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    Clinical Trial Results:
    An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule.

    Summary
    EudraCT number
    		 2005-003437-41
    Trial protocol
    		 SE   DK   SK  
    Global end of trial date
    25 Jan 2007

    Results information
    Results version number
    		 v3(current)
    This version publication date
    13 Apr 2023
    First version publication date
    14 Mar 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    105539
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00307034
    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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the post-dose 2 immune response elicited by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered according to a 2-4-11 months vaccination schedule with co-administration of DTPa combined 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/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 75
    Country: Number of subjects enrolled
    Sweden: 61
    Country: Number of subjects enrolled
    Denmark: 130
    Country: Number of subjects enrolled
    Norway: 85
    Worldwide total number of subjects
    351
    EEA total number of subjects
    351
    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)
    351
    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
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 351
    Number of subjects completed
    		 351

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix I Group
    Arm description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals' 10-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 primary doses of 10Pn-PD-DiT vaccine were administered at 2 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 3rd dose of 10Pn-PD-DiT (i.e. booster dose) was administered at 11 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib, DTPa combined vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of DTPa combined vaccine were administered at 2 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 3rd dose of DTPa combined vaccine was administered at 11 months of age.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa-IPV/Hib, DTPa combined vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of DTPa combined vaccine were administered at 2 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 3rd dose of DTPa combined vaccine was administered at 11 months of age.

    Arm title
    		 Synflorix II Group
    Arm description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix vaccine at 11 months of age, co-administered with one dose of the Infanrix combined vaccine, according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.
    Arm type
    		 Comparator

    Investigational medicinal product name
    GSK Biologicals' 10-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 primary doses of 10Pn-PD-DiT vaccine and 3 doses of DTPa combined vaccine were co-administered at 2, 3 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 4th dose of 10Pn-PD-DiT (i.e. booster dose) was co-administered with a 3rd dose of DTPa combined vaccine at 11 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib, DTPa combined vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of DTPa combined vaccine were administered at 2 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 3rd dose of DTPa combined vaccine was administered at 11 months of age.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa-IPV/Hib, DTPa combined vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of DTPa combined vaccine were administered at 2 and 4 months of age, with first vaccine dose administered at 8-16 weeks of age. A 3rd dose of DTPa combined vaccine was administered at 11 months of age.

    Number of subjects in period 1
    		Synflorix I Group Synflorix II Group
    Started
    175
    176
    Completed
    173
    169
    Not completed
    2
    7
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix I Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Reporting group title
    Synflorix II Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix vaccine at 11 months of age, co-administered with one dose of the Infanrix combined vaccine, according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Reporting group values
    		 Synflorix I Group Synflorix II Group Total
    Number of subjects
    		 175 176 351
    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)
    		 12 ( 1.94 ) 12.1 ( 1.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 86 82 168
        Male
    		 89 94 183

    End points

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    End points reporting groups
    Reporting group title
    Synflorix I Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Reporting group title
    Synflorix II Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix vaccine at 11 months of age, co-administered with one dose of the Infanrix combined vaccine, according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Primary: Number of Seroprotected Subjects Against Pneumococcal Serotypes

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    End point title
    		 Number of Seroprotected Subjects Against Pneumococcal Serotypes [1]
    End point description
    A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.
    End point type
    Primary
    End point timeframe
    One month post-dose 2 (Month 3) administration of Synflorix vaccine
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    153
    153
    Units: Subjects
        Anti-1 (N= 153, 151)
    149
    149
        Anti-4 (N=153, 153)
    150
    152
        Anti-5 (N=152, 149)
    146
    149
        Anti-6B (N=149, 149)
    83
    94
        Anti-7F (N=153, 152)
    148
    151
        Anti-9V (N=152, 153)
    142
    152
        Anti-14 (N=152, 152)
    146
    152
        Anti-18C (N=152, 153)
    146
    152
        Anti-19F (N=152, 152)
    141
    146
        Anti-23F (N=153, 152)
    106
    118
    No statistical analyses for this end point

