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    Clinical Trial Results:
    A phase IIIb, observer-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 12-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-012 (107007) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar.

    Summary
    EudraCT number
    		 2006-005891-41
    Trial protocol
    		 PL  
    Global end of trial date
    07 Oct 2008

    Results information
    Results version number
    		 v1
    This version publication date
    16 Mar 2016
    First version publication date
    17 Jun 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    109509
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00547248
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    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
    09 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine(10Pn-PD-DiT) is non-inferior to Prevenar(7Pn) when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, in terms of post-immunization booster reactions with rectal fever > 39.0°C in children at 12 to 18 months of age. Criteria for safety: Non-inferiority will be demonstrated if one can rule out an increase, in terms of percentage of subjects with rectal fever >39.0°C (10Pn-PD-DiT group as compared to Prevenar group), above 5% + half the incidence in the control group (= the null hypothesis) as shown by an one-sided P-value < 2.5%.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged. As with all injectable vaccines, Tritanrix™-HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Tritanrix™-HepB should under no circumstances be administered intravenously.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 383
    Country: Number of subjects enrolled
    Philippines: 373
    Worldwide total number of subjects
    756
    EEA total number of subjects
    383
    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)
    756
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    The study was conducted in an observer-blind/double-blind fashion. Due to the different appearance of the 10Pn-PD-DiT and Prevenar vaccines, a different person than the one who administered the vaccines, performed the safety assessments in order to keep the study double-blind. In addition, the Clinical Report and the Individual Data Listings of the primary vaccination study 10PN-PD-DIT-012 were not shared with the Investigator before the booster study was over.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10PnEPI Group
    Arm description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose administered in the right thigh or deltoid at 12-18 months of age

    Investigational medicinal product name
    Tritanrix™-HepB
    Investigational medicinal product code
    Other name
    DTPw-HBV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

    Investigational medicinal product name
    Polio Sabin™
    Investigational medicinal product code
    Other name
    OPV vaccine
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1 dose at 12-18 months of age

    Arm title
    		 7PnEPI Group
    Arm description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    7Pn vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose administered in the right thigh or deltoid at 12-18 months of age

    Investigational medicinal product name
    Tritanrix™-HepB
    Investigational medicinal product code
    Other name
    DTPw-HBV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

    Investigational medicinal product name
    Polio Sabin™
    Investigational medicinal product code
    Other name
    OPV vaccine
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1 dose at 12-18 months of age

    Arm title
    		 10Pn246 Group
    Arm description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose administered in the right thigh or deltoid at 12-18 months of age

    Investigational medicinal product name
    Tritanrix™-HepB
    Investigational medicinal product code
    Other name
    DTPw-HBV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    IPV vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the lower left thigh or deltoid at 12-18 months of age

    Arm title
    		 7Pn246 Group
    Arm description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    7Pn vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose administered in the right thigh or deltoid at 12-18 months of age

    Investigational medicinal product name
    Tritanrix™-HepB
    Investigational medicinal product code
    Other name
    DTPw-HBV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    IPV vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered in the lower left thigh or deltoid at 12-18 months of age

    Number of subjects in period 1
    		10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Started
    280
    93
    285
    98
    Completed
    280
    93
    275
    96
    Not completed
    0
    0
    10
    2
         Consent withdrawn by subject
    -
    -
    7
    1
         Protocol deviation
    -
    -
    1
    -
         Migrated/moved from study area
    -
    -
    2
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10PnEPI Group
    Reporting group description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.

    Reporting group title
    7PnEPI Group
    Reporting group description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.

    Reporting group title
    10Pn246 Group
    Reporting group description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age

    Reporting group title
    7Pn246 Group
    Reporting group description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.

    Reporting group values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group Total
    Number of subjects
    		 280 93 285 98 756
    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)
    		 16.2 ( 0.66 ) 16.2 ( 0.59 ) 17.2 ( 0.84 ) 17.2 ( 0.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 133 43 134 43 353
        Male
    		 147 50 151 55 403

    End points

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    End points reporting groups
    Reporting group title
    10PnEPI Group
    Reporting group description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.

    Reporting group title
    7PnEPI Group
    Reporting group description
    		 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.

    Reporting group title
    10Pn246 Group
    Reporting group description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age

    Reporting group title
    7Pn246 Group
    Reporting group description
    		 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.

