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    Clinical Trial Results:
    A phase III, randomized, open, controlled study in healthy Japanese children to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa vaccine as a 3-dose primary immunization course at 3, 4 and 5 months of age and followed by a booster vaccination at 17-19 months of age.

    Summary
    EudraCT number
    		 2011-003710-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Sep 2011

    Results information
    Results version number
    		 v3(current)
    This version publication date
    11 Aug 2022
    First version publication date
    29 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    112640
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01027845
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline K.K.
    Sponsor organisation address
    GSK Building - 6-15, Sendagaya 4-chome - Shibuya-ku, Tokyo , Japan, 151-8566
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000673-PIP01-09
    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
    07 May 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) in healthy Japanese children, one month post-dose 3, to the immune responses of the 10-valent pneumococcal conjugate vaccine as observed in the pivotal non-inferiority study 10PN-PD-DIT-001 (105553) in Europe.
    Protection of trial subjects
    All subjects were supervised after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up after each vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Dec 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
    Japan: 360
    Worldwide total number of subjects
    360
    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)
    360
    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
    		 A total of 360 subjects were enrolled in the study. All subjects received at least one vaccination dose.

    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 trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn Group
    Arm description
    		 Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    10Pn-PD-DiT, 10Pn, GlaxoSmithKline Biologicals’ 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate vaccine.
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of 10Pn vaccine at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age. The 10Pn vaccine was administered intramuscularly on alternating (left/right) sides of the anterolateral thigh.

    Investigational medicinal product name
    DPT "KAKETSUKEN" Syringe
    Investigational medicinal product code
    DTP
    Other name
    DTPa, Kaketsuken’s adsorbed diphtheria-purified pertussis-tetanus combined vaccine.
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 3 doses of DTPa vaccine at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age. The DTPa vaccine was administered subcutaneously on alternating (left/right) sides of the upper arm.

    Arm title
    		 DTPa Group
    Arm description
    		 Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled DTPa sub-groups, at the time of the analysis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DPT "KAKETSUKEN" Syringe
    Investigational medicinal product code
    DTP
    Other name
    DTPa, Kaketsuken’s adsorbed diphtheria-purified pertussis-tetanus combined vaccine.
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 3 doses of DTPa vaccine at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age. The DTPa vaccine was administered subcutaneously on alternating (left/right) sides of the upper arm.

    Number of subjects in period 1
    		10Pn Group DTPa Group
    Started
    237
    123
    Completed
    226
    120
    Not completed
    11
    3
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    5
    1
         Adverse event, non-fatal
    3
    -
         Protocol violation
    1
    -
         Migrated/moved from study area
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

    Reporting group title
    DTPa Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled DTPa sub-groups, at the time of the analysis.

    Reporting group values
    		 10Pn Group DTPa Group Total
    Number of subjects
    		 237 123 360
    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)
    		 237 123 360
        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)
    		 13.6 ( 1.02 ) 13.5 ( 1.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 117 59 176
        Male
    		 120 64 184
    Subject analysis sets

    Subject analysis set title
    DTPa + Prevenar Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the DTPa Group with at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before prebooster blood sample and considered optional treatment as standard of care.

    Subject analysis set title
    DTPa - no Prevenar Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from DTPa Group with no Prevenar vaccination before pre-booster blood sample.

    Subject analysis set title
    105553 10Pn Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Synflorix vaccine group (from 105553 study) that included subjects between 6 to 12 weeks of age at the time of the first vaccination with Synflorix, having received 3-dose primary vaccination course at 2-3-4 months of age of Synflorix (3 different lots) + Infanrix hexa (except for the second dose in France which was coadministered with Infanrix-IPV/Hib) vaccines. The number of subjects in this subject analysis set = 1107 subjects (360 being a placeholder value due to system constraint).

    Subject analysis sets values
    		 DTPa + Prevenar Group DTPa - no Prevenar Group 105553 10Pn Group
    Number of subjects
    119
    1
    360
    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)
    119
    1
    1107
        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)
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    10Pn Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

    Reporting group title
    DTPa Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled DTPa sub-groups, at the time of the analysis.

    Subject analysis set title
    DTPa + Prevenar Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the DTPa Group with at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before prebooster blood sample and considered optional treatment as standard of care.

    Subject analysis set title
    DTPa - no Prevenar Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from DTPa Group with no Prevenar vaccination before pre-booster blood sample.