    Secondary: Number of Seroprotected Subjects Against Pneumococcal Serotypes

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    End point title
    		 Number of Seroprotected Subjects Against Pneumococcal Serotypes
    End point description
    A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    156
    149
    Units: Subjects
        Anti-1 at Month 9 (N= 149, 147)
    77
    101
        Anti-1 at Month 10 (N=156, 147)
    155
    147
        Anti-4 at Month 9 (N= 152, 149)
    120
    137
        Anti-4 at Month 10 (N=155, 147)
    155
    147
        Anti-5 at Month 9 (N= 148, 149)
    121
    133
        Anti-5 at Month 10 (N=155, 147)
    155
    147
        Anti-6B at Month 9 (N= 154, 148)
    101
    111
        Anti-6B at Month 10 (N=156, 147)
    138
    142
        Anti-7F at Month 9 (N= 151, 149)
    135
    146
        Anti-7F at Month 10 (N=156, 147)
    156
    147
        Anti-9V at Month 9 (N= 153, 149)
    133
    142
        Anti-9V at Month 10 (N=156, 147)
    155
    147
        Anti-14 at Month 9 (N= 151, 149)
    140
    147
        Anti-14 at Month 10 (N=156, 147)
    155
    145
        Anti-18C at Month 9 (N= 154, 149)
    133
    144
        Anti-18C at Month 10 (N=156, 147)
    156
    146
        Anti-19F at Month 9 (N= 153, 149)
    140
    143
        Anti-19F at Month 10 (N=156, 147)
    150
    144
        Anti-23F at Month 9 (N= 151, 148)
    108
    116
        Anti-23F at Month 10 (N=154, 147)
    148
    141
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Pneumococcal Serotypes

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    End point title
    		 Antibody Concentrations Against Pneumococcal Serotypes
    End point description
    The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    156
    153
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 at Month 3 (N= 153, 151)
    1.03 (0.9 to 1.18)
    1.23 (1.07 to 1.42)
        Anti-1 at Month 9 (N= 149, 147)
    0.21 (0.19 to 0.24)
    0.3 (0.26 to 0.34)
        Anti-1 at Month 10 (N=156, 147)
    1.85 (1.59 to 2.15)
    1.88 (1.62 to 2.17)
        Anti-4 at Month 3 (N= 153, 153)
    1.37 (1.21 to 1.55)
    1.71 (1.47 to 1.99)
        Anti-4 at Month 9 (N= 152, 149)
    0.4 (0.35 to 0.46)
    0.64 (0.56 to 0.73)
        Anti-4 at Month 10 (N=155, 147)
    3.06 (2.68 to 3.49)
    3.47 (3.03 to 3.98)
        Anti-5 at Month 3 (N= 152, 149)
    1.32 (1.14 to 1.52)
    1.85 (1.63 to 2.1)
        Anti-5 at Month 9 (N= 148, 149)
    0.43 (0.37 to 0.5)
    0.59 (0.51 to 0.68)
        Anti-5 at Month 10 (N=155, 147)
    2.65 (2.31 to 3.03)
    3.21 (2.81 to 3.67)
        Anti-6B at Month 3 (N= 149, 149)
    0.19 (0.15 to 0.24)
    0.31 (0.25 to 0.38)
        Anti-6B at Month 9 (N= 154, 148)
    0.28 (0.23 to 0.35)
    0.44 (0.36 to 0.54)
        Anti-6B at Month 10 (N=156, 147)
    1.12 (0.88 to 1.41)
    1.85 (1.54 to 2.22)
        Anti-7F at Month 3 (N= 153, 152)
    1.28 (1.13 to 1.46)
    2.14 (1.9 to 2.4)
        Anti-7F at Month 9 (N= 151, 149)
    0.55 (0.49 to 0.63)
    0.92 (0.81 to 1.05)
        Anti-7F at Month 10 (N=156, 147)
    2.81 (2.51 to 3.15)
    3.88 (3.45 to 4.37)
        Anti-9V at Month 3 (N= 152, 153)
    0.92 (0.81 to 1.05)
    1.47 (1.29 to 1.68)
        Anti-9V at Month 9 (N= 153, 149)
    0.52 (0.46 to 0.6)
    0.87 (0.77 to 0.99)
        Anti-9V at Month 10 (N=156, 147)
    2.95 (2.59 to 3.37)
    3.97 (3.49 to 4.5)
        Anti-14 at Month 3 (N= 152, 152)
    1.72 (1.45 to 2.05)
    2.57 (2.22 to 2.97)
        Anti-14 at Month 9 (N= 151, 149)
    0.77 (0.64 to 0.93)
    1.53 (1.27 to 1.85)
        Anti-14 at Month 10 (N=156, 147)
    4.19 (3.62 to 4.85)
    5.47 (4.68 to 6.4)
        Anti-18C at Month 3 (N= 152, 153)
    1.26 (1.06 to 1.51)
    3.42 (2.87 to 4.07)
        Anti-18C at Month 9 (N= 154, 149)
    0.59 (0.5 to 0.69)
    1.14 (0.96 to 1.35)
        Anti-18C at Month 10 (N=156, 147)
    6.24 (5.43 to 7.18)
    7.2 (6.08 to 8.52)
        Anti-19F at Month 3 (N= 152, 152)
    2.43 (1.97 to 2.98)
    4.43 (3.6 to 5.45)
        Anti-19F at Month 9 (N= 153, 149)
    1.04 (0.87 to 1.25)
    1.7 (1.41 to 2.04)
        Anti-19F at Month 10 (N=156, 147)
    5.58 (4.65 to 6.69)
    6.95 (5.92 to 8.17)
        Anti-23F at Month 3 (N= 153, 152)
    0.38 (0.3 to 0.47)
    0.52 (0.42 to 0.63)
        Anti-23F at Month 9 (N= 151, 148)
    0.32 (0.26 to 0.4)
    0.44 (0.36 to 0.54)
        Anti-23F at Month 10 (N=154, 147)
    2.41 (1.98 to 2.94)
    2.78 (2.31 to 3.35)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