    Subject analysis set title
    10pn group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    10pn epi+ 10pn246

    Subject analysis set title
    7pn group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    7pnepi +7pn246

    Primary: Number of subjects reporting rectal temperature above (>) 39.0 degree Celsius (°C)

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    End point title
    		 Number of subjects reporting rectal temperature above (>) 39.0 degree Celsius (°C)
    End point description
    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed after booster vaccination of 10Pn-PD-DiT or 7Pn vaccine.
    End point type
    Primary
    End point timeframe
    Within 4-day (Days 0-3) after booster vaccination.
    End point values
    		 10pn group 7pn group
    Number of subjects analysed
    558
    189
    Units: Subjects
        Fever > 39.0°C
    64
    20
    Statistical analysis title
    		 Non-inferiority of 10Pnvs7Pn vaccine after Booster
    Statistical analysis description
    to demonstrate that a booster dose of 10Pn-PD-DiT vaccine administered at 12-18 months of age after a primary vaccination (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to 7Pn in terms of the incidence of rectal fever >39.0°C, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines.Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [10Pn minus 7Pn] in terms of percentages of subjects reporting rectal fever >39.0°C was computed.
    Comparison groups
    10pn group v 7pn group
    Number of subjects included in analysis
    747
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 > 0.001 [2]
    Method
    		 Philips’ statistical test
    Parameter type
    		 Difference in percentage
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.82
         upper limit
    		 5.59
    Notes
    [1] - Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature > 39.0°C) in 10Pn-PD-DiT vaccine minus 7Pn did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in 7Pn.
    [2] - Phillips’ statistical test, an extension of Farrington and Manning's methods, allows the inferiority limit (i.e. the tolerated absolute difference) to vary with the underlying failures rates. Observed P-value < 0.001.

    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
    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
    Within 4-day (Days 0-3) after booster vaccination
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    280
    93
    278
    96
    Units: Subjects
        Any Pain
    203
    66
    248
    77
        Grade 3 Pain
    40
    20
    117
    39
        Any Redness
    107
    37
    197
    66
        Grade 3 Redness
    8
    3
    35
    11
        Any Swelling
    92
    32
    158
    52
        Grade 3 Swelling
    21
    9
    34
    8
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°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 (rectal temperature) above (>) 40.0 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
    Within 4-day (Days 0-3) after booster vaccination
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    280
    93
    278
    96
    Units: Subjects
        Any Drowsiness
    90
    32
    190
    66
        Grade 3 Drowsiness
    5
    1
    7
    2
        Any Fever
    138
    51
    215
    65
        Grade 3 Fever
    0
    0
    1
    0
        Any Irritability
    173
    64
    243
    79
        Grade 3 Irritability
    12
    3
    40
    5
        Any Loss of appetite
    97
    28
    184
    57
        Grade 3 Loss of appetite
    8
    1
    13
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    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
    Within 31-day (Days 0-30) after booster vaccination
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    280
    93
    285
    98
    Units: Subjects
        Any AE(s)
    25
    9
    106
    35
    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
    Throughout the active phase of the study (Month 0 to Month 1)
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    280
    93
    285
    98
    Units: Subjects
        Any SAE(s)
    2
    0
    5
    2
    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
    Throughout the entire study period starting from the beginning of the booster phase (Month 0) up to the end of the 6-month safety follow-up period.
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    280
    93
    285
    98
    Units: Subjects
        Any SAE(s)
    6
    1
    14
    5
    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 above or equal to (≥) 0.20 microgram per milliliter (µg/mL)

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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 above or equal to (≥) 0.20 microgram per milliliter (µg/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    130
    44
    Units: Subjects
        Anti-1, Pre-booster [N=136;42;128;40]
    100
    2
    64
    2
        Anti-1, Post-booster [N=136;42;125;43]
    136
    3
    125
    2
        Anti-4, Pre-booster [N=135;43;130;42]
    113
    25
    78
    23
        Anti-4, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-5, Pre-booster [N=135;42;129;42]
    118
    7
    98
    3
        Anti-5, Post-booster [N=136;43;125;43]
    136
    8
    124
    3
        Anti-6B, Pre-booster [N=135;43;129;44]
    113
    24
    90
    27
        Anti-6B, Post-booster [N=136;42;125;43]
    134
    42
    122
    41
        Anti-7F, Pre-booster [N=135;43;130;42]
    128
    7
    118
    1
        Anti-7F, Post-booster [N=136;43;125;43]
    136
    9
    125
    1
        Anti-9V, Pre-booster [N=135;42;130;44]
    132
    40
    116
    42
        Anti-9V, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-14, Pre-booster [N=134;43;130;43]
    126
    42
    111
    40
        Anti-14, Post-booster [N=136;43;125;43]
    135
    43
    125
    43
        Anti-18C, Pre-booster [N=135;43;130;44]
    130
    36
    111
    35
        Anti-18C, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-19F, Pre-booster [N=135;43;130;44]
    129
    11
    121
    22
        Anti-19F, Post-booster [N=136;43;125;43]
    136
    43
    123
    43
        Anti-23F, Pre-booster [N=133;43;130;44]
    123
    32
    89
    40
        Anti-23F, Post-booster [N=136;43;125;43]
    135
    42
    123
    42
    No statistical analyses for this end point

