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    Clinical Trial Results:
    A phase III, controlled, partially-blind study to assess the reactogenicity, safety and immunogenicity of GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate vaccine (Synflorix) and 13-valent pneumococcal conjugate vaccine (Prevenar 13™) administered to children as a 2-dose primary vaccination at 2 and 4 months of age with either 10Pn-PD-DiT or Prevenar 13™ or with Prevenar 13™ and 10Pn-PD-DiT, respectively, followed by a Synflorix booster vaccination at 12-15 months of age.

    Summary
    EudraCT number
    		 2013-003479-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v3(current)
    This version publication date
    23 May 2019
    First version publication date
    10 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    Opsonophagocytic activity titers results added in this version

    Trial information

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    Trial identification
    Sponsor protocol code
    115992
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01641133
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Estrada dos Bandeirantes 8464, Rio de Janeiro, Brazil, Jacarepaguá CEP 2278
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity of the 10Pn-PD-DiT vaccine and 13-valent pneumococcal conjugate vaccine (Prevenar 13™) in terms of the occurrence of adverse events with grade 3 intensity, after primary vaccination at 2 and 4 months of age with either 10Pn-PD-DiT or Prevenar 13™ or Prevenar 13™ and 10Pn-PD-DiT, respectively.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 31 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2012
    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
    Mexico: 457
    Worldwide total number of subjects
    457
    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)
    457
    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
    		 457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort as study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis due to GCP deficiencies, and 1 subject from another center due to invalid Informed Consent form.

    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, Data analyst, Carer
    Blinding implementation details
    The study was conducted in a partially-blind manner. For the primary epoch, data were collected in an observer-blind manner and for the booster epoch, data collection was open. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint were all unaware of which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SSS Group
    Arm description
    		 Subjects received a 2-dose primary vaccination with 10Pn-PD-DiT vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, GSK1024850A
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2-dose primary vaccination with 10Pn-PD-DiT vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age. The vaccine was administered intramuscularly into the right or left thigh for subjects at 2 and 4 months of age. For children ≥ 12 months, the vaccine was administered intramuscularly into the right or left thigh or in the deltoid if the muscle size is adequate, using a 25 mm (1 inch).

    Arm title
    		 PSS Group
    Arm description
    		 Subjects received primary vaccination with Prev13 vaccine at 2 months of age and 10Pn-PD-DiT at 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, GSK1024850A
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose primary vaccination with 10Pn-PD-DiT vaccine at 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age. The vaccine was administered intramuscularly into the right or left thigh for subjects at 4 months of age. For children ≥ 12 months, the vaccine was administered intramuscularly into the right or left thigh or in the deltoid if the muscle size is adequate, using a 25 mm (1 inch).

    Investigational medicinal product name
    Prevenar 13™
    Investigational medicinal product code
    Other name
    Prev13
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1-dose primary vaccination with Prev13 vaccine at 2 months of age. The vaccine was administered intramuscularly into the right or left thigh.

    Arm title
    		 PPS Group
    Arm description
    		 Subjects received a 2-dose primary vaccination with Prev13 vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, GSK1024850A
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10Pn-PD-DiT booster vaccination dose at 12-15 months of age. For children ≥ 12 months, the vaccine was administered intramuscularly into the right or left thigh or in the deltoid if the muscle size is adequate, using a 25 mm (1 inch).

    Investigational medicinal product name
    Prevenar 13™
    Investigational medicinal product code
    Other name
    Prev13
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2-dose primary vaccination with Prev13 vaccine at 2 and 4 months of age. The vaccine was administered intramuscularly into the right or left thigh.

    Number of subjects in period 1 [1]
    		SSS Group PSS Group PPS Group
    Started
    97
    99
    98
    Completed
    87
    90
    90
    Not completed
    10
    9
    8
         Consent withdrawn by subject
    5
    3
    3
         Adverse event, non-fatal
    -
    -
    1
         Migrated/moved from study area
    5
    3
    1
         Lost to follow-up
    -
    2
    2
         Protocol deviation
    -
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort as study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis due to GCP deficiencies, and 1 subject from another center due to invalid Informed Consent form.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SSS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with 10Pn-PD-DiT vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PSS Group
    Reporting group description
    		 Subjects received primary vaccination with Prev13 vaccine at 2 months of age and 10Pn-PD-DiT at 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PPS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with Prev13 vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group values
    		 SSS Group PSS Group PPS Group Total
    Number of subjects
    		 97 99 98 294
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 7.4 ± 1.3 7.4 ± 1.5 7.4 ± 1.6 -
    Gender categorical
    Units: Subjects
        Female
    		 55 47 53 155
        Male
    		 42 52 45 139