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    End point title
    		 Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
    End point description
    Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    136
    135
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-1 at Month 3 (N= 130, 132)
    21.9 (16.4 to 29.1)
    26.5 (19.8 to 35.4)
        Opsono-1 at Month 9 (N= 136, 134)
    5.1 (4.5 to 5.8)
    6.7 (5.4 to 8.3)
        Opsono-1 at Month 10 (N=131, 126)
    109.9 (76.1 to 158.7)
    100.6 (68.9 to 146.9)
        Opsono-4 at Month 3 (N= 134, 132)
    462.6 (410.4 to 521.4)
    758.9 (647.8 to 888.9)
        Opsono-4 at Month 9 (N= 104, 114)
    13.8 (9.7 to 19.6)
    18.6 (12.7 to 27.2)
        Opsono-4 at Month 10 (N=125, 101)
    634.6 (496.3 to 811.3)
    1204 (990.7 to 1463.2)
        Opsono-5 at Month 3 (N= 132, 130)
    48.3 (37.7 to 61.8)
    68.4 (54 to 86.5)
        Opsono-5 at Month 9 (N= 133, 135)
    9.9 (8.1 to 12)
    10.7 (8.6 to 13.4)
        Opsono-5 at Month 10 (N=133, 121)
    102.1 (75.8 to 137.6)
    157.2 (123.1 to 200.7)
        Opsono-6B at Month 3 (N= 125, 126)
    157.8 (104.7 to 237.8)
    379.6 (272.4 to 529.1)
        Opsono-6B at Month 9 (N= 121, 124)
    56.1 (34.9 to 90.4)
    62.9 (40.2 to 98.5)
        Opsono-6B at Month 10 (N=132, 103)
    220.3 (146.9 to 330.3)
    468.5 (311.6 to 704.3)
        Opsono-7F at Month 3 (N= 127, 131)
    844.8 (591.4 to 1206.7)
    2176.5 (1759.2 to 2692.7)
        Opsono-7F at Month 9 (N= 113, 126)
    148.5 (89.5 to 246.4)
    380.6 (253 to 572.6)
        Opsono-7F at Month 10 (N=128, 109)
    1843.4 (1494.2 to 2274.1)
    3290.6 (2709.1 to 3996.8)
        Opsono-9V at Month 3 (N= 134, 132)
    875.1 (732 to 1046.1)
    1343.4 (1130.8 to 1596)
        Opsono-9V at Month 9 (N= 120, 134)
    266.8 (205.1 to 347.1)
    322.2 (256.4 to 405.1)
        Opsono-9V at Month 10 (N=129, 109)
    1068.1 (874.7 to 1304.2)
    1706.9 (1438.5 to 2025.3)
        Opsono-14 at Month 3 (N= 132, 131)
    692.6 (559.1 to 858)
    1125.3 (946.2 to 1338.3)
        Opsono-14 at Month 9 (N= 102, 123)
    52.1 (32.4 to 84)
    157.3 (108.5 to 228.1)
        Opsono-14 at Month 10 (N=107, 101)
    835.5 (672.1 to 1038.5)
    1280.7 (1054.5 to 1555.5)
        Opsono-18C at Month 3 (N= 134, 131)
    56.2 (42.9 to 73.7)
    218.6 (176.1 to 271.4)
        Opsono-18C at Month 9 (N= 122, 126)
    8.3 (6.5 to 10.7)
    16.9 (12.5 to 22.8)
        Opsono-18C at Month 10 (N=136, 130)
    330 (259.1 to 420.3)
    490.8 (395.3 to 609.4)
        Opsono-19F at Month 3 (N= 131, 128)
    101 (74.9 to 136)
    356.7 (263.2 to 483.4)
        Opsono-19F at Month 9 (N= 130, 134)
    16.5 (12.9 to 21.1)
    31.6 (24.5 to 40.8)
        Opsono-19F at Month 10 (N=131, 129)
    251.3 (193.4 to 326.6)
    734.7 (568.3 to 949.8)
        Opsono-23F at Month 3 (N= 131, 129)
    489.7 (342.6 to 700)
    1233.7 (991.7 to 1534.7)
        Opsono-23F at Month 9 (N= 112, 133)
    190.7 (115.2 to 315.6)
    150.7 (95.9 to 236.8)
        Opsono-23F at Month 10 (N=134, 121)
    1047.3 (748.1 to 1466.3)
    1528.9 (1171.2 to 1996)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Protein D (Anti-PD)