    Secondary: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations

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    End point title
    		 Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations
    End point description
    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 microgram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    130
    44
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1, Pre-booster [N=136;42;128;40]
    0.35 (0.29 to 0.42)
    0.03 (0.03 to 0.04)
    0.19 (0.16 to 0.22)
    0.04 (0.03 to 0.05)
        Anti-1, Post-booster [N=136;42;125;43]
    10.8 (9.22 to 12.66)
    0.04 (0.03 to 0.05)
    2.14 (1.8 to 2.55)
    0.04 (0.03 to 0.05)
        Anti-4, Pre-booster [N=135;43;130;42]
    0.55 (0.45 to 0.67)
    0.34 (0.25 to 0.45)
    0.27 (0.22 to 0.33)
    0.24 (0.19 to 0.3)
        Anti-4, Post-booster [N=136;43;125;43]
    13.16 (11.43 to 15.14)
    11.84 (8.74 to 16.04)
    4.21 (3.61 to 4.91)
    6.86 (5.39 to 8.73)
        Anti-5, Pre-booster [N=135;42;129;42]
    0.55 (0.47 to 0.64)
    0.06 (0.04 to 0.09)
    0.4 (0.34 to 0.47)
    0.04 (0.03 to 0.05)
        Anti-5, Post-booster [N=136;43;125;43]
    14.59 (12.53 to 16.99)
    0.09 (0.06 to 0.13)
    2.54 (2.11 to 3.06)
    0.05 (0.04 to 0.06)
        Anti-6B, Pre-booster [N=135;43;129;44]
    0.66 (0.54 to 0.8)
    0.38 (0.22 to 0.65)
    0.34 (0.28 to 0.41)
    0.34 (0.2 to 0.59)
        Anti-6B, Post-booster [N=136;42;125;43]
    7.02 (5.83 to 8.45)
    9.08 (6.5 to 12.7)
    2.31 (1.93 to 2.75)
    6.28 (4.18 to 9.44)
        Anti-7F, Pre-booster [N=135;43;130;42]
    0.9 (0.77 to 1.04)
    0.05 (0.03 to 0.07)
    0.58 (0.51 to 0.67)
    0.03 (0.03 to 0.04)
        Anti-7F, Post-booster [N=136;43;125;43]
    12.52 (11.09 to 14.13)
    0.06 (0.04 to 0.1)
    4.14 (3.61 to 4.74)
    0.03 (0.03 to 0.04)
        Anti-9V, Pre-booster [N=135;42;130;44]
    1.16 (0.98 to 1.37)
    0.77 (0.59 to 0.99)
    0.59 (0.5 to 0.7)
    0.58 (0.47 to 0.71)
        Anti-9V, Post-booster [N=136;43;125;43]
    14.42 (12.44 to 16.7)
    20.31 (15.44 to 26.71)
    4.63 (4 to 5.36)
    13.6 (11.12 to 16.62)
        Anti-14, Pre-booster [N=134;43;130;43]
    1.32 (1.07 to 1.63)
    1.83 (1.26 to 2.66)
    0.84 (0.66 to 1.07)
    1.04 (0.75 to 1.43)
        Anti-14, Post-booster [N=136;43;125;43]
    17.07 (14.12 to 20.64)
    27.42 (20.96 to 35.86)
    5.93 (4.97 to 7.09)
    15.51 (12.14 to 19.82)
        Anti-18C, Pre-booster [N=135;43;130;44]
    1.43 (1.2 to 1.71)
    0.42 (0.32 to 0.55)
    0.63 (0.52 to 0.77)
    0.4 (0.3 to 0.53)
        Anti-18C, Post-booster [N=136;43;125;43]
    39.59 (34.04 to 46.05)
    12.07 (9.23 to 15.79)
    10.49 (8.81 to 12.49)
    9.92 (7.74 to 12.71)
        Anti-19F, Pre-booster [N=135;43;130;44]
    1.33 (1.08 to 1.64)
    0.16 (0.1 to 0.26)
    0.99 (0.81 to 1.22)
    0.35 (0.2 to 0.61)
        Anti-19F, Post-booster [N=136;43;125;43]
    21.25 (18.07 to 24.98)
    6.61 (4.9 to 8.92)
    12.23 (9.89 to 15.13)
    6.01 (4.75 to 7.6)
        Anti-23F, Pre-booster [N=133;43;130;44]
    0.94 (0.76 to 1.16)
    0.41 (0.26 to 0.64)
    0.33 (0.27 to 0.4)
    0.62 (0.43 to 0.91)
        Anti-23F, Post-booster [N=136;43;125;43]
    13.47 (11.38 to 15.94)
    14.78 (9.45 to 23.11)
    3.16 (2.61 to 3.83)
    10.77 (7.19 to 16.12)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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    End point title
