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    Clinical Trial Results:
    A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life.

    Summary
    EudraCT number
    		 2008-003950-14
    Trial protocol
    		 SK   SE  
    Global end of trial date
    02 Jul 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2016
    First version publication date
    04 Apr 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    111736
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00984139
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Nov 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune responses following vaccination with a booster dose of the 10Pn-PD-DiT vaccine administered at 36-46 months of age in children previously vaccinated with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539) according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age and to assess the immune responses following vaccination with a single dose of the 10Pn-PD-DiT vaccine in age-matched unprimed children.
    Protection of trial subjects
    All subjects were supervised 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 minimum 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 85
    Country: Number of subjects enrolled
    Sweden: 87
    Worldwide total number of subjects
    172
    EEA total number of subjects
    172
    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)
    0
    Children (2-11 years)
    172
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 172
    Number of subjects completed
    		 172

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn-2d group
    Arm description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 2+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one additional dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539) administered intramuscularly in the right deltoid

    Arm title
    		 10Pn-3d group
    Arm description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 3+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one additional dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539) administered intramuscularly in the right deltoid

    Arm title
    		 Unprimed group
    Arm description
    		 Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of 10Pn-PD-DiT at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subject received 2 doses of 10Pn-PD-DiT at 36-46 and 38-48 months of age, administered intramuscularly in the right deltoid.

    Number of subjects in period 1
    		10Pn-2d group 10Pn-3d group Unprimed group
    Started
    51
    59
    62
    Completed
    51
    58
    62
    Not completed
    0
    1
    0
         Consent withdrawn by subject
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn-2d group
    Reporting group description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 2+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).

    Reporting group title
    10Pn-3d group
    Reporting group description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 3+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).

    Reporting group title
    Unprimed group
    Reporting group description
    		 Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of 10Pn-PD-DiT at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

    Reporting group values
    		 10Pn-2d group 10Pn-3d group Unprimed group Total
    Number of subjects
    		 51 59 62 172
    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: months
        arithmetic mean (standard deviation)
    		 38.2 ( 1.83 ) 38 ( 1.81 ) 40.1 ( 2.64 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25 31 81
        Male
    		 26 34 31 91

    End points

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    End points reporting groups
    Reporting group title
    10Pn-2d group
    Reporting group description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 2+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).

    Reporting group title
    10Pn-3d group
    Reporting group description
    		 Subjects previously vaccinated with the 10Pn-PD-DiT vaccine according to a 3+1 schedule, receiving one dose of 10Pn-PD-DiT at 36-46 months of age, i.e. 24-34 months after the last dose given in study 10PN-PD-DIT-002 (105539).

    Reporting group title
    Unprimed group
    Reporting group description
    		 Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of 10Pn-PD-DiT at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

    Primary: Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed group

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    End point title
    		 Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed group [1] [2]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. The results presented for the time point 7-10 days after dose 1 (Day 7), correspond to the primary outcome.
    End point type
    Primary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    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.
    [2] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 at PRE (N= 60)
    0.06 (0.05 to 0.08)
        Anti-1 at Day 7 (N= 60)
    0.6 (0.47 to 0.76)
        Anti-1 at Month 3 (N= 60)
    2.81 (2.25 to 3.51)
        Anti-4 at PRE (N= 60)
    0.04 (0.03 to 0.05)
        Anti-4 at Day 7 (N= 60)
    2.37 (1.91 to 2.94)
        Anti-4 at Month 3 (N= 60)
    8.44 (7.16 to 9.94)
        Anti-5 at PRE (N= 60)
    0.07 (0.05 to 0.09)
        Anti-5 at Day 7 (N= 60)
    0.45 (0.34 to 0.59)
        Anti-5 at Month 3 (N= 60)
    3.54 (2.96 to 4.23)
        Anti-6B at PRE (N= 60)
    0.1 (0.07 to 0.13)
        Anti-6B at Day 7 (N= 58)
    0.2 (0.14 to 0.29)
        Anti-6B at Month 3 (N= 60)
    1.11 (0.84 to 1.46)
        Anti-7F at PRE (N= 60)
    0.08 (0.05 to 0.12)
        Anti-7F at Day 7 (N= 60)
    0.92 (0.67 to 1.25)
        Anti-7F at Month 3 (N= 60)
    6.1 (4.99 to 7.46)
        Anti-9V at PRE (N= 60)
    0.05 (0.04 to 0.07)
        Anti-9V at Day 7 (N= 60)
    0.33 (0.23 to 0.48)
        Anti-9V at Month 3 (N= 60)
    2.22 (1.74 to 2.82)
        Anti-14 at PRE (N= 60)
    0.25 (0.16 to 0.38)
        Anti-14 at Day 7 (N= 60)
    0.54 (0.34 to 0.86)
        Anti-14 at Month 3 (N= 60)
    6.48 (4.98 to 8.44)
        Anti-18C at PRE (N= 60)
    0.06 (0.04 to 0.08)
        Anti-18C at Day 7 (N= 59)
    1.45 (1.01 to 2.06)
        Anti-18C at Month 3 (N= 60)
    22.28 (18.14 to 27.36)
        Anti-19F at PRE (N= 60)
    0.23 (0.14 to 0.38)
        Anti-19F at Day 7 (N= 59)
    1.82 (1.27 to 2.6)
        Anti-19F at Month 3 (N= 60)
    17.03 (13.38 to 21.68)
        Anti-23F at PRE (N= 60)
    0.06 (0.04 to 0.08)
        Anti-23F at Day 7 (N= 60)
    0.1 (0.07 to 0.15)
        Anti-23F at Month 3 (N= 60)
    1.09 (0.81 to 1.45)
    No statistical analyses for this end point

