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    Clinical Trial Results:
    A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life

    Summary
    EudraCT number
    		 2006-002898-47
    Trial protocol
    		 GR   ES  
    Global end of trial date
    02 May 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    107737
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00390910
    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
    11 Jul 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when administered as a 3-dose primary vaccination course and co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 2006
    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
    Spain: 175
    Country: Number of subjects enrolled
    Greece: 111
    Worldwide total number of subjects
    286
    EEA total number of subjects
    286
    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)
    286
    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
    		 For each subject the study duration was approximately 5 months for the active phase (Month 0 till one month after last vaccination) and 10 months when including the 5 months extended safety follow-up.

    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
    Overal study (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
    		 PT1 Group
    Arm description
    		 Very pre-tem infants born after a gestation period of 27-30 weeks (189-216 days)
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT; 10 Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4).

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the left thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4)..

    Arm title
    		 PT2 Group
    Arm description
    		 Mild pre-tem infants born after a gestation period of 31-36 weeks (217-258 days)
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT; 10 Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4).

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the left thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4).

    Arm title
    		 FT Group
    Arm description
    		 Infants born after a gestation period of more than 36 weeks (more than 258 days)
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT; 10 Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the right thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4).

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration in the left thigh, 3 doses according to a 2-4-6 month of age schedule (Months 0, 2 and 4).

    Number of subjects in period 1
    		PT1 Group PT2 Group FT Group
    Started
    50
    87
    149
    Completed
    48
    83
    139
    Not completed
    2
    4
    10
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    1
    3
    5
         Migrated/moved from study area
    -
    -
    3
         Lost to follow-up
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PT1 Group
    Reporting group description
    		 Very pre-tem infants born after a gestation period of 27-30 weeks (189-216 days)

    Reporting group title
    PT2 Group
    Reporting group description
    		 Mild pre-tem infants born after a gestation period of 31-36 weeks (217-258 days)

    Reporting group title
    FT Group
    Reporting group description
    		 Infants born after a gestation period of more than 36 weeks (more than 258 days)

    Reporting group values
    		 PT1 Group PT2 Group FT Group Total
    Number of subjects
    		 50 87 149 286
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 11 ( 3.2 ) 9.5 ( 1.45 ) 9.3 ( 1.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 40 62 121
        Male
    		 31 47 87 165

    End points

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    End points reporting groups
    Reporting group title
    PT1 Group
    Reporting group description
    		 Very pre-tem infants born after a gestation period of 27-30 weeks (189-216 days)

    Reporting group title
    PT2 Group
    Reporting group description
    		 Mild pre-tem infants born after a gestation period of 31-36 weeks (217-258 days)

    Reporting group title
    FT Group
    Reporting group description
    		 Infants born after a gestation period of more than 36 weeks (more than 258 days)

    Subject analysis set title
    PT Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled PT1 and PT2 groups

    Primary: Number of subjects with core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature)