    Subject analysis set title
    105553 10Pn Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Synflorix vaccine group (from 105553 study) that included subjects between 6 to 12 weeks of age at the time of the first vaccination with Synflorix, having received 3-dose primary vaccination course at 2-3-4 months of age of Synflorix (3 different lots) + Infanrix hexa (except for the second dose in France which was coadministered with Infanrix-IPV/Hib) vaccines. The number of subjects in this subject analysis set = 1107 subjects (360 being a placeholder value due to system constraint).

    Primary: Concentrations of Antibodies against Vaccine Pneumococcal Serotypes (primary immunization)

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    End point title
    		 Concentrations of Antibodies against Vaccine Pneumococcal Serotypes (primary immunization)
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (>=) 0.05 microgram per milliliter (μg/mL).
    End point type
    Primary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group 105553 10Pn Group
    Number of subjects analysed
    231
    121
    1107
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 (N=231, 119, 1100)
    6.52 (5.85 to 7.26)
    0.04 (0.03 to 0.04)
    1.05 (1.00 to 1.10)
        Anti-4 (N=231, 120, 1106)
    6.54 (5.86 to 7.30)
    0.03 (0.03 to 0.03)
    1.45 (1.38 to 1.53)
        Anti-5 (N=231, 119, 1104)
    6.54 (5.94 to 7.21)
    0.05 (0.04 to 0.06)
    1.7 (1.62 to 1.78)
        Anti-6B (N=231, 121, 1100)
    1.71 (1.43 to 2.05)
    0.03 (0.03 to 0.03)
    0.33 (0.30 to 0.36)
        Anti-7F (N=231, 120, 1107)
    6.11 (5.50 to 6.78)
    0.03 (0.03 to 0.04)
    1.72 (1.64 to 1.80)
        Anti-9V (N=231, 119, 1103)
    5.42 (4.81 to 6.10)
    0.03 (0.03 to 0.03)
    1.32 (1.25 to 1.38)
        Anti-14 (N=231, 120, 1100)
    10.03 (8.80 to 11.43)
    0.07 (0.06 to 0.09)
    2.9 (2.75 to 3.05)
        Anti-18C (N=231, 121, 1102)
    16.59 (14.40 to 19.13)
    0.04 (0.03 to 0.04)
    1.66 (1.56 to 1.77)
        Anti-19F (N=229, 118, 1104)
    17.39 (15.53 to 19.48)
    0.06 (0.05 to 0.07)
    1.84 (1.71 to 1.98)
        Anti-23F (N=231, 119, 1102)
    2.17 (1.83 to 2.57)
    0.04 (0.03 to 0.04)
    0.53 (0.50 to 0.57)
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-1 GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), Enzyme-Linked Immunosorbent Assay (ELISA) Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 0.18
    Notes
    [1] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-4 GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.25
    Notes
    [2] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-5 GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 0.29
    Notes
    [3] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-6B GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.23
    Notes
    [4] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-7F GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.31
    Notes
    [5] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-9V GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.27
    Notes
    [6] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-14 GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.33
    Notes
    [7] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-18C GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 0.12
    Notes
    [8] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-19F GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 0.12
    Notes
    [9] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.
    Statistical analysis title
    		 105553 10Pn over 10Pn- Anti-23F GMC ratio
    Statistical analysis description
    At one month after primary immunization (post-dose 3), ELISA Geometric Mean Concentration (GMC) ratios (105553 10Pn Group over 10Pn Group) were calculated for each of the 10 pneumococcal serotypes.
    Comparison groups
    10Pn Group v 105553 10Pn Group
    Number of subjects included in analysis
    1338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.29
    Notes
    [10] - Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval (CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) was below a limit of 2-fold for all 10 vaccine pneumococcal serotypes.

    Secondary: Concentrations of Antibodies against Vaccine Pneumococcal Serotypes (booster immunization)