    End points

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    End points reporting groups
    Reporting group title
    SSS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with 10Pn-PD-DiT vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PSS Group
    Reporting group description
    		 Subjects received primary vaccination with Prev13 vaccine at 2 months of age and 10Pn-PD-DiT at 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PPS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with Prev13 vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Primary: Number of subjects with grade 3 Adverse Events (AEs) (solicited and unsolicited) - primary period

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    End point title
    		 Number of subjects with grade 3 Adverse Events (AEs) (solicited and unsolicited) - primary period [1]
    End point description
    The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.
    End point type
    Primary
    End point timeframe
    Within 31-day (Day 0 - Day 30) after any dose of primary vaccination.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    90
    94
    94
    Units: Subjects
        Any AE Dose 1 (N=90,94,94)
    18
    10
    10
        Any AE Dose 2 (N=87,90,90)
    12
    11
    6
        General AEs Dose 1 (N=90,94,94)
    5
    3
    2
        General AEs Dose 2 (N=87,90,90)
    8
    4
    2
        Local AEs Dose 1 (N=90,94,94)
    17
    8
    9
        Local AEs Dose 2 (N=87,90,90)
    7
    9
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms - primary period

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms - primary period
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each primary dose.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    90
    94
    94
    Units: Subjects
        Any pain Dose 1 (N=90,94,94)
    61
    49
    55
        Grade 3 pain Dose 1 (N=90,94,94)
    14
    8
    9
        Any redness Dose 1 (N=90,94,94)
    9
    11
    7
        Grade 3 redness Dose 1 (N=90,94,94)
    1
    0
    0
        Any swelling Dose 1 (N=90,94,94)
    16
    12
    10
        Grade 3 swelling Dose 1 (N=90,94,94)
    3
    0
    0
        Any pain Dose 2 (N=87,90,90)
    48
    49
    42
        Grade 3 pain Dose 2 (N=87,90,90)
    6
    9
    4
        Any redness Dose 2 (N=87,90,90)
    5
    9
    12
        Grade 3 redness Dose 2 (N=87,90,90)
    1
    0
    0
        Any swelling Dose 2 (N=87,90,90)
    5
    9
    11
        Grade 3 swelling Dose 2 (N=87,90,90)
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms - booster period

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms - booster period
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination period.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    86
    87
    85
    Units: Subjects
        Any pain
    44
    44
    45
        Grade 3 pain
    2
    6
    9
        Any redness
    20
    10
    17
        Grade 3 redness
    4
    2
    3
        Any swelling
    12
    14
    19
        Grade 3 swelling
    1
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms - primary period

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms - primary period
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each primary dose.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    90
    94
    94
    Units: Subjects
        Any drowsiness Dose 1 (N=90,94,94)
    35
    36
    45
        Grade 3 drowsiness Dose 1 (N=90,94,94)
    1
    1
    2
        Related drowsiness Dose 1 (N=90,94,94)
    35
    32
    42
        Any irritability Dose 1 (N=90,94,94)
    48
    46
    53
        Grade 3 irritability Dose 1 (N=90,94,94)
    5
    2
    2
        Related irritability Dose 1 (N=90,94,94)
    46
    41
    49
        Any loss of appetite Dose 1 (N=90,94,94)
    21
    20
    19
        Grade 3 loss of appetite Dose 1 (N=90,94,94)
    1
    0
    0
        Related loss of appetite Dose 1 (N=90,94,94)
    20
    18
    16
        Any fever Dose 1 (N=90,94,94)
    18
    12
    11
        Grade 3 fever Dose 1 (N=90,94,94)
    0
    0
    0
        Related fever Dose 1 (N=90,94,94)
    17
    11
    10
        Any drowsiness Dose 2 (N=87,90,90)
    27
    24
    31
        Grade 3 drowsiness Dose 2 (N=87,90,90)
    1
    1
    0
        Related drowsiness Dose 2 (N=87,90,90)
    25
    23
    31
        Any irritability Dose 2 (N=87,90,90)
    39
    52
    41
        Grade 3 irritability Dose 2 (N=87,90,90)
    4
    1
    1
        Related irritability Dose 2 (N=87,90,90)
    37
    51
    39
        Any loss of appetite Dose 2 (N=87,90,90)
    12
    17
    19
        Grade 3 loss of appetite Dose 2 (N=87,90,90)
    0
    0
    0
        Related loss of appetite Dose 2 (N=87,90,90)
    12
    17
    18
        Any fever Dose 2 (N=87,90,90)
    15
    14
    17
        Grade 3 fever Dose 2 (N=87,90,90)
    0
    0
    0
        Related fever Dose 2 (N=87,90,90)
    15
    14
    16
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms - booster period

