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    Clinical Trial Results:
    A phase III, multi-centre, double-blind, randomised study to assess the non-inferiority of a commercial lot of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate (10Pn-PD-DiT) vaccine compared to a clinical phase III vaccine lot, when given as a three-dose primary immunization course.

    Summary
    EudraCT number
    		 2014-000101-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Nov 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Mar 2023
    First version publication date
    27 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111654
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00808444
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), one month following a 3-dose primary vaccination course.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 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
    Malaysia: 168
    Country: Number of subjects enrolled
    Singapore: 298
    Worldwide total number of subjects
    466
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    466
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix Clinical Lot & Infanrix Group
    Arm description
    		 Subjects received 3 doses of the clinical lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A (different lots)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-combined vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa-combined vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, only at 3 months of age in Singapore.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV vaccine
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 2 doses.

    Arm title
    		 Synflorix Commercial Lot Infanrix Group
    Arm description
    		 Subjects received 3 doses of the commercial lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A (different lots)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-combined vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa-combined vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, only at 3 months of age in Singapore.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    HRV vaccine
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 2 doses.

    Number of subjects in period 1
    		Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Started
    233
    233
    Completed
    232
    232
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Clinical Lot & Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the clinical lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Reporting group title
    Synflorix Commercial Lot Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the commercial lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Reporting group values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group Total
    Number of subjects
    		 233 233 466
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 233 233 466
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 7.3 ( 1.35 ) 7.2 ( 1.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 113 104 217
        Male
    		 120 129 249

    End points

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    End points reporting groups
    Reporting group title
    Synflorix Clinical Lot & Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the clinical lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Reporting group title
    Synflorix Commercial Lot Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the commercial lot of Synflorix (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Primary: Concentrations of antibodies against vaccine components of the pneumococcal vaccine

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    End point title
    		 Concentrations of antibodies against vaccine components of the pneumococcal vaccine
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 μg/mL.
    End point type
    Primary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    219
    218
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-1 (N=219; 218)
    2.67 (2.46 to 2.91)
    2.46 (2.25 to 2.69)
        Anti-4 (N=219; 218)
    3.95 (3.59 to 4.36)
    3.14 (2.84 to 3.47)
        Anti-5 (N=219; 218)
    4.34 (3.95 to 4.76)
    3.59 (3.29 to 3.92)
        Anti-6B (N=219; 218)
    1.31 (1.16 to 1.48)
    1.23 (1.07 to 1.41)
        Anti-7 (N= 218; 217)
    3.1 (2.83 to 3.39)
    3.2 (2.92 to 3.51)
        Anti-9V (N=219; 218)
    3.34 (3.03 to 3.69)
    3.14 (2.83 to 3.49)
        Anti-14 (N=219; 218)
    5.13 (4.54 to 5.79)
    4.74 (4.23 to 5.32)
        Anti-18C (N=219; 218)
    5 (4.4 to 5.69)
    5.15 (4.43 to 5.97)
        Anti-19F (N=219; 218)
    6.69 (6.04 to 7.41)
    6.96 (6.26 to 7.73)
        Anti-23F (N=219; 218)
    1.98 (1.76 to 2.23)
    1.68 (1.49 to 1.9)
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-1
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Commercial Lot Infanrix Group v Synflorix Clinical Lot & Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.23
    Notes
    [1] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-4
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMC ajusted ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.45
    Notes
    [2] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-5
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 1.37
    Notes
    [3] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-6B
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.28
    Notes
    [4] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-7F
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.1
    Notes
    [5] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-9V
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Commercial Lot Infanrix Group v Synflorix Clinical Lot & Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.23
    Notes
    [6] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-14
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.27
    Notes
    [7] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-18C
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.18
    Notes
    [8] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-19F
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.11
    Notes
    [9] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.
    Statistical analysis title
    		 Immune response non-inferiority–serotype Anti-23F
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.4
    Notes
    [10] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.