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    End point title
    		 Number of subjects with core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) [1] [2]
    End point description
    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of 10Pn-PD-DiT or DTPa-HBV-IPV/Hib vaccine.
    End point type
    Primary
    End point timeframe
    Within 4 days (Days 0-3) after each dose
    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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    146
    135
    Units: Subjects
        Fever > 39.0°C, post Dose 1 [N=146;135]
    5
    2
        Fever > 39.0°C, post Dose 2 [N=141;133]
    1
    1
        Fever > 39.0°C, post Dose 3 [N=138;131]
    3
    1
    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 [3]
    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) post-vaccination period after each dose
    Notes
    [3] - 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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    146
    135
    Units: Subjects
        Any pain, Post Dose 1 [N=146,135]
    58
    40
        Grade 3 pain, Post Dose 1 [N=146,135]
    6
    6
        Any redness, Post Dose 1 [N=146,135]
    67
    39
        Grade 3 redness, Post Dose 1 [N=146,135]
    0
    1
        Any swelling, Post Dose 1 [N=146,135]
    67
    30
        Grade 3 swelling, Post Dose 1 [N=146,135]
    2
    1
        Any pain, Post Dose 2 [N=141;133]
    39
    39
        Grade 3 pain, Post Dose 2 [N=141;133]
    1
    9
        Any redness, Post Dose 2 [N=141;133]
    72
    41
        Grade 3 redness, Post Dose 2 [N=141;133]
    7
    0
        Any swelling, Post Dose 2 [N=141;133]
    60
    30
        Grade 3 swelling, Post Dose 2 [N=141;133]
    4
    0
        Any pain, Post Dose 3 [N=138;131]
    42
    30
        Grade 3 pain, Post Dose 3 [N=138;131]
    6
    3
        Any redness, Post Dose 3 [N=138;131]
    66
    33
        Grade 3 redness, Post Dose 3 [N=138;131]
    9
    3
        Any swelling, Post Dose 3 [N=138;131]
    58
    24
        Grade 3 swelling, Post Dose 3 [N=138;131]
    6
    2
    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 [4]
    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) post-vaccination period after each dose
    Notes
    [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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    146
    135
    Units: Subjects
        Any drowsiness, Post Dose 1 [N=146,135]
    53
    44
        Grade 3 drowsiness, Post Dose 1 [N=146,135]
    2
    1
        Any fever(rectally), Post Dose 1 [N=146,135]
    38
    41
        Grade 3 fever(rectally), Post Dose 1 [N=146,135]
    1
    0
        Any irritability, Post Dose 1 [N=146,135]
    73
    53
        Grade 3 irritability, Post Dose 1 [N=146,135]
    9
    6
        Any loss of appetite, Post Dose 1 [N=146,135]
    36
    33
        Grade 3 loss of appetite, Post Dose 1 [N=146,135]
    0
    0
        Any drowsiness, Post Dose 2 [N=141;133]
    34
    32
        Grade 3 drowsiness, Post Dose 2 [N=141;133]
    0
    1
        Any fever(rectally), Post Dose 2 [N=141;133]
    34
    40
        Grade 3 fever(rectally), Post Dose 2 [N=141;133]
    0
    0
        Any irritability, Post Dose 2 [N=141;133]
    53
    51
        Grade 3 irritability, Post Dose 2 [N=141;133]
    2
    4
        Any loss of appetite, Post Dose 2 [N=141;133]
    23
    35
        Grade 3 loss of appetite, Post Dose 2 [N=141;133]
    0
    2
        Any drowsiness, Post Dose 3 [N=138;131]
    22
    18
        Grade 3 drowsiness, Post Dose 3 [N=138;131]
    1
    4
        Any fever(rectally), Post Dose 3 [N=138;131]
    25
    16
        Grade 3 fever(rectally), Post Dose 3 [N=138;131]
    1
    0
        Any irritability, Post Dose 3 [N=138;131]
    44
    40
        Grade 3 irritability, Post Dose 3 [N=138;131]
    1
    3
        Any loss of appetite, Post Dose 3 [N=138;131]
    22
    26
        Grade 3 loss of appetite, Post Dose 3 [N=138;131]
    0
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any unsolicited adverse events (AEs) [5]
    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 (Day 0-30) post-vaccination period after each vaccination
    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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    149
    137
    Units: Subjects
        Any AEs
    58
    43
    No statistical analyses for this end point

    Secondary: Number of subjects with any serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any serious adverse events (SAEs) [6]
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
    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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    149
    137
    Units: Subjects
        Any SAEs
    13
    18
    No statistical analyses for this end point

    Secondary: Number of subjects with any serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any serious adverse events (SAEs) [7]
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
    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: The analysis was not based on individual groups but rather on the pooled preterm groups and the full-term group.
    End point values
    		 FT Group PT Group
    Number of subjects analysed
    149
    137
    Units: Subjects
        Any SAEs
    19
    29
    No statistical analyses for this end point