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    End point title
    		 Antibody Concentrations Against Protein D (Anti-PD)
    End point description
    Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    154
    148
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD at Month 3 (N=149, 148)
    861.8 (740.4 to 1003.1)
    1223.3 (1066.5 to 1403.2)
        Anti-PD at Month 9 (N= 151, 148)
    349.7 (294.2 to 415.7)
    499.8 (425.3 to 587.2)
        Anti-PD at Month 10 (N= 154, 146)
    1629.8 (1346.4 to 1972.8)
    2113 (1808.9 to 2468.2)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids

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    End point title
    		 Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    156
    151
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D at Month 3 (N=154, 151)
    1.791 (1.503 to 2.133)
    3.123 (2.621 to 3.723)
        Anti-D at Month 9 (N= 154, 148)
    0.326 (0.275 to 0.386)
    0.725 (0.622 to 0.846)
        Anti-D at Month 10 (N= 156, 148)
    5.423 (4.815 to 6.108)
    8.262 (7.339 to 9.301)
        Anti-T at Month 3 (N=154, 151)
    2.504 (2.17 to 2.89)
    4.602 (4.062 to 5.213)
        Anti-T at Month 9 (N= 153, 149)
    0.565 (0.487 to 0.656)
    1.191 (1.055 to 1.344)
        Anti-T at Month 10 (N= 156, 148)
    7.678 (6.997 to 8.425)
    9.597 (8.749 to 10.526)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)

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    End point title
    		 Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    155
    148
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP at Month 3 (N=146, 147)
    1.179 (0.893 to 1.556)
    2.186 (1.648 to 2.9)
        Anti-PRP at Month 9 (N= 150, 148)
    0.431 (0.349 to 0.532)
    0.777 (0.613 to 0.984)
        Anti-PRP at Month 10 (N= 155, 147)
    16.943 (13.485 to 21.287)
    21.654 (17.263 to 27.161)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

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    End point title
    		 Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    150
    147
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT at Month 3 (N=145, 144)
    36.1 (32.9 to 39.6)
    33.8 (30.2 to 37.9)
        Anti-PT at Month 9 (N= 144, 145)
    9.8 (8.7 to 11.1)
    10.2 (8.9 to 11.7)
        Anti-PT at Month 10 (N= 149, 145)
    78.2 (70.5 to 86.8)
    65.5 (58.7 to 73.1)
        Anti-FHA at Month 3 (N=145, 144)
    166.7 (150.1 to 185.2)
    142.2 (125.6 to 161.1)
        Anti-FHA at Month 9 (N= 144, 145)
    46.6 (41.3 to 52.6)
    46.9 (41.1 to 53.6)
        Anti-FHA at Month 10 (N= 149, 144)
    360.3 (323.7 to 401)
    276.6 (249.4 to 306.7)
        Anti-PRN at Month 3 (N=145, 144)
    83.9 (69.6 to 101.1)
    89 (74.1 to 106.8)
        Anti-PRN at Month 9 (N= 144, 145)
    13.7 (11.2 to 16.6)
    18 (14.8 to 21.8)
        Anti-PRN at Month 10 (N= 150, 147)
    275.5 (235.9 to 321.7)
    209.3 (181.8 to 241)
    No statistical analyses for this end point

