory, thoracic and mediastinal disorders
    Wheezing - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    15 / 260 (5.77%)
    7 / 260 (2.69%)
    10 / 260 (3.85%)
         occurrences all number
    15
    7
    10
    Skin and subcutaneous tissue disorders
    Eczema - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    24 / 260 (9.23%)
    15 / 260 (5.77%)
    18 / 260 (6.92%)
         occurrences all number
    24
    15
    18
    Infections and infestations
    Upper respiratory tract infection - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    99 / 260 (38.08%)
    108 / 260 (41.54%)
    111 / 260 (42.69%)
         occurrences all number
    99
    108
    111
    Gastroenteritis - PRI
    alternative dictionary used: MedDRA 12.1
         subjects affected / exposed
    16 / 260 (6.15%)
    13 / 260 (5.00%)
    13 / 260 (5.00%)
         occurrences all number
    16
    13
    13
    Viral infection - BST
         subjects affected / exposed [9]
    5 / 257 (1.95%)
    17 / 259 (6.56%)
    5 / 258 (1.94%)
         occurrences all number
    5
    17
    5
    Upper respiratory tract infection - BST
         subjects affected / exposed [10]
    27 / 257 (10.51%)
    32 / 259 (12.36%)
    34 / 258 (13.18%)
         occurrences all number
    27
    32
    34
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this specified phase was performed solely on subjects with available results.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2007
    A first amendment was made to the protocol in response to comments from the Dutch Authorities to clarify that this study was a single-centre study.
    30 Jan 2008
    On request of the Dutch Authorities, a second amendment to the protocol was made. Changes concerned the study design: 1) Before vaccination at Visit 1 no blood sample was to be collected; 2) The priority ranking for testing of opsonophagocytic activity (OPA) activity against the 10 pneumococcal vaccine serotypes in case of insufficient blood sample volume was changed; 3) Testing of OPA activity against the 10 pneumococcal vaccine serotypes was to be done for all subjects i.e. all subjects for which the amount of remaining/available serum is sufficient; 4) The sample size was increased.
    14 Aug 2008
    Changes concerned the study design: 1) To collect information about factors that could potentially influence nasopharyngeal carriage of Streptococcus (S.). pneumoniae and Haemophilus (H.) influenzae, it was planned that the subjects’ parents/ guardian(s) would be asked some questions at Visits 4, 5, 7, 8 and 9; 2) The recruitment period was changed to 9 months.
    22 Mar 2010
    The following changes were introduced: 1) Due to the H1N1 influenza pandemic, the children were offered H1N1 influenza vaccine as part of a national pandemic prevention plan. Thus, the age range for the booster vaccination visit and subsequent visits was extended; 2) Further details on microbiological testing were included; 3) A second Interim Analysis was added to evaluate carriage (at 3 timepoints) using classical methods for bacterial identification / typing, additional microbiological techniques for H. influenzae/H. haemolyticus discrimination and quantitative molecular techniques for H. influenzae carriage; 4) The back-up contact details for reporting SAEs were updated.

    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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