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms - booster period
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination period.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    86
    87
    84
    Units: Subjects
        Any drowsiness
    25
    27
    26
        Grade 3 drowsiness
    1
    0
    3
        Related drowsiness
    25
    24
    26
        Any irritability
    33
    39
    45
        Grade 3 irritability
    1
    2
    3
        Related irritability
    33
    36
    44
        Any loss of appetite
    24
    22
    17
        Grade 3 loss of appetite
    0
    1
    0
        Related loss of appetite
    22
    21
    17
        Any fever
    9
    11
    11
        Grade 3 fever
    0
    0
    0
        Related fever
    9
    8
    10
    No statistical analyses for this end point

    Secondary: Number (%) of subjects reporting any and grade 3 symptoms (solicited and unsolicited) - booster period

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    End point title
    		 Number (%) of subjects reporting any and grade 3 symptoms (solicited and unsolicited) - booster period
    End point description
    The number of subjects with any and grade 3 AEs (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-booster vaccination period.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    86
    87
    85
    Units: Subjects
        Any symptom (N=86,87,85)
    66
    70
    67
        Any grade 3 symptom (N=86,87,85)
    10
    12
    14
        General symptom (N=86,87,84)
    57
    66
    61
        Grade 3 general symptom (N=86,87,84)
    4
    5
    4
        Local symptom (N=86,87,85)
    50
    47
    47
        Grade 3 local symptom (N=86,87,85)
    6
    9
    13
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with unsolicited adverse events - primary period

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    End point title
    		 Number (%) of subjects with unsolicited adverse events - primary period
    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. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-primary vaccination period.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    97
    99
    98
    Units: Subjects
        Any AE
    55
    58
    61
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with unsolicited adverse events - booster period

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    End point title
    		 Number (%) of subjects with unsolicited adverse events - booster period
    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. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-booster vaccination period.
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    86
    88
    87
    Units: Subjects
        Any AE
    25
    27
    28
    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
    End point type
    Secondary
    End point timeframe
    During the whole study period i.e. from first vaccination (Month 0) up to study end (11-14 months)
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    97
    99
    98
    Units: Subjects
        Any SAE
    3
    4
    1
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal serotypes