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    End point title
    		 Concentrations of Antibodies against Vaccine Pneumococcal Serotypes (booster immunization) [11]
    End point description
    Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in µg/mL. The seropositivity cut-off of the assay was an antibody concentration >= 0.05 µg/mL. Antibody concentrations <0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. Lower and Upper Limits of the 95% confidence interval could not be calculated in the DTPa - no Prevenar Group because number of subjects affected = 0: both limits have been entered = to GMC value (system constraint workaround).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the 10Pn Group, the DTPa + Prevenar Group and the DTPa - no Prevenar Group.
    End point values
    		 10Pn Group DTPa + Prevenar Group DTPa - no Prevenar Group
    Number of subjects analysed
    216
    114
    1
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 PRE (N=216,113,1)
    0.8 (0.69 to 0.92)
    0.04 (0.03 to 0.04)
    0.03 (-99999 to 99999)
        Anti-1 POST (N=214,114,1)
    7.81 (6.91 to 8.82)
    0.04 (0.04 to 0.05)
    0.24 (-99999 to 99999)
        Anti-4 PRE (N=215,114,1)
    0.81 (0.7 to 0.93)
    0.85 (0.71 to 1.02)
    0.03 (-99999 to 99999)
        Anti-4 POST (N=213,114,1)
    12.89 (11.41 to 14.56)
    0.78 (0.64 to 0.94)
    0.03 (-99999 to 99999)
        Anti-5 PRE (N=216,114,1)
    1.22 (1.05 to 1.41)
    0.08 (0.07 to 0.1)
    0.05 (-99999 to 99999)
        Anti-5 POST (N=214,114,1)
    8.81 (7.87 to 9.86)
    0.15 (0.12 to 0.17)
    0.03 (-99999 to 99999)
        Anti-6B PRE (N=215,114,1)
    0.93 (0.79 to 1.1)
    0.34 (0.27 to 0.44)
    0.03 (-99999 to 99999)
        Anti-6B POST (N=214,114,1)
    3.66 (3.14 to 4.27)
    0.33 (0.25 to 0.42)
    0.03 (-99999 to 99999)
        Anti-7F PRE (N=215,114,1)
    1.48 (1.32 to 1.65)
    0.05 (0.04 to 0.05)
    0.03 (-99999 to 99999)
        Anti-7F POST (N=214,114,1)
    10.68 (9.66 to 11.81)
    0.09 (0.08 to 0.11)
    0.03 (-99999 to 99999)
        Anti-9V PRE (N=212,114,1)
    1.81 (1.61 to 2.03)
    1.01 (0.83 to 1.25)
    0.03 (-99999 to 99999)
        Anti-9V POST (N=214,114,1)
    12.79 (11.49 to 14.23)
    0.96 (0.79 to 1.17)
    0.03 (-99999 to 99999)
        Anti-14 PRE (N=216,114,1)
    2.37 (2.04 to 2.74)
    3.17 (2.74 to 3.67)
    0.09 (-99999 to 99999)
        Anti-14 POST (N=214,114,1)
    15.72 (13.97 to 17.69)
    2.92 (2.53 to 3.38)
    0.16 (-99999 to 99999)
        Anti-18C PRE (N=215,114,1)
    2.18 (1.89 to 2.51)
    0.94 (0.79 to 1.11)
    0.03 (-99999 to 99999)
        Anti-18C POST (N=213,114,1)
    34.9 (31.05 to 39.23)
    0.77 (0.65 to 0.92)
    0.03 (-99999 to 99999)
        Anti-19F PRE (N=215,114,1)
    2.92 (2.5 to 3.41)
    0.51 (0.38 to 0.68)
    0.03 (-99999 to 99999)
        Anti-19F POST (N=214,114,1)
    28.72 (25.29 to 32.63)
    0.68 (0.51 to 0.91)
    0.03 (-99999 to 99999)
        Anti-23F PRE (N=213,114,1)
    1.14 (0.93 to 1.39)
    0.55 (0.42 to 0.73)
    0.03 (-99999 to 99999)
        Anti-23F POST (N=214,114,1)
    7.68 (6.68 to 8.83)
    0.88 (0.7 to 1.12)
    0.03 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Titers against Vaccine Pneumococcal Serotypes (primary immunization)

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    End point title
    		 Opsonophagocytic Titers against Vaccine Pneumococcal Serotypes (primary immunization)
    End point description
    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    224
    116
    Units: Titer
    geometric mean (confidence interval 95%)
        OPSONO-1 (N=223,115)
    619.8 (511.9 to 750.6)
    4.8 (4.2 to 5.5)
        OPSONO-4 (N=221,115)
    1184.6 (1043.7 to 1344.5)
    4.1 (3.9 to 4.3)
        OPSONO-5 (N=224,115)
    335.1 (286.4 to 392.1)
    4.2 (4 to 4.5)
        OPSONO-6B (N=222,116)
    1926.6 (1559.6 to 2380)
    5 (4.2 to 5.9)
        OPSONO-7F (N=216,108)
    7905.9 (6854.5 to 9118.6)
    69.5 (43.2 to 111.9)
        OPSONO-9V (N=219,108)
    4063.4 (3565.8 to 4630.4)
    4.9 (4.2 to 5.6)
        OPSONO-14 (N=217,103)
    3392.4 (2962.5 to 3884.8)
    6.5 (5 to 8.5)
        OPSONO-18C (N=217,108)
    893.2 (727.7 to 1096.2)
    4.8 (4 to 5.7)
        OPSONO-19F (N=219,115)
    1254.6 (1031.1 to 1526.5)
    4.4 (4 to 4.9)
        OPSONO-23F (N=218,107)
    4312.1 (3401.5 to 5466.5)
    6 (4.5 to 8)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies against Cross-reactive Pneumococcal Serotypes 6A and 19A (primary immunization)