    Secondary: Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)

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    End point title
    		 Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa as the co-administered vaccine.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    40
    46
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs at Month 3 (N=37, 38)
    293.7 (195.9 to 440.5)
    478.6 (294.8 to 776.9)
        Anti-HBs at Month 9 (N= 40, 46)
    84.3 (55.4 to 128.2)
    156.6 (106.4 to 230.4)
        Anti-HBs at Month 10 (N= 27, 28)
    1892.3 (1012.2 to 3537.6)
    2922.4 (2010.4 to 4248.1)
    No statistical analyses for this end point

    Secondary: Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)

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    End point title
    		 Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)
    End point description
    Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa as the co-administered vaccine.
    End point type
    Secondary
    End point timeframe
    One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    50
    59
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Polio 1 at Month 3 (N=47, 57)
    88.5 (56.3 to 139.1)
    99.1 (63.4 to 154.8)
        Anti-Polio 1 at Month 9 (N=45,39)
    24.6 (15.6 to 38.8)
    14.4 (8.9 to 23.1)
        Anti-Polio 1 at Month 10 (N=20,15)
    1006.4 (541.8 to 1869.4)
    645 (399.4 to 1041.7)
        Anti-Polio 2 at Month 3 (N=47,59)
    57.7 (36.8 to 90.6)
    40.5 (25 to 65.6)
        Anti-Polio 2 at Month 9 (N=44,40)
    14.9 (10.7 to 20.9)
    10.9 (7.2 to 16.4)
        Anti-Polio 2 at Month 10 (N=17,14)
    522.4 (235.7 to 1157.7)
    512.2 (186.4 to 1407.7)
        Anti-Polio 3 at Month 3 (N=50,57)
    165.6 (109.3 to 250.8)
    161 (98.7 to 262.8)
        Anti-Polio 3 at Month 9 (N=44,38)
    15.1 (9.8 to 23.2)
    14.7 (9 to 24.1)
        Anti-Polio 3 at Month 10 (N=5,11)
    1910.8 (257.4 to 14185.3)
    961.4 (388.3 to 2380.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with booster vaccine response to Anti-PT, Anti-FHA and Anti-PRN antibody