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    End point title
    		 Antibody concentrations against pneumococcal serotypes
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    At study Month 3 (one month after primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after booster vaccination)
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    86
    89
    86
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 Month 3 (N=86, 89, 85)
    2.74 (2.32 to 3.24)
    3.12 (2.63 to 3.7)
    4 (3.44 to 4.65)
        Anti-1 Month 10 (N=86, 86, 86)
    0.34 (0.29 to 0.4)
    0.53 (0.44 to 0.64)
    0.62 (0.52 to 0.74)
        Anti-1 Month 11 (N=84, 82, 82)
    4.61 (3.93 to 5.41)
    4.2 (3.6 to 4.9)
    5.22 (4.52 to 6.03)
        Anti-3 Month 3 (N=85, 86, 85)
    0.06 (0.05 to 0.08)
    0.84 (0.73 to 0.97)
    2.48 (2.21 to 2.78)
        Anti-3 Month 10 (N=86, 86, 86)
    0.09 (0.07 to 0.12)
    0.21 (0.18 to 0.25)
    0.37 (0.3 to 0.44)
        Anti-3 Month 11 (N=84, 82, 82)
    0.1 (0.07 to 0.14)
    0.21 (0.18 to 0.25)
    0.33 (0.27 to 0.41)
        Anti-4 Month 3 (N=86, 89, 85)
    3.54 (3.12 to 4.02)
    2.73 (2.22 to 3.34)
    2.74 (2.34 to 3.21)
        Anti-4 Month 10 (N=85, 86, 86)
    0.57 (0.49 to 0.66)
    0.56 (0.46 to 0.68)
    0.39 (0.32 to 0.48)
        Anti-4 Month 11 (N=84, 82, 82)
    6.76 (5.87 to 7.79)
    4.7 (3.94 to 5.6)
    8.77 (7.26 to 10.59)
        Anti-5 Month 3 (N=86, 89, 85)
    4.55 (3.95 to 5.24)
    2.59 (2.1 to 3.18)
    4.89 (4.11 to 5.8)
        Anti-5 Month 10 (N=85, 86, 86)
    0.96 (0.79 to 1.17)
    0.77 (0.64 to 0.92)
    1.05 (0.88 to 1.25)
        Anti-5 Month 11 (N=84, 82, 82)
    8.31 (7.08 to 9.77)
    5.27 (4.33 to 6.41)
    6.15 (5.17 to 7.32)
        Anti-6A Month 3 (N=84, 85, 85)
    0.22 (0.16 to 0.29)
    0.36 (0.3 to 0.45)
    3.35 (2.53 to 4.42)
        Anti-6A Month 10 (N=85, 84, 85)
    0.25 (0.2 to 0.31)
    0.28 (0.22 to 0.36)
    0.67 (0.55 to 0.82)
        Anti-6A Month 11 (N=84, 82, 82)
    1.3 (0.98 to 1.72)
    0.93 (0.69 to 1.24)
    1.97 (1.52 to 2.55)
        Anti-6B Month 3 (N=86, 88, 85)
    0.96 (0.78 to 1.18)
    0.21 (0.17 to 0.27)
    0.38 (0.29 to 0.51)
        Anti-6B Month 10 (N=86, 86, 86)
    0.48 (0.39 to 0.59)
    0.3 (0.23 to 0.37)
    0.24 (0.19 to 0.3)
        Anti-6B Month 11 (N=84, 82, 82)
    3.53 (2.96 to 4.2)
    1.92 (1.53 to 2.42)
    3.03 (2.56 to 3.57)