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    End point title
    		 Concentrations of Antibodies against Cross-reactive Pneumococcal Serotypes 6A and 19A (primary immunization)
    End point description
    Concentrations were given in µg/mL and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration >= 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    231
    121
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A (N=230,121)
    0.41 (0.34 to 0.49)
    0.04 (0.03 to 0.04)
        Anti-19A (N=231,121)
    0.48 (0.4 to 0.57)
    0.04 (0.04 to 0.05)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (booster immunization)

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    End point title
    		 Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (booster immunization) [12]
    End point description
    Concentrations were given in µg/mL and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration >= 0.05 µg/mL. Antibody concentrations < 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. Lower and Upper Limits of the 95% confidence interval could not be calculated in the DTPa - no Prevenar Group because number of subjects affected = 0: both limits have been entered = to GMC value (system constraint workaround).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the 10Pn Group, the DTPa + Prevenar Group and the DTPa - no Prevenar Group.
    End point values
    		 10Pn Group DTPa + Prevenar Group DTPa - no Prevenar Group
    Number of subjects analysed
    214
    114
    1
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A PRE (N=209,114,1)
    0.61 (0.5 to 0.75)
    0.19 (0.14 to 0.26)
    0.03 (-99999 to 99999)
        Anti-6A POST (N=214,114,1)
    2.72 (2.24 to 3.3)
    0.21 (0.16 to 0.27)
    0.03 (-99999 to 99999)
        Anti-19A PRE (N=214,114,1)
    0.57 (0.45 to 0.71)
    0.12 (0.09 to 0.16)
    0.03 (-99999 to 99999)
        Anti-19A POST (N=214,114,1)
    5.16 (4.18 to 6.37)
    0.15 (0.11 to 0.2)
    0.03 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Titers against Cross-reactive Pneumococcal Serotypes 6A and 19A (primary immunization)

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    End point title
    		 Opsonophagocytic Titers against Cross-reactive Pneumococcal Serotypes 6A and 19A (primary immunization)
    End point description
    Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as GMTs. The seropositivity cut-off for the assay was >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    213
    115
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-6A (N=206,106)
    339.6 (253.8 to 454.4)
    4.6 (4.1 to 5.1)
        Opsono-19A (N=213,115)
    34.3 (26.2 to 44.9)
    4.3 (4 to 4.6)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Titers against Cross-reactive Pneumococcal Serotypes 6A and 19A (booster immunization)

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    End point title
    		 Opsonophagocytic Titers against Cross-reactive Pneumococcal Serotypes 6A and 19A (booster immunization) [13]
    End point description
    Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as GMTs. The seropositivity cut-off for the assay was >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. Lower and Upper Limits of the 95% confidence interval could not be calculated in the DTPa - no Prevenar Group because number of subjects affected = 0: both limits have been entered = to GMC value (system constraint workaround).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the 10Pn Group, the DTPa + Prevenar Group and the DTPa - no Prevenar Group.
    End point values
    		 10Pn Group DTPa + Prevenar Group DTPa - no Prevenar Group
    Number of subjects analysed
    213
    111
    1
    Units: Titer
    geometric mean (confidence interval 95%)
        OPSONO-6A PRE (N=196,107,1)
    138.5 (103.3 to 185.7)
    60.4 (35.2 to 103.7)
    4 (-99999 to 99999)
        OPSONO-6A POST (N=212,107,1)
    767.9 (593.1 to 994.1)
    103.3 (60.4 to 176.6)
    4 (-99999 to 99999)
        OPSONO-19A PRE (N=213,111,1)
    13.1 (10.1 to 16.9)
    7.7 (5.5 to 10.6)
    4 (-99999 to 99999)
        OPSONO-19A POST (N=212,109,1)
    431.4 (330.9 to 562.4)
    8.6 (6 to 12.2)
    4 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies against Protein D (PD) (primary immunization)