    		 Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    End point description
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    125
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        OPA Anti-1, Pre-booster [N=134;43;122;37]
    13.2 (10.2 to 16.9)
    4.6 (3.9 to 5.4)
    8.5 (7 to 10.5)
    4.7 (3.8 to 5.8)
        OPA Anti-1, Post-booster [N=134;43;120;37]
    1571.6 (1210.7 to 2040)
    4.9 (4.1 to 5.8)
    161.4 (120.7 to 215.9)
    5.4 (4 to 7.4)
        OPA Anti-4, Pre-booster [N=127;42;114;33]
    40.5 (27.6 to 59.2)
    18.5 (10 to 34.2)
    12.5 (8.9 to 17.4)
    12.4 (6.7 to 22.8)
        OPA Anti-4, Post-booster [N=134;43;119;35]
    5035.8 (4214 to 6017.8)
    4783.5 (3432 to 6667.2)
    2498.7 (2103.3 to 2968.4)
    4812.5 (3167.8 to 7311.3)
        OPA Anti-5, Pre-booster [N=133;43;119;36]
    19.8 (16 to 24.7)
    4.2 (3.8 to 4.6)
    10.9 (8.8 to 13.6)
    4.5 (3.7 to 5.5)
        OPA Anti-5, Post-booster [N=130;43;117;36]
    1135.8 (928.5 to 1389.6)
    4.9 (3.9 to 6)
    149.1 (115.4 to 192.5)
    4.3 (3.8 to 4.8)
        OPA Anti-6B, Pre-booster [N=132;43;124;37]
    97.8 (61.5 to 155.5)
    56.6 (21.3 to 150.1)
    9.9 (7.2 to 13.5)
    23.3 (9.1 to 60.1)
        OPA Anti-6B, Post-booster [N=136;43;120;35]
    2896.8 (2247.5 to 3733.8)
    9302.7 (7187.3 to 12040.8)
    405.3 (267.4 to 614.3)
    3547.1 (1500.7 to 8384.5)
        OPA Anti-7F, Pre-booster [N=135;41;116;31]
    2278.4 (1803.1 to 2879)
    378.8 (136.9 to 1048)
    796.3 (582.2 to 1089.1)
    63.6 (21.3 to 190.1)
        OPA Anti-7F, Post-booster [N=136;40;122;24]
    12484 (10750.7 to 14496.8)
    1407.7 (694.6 to 2852.9)
    6436.1 (5507.6 to 7521)
    90.6 (25.2 to 325.5)
        OPA Anti-9V, Pre-booster [N=136;42;122;37]
    788 (655.1 to 947.8)
    666.8 (482.1 to 922.2)
    380.2 (313.1 to 461.7)
    247.5 (164.9 to 371.3)
        OPA Anti-9V, Post-booster [N=134;42;121;35]
    4842 (4122.7 to 5686.9)
    7387.8 (5429.2 to 10052.9)
    3499.9 (2950.8 to 4151.3)
    6881.4 (4883.6 to 9696.4)
        OPA Anti-14, Pre-booster [N=130;42;106;31]
    298.4 (220.1 to 404.7)
    337.2 (207 to 549.2)
    179.6 (127.4 to 253.2)
    236.6 (132.6 to 422.2)
        OPA Anti-14, Post-booster [N=132;42;120;36]
    3579.7 (2966.3 to 4319.9)
    4097.3 (3019.2 to 5560.2)
    1961.3 (1630 to 2359.8)
    2939.5 (2022.3 to 4272.7)
        OPA Anti-18C, Pre-booster [N=129;42;121;37]
    19.8 (15.2 to 25.9)
    4.5 (3.9 to 5.2)
    7.8 (6.5 to 9.4)
    4.5 (4 to 5.2)
        OPA Anti-18C, Post-booster [N=134;43;115;36]
    2417.2 (1989.9 to 2936.2)
    966.5 (607.1 to 1538.6)
    694 (532.9 to 903.7)
    612.1 (338.4 to 1107)
        OPA Anti-19F, Pre-booster [N=135;43;125;37]
    58.6 (45.2 to 76)
    7.3 (4.5 to 11.8)
    33.3 (25.7 to 43.2)
    11.1 (6 to 20.6)
        OPA Anti-19F, Post-booster [N=136;42;122;37]
    2016 (1609 to 2526)
    473.2 (263.5 to 849.9)
    1059.8 (808.2 to 1389.7)
    471 (270 to 821.8)
        OPA Anti-23F, Pre-booster [N=136;43;118;36]
    948.9 (688.4 to 1308.2)
    661.9 (312.5 to 1402)
    301.8 (198.4 to 459)
    790.6 (326.8 to 1912.6)
        OPA Anti-23F, Post-booster [N=136;43;121;37]
    7456.2 (6301.9 to 8822)
    23177.9 (13235.9 to 40587.7)
    3427.3 (2727.7 to 4306.3)
    19943.3 (13473.1 to 29520.5)
    No statistical analyses for this end point