        Anti-7F Month 3 (N=86, 88, 85)
    3.36 (2.96 to 3.81)
    2.74 (2.35 to 3.19)
    4.83 (4.32 to 5.4)
        Anti-7F Month 10 (N=85, 85, 86)
    1.16 (0.99 to 1.37)
    1 (0.84 to 1.19)
    1.24 (1.07 to 1.45)
        Anti-7F Month 11 (N=84, 82, 82)
    7.63 (6.69 to 8.71)
    5.07 (4.38 to 5.87)
    5.83 (5.07 to 6.69)
        Anti-9V Month 3 (N=85, 87, 85)
    2.67 (2.28 to 3.13)
    1.34 (1.12 to 1.59)
    2.96 (2.49 to 3.51)
        Anti-9V Month 10 (N=86, 86, 86)
    0.86 (0.7 to 1.04)
    0.49 (0.42 to 0.56)
    0.53 (0.45 to 0.62)
        Anti-9V Month 11 (N=84, 82, 82)
    7.04 (5.99 to 8.26)
    2.48 (2.11 to 2.92)
    2.84 (2.42 to 3.34)
        Anti-14 Month 3 (N=86, 89, 85)
    4.74 (3.87 to 5.81)
    3.45 (2.79 to 4.25)
    4.99 (3.89 to 6.42)
        Anti-14 Month 10 (N=86, 86, 86)
    1.15 (0.89 to 1.49)
    1.05 (0.86 to 1.29)
    1.78 (1.45 to 2.19)
        Anti-14 Month 11 (N=84, 82, 82)
    10.04 (8.44 to 11.95)
    8.1 (6.68 to 9.83)
    7.62 (6.3 to 9.22)
        Anti-18C Month 3 (N=86, 89, 85)
    3.3 (2.54 to 4.28)
    3.22 (2.5 to 4.14)
    3.24 (2.62 to 4)
        Anti-18C Month 10 (N=86, 86, 85)
    0.81 (0.67 to 0.98)
    0.65 (0.53 to 0.81)
    0.56 (0.47 to 0.66)
        Anti-18C Month 11 (N=84, 82, 82)
    25.18 (20.92 to 30.31)
    19.39 (15.36 to 24.48)
    19.27 (15.57 to 23.85)
        Anti-19A Month 3 (N=86, 89, 85)
    0.24 (0.18 to 0.32)
    0.72 (0.6 to 0.87)
    2.43 (1.91 to 3.1)
        Anti-19A Month 10 (N=86, 86, 86)
    0.19 (0.15 to 0.25)
    0.36 (0.27 to 0.5)
    0.34 (0.25 to 0.46)
        Anti-19A Month 11 (N=84, 82, 82)
    1.64 (1.2 to 2.23)
    1.67 (1.17 to 2.38)
    2.17 (1.64 to 2.86)
        Anti-19F Month 3 (N=86, 89, 85)
    4.62 (3.76 to 5.69)
    5.67 (4.63 to 6.95)
    4.17 (3.69 to 4.72)
        Anti-19F Month 10 (N=86, 86, 86)
    1.19 (0.96 to 1.48)
    1.39 (1.14 to 1.71)
    0.53 (0.43 to 0.65)
        Anti-19F Month 11 (N=84, 82, 82)
    14.43 (12.02 to 17.32)
    13.57 (11.29 to 16.32)
    13.81 (11.63 to 16.4)
        Anti-23F Month 3 (N=86, 88, 85)
    1.43 (1.11 to 1.85)
    0.53 (0.41 to 0.68)
    1.74 (1.28 to 2.37)
        Anti-23F Month 10 (N=86, 86, 86)
    0.53 (0.41 to 0.67)
    0.24 (0.19 to 0.3)
    0.36 (0.29 to 0.45)
        Anti-23F Month 11 (N=84, 82, 82)
    4.16 (3.23 to 5.36)
    1.76 (1.42 to 2.18)
    2.76 (2.29 to 3.34)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (Anti-PD)