    Primary: Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the 10Pn-2d and 10Pn-3d groups [3] [4]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. The results presented for the time point 7-10 days after immunization (Mth34+D7), correspond to the primary outcome.
    End point type
    Primary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [3] - 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.
    [4] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 at Month 10 (N=50,57)
    1.91 (1.52 to 2.42)
    1.87 (1.49 to 2.33)
        Anti-1 at Month 34 (N=49,57)
    0.13 (0.1 to 0.17)
    0.17 (0.14 to 0.22)
        Anti-1 at Mth34+D7(N=50,55)
    4.06 (3.2 to 5.15)
    4.72 (3.77 to 5.92)
        Anti-4 at Month 10 (N=50,57)
    2.97 (2.34 to 3.77)
    3.2 (2.62 to 3.91)
        Anti-4 at Month 34 (N=48,54)
    0.15 (0.1 to 0.23)
    0.19 (0.14 to 0.25)
        Anti-4 at Mth34+D (N=49,55)
    7.54 (5.98 to 9.5)
    9.97 (7.68 to 12.95)
        Anti-5 at Month 10 (N=50,57)
    2.71 (2.15 to 3.41)
    3.01 (2.4 to 3.76)
        Anti-5 at Month 34 (N=50,57)
    0.24 (0.19 to 0.31)
    0.33 (0.26 to 0.42)
        Anti-5 at Mth34+D (N=50,55)
    5.38 (4.09 to 7.08)
    7.07 (5.51 to 9.09)
        Anti-6B at Month 10 (N=50,57)
    0.9 (0.59 to 1.36)
    1.62 (1.16 to 2.27)
        Anti-6B at Month 34 (N=48,57)
    0.5 (0.29 to 0.88)
    1.01 (0.62 to 1.64)
        Anti-6B at Mth34+D7 (N=50,55)
    4 (2.82 to 5.69)
    6.33 (4.75 to 8.45)
        Anti-7F at Month 10 (N=50,57)
    2.94 (2.4 to 3.59)
    3.88 (3.23 to 4.65)
        Anti-7F at Month 34 (N=49,56)
    0.33 (0.24 to 0.46)
    0.51 (0.42 to 0.61)
        Anti-7F at Mth34+D7 (N=50,55)
    6.18 (5.05 to 7.56)
    7.27 (5.87 to 9.01)
        Anti-9V at Month 10 (N=50,57)
    2.59 (2.03 to 3.31)
    3.81 (3.11 to 4.67)
        Anti-9V at Month 34 (N=50,57)
    0.24 (0.18 to 0.33)
    0.49 (0.34 to 0.69)
        Anti-9V at Mth34+D7 (N=50,55)
    7.48 (5.88 to 9.51)
    10.17 (7.86 to 13.16)
        Anti-14 at Month 10 (N=50,57)
    3.91 (3.05 to 5)
    5.22 (4.22 to 6.46)
        Anti-14 at Month 34 (N=50,56)
    0.62 (0.39 to 0.97)
    1.1 (0.69 to 1.75)
        Anti-14 at Mth34+D7 (N=50,55)
    13.42 (9.7 to 18.55)
    19.67 (14.97 to 25.84)
        Anti-18C at Month 10 (N=50,57)
    4.87 (3.77 to 6.29)
    5.52 (4.2 to 7.26)
        Anti-18C at Month 34 (N=50,56)
    0.37 (0.26 to 0.54)
    0.49 (0.35 to 0.7)
        Anti-18C at Mth34+D7 (N=50,55)
    17.12 (12.77 to 22.94)
    22.62 (17.58 to 29.11)
        Anti-19F at Month 10 (N=50,57)
    6.68 (5.2 to 8.59)
    6.6 (5.16 to 8.46)
        Anti-19F at Month 34 (N=47,56)
    1.42 (0.8 to 2.51)
    1.44 (0.82 to 2.53)
        Anti-19F at Mth34+D7 (N=50,55)
    20.28 (15.71 to 26.19)
    30.55 (24.32 to 38.37)
        Anti-23F at Month 10 (N=50,57)
    2.12 (1.52 to 2.97)
    2.67 (1.99 to 3.59)
        Anti-23F at Month 34 (N=49,56)
    0.41 (0.23 to 0.71)
    0.67 (0.41 to 1.11)
        Anti-23F at Mth34+D7 (N=50,55)
    6.23 (4.34 to 8.94)
    8.42 (6.38 to 11.11)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL in the 10Pn-2d and 10Pn-3d groups [5]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL..
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [5] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: Subjects
        Anti-1 at Month 10 (N=50,57)
    50
    57
        Anti-1 at Month 34 (N=49,57)
    43
    55
        Anti-1 at Mth34+D7(N=50,55)
    50
    55
        Anti-4 at Month 10 (N=50,57)
    50
    57
        Anti-4 at Month 34 (N=48,54)
    41
    54
        Anti-4 at Mth34+D7(N=49,55)
    49
    55
        Anti-5 at Month 10 (N=50,57)
    50
    57
        Anti-5 at Month 34 (N=50,57)
    49
    57
        Anti-5 at Mth34+D7(N=50,55)
    50
    55
        Anti-6B at Month 10 (N=50,57)
    45
    54
        Anti-6B at Month 34 (N=48,57)
    43
    56
        Anti-6B at Mth34+D7(N=50,55)
    50
    55
        Anti-7F at Month 10 (N=50,57)
    50
    57
        Anti-7F at Month 34 (N=49,56)
    47
    56
        Anti-7F at Mth34+D7(N=50,55)
    50
    55
        Anti-9V at Month 10 (N=50,57)
    50
    57
        Anti-9V at Month 34 (N=50,57)
    48
    56
        Anti-9V at Mth34+D7(N=50,55)
    50
    55
        Anti-14 at Month 10 (N=50,57)
    50
    57
        Anti-14 at Month 34 (N=50,56)
    50
    56
        Anti-14 at Mth34+D7 (N=50,55
    50
    55
        Anti-18C at Month 10 (N=50,57
    50
    57
        Anti-18C at Month 34 (N=50,56)
    48
    56
        Anti-18C at Mth34+D7(N=50,55)
    50
    55
        Anti-19F at Month 10 (N=50,57)
    50
    57
        Anti-19F at Month 34 (N=47,56)
    47
    56
        Anti-19F at Mth34+D7(N=50,55)
    50
    55
        Anti-23F at Month 10 (N=50,57)
    49
    56
        Anti-23F at Month 34 (N=49,56)
    43
    56
        Anti-23F at Mth34+D7(N=50,55)
    49
    55
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL in the Unprimed group