    Secondary: Antibody concentrations to protein D (Anti-PD)

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    End point title
    		 Antibody concentrations to protein D (Anti-PD)
    End point description
    Seropositivity status, defined as anti-PD antibody concentrations >=100 ELISA units per milliliter (EL.U/mL)
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    135
    43
    128
    43
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, Pre-booster [N=132;43;128;43]
    573.1 (495.7 to 662.6)
    136.8 (102 to 183.3)
    526.8 (427.4 to 649.3)
    73.8 (58.4 to 93.2)
        Anti-PD, Post-booster [N= 135;43;125;43]
    4973.9 (4280.2 to 5780)
    124.1 (92.8 to 166)
    2769.6 (2308.5 to 3322.7)
    91.6 (72 to 116.7)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A

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    End point title
    		 Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A
    End point description
    Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations >=0.05 microgram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    130
    44
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A, Pre-booster [N=135;43;130;43]
    0.46 (0.36 to 0.6)
    0.24 (0.14 to 0.4)
    0.12 (0.1 to 0.14)
    0.13 (0.08 to 0.2)
        Anti-6A, Post-booster [N=136;43;125;43]
    4.07 (3.09 to 5.36)
    4.57 (2.92 to 7.17)
    0.84 (0.65 to 1.08)
    2.54 (1.65 to 3.93)
        Anti-19A, Pre-booster [N=134;43;130;44]
    0.24 (0.19 to 0.3)
    0.08 (0.05 to 0.12)
    0.16 (0.12 to 0.2)
    0.06 (0.04 to 0.08)
        Anti-19A, Post-booster [N=136;43;125;43]
    3.22 (2.46 to 4.21)
    0.58 (0.37 to 0.91)
    1.75 (1.27 to 2.43)
    0.38 (0.25 to 0.58)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A

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    End point title
    		 Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A
    End point description
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >=8
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    134
    43
    123
    36
    Units: Titers
    geometric mean (confidence interval 95%)
        OPA Anti-6A Pre-booster [N=117;39;108;32]
    113.6 (73.6 to 175.4)
    191.4 (89.7 to 408.2)
    46.8 (30.8 to 71.1)
    42.2 (19.3 to 92.1)
        OPA Anti-6A Post-booster [N=133;43;109;32]
    882.8 (665.9 to 1170.3)
    2563.8 (1689.9 to 3889.4)
    369.7 (258.5 to 528.8)
    1394.5 (827.9 to 2348.9)
        OPA Anti-19A Pre-booster [N=134;43;123;36]
    5.3 (4.5 to 6.3)
    5.1 (3.6 to 7.3)
    5.3 (4.5 to 6.2)
    4.4 (3.6 to 5.3)
        OPA Anti-19A Post-booster [N=133;40;115;32]
    89.3 (58.9 to 135.4)
    8.7 (5.4 to 14.2)
    70.7 (45.3 to 110.4)
    20.3 (8.8 to 46.8)
    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

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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
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    130
    44
    Units: Subjects
        Anti-1, Pre-booster [N=136;42;128;40]
    135
    7
    122
    8
        Anti-1, Post-booster [N=136;42;125;43]
    136
    11
    125
    9
        Anti-4, Pre-booster [N=135;43;130;42]
    134
    43
    126
    42
        Anti-4, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-5, Pre-booster [N=135;42;129;42]
    135
    18
    128
    13
        Anti-5, Post-booster [N=136;43;125;43]
    136
    31
    125
    20
        Anti-6B, Pre-booster [N=135;43;129;44]
    132
    40
    127
    39
        Anti-6B, Post-booster [N=136;42;125;43]
    135
    42
    124
    42
        Anti-7F, Pre-booster [N=135;43;130;42]
    135
    13
    130
    8
        Anti-7F, Post-booster [N=136;43;125;43]
    136
    17
    125
    11
        Anti-9V, Pre-booster [N=135;42;130;44]
    135
    42
    130
    44
        Anti-9V, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-14, Pre-booster [N=134;43;130;43]
    134
    42
    130
    43
        Anti-14, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-18C, Pre-booster [N=135;43;130;44]
    135
    43
    129
    44
        Anti-18C, Post-booster [N=136;43;125;43]
    136
    43
    125
    43
        Anti-19F, Pre-booster [N=135;43;130;44]
    134
    37
    129
    43
        Anti-19F, Post-booster [N=136;43;125;43]
    136
    43
    124
    43
        Anti-23F, Pre-booster [N=133;43;130;44]
    132
    40
    125
    43
        Anti-23F, Post-booster [N=136;43;125;43]
    136
    42
    124
    42
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8