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    End point title
    		 Concentrations of Antibodies against Protein D (PD) (primary immunization)
    End point description
    Anti-protein D (Anti-PD) antibody concentrations by ELISA were calculated, expressed as GMCs in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    229
    119
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD
    2548.6 (2315.1 to 2805.7)
    87.9 (75.8 to 102)
    No statistical analyses for this end point

    Secondary: Concentrations of Anti-PD (booster immunization)

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    End point title
    		 Concentrations of Anti-PD (booster immunization)
    End point description
    Anti-PD antibody concentrations by ELISA were calculated, expressed as GMCs)in ELISA EL.U/mL and tabulated. The seropositivity cut-off for the assay was >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. The DTPa Group, at the time of the booster immunization, include subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    214
    113
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD PRE (N=210,112)
    702.6 (601 to 821.5)
    82.3 (71.7 to 94.5)
        Anti-PD POST (N=214,113)
    2916.9 (2552.9 to 3332.7)
    86.9 (75.1 to 100.4)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) (primary immunization)

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    End point title
    		 Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) (primary immunization)
    End point description
    Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    230
    120
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT (N=229,120)
    5.363 (5.002 to 5.749)
    3.829 (3.464 to 4.233)
        Anti-TT (N=230,120)
    5.427 (4.94 to 5.962)
    3.626 (3.174 to 4.143)
    No statistical analyses for this end point

    Secondary: Concentrations of Anti-DT and Anti-TT (booster immunization)

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    End point title
    		 Concentrations of Anti-DT and Anti-TT (booster immunization)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations expressed as IU/mL. Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration >= 0.1 IU/mL. The DTPa Group, at the time of the booster immunization, included subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    226
    119
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT PRE (N=219,118)
    0.625 (0.564 to 0.692)
    0.707 (0.611 to 0.817)
        Anti-DT POST (N=226,119)
    15.324 (13.965 to 16.815)
    10.587 (9.470 to 11.834)
        Anti-TT PRE (N=221,116)
    2.007 (1.662 to 2.424)
    1.328 (1.029 to 1.715)
        Anti-TT POST (N=226,119)
    10.724 (9.664 to 11.901)
    6.059 (5.160 to 7.114)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies against pertussis (PT) and filamentous haemagglutinin (FHA) (primary immunization)

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    End point title
    		 Concentrations of Antibodies against pertussis (PT) and filamentous haemagglutinin (FHA) (primary immunization)
    End point description
    Concentrations of antibodies are presented as GMCs expressed as ELISA EL.U/mL. Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    1 month following primary immunization (at Month 3)
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    231
    121
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    123.2 (115.2 to 131.7)
    133.1 (119.5 to 148.3)
        Anti-FHA
    308.6 (284.8 to 334.3)
    365 (327.9 to 406.2)
    No statistical analyses for this end point

    Secondary: Concentrations of Anti-PT and FHA (booster immunization)

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    End point title
    		 Concentrations of Anti-PT and FHA (booster immunization)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations expressed as ELISA EL.U/mL. Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL. The DTPa Group, at the time of the booster immunization, include subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    214
    114
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT PRE (N=210,113)
    14.9 (13.2 to 16.8)
    18.1 (15.1 to 21.7)
        Anti-PT POST (N=213,114)
    158.4 (143.7 to 174.7)
    204 (176.7 to 235.6)
        Anti-FHA PRE (N=210,114)
    37.9 (33.3 to 43.1)
    48.4 (40.6 to 57.8)
        Anti-FHA POST (N=214,113)
    460.6 (421.2 to 503.7)
    584.5 (512.6 to 666.6)
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Any and Grade 3 Solicited Local Symptoms after Primary Vaccination
    End point description
    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) after each primary vaccine dose
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    237
    123
    Units: Subjects
        Any pain Dose 1 (N=237,123)
    83
    19
        Grade 3 pain Dose 1 (N=237,123)
    1
    0
        Any redness Dose 1 (N=237,123)
    182
    71
        Grade 3 Redness Dose 1 (N=237,123)
    10
    0
        Any swelling Dose 1 (N=237,123)
    126
    33
        Grade 3 Swelling Dose 1 (N=237,123)
    16
    0
        Any pain Dose 2 (N=235,123)
    74
    26
        Grade 3 pain Dose 2 (N=235,123)
    0
    0
        Any redness Dose 2 (N=235,123)
    200
    96
        Grade 3 Redness Dose 2 (N=235,123)
    25
    4
        Any swelling Dose 2 (N=235,123)
    160
    75
        Grade 3 Swelling Dose 2 (N=235,123)
    26
    4
        Any pain Dose 3 (N=233,122)
    63
    23
        Grade 3 pain Dose 3 (N=233,122)
    1
    0
        Any redness Dose 3 (N=233,122)
    178
    84
        Grade 3 Redness Dose 3 (N=233,122)
    24
    0
        Any swelling Dose 3 (N=233,122)
    142
    65
        Grade 3 Swelling Dose 3 (N=233,122)
    27
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Any, Grade 3 and Related Solicited General Symptoms after Primary Vaccination