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL in the Unprimed group [6]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [6] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: Subjects
        Anti-1 at PRE (N= 60)
    34
        Anti-1 at Day 7 (N= 60)
    60
        Anti-1 at Month 3 (N= 60)
    60
        Anti-4 at PRE (N= 60)
    9
        Anti-4 at Day 7 (N= 60)
    60
        Anti-4 at Month 3 (N= 60)
    60
        Anti-5 at PRE (N= 60)
    37
        Anti-5 at Day 7 (N= 60)
    60
        Anti-5 at Month 3 (N= 60)
    60
        Anti-6B at PRE (N= 60)
    40
        Anti-6B at Day 7 (N= 58)
    49
        Anti-6B at Month 3 (N= 60)
    60
        Anti-7F at PRE (N= 60)
    29
        Anti-7F at Day 7 (N= 60)
    60
        Anti-7F at Month 3 (N= 60)
    60
        Anti-9V at PRE (N= 60)
    21
        Anti-9V at Day 7 (N= 60)
    58
        Anti-9V at Month 3 (N= 60)
    60
        Anti-14 at PRE (N= 60)
    56
        Anti-14 at Day 7 (N= 60)
    58
        Anti-14 at Month 3 (N= 60)
    60
        Anti-18C at PRE (N= 60)
    23
        Anti-18C at Day 7 (N= 59)
    59
        Anti-18C at Month 3 (N= 60)
    60
        Anti-19F at PRE (N= 60)
    44
        Anti-19F at Day 7 (N= 59)
    59
        Anti-19F at Month 3 (N= 60)
    60
        Anti-23F at PRE (N= 60)
    23
        Anti-23F at Day 7 (N= 60)
    39
        Anti-23F at Month 3 (N= 60)
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.20 µg/mL in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.20 µg/mL in the 10Pn-2d and 10Pn-3d groups [7]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [7] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: Subjects
        Anti-1 at Month 10(N=50,57)
    50
    57
        Anti-1 at Month 34(N=49,57)
    16
    28
        Anti-1 at Mth34+D7(N=50,55)
    50
    55
        Anti-4 at Month 10(N=50,57)
    50
    57
        Anti-4 at Month 34(N=48,54)
    12
    20
        Anti-4 at Mth34+D7(N=49,55)
    49
    55
        Anti-5 at Month 10(N=50,57)
    50
    57
        Anti-5 at Month 34(N=50,57)
    31
    35
        Anti-5 at Mth34+D7(N=50,55)
    50
    55
        Anti-6B at Month 10 (N=50,57)
    44
    54
        Anti-6B at Month 34(N=48,57)
    29
    44
        Anti-6B at Mth34+D7(N=50,55)
    49
    55
        Anti-7F at Month 10(N=50,57)
    50
    57
        Anti-7F at Month 34(N=49,56)
    37
    53
        Anti-7F at Mth34+D7(N=50,55)
    50
    55
        Anti-9V at Month 10(N=50,57)
    49
    57
        Anti-9V at Month 34(N=50,57
    27
    45
        Anti-9V at Mth34+D7(N=50,55)
    50
    55
        Anti-14 at Month 10(N=50,57)
    50
    57
        Anti-14 at Month 34(N=50,56)
    37
    49
        Anti-14 at Mth34+D7(N=50,55)
    50
    55
        Anti-18C at Month 1(N=50,57)
    50
    56
        Anti-18C at Month 34(N=50, 56)
    35
    44
        Anti-18C at Mth34+D7(N=50,55)
    50
    55
        Anti-19F at Month 10(N=50,57)
    49
    56
        Anti-19F at Month 34(N=47,56)
    39
    47
        Anti-19F at Mth34+D7(N=50,55)
    50
    55
        Anti-23F at Month 10(N=50,57)
    47
    55
        Anti-23F at Month 34(N=49,56)
    29
    36
        Anti-23F at Mth34+D7(N=50,55)
    49
    55
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.20 µg/mL in the Unprimed group