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    End point title
    		 Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    125
    37
    Units: Subjects
        OPA Anti-1, Pre-booster [N=134;43;122;37]
    61
    3
    45
    3
        OPA Anti-1, Post-booster [N=134;43;120;37]
    134
    5
    114
    5
        OPA Anti-4, Pre-booster [N=127;42;114;33]
    83
    20
    39
    12
        OPA Anti-4, Post-booster [N=134;43;119;35]
    134
    43
    119
    35
        OPA Anti-5, Pre-booster [N=133;43;119;36]
    94
    1
    56
    2
        OPA Anti-5, Post-booster [N=130;43;117;36]
    130
    4
    114
    1
        OPA Anti-6B, Pre-booster [N=132;43;124;37]
    93
    21
    34
    14
        OPA Anti-6B, Post-booster [N=136;43;120;35]
    134
    43
    106
    32
        OPA Anti-7F, Pre-booster [N=135;41;116;31]
    133
    28
    109
    15
        OPA Anti-7F, Post-booster [N=136;40;122;24]
    136
    36
    122
    13
        OPA Anti-9V, Pre-booster [N=136;42;122;37]
    135
    42
    121
    36
        OPA Anti-9V, Post-booster [N=134;42;121;35]
    134
    42
    121
    35
        OPA Anti-14, Pre-booster [N=130;42;106;31]
    119
    39
    93
    29
        OPA Anti-14, Post-booster [N=132;42;120;36]
    132
    42
    120
    36
        OPA Anti-18C, Pre-booster [N=129;42;121;37]
    84
    3
    42
    4
        OPA Anti-18C, Post-booster [N=134;43;115;36]
    133
    42
    114
    36
        OPA Anti-19F, Pre-booster [N=135;43;125;37]
    117
    7
    96
    12
        OPA Anti-19F, Post-booster [N=136;42;122;37]
    135
    39
    118
    36
        OPA Anti-23F, Pre-booster [N=136;43;118;36]
    130
    37
    99
    30
        OPA Anti-23F, Post-booster [N=136;43;121;37]
    136
    42
    120
    37
    No statistical analyses for this end point

    Secondary: Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL

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    End point title
    		 Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    136
    43
    130
    44
    Units: Subjects
        Anti-6A, Pre-booster [N=135;43;130;43]
    128
    37
    105
    33
        Anti-6A, Post-booster [N=136;43;125;43]
    133
    42
    125
    42
        Anti-19A, Pre-booster [N=134;43;130;44]
    124
    25
    105
    27
        Anti-19A, Post-booster [N=136;43;125;43]
    135
    42
    119
    42
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8

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    End point title
    		 Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    134
    43
    123
    36
    Units: Subjects
        OPA Anti-6A Pre-booster [N=117;39;108;32]
    82
    30
    63
    19
        OPA Anti-6A Post-booster [N=133;43;109;32]
    127
    43
    97
    32
        OPA Anti-19A Pre-booster [N=134;43;123;36]
    14
    2
    11
    1
        OPA Anti-19A Post-booster [N=133;40;115;32]
    92
    11
    74
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 ELISA units per milliliter (EL.U/mL).

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    End point title
    		 Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 ELISA units per milliliter (EL.U/mL).
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    135
    43
    128
    43
    Units: Subjects
        Anti-PD, Pre-booster [N=132;43;128;43]
    131
    28
    117
    11
        Anti-PD, Post-booster [N= 135;43;125;43]
    135
    23
    125
    19
    No statistical analyses for this end point

    Secondary: Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations
    End point description
    Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations >= 0.1 IU/mL
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT, Pre-booster [N=65;25;62;24]
    0.258 (0.209 to 0.319)
    0.17 (0.118 to 0.243)
    0.188 (0.153 to 0.231)
    0.126 (0.088 to 0.179)
        Anti-DT, Post-booster [N=65;25;59;24]
    7.829 (6.339 to 9.671)
    4.768 (3.699 to 6.145)
    8.463 (7.11 to 10.074)
    4.876 (3.503 to 6.787)
        Anti-TT, Pre-booster [N= 65;25;62;24]
    0.735 (0.629 to 0.858)
    0.455 (0.314 to 0.66)
    0.568 (0.432 to 0.748)
    0.525 (0.29 to 0.951)
        Anti-TT, Post-booster [N= 65;25;59;24]
    20.979 (18.359 to 23.972)
    9.703 (8.173 to 11.518)
    12.171 (9.772 to 15.16)
    6.719 (4.598 to 9.819)
    No statistical analyses for this end point

    Secondary: Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations

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    End point title
    		 Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations
    End point description
    Seroprotection status, defined as anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, Pre-booster [N=65;25;62;24]
    5.335 (3.578 to 7.953)
    6.433 (2.93 to 14.124)
    1.03 (0.745 to 1.423)
    0.894 (0.57 to 1.401)
        Anti-PRP, Post-booster [N=65;25;59;24]
    106.004 (79.937 to 140.572)
    89.376 (55.131 to 144.891)
    53.386 (34.817 to 81.858)
    33.656 (19.464 to 58.198)
    No statistical analyses for this end point