    Primary: Concentration of antibody against protein D (PD)

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    End point title
    		 Concentration of antibody against protein D (PD)
    End point description
    Concentration was expressed as GMC in GSK’s 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay is 100 EL.U/mL.
    End point type
    Primary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    219
    218
    Units: EL.U/mL
        geometric mean (confidence interval 95%)
    2543.6 (2319.4 to 2789.4)
    1869.8 (1671.2 to 2091.9)
    Statistical analysis title
    		 Immune response non-inferiority-Anti-PD
    Statistical analysis description
    To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK1024850A vaccine, one month following a 3-dose primary vaccination course.
    Comparison groups
    Synflorix Clinical Lot & Infanrix Group v Synflorix Commercial Lot Infanrix Group
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 GMC adjusted ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 1.58
    Notes
    [11] - Comparability between the commercial lot and the phase III clinical lot in terms of non-inferiority was demonstrated if the upper limit of the two-sided 95% confidence intervals (95% CIs) on the adjusted (for country) geometric mean concentration (GMC) ratios [adjusted GMC of the phase III clinical lot over the adjusted GMC of the commercial lot] was below a limit of 2-fold for antibodies against all vaccine pneumococcal serotypes and protein D (PD) measured by ELISA.

    Secondary: Number of subjects with anti-pneumococcal vaccine serotype antibody concentrations equal to or above 0.20 µg/mL

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    End point title
    		 Number of subjects with anti-pneumococcal vaccine serotype antibody concentrations equal to or above 0.20 µg/mL
    End point description
    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    219
    218
    Units: Subjects
        Anti-1 (N= 219; 218)
    219
    218
        Anti-4 (N= 219; 218)
    219
    218
        Anti-5 (N=219; 218)
    218
    218
        Anti-6B (N=219; 218)
    211
    204
        Anti-7F (N=218; 217)
    218
    217
        Anti-9V (N=219; 218)
    219
    218
        Anti-14 (N=219; 218)
    218
    218
        Anti-18C (N=219; 218)
    219
    217
        Anti-19F (N=219; 218)
    218
    217
        Anti-23F (N=219; 218)
    215
    212
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pneumococcal cross-reactive serotype concentrations equal to or above 0.20 µg/mL

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    End point title
    		 Number of subjects with anti-pneumococcal cross-reactive serotype concentrations equal to or above 0.20 µg/mL
    End point description
    Anti-pneumococcal cross-reactive serotypes were 6A and 19A.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    219
    218
    Units: Subjects
        Anti-6A
    152
    132
        Anti-19A
    135
    119
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes

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    End point title
    		 Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes
    End point description
    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    209
    210
    Units: Subjects
        Opsono-1 (N=209; 210)
    185
    189
        Opsono-4 (N=207; 207)
    207
    203
        Opsono-5 (N=207; 210)
    204
    203
        Opsono-6B (N=205; 206)
    196
    191
        Opsono-7F (N=206; 208)
    206
    208
        Opsono-9V (N=207; 208)
    207
    208
        Opsono-14 (N=209; 208)
    208
    207
        Opsono-18C (N=204; 206)
    202
    199
        Opsono-19F (N=206; 206)
    202
    200
        Opsono-23F (N=209; 207)
    207
    206
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes
    End point description
    Cross-reactive pneumococcal serotypes were 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    197
    200
    Units: Subjects
        Opsono-6A (N=197; 200)
    173
    171
        Opsono-19A (N=197; 199)
    83
    75
    No statistical analyses for this end point

    Secondary: Opsonophagocytic titers of cross-reactive pneumococcal serotypes

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    End point title
    		 Opsonophagocytic titers of cross-reactive pneumococcal serotypes
    End point description
    Opsonophagocytic titers were expressed as GMTs. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes ≥ 8.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    197
    200
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-6A (N=197;200)
    230.8 (180.3 to 295.4)
    173.7 (133.9 to 225.3)
        Opsono-19A (N=197;199)
    18.1 (13.7 to 23.8)
    15.1 (11.5 to 19.8)
    No statistical analyses for this end point