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.20 µg/mL in the Unprimed group [8]
    End point description
    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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [8] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: Subjects
        Anti-1 at PRE (N= 60)
    10
        Anti-1 at Day 7 (N= 60)
    54
        Anti-1 at Month 3 (N= 60)
    60
        Anti-4 at PRE (N= 60)
    4
        Anti-4 at Day 7 (N= 60)
    60
        Anti-4 at Month 3 (N= 60)
    60
        Anti-5 at PRE (N= 60)
    9
        Anti-5 at Day 7 (N= 60)
    47
        Anti-5 at Month 3 (N= 60)
    60
        Anti-6B at PRE (N= 60)
    19
        Anti-6B at Day 7 (N= 58)
    29
        Anti-6B at Month 3 (N= 60)
    56
        Anti-7F at PRE (N= 60)
    11
        Anti-7F at Day 7 (N= 60)
    54
        Anti-7F at Month 3 (N= 60)
    60
        Anti-9V at PRE (N= 60)
    7
        Anti-9V at Day 7 (N= 60)
    40
        Anti-9V at Month 3 (N= 60)
    60
        Anti-14 at PRE (N= 60)
    27
        Anti-14 at Day 7 (N= 60)
    42
        Anti-14 at Month 3 (N= 60)
    60
        Anti-18C at PRE (N= 60)
    8
        Anti-18C at Day 7 (N= 59)
    56
        Anti-18C at Month 3 (N= 60)
    60
        Anti-19F at PRE (N= 60)
    29
        Anti-19F at Day 7 (N= 59)
    57
        Anti-19F at Month 3 (N= 60)
    60
        Anti-23F at PRE (N= 60)
    11
        Anti-23F at Day 7 (N= 60)
    16
        Anti-23F at Month 3 (N= 60)
    56
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the 10Pn-2d and 10Pn-3d groups [9]
    End point description
    Seropositivity status defined as Opsonophacocytic activity against pneumococcal serotypes ≥ 8.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [9] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    48
    55
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-1 at Month 10(N=44,53)
    243.9 (137.3 to 433.3)
    176.9 (104 to 301)
        Opsono-1 at Month 34 N=47,55)
    5.5 (4.3 to 7)
    6.2 (4.9 to 8)
        Opsono-1 at Mth34+D7(N=48,55)
    2342.2 (1788.8 to 3066.7)
    2321.5 (1827.1 to 2949.7)
        Opsono-4 at Month 10(N=43,51)
    937.6 (600.8 to 1463.4)
    1347 (1068.8 to 1697.7)
        Opsono-4 at Month 34(N=44,52)
    9.6 (4.9 to 18.8)
    9.5 (5.8 to 15.6)
        Opsono-4 at Mth34+D7(N=48,53)
    13247.5 (9898 to 17730.4)
    17732.6 (13218.8 to 23787.7)
        Opsono-5 at Month 10(N=45,54)
    154 (94.2 to 251.6)
    181.2 (125.4 to 262)
        Opsono-5 at Month 34(N=47,54)
    6.7 (5.2 to 8.6)
    8 (6.1 to 10.6)
        Opsono-5 at Mth34+D7(N=48,55)
    991.5 (769.8 to 1277.1)
    1221.1 (912.4 to 1634.2)
        Opsono-6B at Month 10(N=44,51)
    292.2 (147.1 to 580.3)
    458.8 (254.8 to 825.9)
        Opsono-6B at Month 34(N=42,54)
    61.5 (22.8 to 165.6)
    126.3 (59.4 to 268.5)
        Opsono-6B at Mth34+D7(N=47,54)
    3312.9 (1751.2 to 6267.2)
    3136 (1730 to 5684.6)
        Opsono-7F at Month 10(N=44,53)
    2257.8 (1601.9 to 3182.3)
    3856.8 (2890.4 to 5146.2)
        Opsono-7F at Month 34(N=45,53)
    1329.1 (778.8 to 2268.4)
    1225.5 (842.5 to 1782.6)
        Opsono-7F at Mth34+D7(N=48,52)
    20779 (14616.7 to 29539.1)
    22461.4 (16876.9 to 29893.7)
        Opsono-9V at Month 10(N=44,54)
    1581.7 (1147.7 to 2179.9)
    2013.9 (1565.3 to 2591)
        Opsono-9V at Month 34(N=43,53)
    307.4 (210.3 to 449.4)
    292.3 (221 to 386.6)
        Opsono-9V at Mth34+D7(N=48,52
    21193.6 (16100.3 to 27898.2)
    19038.4 (14154.7 to 25607.2)
        Opsono-14 at Month 10(N=35,52)
    1092.5 (691.9 to 1725)
    1207.1 (961.4 to 1515.5)
        Opsono-14 at Month 34(N=41,49)
    421.5 (258.8 to 686.5)
    738.6 (540 to 1010.2)
        Opsono-14 at Mth34+D7(N=48,54)
    14310 (10214 to 20048.7)
    14670.9 (10258 to 20982.2)
        Opsono-18C at Month 10(N=45,54)
    375.8 (251.3 to 562.1)
    567.4 (422.8 to 761.5)
        Opsono-18C at Month 34(N=45,54)
    11 (6 to 20.2)
    17.7 (9.6 to 32.9)
        Opsono-18C at Mth34+D7(N=48,51)
    6095.8 (4090.7 to 9083.8)
    6448.7 (4258.7 to 9764.9)
        Opsono-19F at Month 10(N=43,54)
    463.7 (318.3 to 675.6)
    950.5 (653.3 to 1383)
        Opsono-19F at Month 34(N= 47,55)
    34.1 (18.4 to 63.2)
    48.4 (25.9 to 90.6)
        Opsono-19F at Mth34+D7(N=48,55)
    2231.5 (1267.7 to 3927.9)
    5684.4 (3647.8 to 8858)
        Opsono-23F at Month 10(N=45,53)
    1414.6 (827.9 to 2417.1)
    1984.8 (1520.3 to 2591.3)
        Opsono-23F at Month 34(N=43,49)
    458.5 (186.3 to 1128.2)
    465.6 (209.6 to 1034)
        Opsono-23F at Mth34+D7(N=48,54)
    15688.3 (10571.2 to 23282.4)
    13812.6 (9566 to 19944.4)
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed group