    Secondary: Anti-Bordetella pertussis (BPT) antibody concentrations

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    End point title
    		 Anti-Bordetella pertussis (BPT) antibody concentrations
    End point description
    Seropositivity status, defined as anti-BPT antibody concentrations ≥15 EL.U/mL
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT, Pre-booster [N=65;25;62;24]
    12.88 (10.86 to 15.28)
    12.46 (9.32 to 16.65)
    9.54 (8.34 to 10.91)
    10 (8.21 to 12.19)
        Anti-BPT, Post-booster [N=65;25;59;24]
    139.51 (123.26 to 157.89)
    133.45 (110.33 to 161.4)
    121.73 (103.16 to 143.64)
    121.76 (91.81 to 161.47)
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (HBs) antibody concentrations

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    End point title
    		 Anti-hepatitis B surface antigen (HBs) antibody concentrations
    End point description
    Seroprotection status, defined as anti-HBs antibody concentrations ≥10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    69
    21
    64
    19
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, Pre-booster [N=69;21;64;19]
    30 (21.1 to 42.8)
    23.4 (11.5 to 47.7)
    97.9 (77 to 124.5)
    113 (55.1 to 231.7)
        Anti-HBs, Post-booster [N=69;21;62;19]
    1220.5 (790.6 to 1884)
    1098.1 (358.4 to 3364.9)
    4428.7 (2980.3 to 6581)
    3188.6 (1171.7 to 8677.1)
    No statistical analyses for this end point

    Secondary: Anti-polio type 1, 2 and 3 antibody titers

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    End point title
    		 Anti-polio type 1, 2 and 3 antibody titers
    End point description
    Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥8
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    69
    21
    64
    20
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, Pre-booster [N=69;21;63;20]
    329.1 (214.9 to 504.1)
    269 (114.8 to 630.3)
    46.5 (33.6 to 64.4)
    51.1 (28.4 to 91.9)
        Anti-Polio 1, Post-booster [N=69;21;63;19]
    854.6 (573.5 to 1273.5)
    426.9 (166.2 to 1096.7)
    932.5 (770.5 to 1128.6)
    727.3 (512.9 to 1059.9)
        Anti-Polio 2, Pre-booster [N=69;21;64;20]
    222.6 (171.8 to 288.3)
    210.4 (115.4 to 383.6)
    50.2 (36.9 to 68.2)
    60.8 (33.4 to 110.8)
        Anti-Polio 2, Post-booster [N=69;21;63;19]
    716.9 (487.6 to 1054.1)
    689.1 (304.8 to 1557.9)
    1195.7 (977.8 to 1462.2)
    1206.6 (737 to 1975.4)
        Anti-Polio 3, Pre-booster [N=69;21;64;20]
    102.2 (73.9 to 141.5)
    38.4 (20.3 to 72.9)
    51.8 (37.4 to 71.7)
    71.1 (36.2 to 139.5)
        Anti-Polio 3, Post-booster [N=69;21;63;19]
    232.7 (159.6 to 339.4)
    190.4 (78.2 to 463.6)
    1464.2 (1128 to 1900.6)
    1346.2 (857.6 to 2113.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-Bordetella pertussis (BPT) with concentrations ≥ 15 EL.U/mL

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    End point title
    		 Number of subjects with Anti-Bordetella pertussis (BPT) with concentrations ≥ 15 EL.U/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: Subjects
        Anti-BPT, Pre-booster [N=65;25;62;24]
    28
    10
    12
    7
        Anti-BPT, Post-booster [N=65;25;59;24]
    65
    25
    59
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 mili-international units per mililiter (mIU/mL)

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    End point title
    		 Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 mili-international units per mililiter (mIU/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: Subjects
        Anti-DT, Pre-booster [N=65;25;62;24]
    56
    18
    49
    15
        Anti-DT, Post-booster [N=65;25;59;24]
    65
    25
    59
    24
        Anti-TT, Pre-booster [N= 65;25;62;24]
    65
    24
    60
    23
        Anti-TT, Post-booster [N= 65;25;59;24]
    65
    25
    58
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: Subjects
        Anti-PRP, Pre-booster [N=65;25;62;24]
    65
    25
    58
    23
        Anti-PRP, Post-booster [N=65;25;59;24]
    65
    25
    59
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    65
    25
    62
    24
    Units: Subjects
        Anti-PRP, Pre-booster [N=65;25;62;24]
    56
    22
    32
    12
        Anti-PRP, Post-booster [N=65;25;59;24]
    65
    25
    57
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    69
    21
    64
    19
    Units: Subjects
        Anti-HBs, Pre-booster [N=69;21;64;19]
    53
    13
    63
    19
        Anti-HBs, Post-booster [N=69;21;62;19]
    68
    19
    62
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8