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    End point title
    		 Concentrations of antibodies against protein D (Anti-PD)
    End point description
    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination).
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    45
    50
    37
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD Month 3 (N=45, 50, 37)
    2025.1 (1601 to 2561.4)
    117.2 (90.4 to 152.1)
    143.2 (106.8 to 192.1)
        Anti-PD Month 11 (N=45, 42, 37)
    3658.5 (2741.1 to 4882.8)
    791 (576.2 to 1085.8)
    219.7 (156.2 to 309.1)
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against pneumococcal serotypes

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    End point title
    		 Titers for opsonophagocytic activity against pneumococcal serotypes
    End point description
    The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F. OPA testing was performed on a random subset of 50% per group.
    End point type
    Secondary
    End point timeframe
    At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)
    End point values
    		 SSS Group PSS Group PPS Group
    Number of subjects analysed
    45
    50
    40
    Units: Titers
    geometric mean (confidence interval 95%)
        OPA-1 Month 3 (N=45, 50, 37)
    58.9 (39.4 to 87.9)
    51.5 (35.6 to 74.5)
    96.4 (69.4 to 134.1)
        OPA-1 Month 10 (N=45, 44, 40)
    10.3 (8.1 to 13.2)
    8.8 (7.3 to 10.6)
    9.4 (7.6 to 11.6)
        OPA-1 Month 11 (N=45, 42, 37)
    311.6 (224.6 to 432.5)
    139.3 (97.7 to 198.8)
    240.3 (186.5 to 309.7)
        OPA-3 Month 3 (N=45, 50, 37)
    5.7 (5.4 to 6.1)
    50.5 (39.5 to 64.6)
    190.7 (164.2 to 221.6)
        OPA-3 Month 10 (N=45, 44, 40)
    18.0 (12.7 to 25.6)
    33.2 (24.7 to 44.6)
    41.3 (29.4 to 58.0)
        OPA-3 Month 11 (N=45, 42, 37)
    11.2 (8.6 to 14.6)
    22.7 (17.3 to 29.9)
    29.7 (22.1 to 39.8)
        OPA-4 Month 3 (N=45, 50, 37)
    1327.9 (1127.4 to 1563.9)
    812.1 (623.2 to 1058.2)
    1391.5 (1135.4 to 1705.4)
        OPA-4 Month 10 (N=45, 44, 40)
    128.1 (75.5 to 217.5)
    123.5 (75.0 to 203.6)
    91.4 (56.4 to 148.1)
        OPA-4 Month 11 (N=45, 42, 37)
    2729.6 (2191.8 to 3399.3)
    1583.4 (1297.1 to 1932.9)
    3033.2 (2333.0 to 3943.5)
        OPA-5 Month 3 (N=45, 50, 37)
    335.9 (258.5 to 436.5)
    132.0 (91.8 to 189.8)
    250.2 (177.3 to 353.1)
        OPA-5 Month 10 (N=45, 44, 40)
    68.7 (47.0 to 100.3)
    29.3 (21.3 to 40.3)
    37.3 (26.5 to 52.5)
        OPA-5 Month 11 (N=45, 42, 37)
    669.2 (504.7 to 887.3)
    266.2 (198.0 to 357.8)
    379.4 (280.2 to 513.8)
        OPA-6A Month 3 (N=45, 50, 37)
    60.4 (38.6 to 94.6)
    91.9 (59.5 to 142.1)
    1185.5 (781.5 to 1798.2)
        OPA-6A Month 10 (N=45, 43, 40)
    96.1 (56.2 to 164.3)
    73.5 (41.7 to 129.5)
    112.1 (68.3 to 183.9)
        OPA-6A Month 11 (N=45, 42, 37)
    480.2 (315.8 to 730.1)
    216.8 (120.5 to 390.2)
    363.5 (227.8 to 580.1)
        OPA-6B Month 3 (N=45, 50, 37)
    603.6 (393.5 to 925.8)
    107.4 (66.4 to 173.6)
    331.6 (192.2 to 572.0)
        OPA-6B Month 10 (N=45, 43, 40)
    182.8 (100.7 to 331.6)
    131.3 (70.8 to 243.7)
    60.1 (35.1 to 102.9)
        OPA-6B Month 11 (N=45, 42, 37)
    1868.1 (1373.4 to 2540.8)
    958.5 (654.5 to 1403.7)
    1202.2 (946.7 to 1526.7)
        OPA-7F Month 3 (N=45, 50, 37)
    2595.4 (2133.8 to 3156.9)
    1702.1 (1330.8 to 2176.8)