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    End point title
    		 Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed group [10]
    End point description
    Seropositivity status defined as Opsonophacocytic activity against pneumococcal serotypes ≥ 8.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [10] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-1 at PRE (N= 58)
    4 (4 to 4)
        Opsono-1 at Day 7 (N= 58)
    441.1 (302.4 to 643.4)
        Opsono-1 at Month 3 (N= 56)
    103 (67.6 to 157)
        Opsono-4 at PRE (N= 58)
    5.1 (3.9 to 6.7)
        Opsono-4 at Day 7 (N= 58)
    9675.9 (7792.2 to 12014.9)
        Opsono-4 at Month 3 (N= 56)
    2687.5 (2165 to 3336.1)
        Opsono-5 at PRE (N= 59
    4.1 (3.9 to 4.5)
        Opsono-5 at Day 7 (N= 57)
    330 (200.5 to 543)
        Opsono-5 at Month 3 (N= 56)
    127.6 (92.7 to 175.6)
        Opsono-6B at PRE (N= 55)
    21.6 (11 to 42.4)
        Opsono-6B at Day 7 (N= 54)
    438.2 (208.4 to 921.5)
        Opsono-6B at Month 3 (N= 57)
    1040.9 (652.8 to 1659.5)
        Opsono-7F at PRE (N= 55)
    644.2 (355.5 to 1167.3)
        Opsono-7F at Day 7 (N=57)
    11048.4 (8626.3 to 14150.5)
        Opsono-7F at Month 3 (N= 55)
    6213.1 (4793.1 to 8053.7)
        Opsono-9V at PRE (N= 55)
    103.1 (53.8 to 197.6)
        Opsono-9V at Day 7 (N= 57)
    12217.8 (9359.1 to 15949.8)
        Opsono-9V at Month 3 (N= 55)
    6085.2 (4718.5 to 7847.9)
        Opsono-14 at PRE (N= 53)
    252.5 (138.1 to 461.5)
        Opsono-14 at Day 7 (N= 57)
    3948.7 (2958.9 to 5269.5)
        Opsono-14 at Month 3 (N= 56)
    4978.9 (3857.8 to 6425.9)
        Opsono-18C at PRE (N= 48)
    6.1 (4 to 9.3)
        Opsono-18C at Day 7 (N= 57)
    3905.6 (2648 to 5760.4)
        Opsono-18C at Month 3 (N= 56)
    3984.5 (3187.9 to 4980.2)
        Opsono-19F at PRE (N= 59)
    8.4 (5.6 to 12.7)
        Opsono-19F at Day 7 (N= 57)
    367.5 (202.7 to 666.5)
        Opsono-19F at Month 3 (N= 56)
    1772.5 (1285.9 to 2443.3)
        Opsono-23F at PRE (N= 52)
    265.3 (121.5 to 579.6)
        Opsono-23F at Day 7 (N= 58)
    5059 (3800.6 to 6734)
        Opsono-23F at Month 3 (N= 57)
    5095.5 (3992.3 to 6503.6)
    No statistical analyses for this end point

    Secondary: Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the 10Pn-2d and 10Pn-3d groups [11]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A at Month 10 (N= 49, 57)
    0.31 (0.2 to 0.48)
    0.51 (0.33 to 0.77)
        Anti-6A at Month 34 (N= 48, 55)
    0.26 (0.16 to 0.42)
    0.45 (0.28 to 0.71)
        Anti-6A at Mth34+D7 (N= 50, 55)
    1.13 (0.71 to 1.79)
    2 (1.32 to 3.03)
        Anti-19A at Month 10 (N= 50, 57)
    0.8 (0.53 to 1.2)
    0.75 (0.5 to 1.12)
        Anti-19A at Month 34 (N= 49, 57)
    0.31 (0.2 to 0.49)
    0.26 (0.17 to 0.4)
        Anti-19A at Mth34+D7 (N= 50, 55)
    3.44 (2.3 to 5.15)
    3.76 (2.47 to 5.73)
    No statistical analyses for this end point