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    End point title
    		 Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    69
    21
    64
    20
    Units: Subjects
        Anti-Polio 1, Pre-booster [N=69;21;63;20]
    64
    19
    56
    19
        Anti-Polio 1, Post-booster [N=69;21;63;19]
    68
    19
    63
    19
        Anti-Polio 2, Pre-booster [N=69;21;64;20]
    69
    21
    59
    19
        Anti-Polio 2, Post-booster [N=69;21;63;19]
    69
    21
    63
    19
        Anti-Polio 3, Pre-booster [N=69;21;64;20]
    65
    17
    61
    18
        Anti-Polio 3, Post-booster [N=69;21;63;19]
    66
    20
    63
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response to Anti-Bordetella pertussis (BPT)

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    End point title
    		 Number of subjects with vaccine response to Anti-Bordetella pertussis (BPT)
    End point description
    Vaccine response for anti-BPT, defined as the appearance of antibodies (i.e. concentrations ≥ 15 EL.U/mL) in subjects seronegative at pre-vaccination (i.e. with concentrations < 15 EL.U/mL), or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination (i.e. with concentrations ≥ 15 EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
    End point values
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Number of subjects analysed
    37
    15
    48
    16
    Units: Subjects
        Anti-BPT, S- [N=37;15;48;16]
    37
    15
    48
    16
        Anti-BPT, S+ [N=28;10;11;7]
    27
    8
    11
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms during the 4-day and Unsolicited AEs during the 31-day after booster vaccination; SAEs: throughout the entire study period from the beginning of the booster phase up to the end of the 6-month safety follow-up period
    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
    11.1
    Reporting groups
    Reporting group title
    10PnEPI Group
    Reporting group description
    		 -

    Reporting group title
    7PnEPI Group
    Reporting group description
    		 -

    Reporting group title
    10Pn246 Group
    Reporting group description
    		 -

    Reporting group title
    7Pn246 Group
    Reporting group description
    		 -

    Serious adverse events
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 280 (2.14%)
    1 / 93 (1.08%)
    14 / 285 (4.91%)
    5 / 98 (5.10%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 93 (1.08%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hepatoblastoma
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Internal injury
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 93 (1.08%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    3 / 280 (1.07%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglobulinaemia
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 93 (1.08%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    5 / 285 (1.75%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    3 / 285 (1.05%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    2 / 285 (0.70%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    3 / 285 (1.05%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    2 / 285 (0.70%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infestation
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    1 / 285 (0.35%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 93 (0.00%)
    0 / 285 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    203 / 280 (72.50%)
    66 / 93 (70.97%)
    248 / 285 (87.02%)
    79 / 98 (80.61%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    203 / 280 (72.50%)
    66 / 93 (70.97%)
    248 / 278 (89.21%)
    77 / 96 (80.21%)
         occurrences all number
    203
    66
    248
    77
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    107 / 280 (38.21%)
    37 / 93 (39.78%)
    197 / 278 (70.86%)
    66 / 96 (68.75%)
         occurrences all number
    107
    37
    197
    66
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    92 / 280 (32.86%)
    32 / 93 (34.41%)
    158 / 278 (56.83%)
    52 / 96 (54.17%)
         occurrences all number
    92
    32
    158
    52
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    90 / 280 (32.14%)
    32 / 93 (34.41%)
    190 / 278 (68.35%)
    66 / 96 (68.75%)
         occurrences all number
    90
    32
    190
    66
    Fever (Rectally)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    138 / 280 (49.29%)
    51 / 93 (54.84%)
    215 / 278 (77.34%)
    65 / 96 (67.71%)
         occurrences all number
    138
    51
    215
    65
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    173 / 280 (61.79%)
    64 / 93 (68.82%)
    243 / 278 (87.41%)
    79 / 96 (82.29%)
         occurrences all number
    173
    64
    243
    79
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    97 / 280 (34.64%)
    28 / 93 (30.11%)
    184 / 278 (66.19%)
    57 / 96 (59.38%)
         occurrences all number
    97
    28
    184
    57
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    6 / 280 (2.14%)
    3 / 93 (3.23%)
    10 / 285 (3.51%)
    5 / 98 (5.10%)
         occurrences all number
    6
    3
    10
    5
    Nasopharyngitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    15 / 285 (5.26%)
    5 / 98 (5.10%)
         occurrences all number
    0
    0
    15
    5
    Pharyngitis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 93 (0.00%)
    5 / 285 (1.75%)
    6 / 98 (6.12%)
         occurrences all number
    0
    0
    5
    6
    Rhinitis
         subjects affected / exposed
    3 / 280 (1.07%)
    2 / 93 (2.15%)
    11 / 285 (3.86%)
    5 / 98 (5.10%)
         occurrences all number
    3
    2
    11
    5
    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 solicited symptom 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 solicited symptom 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 solicited symptom 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 solicited symptom 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 solicited symptom 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 solicited symptom 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 solicited symptom 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
    14 Mar 2008
    The protocol was amended to plan for an interim analysis on final cleaned safety and reactogenicity data. This allowed providing to the authorities additional safety and reactogenicity data of a booster dose of GSK Biologicals’ 10Pn-PD-DiT vaccine co-administered with a DTPw-combined vaccine.

    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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