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    End point title
    		 Number of subjects with booster vaccine response to Anti-PT, Anti-FHA and Anti-PRN antibody
    End point description
    Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations < 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.
    End point type
    Secondary
    End point timeframe
    One month after (Month 9) the administration of the booster dose of Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    137
    142
    Units: Subjects
        Anti-PT-Pre-booster status S-(N=20,23)
    20
    23
        Anti-PT-Pre-booster status S+(N=117,117)
    115
    114
        Anti-PT-Pre-booster status Total(N=137,140)
    135
    137
        Anti-FHA-Pre-booster status S-(N=0,1)
    0
    1
        Anti-FHA-Pre-booster status S+(N=137,138)
    132
    129
        Anti-FHA-Pre-booster status Total(N=137,139)
    132
    130
        Anti-PRN-Pre-booster status S-(N=35,21)
    35
    21
        Anti-PRN-Pre-booster status S+(N=102,121)
    101
    119
        Anti-PRN-Pre-booster status Total(N=137,142)
    136
    140
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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    End point title
    		 Number of Subjects With Any and Grade 3 Solicited Local Symptoms
    End point description
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix vaccine in the Synflorix I Group and across the 3 doses of the Synflorix vaccine in the Synflorix II Group.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Bst) with the Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    175
    176
    Units: Subjects
        Any Pain, across doses (N=175;176)
    92
    110
        Grade 3 Pain, across doses (N=175;176)
    14
    12
        Any Redness, across doses (N=175;176)
    137
    135
        Grade 3 Redness, across doses (N=175;176)
    4
    6
        Any Swelling, across doses (N=175;176)
    111
    105
        Grade 3 Swelling, across doses (N=175;176)
    20
    16
        Any Pain, post Bst (N=174,169)
    103
    93
        Grade 3 Pain, post Bst (N=174,169)
    7
    5
        Any Redness, post Bst (N=174,169)
    118
    115
        Grade 3 Redness, post Bst (N=174,169)
    20
    20
        Any Swelling, post Bst (N=174,169)
    97
    99
        Grade 3 Swelling, post Bst (N=174,169)
    19
    15
    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
    Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 2 doses of the Synflorix vaccine in the Synflorix I group and across the 3 doses of the Synflorix vaccine in the Synflorix II group.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Bst) with the Synflorix vaccine
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    175
    176
    Units: Subjects
        Any Drowsiness, across doses (N=175;176)
    130
    130
        Grade 3 Drowsiness, across doses (N=175,176)
    9
    4
        Related Drowsiness, across doses (N=175,176)
    123
    124
        Any Fever, across doses (N=175,176)
    108
    116
        Grade 3 Fever, across doses (N=175,176)
    0
    0
        Related Fever, across doses (N=175,176)
    106
    108
        Any Irr./Fuss., across doses (N=175,176)
    149
    158
        Grade 3 Irr./Fuss., across doses (N=175,176)
    18
    28
        Related Irr./Fuss., across doses (N=175,176)
    142
    147
        Any Loss Appet., across doses (N=175,176)
    81
    88
        Grade 3 Loss Appet., across doses (N=175,176)
    5
    1
        Related Loss Appet., across doses (N=175,176)
    75
    81
        Any Drowsiness, post Bst (N=174,169)
    97
    79
        Grade 3 Drowsiness, post Bst (N=174,169)
    6
    2
        Related Drowsiness, post Bst (N=174,169)
    83
    71
        Any Fever, post Bst (N=174,169)
    96
    78
        Grade 3 Fever, post Bst (N=174,169)
    1
    0
        Related Fever, post Bst (N=174,169)
    84
    67
        Any Irr./Fuss., post Bst (N=174,169)
    113
    104
        Grade 3 Irr./Fuss., post Bst (N=174,169)
    6
    2
        Related Irr./Fuss., post Bst (N=174,169)
    99
    89
        Any Loss Appet., post Bst (N=174,169)
    61
    56
        Grade 3 Loss Appet., post Bst (N=174,169)
    3
    0
        Related Loss Appet., post Bst (N=174,169)
    53
    43
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited Adverse Events

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    End point title
    		 Number of Subjects With Unsolicited Adverse Events
    End point description
    An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post-primary vaccination period, across doses
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    175
    176
    Units: Subjects
        Any AE
    78
    114
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited Adverse Events

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    End point title
    		 Number of Subjects With Unsolicited Adverse Events
    End point description
    An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post booster vaccination period
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    174
    171
    Units: Subjects
        Any AE
    63
    72
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events

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    End point title
    		 Number of Subjects With Serious Adverse Events
    End point description
    A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the primary vaccination period
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    175
    176
    Units: Subjects
        Any SAE
    5
    7
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events

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    End point title
    		 Number of Subjects With Serious Adverse Events
    End point description
    A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the booster vaccination period
    End point values
    		 Synflorix I Group Synflorix II Group
    Number of subjects analysed
    174
    171
    Units: Subjects
        Any SAE
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods.
    Adverse event reporting additional description
    Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and “related to the treatment”) were not calculated during the analysis and are filled in with “subjects affected” similar information.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Synflorix I Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Reporting group title
    Synflorix II Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix vaccine at 11 months of age, co-administered with one dose of the Infanrix combined vaccine, according to national recommendations. Synflorix vaccine was administered intramuscularly into the right anterolateral thigh and Infanrix combined vaccine was administered intramuscularly into the left anterolateral thigh.