    Secondary: Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the Unprimed group

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    End point title
    		 Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the Unprimed group [12]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A at PRE (N= 60)
    0.11 (0.08 to 0.16)
        Anti-6A at Day 7 (N= 60)
    0.15 (0.11 to 0.21)
        Anti-6A at Month 3 (N= 60)
    0.58 (0.42 to 0.79)
        Anti-19A at PRE (N= 60)
    0.13 (0.09 to 0.2)
        Anti-19A at Day 7 (N= 59)
    0.32 (0.21 to 0.49)
        Anti-19A at Month 3 (N= 60)
    1.97 (1.46 to 2.65)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ 0.05 µg/mL in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ 0.05 µg/mL in the 10Pn-2d and 10Pn-3d groups [13]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: Subjects
        Anti-6A at Month 10 (N= 49, 57)
    42
    51
        Anti-6A at Month 34 (N= 48, 55)
    43
    51
        Anti-6A at Mth34+D7 (N= 50, 55)
    48
    55
        Anti-19A at Month 10 (N= 50, 57)
    48
    54
        Anti-19A at Month 34 (N= 49, 57)
    44
    50
        Anti-19A at Mth34+D7 (N= 50, 55)
    50
    55
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 6A and19A antibody concentrations ≥ 0.05 µg/mL in the Unprimed group

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 6A and19A antibody concentrations ≥ 0.05 µg/mL in the Unprimed group [14]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: Subjects
        Anti-6A at PRE (N= 60)
    47
        Anti-6A at Day 7 (N= 60)
    50
        Anti-6A at Month 3 (N= 60)
    59
        Anti-19A at PRE (N= 60)
    41
        Anti-19A at Day 7 (N= 59)
    55
        Anti-19A at Month 3 (N= 60)
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ 0.20 µg/mL in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ 0.20 µg/mL in the 10Pn-2d and 10Pn-3d groups [15]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [15] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: Subjects
        Anti-6A at Month 10 (N= 49, 57)
    31
    43
        Anti-6A at Month 34 (N= 48, 55)
    22
    38
        Anti-6A at Mth34+D7 (N= 50, 55)
    44
    51
        Anti-19A at Month 10 (N= 50, 57)
    41
    45
        Anti-19A at Month 34 (N= 49, 57)
    26
    30
        Anti-19A at Mth34+D7 (N= 50, 55)
    47
    54
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-pneumococcal serotypes 6A and19A antibody concentrations ≥ 0.20 µg/mL in the Unprimed group

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    End point title
    		 Number of subjects with Anti-pneumococcal serotypes 6A and19A antibody concentrations ≥ 0.20 µg/mL in the Unprimed group [16]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [16] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: Subjects
        Anti-6A at PRE (N= 60)
    13
        Anti-6A at Day 7 (N= 60)
    24
        Anti-6A at Month 3 (N= 60)
    49
        Anti-19A at PRE (N= 60)
    22
        Anti-19A at Day 7 (N= 59)
    33
        Anti-19A at Month 3 (N= 60)
    58
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the 10Pn-2d and 10Pn-3d groups [17]
    End point description
    Seropositivity status defined as Opsonophacocytic activity against pneumococcal serotypes ≥ 8
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [17] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    48
    55
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-6A at Month 10 (N= 35, 44)
    60.9 (25.9 to 143.1)
    135 (68.3 to 267)
        Opsono-6A at Month 34 (N= 40, 47)
    64.3 (27.1 to 152.7)
    81.5 (39.7 to 167.5)
        Opsono-6A at Mth34+D7 (N= 45, 50)
    1639.4 (958.6 to 2803.9)
    1267.3 (713.8 to 2250)
        Opsono-19A at Month 10 (N= 36, 46)
    14.4 (7.6 to 27.3)
    35.9 (18 to 71.6)
        Opsono-19A at Month 34 (N= 45, 55)
    8 (5.2 to 12.2)
    8.6 (5.6 to 13.4)
        Opsono-19A at Mth34+D7 (N= 48, 55)
    799.3 (372.8 to 1713.4)
    1871.6 (975.8 to 3589.8)
    No statistical analyses for this end point

    Secondary: Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the Unprimed group

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    End point title
    		 Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the Unprimed group [18]
    End point description
    Seropositivity status defined as Opsonophacocytic activity against pneumococcal serotypes ≥ 8
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [18] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    58
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-6A at PRE (N= 50)
    36.3 (18.9 to 69.6)
        Opsono-6A at Day 7 (N= 52)
    389.6 (215.2 to 705.5)
        Opsono-6A at Month 3 (N= 52)
    715.2 (487.3 to 1049.6)
        Opsono-19A at PRE (N= 58)
    5.4 (4.2 to 6.9)
        Opsono-19A at Day 7 (N= 55)
    211.9 (99.9 to 449.7)
        Opsono-19A at Month 3 (N= 53)
    406.4 (227.3 to 726.9)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (ANTI-PD) in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Concentrations of antibodies against protein D (ANTI-PD) in the 10Pn-2d and 10Pn-3d groups [19]
    End point description
    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status is defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose (Month 10) –in primary study 105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [19] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    50
    57
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD at Month 10 (N= 48, 56)
    1438 (1018.9 to 2029.4)
    2241.3 (1752.5 to 2866.3)
        Anti-PD at Month 34 (N= 50, 57)
    301.6 (219.5 to 414.3)
    461.3 (351.1 to 606)
        Anti-PD at Mth34+D7 (N= 50, 55)
    1724.1 (1299.4 to 2287.5)
    2113.2 (1651.2 to 2704.5)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (ANTI-PD) in the Unprimed group