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    End point title
    		 Number of Subjects with Any, Grade 3 and Related Solicited General Symptoms after Primary Vaccination
    End point description
    General AEs = drowsiness, fever (axillary >= 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = greater than (>) 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) after each primary vaccine dose
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    237
    123
    Units: Subjects
        Any drowsiness Dose 1 (N=237,123)
    67
    24
        Grade 3 drowsiness Dose 1 (N=237,123)
    3
    0
        Related drowsiness Dose 1 (N=237,123)
    24
    6
        Any Fever Dose 1 (N=237,123)
    61
    20
        Grade 3 Fever Dose 1 (N=237,123)
    1
    0
        Related fever Dose 1 (N=237,123)
    20
    5
        Any irritability Dose 1 (N=237,123)
    100
    43
        Grade 3 irritability Dose 1 (N=237,123)
    6
    3
        Related irritability Dose 1 (N=237,123)
    40
    12
        Any loss of appetite Dose 1 (N=237,123)
    32
    12
        Grade 3 loss of appetite Dose 1 (N=237,123)
    0
    0
        Related loss of appetite Dose 1 (N=237,123)
    4
    1
        Any drowsiness Dose 2 (N=235,123)
    67
    34
        Grade 3 drowsiness Dose 2 (N=235,123)
    2
    0
        Related drowsiness Dose 2 (N=235,123)
    26
    9
        Any Fever Dose 2 (N=235,123)
    65
    22
        Grade 3 Fever Dose 2 (N=235,123)
    0
    0
        Related fever Dose 2 (N=235,123)
    31
    7
        Any irritability Dose 2 (N=235,123)
    88
    45
        Grade 3 irritability Dose 2 (N=235,123)
    4
    0
        Related irritability Dose 2 (N=235,123)
    30
    12
        Any loss of appetite Dose 2 (N=235,123)
    27
    7
        Grade 3 loss of appetite Dose 2 (N=235,123)
    0
    0
        Related loss of appetite Dose 2 (N=235,123)
    7
    2
        Any drowsiness Dose 3 (N=233,122)
    41
    25
        Grade 3 drowsiness Dose 3 (N=233,122)
    0
    0
        Related drowsiness Dose 3 (N=233,122)
    15
    10
        Any Fever Dose 3 (N=233,122)
    51
    21
        Grade 3 Fever Dose 3 (N=233,122)
    2
    0
        Related fever Dose 3 (N=233,122)
    21
    2
        Any irritability Dose 3 (N=233,122)
    80
    31
        Grade 3 irritability Dose 3 (N=233,122)
    3
    0
        Related irritability Dose 3 (N=233,122)
    31
    10
        Any loss of appetite Dose 3 (N=233,122)
    25
    7
        Grade 3 loss of appetite Dose 3 (N=233,122)
    0
    0
        Related loss of appetite Dose 3 (N=233,122)
    5
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Any and Grade 3 Solicited Local Symptoms after Booster Vaccination
    End point description
    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetres. The DTPa Group, at the time of the booster immunization, include subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) period following booster vaccination
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    228
    120
    Units: Subjects
        Any pain
    134
    47
        Grade 3 pain
    12
    0
        Any redness
    197
    102
        Redness > 30 mm
    72
    20
        Any swelling
    180
    90
        Swelling > 30 mm
    65
    18
    No statistical analyses for this end point

    Secondary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms after Booster Vaccination