    Serious adverse events
    		 Synflorix I Group Synflorix II Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 175 (2.86%)
    7 / 176 (3.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Febrile convulsion
    Additional description: Reported during Booster phase
         subjects affected / exposed [1]
    1 / 174 (0.57%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
    Additional description: Reported during Primary phase
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory syncytial virus infection
    Additional description: Reported during Primary phase
         subjects affected / exposed
    1 / 175 (0.57%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
    Additional description: Reported during Primary phase
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
    Additional description: Reported during Primary phase
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection (Primary phase)
    Additional description: Reported during Primary phase
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    Additional description: Reported during Primary phase
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
    Additional description: Reported during Booster phase
         subjects affected / exposed [2]
    0 / 174 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Reported during Booster phase
         subjects affected / exposed [3]
    1 / 174 (0.57%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection (Booster phase)
    Additional description: Reported during Booster phase
         subjects affected / exposed [4]
    1 / 174 (0.57%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis of serious adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis of serious adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis of serious adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis of serious adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix I Group Synflorix II Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    173 / 175 (98.86%)
    175 / 176 (99.43%)
    General disorders and administration site conditions
    Pain (Primary phase)
         subjects affected / exposed
    92 / 175 (52.57%)
    110 / 176 (62.50%)
         occurrences all number
    92
    110
    Redness (Primary phase)
         subjects affected / exposed
    137 / 175 (78.29%)
    135 / 176 (76.70%)
         occurrences all number
    137
    135
    Swelling (Primary phase)
         subjects affected / exposed
    111 / 175 (63.43%)
    105 / 176 (59.66%)
         occurrences all number
    111
    105
    Pain (Booster phase)
         subjects affected / exposed [5]
    103 / 174 (59.20%)
    93 / 169 (55.03%)
         occurrences all number
    103
    93
    Redness (Booster phase)
         subjects affected / exposed [6]
    118 / 174 (67.82%)
    115 / 169 (68.05%)
         occurrences all number
    118
    115
    Swelling (Booster phase)
         subjects affected / exposed [7]
    97 / 174 (55.75%)
    99 / 169 (58.58%)
         occurrences all number
    97
    99
    Drowsiness (Primary phase)
         subjects affected / exposed
    130 / 175 (74.29%)
    130 / 176 (73.86%)
         occurrences all number
    130
    130
    Fever - rectal (Primary phase)
         subjects affected / exposed
    108 / 175 (61.71%)
    116 / 176 (65.91%)
         occurrences all number
    108
    116
    Irritability (Primary phase)
         subjects affected / exposed
    149 / 175 (85.14%)
    158 / 176 (89.77%)
         occurrences all number
    149
    158
    Loss of appetite (Primary phase)
         subjects affected / exposed
    81 / 175 (46.29%)
    88 / 176 (50.00%)
         occurrences all number
    81
    88
    Drowsiness (Booster phase)
         subjects affected / exposed [8]
    97 / 174 (55.75%)
    79 / 169 (46.75%)
         occurrences all number
    97
    79
    Fever - rectal (Booster phase)
         subjects affected / exposed [9]
    96 / 174 (55.17%)
    78 / 169 (46.15%)
         occurrences all number
    96
    78
    Irritability (Booster phase)
         subjects affected / exposed [10]
    113 / 174 (64.94%)
    104 / 169 (61.54%)
         occurrences all number
    113
    104
    Loss of appetite (Booster phase)
         subjects affected / exposed [11]
    61 / 174 (35.06%)
    56 / 169 (33.14%)
         occurrences all number
    61
    56
    Pyrexia (Primary phase)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 175 (6.86%)
    12 / 176 (6.82%)
         occurrences all number
    12
    12
    Pyrexia (Booster phase)
    alternative assessment type: Non-systematic
         subjects affected / exposed [12]
    8 / 174 (4.60%)
    10 / 171 (5.85%)
         occurrences all number
    8
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 175 (6.29%)
    8 / 176 (4.55%)
         occurrences all number
    11
    8
    Vomiting
         subjects affected / exposed
    4 / 175 (2.29%)
    10 / 176 (5.68%)
         occurrences all number
    4
    10
    Respiratory, thoracic and mediastinal disorders
    Cough (Primary phase)
         subjects affected / exposed
    9 / 175 (5.14%)
    9 / 176 (5.11%)
         occurrences all number
    9
    9
    Cough (Booster phase)
         subjects affected / exposed [13]
    6 / 174 (3.45%)
    11 / 171 (6.43%)
         occurrences all number
    6
    11
    Infections and infestations
    Nasopharyngitis (Primary phase)
         subjects affected / exposed
    26 / 175 (14.86%)
    46 / 176 (26.14%)
         occurrences all number
    26
    46
    Nasopharyngitis (Booster phase)
         subjects affected / exposed [14]
    16 / 174 (9.20%)
    20 / 171 (11.70%)
         occurrences all number
    16
    20
    Otitis media (Booster phase)
         subjects affected / exposed [15]
    9 / 174 (5.17%)
    7 / 171 (4.09%)
         occurrences all number
    9
    7
    Notes
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [11] - 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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [12] - 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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [13] - 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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [14] - 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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.
    [15] - 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: Analysis of adverse events during the booster phase was done on subjects with at least 1 primary dose and with results available during this phase.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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