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    End point title
    		 Concentrations of antibodies against protein D (ANTI-PD) in the Unprimed group [20]
    End point description
    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status is defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
    Notes
    [20] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    60
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD at PRE (N= 60)
    110.9 (88.8 to 138.6)
        Anti-PD at Day 7 (N= 60)
    536.3 (390.7 to 736.2)
        Anti-PD at Month 3 (N= 60)
    960.4 (752.7 to 1225.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with B-cells detection in the 10Pn-2d and 10Pn-3d groups

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    End point title
    		 Number of subjects with B-cells detection in the 10Pn-2d and 10Pn-3d groups [21]
    End point description
    Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post- additional dose. Since none of the blood samples for memory B-cell quantification taken at the Slovakian site were suitable for testing, the assay for memory B-cell quantification was only performed on blood samples from all other evaluable subjects.
    End point type
    Secondary
    End point timeframe
    pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Mont 34+7 days (Mth34+D7)
    Notes
    [21] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group
    Number of subjects analysed
    10
    13
    Units: Subjects
    arithmetic mean (standard deviation)
        18C PS at Month 34 (N=10,11)
    377 ( 459.3 )
    424.9 ( 668.2 )
        18C PS at Mth34+D7 (N= 7,13)
    1205.3 ( 661.4 )
    2891.2 ( 2274.5 )
        19F PS at Month 34 (N= 10,11)
    163.1 ( 306.4 )
    635.4 ( 1196.6 )
        19F PS at Mth34+D7 (N= 7,13)
    856.7 ( 1211.7 )
    1626 ( 1760.5 )
        23F PS at Month 34 (N= 10,11)
    174.2 ( 285 )
    212.2 ( 320.8 )
        23F PS at Mth34+D7 (N= 7,13)
    120.1 ( 92 )
    351.9 ( 400.4 )
        6B PS at Month 34 (N= 10,11)
    136.1 ( 131.8 )
    508.5 ( 606.3 )
        6B PS at Mth34+D7 (N= 7,13)
    153.1 ( 216 )
    469.7 ( 554.5 )
        C-PS at Month 34 (N= 10,11)
    246.3 ( 247.3 )
    751.2 ( 790.5 )
        C-PS at Mth34+D7 (N= 7,13)
    167.6 ( 92 )
    600.5 ( 488.8 )
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).
    End point type
    Secondary
    End point timeframe
    during the 4-day (Days 0-3)post-vaccination period with the 10Pn-PD-DiT vaccine, following the additional dose in the 10Pn-2d and the 10Pn-3d groups and across the 2 doses in the Unprimed group
    End point values
    		 10Pn-2d group 10Pn-3d group Unprimed group
    Number of subjects analysed
    51
    59
    62
    Units: Subjects
        Any Pain (N=51, 59, 62)
    41
    44
    49
        Grade 3 Pain (N=51, 59, 62)
    3
    4
    6
        Any Redness (N=51, 59, 62)
    34
    35
    41
        Grade 3 Redness (N=51, 59, 62)
    9
    12
    15
        Any Swelling (N=51, 59, 62)
    28
    27
    30
        Grade 3 Swelling (N=51, 59, 62)
    5
    9
    9
    No statistical analyses for this end point

    Secondary: Number/percentage of subjects with any, Grade 3 and Related solicited general symptoms

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    End point title
    		 Number/percentage of subjects with any, Grade 3 and Related solicited general symptoms
    End point description
    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.
    End point type
    Secondary
    End point timeframe
    during the 4-day (Days 0-3)post-vaccination period with the 10Pn-PD-DiT vaccine, following the additional dose in the 10Pn-2d and the 10Pn-3d groups and across the 2 doses in the Unprimed group.
    End point values
    		 10Pn-2d group 10Pn-3d group Unprimed group
    Number of subjects analysed
    51
    59
    62
    Units: Subjects
        Any Drowsiness (N=51, 59, 62)
    20
    23
    17
        Grade 3 Drowsiness (N=51, 59, 62)
    0
    0
    0
        Related Drowsiness (N=51, 59, 62)
    20
    23
    17
        Any Fever (N=51, 59, 62)
    9
    5
    8
        Grade 3 Fever (N=51, 59, 62)
    0
    0
    0
        Related Fever (N=51, 59, 62)
    9
    4
    7
        Any Irr./Fuss (N=51, 59, 62)
    20
    27
    21
        Grade 3 Irr./Fuss. (N=51, 59, 62)
    0
    0
    0
        Related Irr./Fuss. (N=51, 59, 62)
    20
    25
    20
        Any Loss Appet. (N=51, 59, 62)
    12
    13
    14
        Grade 3 Loss Appet. (N=51, 59, 62)
    0
    0
    0
        Related Loss Appet. (N=51, 59, 62)
    12
    13
    14
    No statistical analyses for this end point