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    End point title
    		 Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms after Booster Vaccination
    End point description
    Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary >= 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination. The DTPa Group, at the time of the booster immunization, include subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) period following booster vaccination
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    228
    120
    Units: Subjects
        Any drowsiness
    69
    30
        Grade 3 drowsiness
    3
    3
        Related drowsiness
    19
    7
        Fever >= 37.5°C
    90
    24
        Fever > 39.5°C
    6
    0
        Related fever
    41
    11
        Any irritability
    90
    35
        Grade 3 irritability
    8
    2
        Related irritability
    36
    10
        Any loss of appetite
    48
    17
        Grade 3 loss of appetite
    4
    1
        Related loss of appetite
    12
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited AEs after Primary Vaccination

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    End point title
    		 Number of Subjects With Unsolicited AEs after Primary Vaccination
    End point description
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post-primary vaccination period, across doses
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    237
    123
    Units: Subjects
        Any AE(s)
    193
    97
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited AEs after Booster Vaccination

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    End point title
    		 Number of Subjects With Unsolicited AEs after Booster Vaccination
    End point description
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The DTPa Group, at the time of the booster immunization, include subjects with or without Prevenar vaccination administered before the booster dose.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post booster vaccination period
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    228
    120
    Units: Subjects
        Any AE(s)
    132
    66
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
    End point type
    Secondary
    End point timeframe
    From study start at Month 0 up to study end at Month 15-17
    End point values
    		 10Pn Group DTPa Group
    Number of subjects analysed
    237
    123
    Units: Subjects
        Any SAE(s)
    28
    19
    No statistical analyses for this end point

    Secondary: Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (booster immunization)

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    End point title
    		 Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (booster immunization) [14]
    End point description
    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as GMTs. The seropositivity cut-off for the assay was >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group. Lower and Upper Limits of the 95% confidence interval could not be calculated in the DTPa - no Prevenar Group because number of subjects affected = 0: both limits have been entered = to GMC value (system constraint workaround).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the 10Pn Group, the DTPa + Prevenar Group and the DTPa - no Prevenar Group.
    End point values
    		 10Pn Group DTPa + Prevenar Group DTPa - no Prevenar Group
    Number of subjects analysed
    214
    113
    1
    Units: Titer
    geometric mean (confidence interval 95%)
        OPSONO-1 PRE (N=214,113,1)
    45.9 (34.9 to 60.4)
    4.5 (4 to 5.1)
    4 (-99999 to 99999)
        OPSONO-1 POST (N=214,112,1)
    2320.7 (1941.8 to 2773.6)
    4.7 (4.1 to 5.5)
    4 (-99999 to 99999)
        OPSONO-4 PRE (N=205,105,1)
    58.3 (43.6 to 77.9)
    79 (49.3 to 126.7)
    371 (-99999 to 99999)
        OPSONO-4 POST (N=214,109,1)
    3863.1 (3319.7 to 4495.5)
    69.3 (43.1 to 111.5)
    493 (-99999 to 99999)
        OPSONO-5 PRE (N=212,113,1)
    22.9 (19.1 to 27.6)
    4.2 (3.9 to 4.5)
    4 (-99999 to 99999)
        OPSONO-5 POST (N=214,112,1)
    686.7 (583.8 to 807.9)
    4.7 (4.1 to 5.3)
    4 (-99999 to 99999)
        OPSONO-6B PRE (N=212,110,1)
    191.2 (141.9 to 257.5)
    118.5 (66.3 to 211.7)
    4 (-99999 to 99999)
        OPSONO-6B POST (N=214,110,1)
    1682.9 (1379.1 to 2053.7)
    119 (68.5 to 206.9)
    4 (-99999 to 99999)
        OPSONO-7F PRE (N=209,111,1)
    2244.8 (1921.9 to 2621.9)
    1014.7 (743.8 to 1384.1)
    588 (-99999 to 99999)
        OPSONO-7F POST (N=214,112,1)
    14144.3 (12109.3 to 16521.4)
    1165.6 (855.7 to 1587.8)
    1278 (-99999 to 99999)
        OPSONO-9V PRE (N=213,113,1)
    520 (437.3 to 618.5)
    1081.6 (803.3 to 1456.4)
    4595 (-99999 to 99999)
        OPSONO-9V POST (N=214,112,1)
    4693.7 (4099 to 5374.6)
    958.8 (680 to 1351.8)
    367 (-99999 to 99999)
        OPSONO-14 PRE (N=211,111,1)
    673.1 (573.1 to 790.6)
    826.7 (669.3 to 1021)
    4 (-99999 to 99999)
        OPSONO-14 POST (N=213,112,1)
    6209 (5299.3 to 7274.8)
    819.1 (651.4 to 1030.1)
    4 (-99999 to 99999)
        OPSONO-18C PRE (N=207,112,1)
    26.3 (21.1 to 32.6)
    11.5 (8.2 to 16)
    4 (-99999 to 99999)
        OPSONO-18C POST (N=214,109,1)
    2181 (1900.1 to 2503.4)
    12.7 (9.1 to 17.7)
    4 (-99999 to 99999)
        OPSONO-19F PRE (N=204,110,1)
    83.4 (64.7 to 107.6)
    21.1 (13.5 to 32.9)
    4 (-99999 to 99999)
        OPSONO-19F POST (N=212,108,1)
    3496.3 (2938.8 to 4159.6)
    20.9 (13.7 to 31.8)
    191 (-99999 to 99999)
        OPSONO-23F PRE (N=209,111,1)
    600.5 (417.6 to 863.4)
    1048 (561.5 to 1956.1)
    4 (-99999 to 99999)
        OPSONO-23F POST (N=214,111,1)
    7057.2 (5896.6 to 8446.1)
    1758.3 (949.4 to 3256.5)
    4 (-99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17).
    Adverse event reporting additional description
    All-causes mortality, SAEs and other AEs data collection was analyzed for primary vaccination phase groups, including all vaccinated subjects in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    10Pn Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