    Secondary: Poliovirus types 1, 2 and 3 titers

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    End point title
    		 Poliovirus types 1, 2 and 3 titers
    End point description
    Titers were given as Geometric Mean Titers (GMTs).Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    99
    93
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Polio 1 (N=99; 93)
    313.8 (250.4 to 393.3)
    328.7 (253.1 to 427)
        Anti-Polio 2 (N=98; 93)
    278.7 (225.4 to 344.7)
    229.1 (176.9 to 296.6)
        Anti-Polio 3 (N=97; 93)
    408.8 (330.1 to 506.4)
    449.4 (351.9 to 573.8)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against diphteria toxoid (DT) and tetanus toxoid (TT)

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    End point title
    		 Concentrations of antibodies against diphteria toxoid (DT) and tetanus toxoid (TT)
    End point description
    Concentrations were defined as GMCs in international units per milliter (IU/mL). Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    109
    107
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT
    3.317 (2.895 to 3.8)
    3.353 (2.991 to 3.759)
        Anti-TT
    4.897 (4.358 to 5.502)
    4.476 (4.013 to 4.992)
    No statistical analyses for this end point

    Secondary: Concentration of antibody against hepatitis B surface antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA)

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    End point title
    		 Concentration of antibody against hepatitis B surface antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA)
    End point description
    Concentration was given as GMC in milli international units per milliliter (mIU/mL).Seroprotection status, defined as Anti-HBs antibody concentrations >= 10 mIU/mL. As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    87
    97
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    1521.2 (1129.7 to 2048.4)
    2114.1 (1658.5 to 2694.9)
    No statistical analyses for this end point

    Secondary: Concentration of antibody against rotavirus immunoglobulin A (IgA)

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    End point title
    		 Concentration of antibody against rotavirus immunoglobulin A (IgA)
    End point description
    Concentration was expressed as GMC in units per milliliter (U/mL). Seroprotection status, defined as Anti-rotavirus IgA antibody concentration >= 20 U/mL.
    End point type
    Secondary
    End point timeframe
    3 months after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    105
    106
    Units: U/mL
        geometric mean (confidence interval 95%)
    141.1 (103 to 193.4)
    114.8 (85 to 155.1)
    No statistical analyses for this end point

    Secondary: Occurrence of serious adverse events

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    End point title
    		 Occurrence of serious adverse events
    End point description
    SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Following vaccination and throughout the entire study period (Month 0 to Month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    233
    233
    Units: Subjects
    18
    7
    No statistical analyses for this end point

    Secondary: Opsonophagocytic titers of vaccine pneumococcal serotypes

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    End point title
    		 Opsonophagocytic titers of vaccine pneumococcal serotypes
    End point description
    Titers are presented as Geometric Mean Titers (GMTs). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes ≥ 8.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    209
    210
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-1 (N=209;210)
    128.9 (102.7 to 161.7)
    122.1 (98.3 to 151.7)
        Opsono-4 (N=207;207)
    698.3 (619.6 to 786.9)
    609.3 (519.6 to 714.3)
        Opsono-5 (N=207;210)
    127.9 (109 to 149.9)
    98.6 (83 to 117.1)
        Opsono-6B (N=205;206)
    870.7 (710.2 to 1067.6)
    619.2 (483.4 to 793.2)
        Opsono-7F (N=206;208)
    3905.8 (3420.2 to 4460.4)
    3585.7 (3119.8 to 4121.2)
        Opsono-9V (N=207;208)
    1800 (1596.6 to 2029.3)
    1851.3 (1612.3 to 2125.8)
        Opsono-14 (N=209;208)
    1521 (1313.3 to 1761.6)
    1485.8 (1280.5 to 1724)
        Opsono-18C (N=204;206)
    533.5 (461.8 to 616.4)
    383.9 (319.3 to 461.5)
        Opsono-19F (N=206;206)
    689.6 (581.1 to 818.2)
    573.5 (477.2 to 689.3)
        Opsono-23F (N=209;207)
    2716.7 (2316.3 to 3186.3)
    2379.5 (2043.4 to 2770.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local and general symptoms