    4654.8 (3739.1 to 5794.8)
        OPA-7F Month 10 (N=45, 44, 40)
    654.5 (430.9 to 994.1)
    676.6 (499.3 to 916.8)
    858.3 (582.1 to 1265.4)
        OPA-7F Month 11 (N=45, 42, 37)
    3557.9 (2936.0 to 4311.6)
    2337.9 (1901.8 to 2874.2)
    2178.5 (1671.3 to 2839.7)
        OPA-9V Month 3 (N=45, 50, 37)
    1904.8 (1457.9 to 2488.7)
    1141.6 (809.2 to 1610.7)
    2916.6 (2422.6 to 3511.3)
        OPA-9V Month 10 (N=45, 42, 40)
    424.8 (295.2 to 611.1)
    441.3 (302.3 to 644.2)
    353.9 (235.9 to 531.0)
        OPA-9V Month 11 (N=45, 42, 37)
    5130.2 (4255.2 to 6185.2)
    2391.0 (1944.4 to 2940.3)
    1720.7 (1407.4 to 2103.8)
        OPA-14 Month 3 (N=45, 50, 37)
    1497.1 (1102.1 to 2033.6)
    924.2 (624.0 to 1368.8)
    1391.5 (807.6 to 2397.5)
        OPA-14 Month 10 (N=45, 44, 40)
    303.4 (181.6 to 506.9)
    270.2 (165.2 to 442.0)
    342.3 (217.3 to 539.0)
        OPA-14 Month 11 (N=45, 42, 37)
    3132.1 (2355.4 to 4164.8)
    2043.1 (1539.0 to 2712.3)
    1413.9 (1103.9 to 1811.0)
        OPA-18C Month 3 (N=45, 50, 37)
    965.3 (636.3 to 1464.6)
    685.5 (473.4 to 992.7)
    1114.7 (835.1 to 1488.1)
        OPA-18C Month 10 (N=45, 44, 40)
    116.5 (68.6 to 197.8)
    72.3 (48.6 to 107.5)
    61.8 (39.5 to 96.8)
        OPA-18C Month 11 (N=45, 42, 37)
    6271.0 (5032.6 to 7814.2)
    4731.5 (3739.3 to 5987.0)
    4358.6 (3271.4 to 5807.2)
        OPA-19A Month 3 (N=45, 50, 37)
    85.2 (44.3 to 163.9)
    173.4 (111.5 to 269.8)
    677.2 (425.5 to 1077.8)
        OPA-19A Month 10 (N=45, 44, 40)
    37.2 (20.0 to 69.3)
    71.7 (39.6 to 129.9)
    69.5 (33.7 to 143.6)
        OPA-19A Month 11 (N=45, 42, 37)
    748.8 (446.0 to 1257.3)
    642.2 (401.2 to 1028.0)
    1061.6 (663.1 to 1699.6)
        OPA-19F Month 3 (N=45, 50, 37)
    1306.1 (1016.4 to 1678.3)
    1492.8 (1157.3 to 1925.6)
    842.3 (706.0 to 1005.0)
        OPA-19F Month 10 (N=45, 43, 40)
    127.6 (82.7 to 196.9)
    158.8 (106.3 to 237.2)
    42.0 (28.6 to 61.8)
        OPA-19F Month 11 (N=45, 42, 37)
    2900.7 (2180.8 to 3858.1)
    2749.9 (2133.7 to 3544.1)
    3696.9 (2753.6 to 4963.1)
        OPA-23F Month 3 (N=45, 50, 37)
    633.3 (405.4 to 989.3)
    143.9 (94.3 to 219.4)
    1089.4 (735.9 to 1612.8)
        OPA-23F Month 10 (N=45, 44, 40)
    234.9 (134.8 to 409.3)
    199.1 (105.6 to 375.3)
    164.3 (91.8 to 294.2)
        OPA-23F Month 11 (N=45, 42, 37)
    1500.7 (1023.4 to 2200.6)
    1005.7 (653.4 to 1548.0)
    1097.8 (774.6 to 1555.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local & general symptoms during the 4-day post primary & booster vaccination period; Unsolicited AEs during the 31-day post primary & booster vaccination period; SAEs: during the whole study period i.e. from Month 0 up study end (11-14 Months).
    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
    17.1
    Reporting groups
    Reporting group title
    SSS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with 10Pn-PD-DiT vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PSS Group
    Reporting group description
    		 Subjects received primary vaccination with Prev13 vaccine at 2 months of age and 10Pn-PD-DiT at 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Reporting group title
    PPS Group
    Reporting group description
    		 Subjects received a 2-dose primary vaccination with Prev13 vaccine at 2 and 4 months of age and a 10Pn-PD-DiT booster vaccination dose at 12-15 months of age.