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

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    End point title
    		 Number (%) of subjects with unsolicited adverse events
    End point description
    An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) period post vaccination, with the 10Pn-PD-DiT vaccine, following the additional dose in the 10Pn-2d and the 10Pn-3d groups and across the 2 doses in the Unprimed group
    End point values
    		 10Pn-2d group 10Pn-3d group Unprimed group
    Number of subjects analysed
    51
    59
    62
    Units: Subjects
        Any AE
    24
    24
    40
    No statistical analyses for this end point

    Secondary: Number (%) of subjects with serious adverse events

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    End point title
    		 Number (%) of subjects with serious adverse events
    End point description
    A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day period following vaccination period
    End point values
    		 10Pn-2d group 10Pn-3d group Unprimed group
    Number of subjects analysed
    51
    59
    62
    Units: Subjects
        Any SAE
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with B-cells detection in the Unprimed group

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    End point title
    		 Number of subjects with B-cells detection in the Unprimed group [22]
    End point description
    Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1. Since none of the blood samples for memory B-cell quantification taken at the Slovakian site were suitable for testing, the assay for memory B-cell quantification was only performed on blood samples from all other evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination (PRE), one week after dose 1 (Day 7)
    Notes
    [22] - 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: When time frames are not the same for the 3 groups for a same endpoint, the endpoint has been duplicated: the first one for presenting results in the 10Pn-2d and 10Pn-3d groups and the second one for presenting the results in the Unprimed group.
    End point values
    		 Unprimed group
    Number of subjects analysed
    13
    Units: Subjects
    arithmetic mean (standard deviation)
        18C PS at PRE (N= 12)
    246.5 ( 310.8 )
        18C PS at Day 7 (N= 13)
    3014.2 ( 4168.4 )
        19F PS at PRE (N= 12)
    306.4 ( 423.1 )
        19F PS at Day 7 (N= 13)
    599.8 ( 643.8 )
        23F PS at PRE (N= 12)
    280 ( 492.2 )
        23F PS at Day 7 (N= 13)
    450 ( 529.4 )
        6B PS at PRE (N= 12)
    159.8 ( 220.7 )
        6B PS at Day 7 (N= 13)
    432.4 ( 478.3 )
        C-PS at PRE (N= 12)
    751.9 ( 463 )
        C-PS at Day 7 (N= 13)
    789.2 ( 751.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period and Unsolicited AEs & SAEs: during the 31-day post-vaccination period, following additional dose in the 10Pn-2d and the 10Pn-3d groups and across the 2 doses in the Unprimed group.
    Adverse event reporting additional description
    Occurrences (all and “related to the treatment”) were not calculated during the analysis and are filled in with “subjects affected” similar information.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    10Pn-2d Group
    Reporting group description
    		 -

    Reporting group title
    10Pn-3d Group
    Reporting group description
    		 -

    Reporting group title
    Unprimed Group
    Reporting group description
    		 -

    Serious adverse events
    		 10Pn-2d Group 10Pn-3d Group Unprimed Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 59 (1.69%)
    1 / 62 (1.61%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 59 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 59 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 59 (1.69%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10Pn-2d Group 10Pn-3d Group Unprimed Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 51 (80.39%)
    44 / 59 (74.58%)
    49 / 62 (79.03%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 51 (80.39%)
    44 / 59 (74.58%)
    49 / 62 (79.03%)
         occurrences all number
    41
    44
    49
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 51 (66.67%)
    35 / 59 (59.32%)
    41 / 62 (66.13%)
         occurrences all number
    34
    35
    41
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 51 (54.90%)
    27 / 59 (45.76%)
    30 / 62 (48.39%)
         occurrences all number
    28
    27
    30
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 51 (39.22%)
    23 / 59 (38.98%)
    17 / 62 (27.42%)
         occurrences all number
    20
    23
    17
    Fever (Rectally, ≥ 38.0°C)
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 51 (17.65%)
    5 / 59 (8.47%)
    8 / 62 (12.90%)
         occurrences all number
    9
    5
    8
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 51 (39.22%)
    27 / 59 (45.76%)
    21 / 62 (33.87%)
         occurrences all number
    20
    27
    21
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 51 (23.53%)
    13 / 59 (22.03%)
    14 / 62 (22.58%)
         occurrences all number
    12
    13
    14
    Pyrexia
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 59 (13.56%)
    7 / 62 (11.29%)
         occurrences all number
    7
    8
    7
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 59 (5.08%)
    2 / 62 (3.23%)
         occurrences all number
    3
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 51 (1.96%)
    5 / 59 (8.47%)
    5 / 62 (8.06%)
         occurrences all number
    1
    5
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 59 (6.78%)
    12 / 62 (19.35%)
         occurrences all number
    1
    4
    12
    Bronchitis
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 59 (5.08%)
    6 / 62 (9.68%)
         occurrences all number
    2
    3
    6
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 59 (5.08%)
    4 / 62 (6.45%)
         occurrences all number
    2
    3
    4
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 59 (1.69%)
    6 / 62 (9.68%)
         occurrences all number
    0
    1
    6

    More information

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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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