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    End point title
    		 Number of subjects with solicited local and general symptoms
    End point description
    Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.
    End point type
    Secondary
    End point timeframe
    Within 4 days (day 0-3) after vaccination
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    233
    233
    Units: Subjects
        Pain
    162
    157
        Redness
    149
    142
        Swelling
    133
    124
        Drowsiness
    151
    136
        Fever
    193
    175
        Irritability
    168
    171
        Loss of appetite
    127
    121
        Diarrhoea
    53
    54
        Vomiting
    44
    46
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN)

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    End point title
    		 Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN)
    End point description
    Concentrations are expressed as GMCs in EL.U/mL. Seropositivity status, defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    109
    107
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=109; 107)
    46.5 (41.1 to 52.6)
    45.4 (39.8 to 51.7)
        Anti-FHA (N=107; 107)
    179.2 (157.5 to 203.9)
    186.2 (165.5 to 209.5)
        Anti-PRN (N=109; 107)
    142.1 (123.2 to 164)
    128.3 (110.9 to 148.5)
    No statistical analyses for this end point

    Secondary: Concentration of antibody against polyribosyl-ribitol phosphate (PRP)

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    End point title
    		 Concentration of antibody against polyribosyl-ribitol phosphate (PRP)
    End point description
    Concentrain was expressed as GMC in µg/mL. Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 4)
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    112
    108
    Units: µg/mL
        geometric mean (confidence interval 95%)
    9.745 (7.807 to 12.164)
    6.387 (5.051 to 8.078)
    No statistical analyses for this end point

    Secondary: Occurrence of unsolicited adverse events

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    End point title
    		 Occurrence of unsolicited adverse events
    End point description
    An AE is 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.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0-30) after vaccination
    End point values
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group
    Number of subjects analysed
    233
    233
    Units: Subjects
    88
    96
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Frequent AEs were assessed during the 4-day (Days 0-3) follow-up period after vaccination for solicited AEs and 31-day (Days 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
    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
    13.0
    Reporting groups
    Reporting group title
    Synflorix Clinical Lot & Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Reporting group title
    Synflorix Commercial Lot & Infanrix Group
    Reporting group description
    		 Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

    Serious adverse events
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot & Infanrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 233 (7.73%)
    7 / 233 (3.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    2 / 233 (0.86%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Spinal muscular atrophy
         subjects affected / exposed
    0 / 233 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    1 / 233 (0.43%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Vith nerve parlysis
         subjects affected / exposed
    0 / 233 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (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
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 233 (2.15%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    3 / 233 (1.29%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 233 (1.72%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 233 (0.86%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 233 (0.43%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 233 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 233 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 233 (0.43%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 233 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot & Infanrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    230 / 233 (98.71%)
    228 / 233 (97.85%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    162 / 233 (69.53%)
    157 / 233 (67.38%)
         occurrences all number
    162
    157
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    149 / 233 (63.95%)
    142 / 233 (60.94%)
         occurrences all number
    149
    142
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    133 / 233 (57.08%)
    124 / 233 (53.22%)
         occurrences all number
    133
    124
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    151 / 233 (64.81%)
    136 / 233 (58.37%)
         occurrences all number
    151
    136
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    193 / 233 (82.83%)
    175 / 233 (75.11%)
         occurrences all number
    193
    175
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    168 / 233 (72.10%)
    171 / 233 (73.39%)
         occurrences all number
    168
    171
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    53 / 233 (22.75%)
    54 / 233 (23.18%)
         occurrences all number
    53
    54
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 233 (18.88%)
    46 / 233 (19.74%)
         occurrences all number
    44
    46
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    127 / 233 (54.51%)
    121 / 233 (51.93%)
         occurrences all number
    127
    121
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    33 / 233 (14.16%)
    40 / 233 (17.17%)
         occurrences all number
    33
    40

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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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