    Serious adverse events
    		 SSS Group PSS Group PPS Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 97 (3.09%)
    4 / 99 (4.04%)
    1 / 98 (1.02%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SSS Group PSS Group PPS Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 97 (87.63%)
    88 / 99 (88.89%)
    86 / 98 (87.76%)
    General disorders and administration site conditions
    Pain (primary phase)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    69 / 90 (76.67%)
    63 / 94 (67.02%)
    65 / 94 (69.15%)
         occurrences all number
    69
    63
    65
    Redness (primary phase)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    12 / 90 (13.33%)
    16 / 94 (17.02%)
    15 / 94 (15.96%)
         occurrences all number
    12
    16
    15
    Swelling (primary phase)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    17 / 90 (18.89%)
    19 / 94 (20.21%)
    14 / 94 (14.89%)
         occurrences all number
    17
    19
    14
    Pain (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    44 / 86 (51.16%)
    44 / 87 (50.57%)
    45 / 85 (52.94%)
         occurrences all number
    44
    44
    45
    Redness (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    20 / 86 (23.26%)
    10 / 87 (11.49%)
    17 / 85 (20.00%)
         occurrences all number
    20
    10
    17
    Swelling (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    12 / 86 (13.95%)
    14 / 87 (16.09%)
    19 / 85 (22.35%)
         occurrences all number
    12
    14
    19
    Drowsiness (primary phase)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    47 / 90 (52.22%)
    44 / 94 (46.81%)
    55 / 94 (58.51%)
         occurrences all number
    47
    44
    55
    Irritability (primary phase)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    62 / 90 (68.89%)
    68 / 94 (72.34%)
    62 / 94 (65.96%)
         occurrences all number
    62
    68
    62
    Loss of appetite (primary phase)
         subjects affected / exposed [9]
    28 / 90 (31.11%)
    31 / 94 (32.98%)
    29 / 94 (30.85%)
         occurrences all number
    28
    31
    29
    Fever (primary phase)
         subjects affected / exposed [10]
    28 / 90 (31.11%)
    21 / 94 (22.34%)
    25 / 94 (26.60%)
         occurrences all number
    28
    21
    25
    Drowsiness (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    25 / 86 (29.07%)
    27 / 87 (31.03%)
    26 / 84 (30.95%)
         occurrences all number
    25
    27
    26
    Irritability (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    33 / 86 (38.37%)
    39 / 87 (44.83%)
    45 / 84 (53.57%)
         occurrences all number
    33
    39
    45
    Loss of appetite (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    24 / 86 (27.91%)
    22 / 87 (25.29%)
    17 / 84 (20.24%)
         occurrences all number
    24
    22
    17
    Fever (booster phase)
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    9 / 86 (10.47%)
    11 / 87 (12.64%)
    11 / 84 (13.10%)
         occurrences all number
    9
    11
    11
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 97 (2.06%)
    3 / 99 (3.03%)
    5 / 98 (5.10%)
         occurrences all number
    2
    3
    5
    Constipation
         subjects affected / exposed
    1 / 97 (1.03%)
    5 / 99 (5.05%)
    2 / 98 (2.04%)
         occurrences all number
    1
    5
    2
    Diarrhoea
         subjects affected / exposed [15]
    1 / 86 (1.16%)
    1 / 88 (1.14%)
    5 / 87 (5.75%)
         occurrences all number
    1
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 97 (2.06%)
    1 / 99 (1.01%)
    5 / 98 (5.10%)
         occurrences all number
    2
    1
    5
    Infections and infestations
    Nasopharyngits (primary phase)
         subjects affected / exposed
    34 / 97 (35.05%)
    35 / 99 (35.35%)
    31 / 98 (31.63%)
         occurrences all number
    34
    35
    31
    Bronchiolitis
         subjects affected / exposed
    6 / 97 (6.19%)
    8 / 99 (8.08%)
    8 / 98 (8.16%)
         occurrences all number
    6
    8
    8
    Pharyngitis
         subjects affected / exposed
    2 / 97 (2.06%)
    3 / 99 (3.03%)
    7 / 98 (7.14%)
         occurrences all number
    2
    3
    7
    Conjunctivitis
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 99 (1.01%)
    5 / 98 (5.10%)
         occurrences all number
    1
    1
    5
    Nasopharyngitis (booster phase)
         subjects affected / exposed [16]
    13 / 86 (15.12%)
    13 / 88 (14.77%)
    16 / 87 (18.39%)
         occurrences all number
    13
    13
    16
    Gastroenteritis
         subjects affected / exposed [17]
    7 / 86 (8.14%)
    3 / 88 (3.41%)
    3 / 87 (3.45%)
         occurrences all number
    7
    3
    3
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the non-serious adverse event included only subjects with documented data.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2012
    Change in number of participating countries in this study. Initially this study was planned to be conducted in two countries and now it will be conducted in a single country.
    13 Jun 2012
    At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code.
    24 Sep 2013
    In the past few months, GSK Biologicals has been investigating the quality of some serology assays used in clinical studies, including the Streptococcus pneumoniae opsonophagocytic activity (OPA) assay used in the present trial. This protocol amendment reflects the fact that delays in the availability of the assay results lead to changes in the analysis plan and scope of serological testing as follows: •The sequence of analysis has been modified to perform study analyses in 2 steps: in the first step – final analysis of safety and reactogenicity data from primary epoch excluding analysis of immunogenicity, and in the second step – final analysis of all immunogenicity data from primary and booster epochs and safety/reactogenicity data of booster epoch except for SAEs that will be analyzed throughout the study. •Cancellation of anti-protein D antibody testing at pre-booster time point, while testing at post-primary and post-booster time points will be performed as described previously in the study protocol. This has been considered sufficient to characterize immune response to protein D.

    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.
    Opsonophagocytic activity results against pneumococcal serotypes were not available at the time of writing this summary. It will be updated when the results become available.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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