    Reporting group title
    DTPa Group
    Reporting group description
    		 Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer’s (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled DTPa sub-groups, at the time of the analysis.

    Serious adverse events
    		 10Pn Group DTPa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 237 (11.81%)
    19 / 123 (15.45%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Congenital, familial and genetic disorders
    Ear malformation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faciodigitogenital dysplasia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         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
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden infant death syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Food allergy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Strabismus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (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
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 237 (0.84%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrinous bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Tuberculid
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 237 (2.53%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 237 (1.27%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 237 (2.11%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 237 (1.27%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 237 (0.84%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis staphylococcal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia adenoviral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 123 (0.81%)
         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
    		 10Pn Group DTPa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    236 / 237 (99.58%)
    122 / 123 (99.19%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    131 / 237 (55.27%)
    63 / 123 (51.22%)
         occurrences all number
    244
    113
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    167 / 237 (70.46%)
    62 / 123 (50.41%)
         occurrences all number
    354
    115
    Swelling
         subjects affected / exposed
    214 / 237 (90.30%)
    113 / 123 (91.87%)
         occurrences all number
    610
    265
    Pyrexia
         subjects affected / exposed
    156 / 237 (65.82%)
    64 / 123 (52.03%)
         occurrences all number
    284
    92
    Injection site induration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    56 / 237 (23.63%)
    23 / 123 (18.70%)
         occurrences all number
    86
    34
    Drowsiness
         subjects affected / exposed
    131 / 237 (55.27%)
    63 / 123 (51.22%)
         occurrences all number
    244
    113
    Eye disorders
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 237 (7.59%)
    9 / 123 (7.32%)
         occurrences all number
    22
    13
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    29 / 237 (12.24%)
    14 / 123 (11.38%)
         occurrences all number
    32
    14
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 237 (5.91%)
    4 / 123 (3.25%)
         occurrences all number
    16
    4
    Upper respiratory tract inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 237 (8.02%)
    7 / 123 (5.69%)
         occurrences all number
    20
    9
    Skin and subcutaneous tissue disorders
    Eczema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    49 / 237 (20.68%)
    25 / 123 (20.33%)
         occurrences all number
    65
    28
    Dermatitis diaper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 237 (6.33%)
    9 / 123 (7.32%)
         occurrences all number
    19
    9
    Erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    230 / 237 (97.05%)
    114 / 123 (92.68%)
         occurrences all number
    768
    368
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    177 / 237 (74.68%)
    81 / 123 (65.85%)
         occurrences all number
    358
    154
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    85 / 237 (35.86%)
    43 / 123 (34.96%)
         occurrences all number
    131
    69
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    41 / 237 (17.30%)
    24 / 123 (19.51%)
         occurrences all number
    60
    41
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 237 (7.17%)
    15 / 123 (12.20%)
         occurrences all number
    21
    18
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 237 (7.59%)
    5 / 123 (4.07%)
         occurrences all number
    19
    5
    Impetigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 237 (2.11%)
    8 / 123 (6.50%)
         occurrences all number
    5
    9
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 237 (3.80%)
    7 / 123 (5.69%)
         occurrences all number
    10
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    91 / 237 (38.40%)
    37 / 123 (30.08%)
         occurrences all number
    133
    43

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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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