    Secondary: Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F above or equal to (≥) 0.20 microgram per mililiter (µg/ mL)

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    End point title
    		 Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F above or equal to (≥) 0.20 microgram per mililiter (µg/ mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    82
    131
    Units: Subjects
        Anti-1 [N=42;82;130]
    41
    82
    129
        Anti-4 [N=41;82;130]
    40
    81
    130
        Anti-5 [N=42;82;129]
    42
    82
    129
        Anti-6B [N=41;82;131]
    38
    78
    123
        Anti-7F [N=41;82;131]
    41
    82
    131
        Anti-9V [N=41;82;132]
    40
    82
    132
        Anti-14 [N=41;82;132]
    41
    82
    132
        Anti-18C [N=41;81;132]
    41
    81
    130
        Anti-19F [N=42;82;132]
    42
    82
    132
        Anti-23F [N=41;82;131]
    39
    79
    125
    No statistical analyses for this end point

    Secondary: Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F above or equal to (≥) 0.05 microgram per mililiter (μg/mL)

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    End point title
    		 Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F above or equal to (≥) 0.05 microgram per mililiter (μg/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    82
    132
    Units: Subjects
        Anti-1 [N=42;82;130]
    42
    82
    130
        Anti-4 [N=41;82;130]
    41
    82
    130
        Anti-5 [N=42;82;129]
    42
    82
    129
        Anti-6B [N=41;82;131]
    40
    81
    131
        Anti-7F [N=41;82;131]
    41
    82
    131
        Anti-9V [N=41;82;132]
    41
    82
    132
        Anti-14 [N=41;82;132]
    41
    82
    132
        Anti-18C [N=41;81;132]
    41
    81
    131
        Anti-19F [N=42;82;132]
    42
    82
    132
        Anti-23F [N=41;82;131]
    39
    81
    129
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    82
    132
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 [N=42;82;130]
    0.97 (0.75 to 1.26)
    1.1 (0.93 to 1.3)
    1.35 (1.18 to 1.55)
        Anti-4 [N=41;82;130]
    1.53 (1.19 to 1.98)
    1.88 (1.61 to 2.2)
    2.42 (2.13 to 2.74)
        Anti-5 [N=42;82;129]
    1.45 (1.13 to 1.86)
    1.93 (1.65 to 2.25)
    2.31 (2 to 2.66)
        Anti-6B [N=41;82;131]
    0.85 (0.61 to 1.19)
    1.11 (0.89 to 1.37)
    1.18 (1 to 1.39)
        Anti-7F [N=41;82;131]
    1.87 (1.47 to 2.39)
    2.37 (2.07 to 2.73)
    2.69 (2.39 to 3.03)
        Anti-9V [N=41;82;132]
    1.43 (1.17 to 1.74)
    1.69 (1.44 to 1.99)
    2.41 (2.13 to 2.73)
        Anti-14 [N=41;82;132]
    3.52 (2.81 to 4.42)
    3.28 (2.77 to 3.89)
    3.71 (3.21 to 4.3)
        Anti-18C [N=41;81;132]
    3.28 (2.51 to 4.29)
    4.86 (3.92 to 6.02)
    5.22 (4.27 to 6.38)
        Anti-19F [N=42;82;132]
    3.6 (2.83 to 4.57)
    4.8 (4.15 to 5.55)
    4.56 (3.95 to 5.26)
        Anti-23F [N=41;82;131]
    1.05 (0.74 to 1.49)
    1.33 (1.07 to 1.65)
    1.54 (1.28 to 1.85)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F above or equal to (≥) 8
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    36
    74
    113
    Units: Subjects
        Opsono-1 [N=34;72;110]
    20
    49
    80
        Opsono-4 [N=36;73;111]
    36
    72
    110
        Opsono-5 [N=34;74;109]
    29
    69
    104
        Opsono-6B [N=35;69;104]
    30
    59
    85
        Opsono-7F [N=36;74;113]
    36
    74
    113
        Opsono-9V [N=36;72;103]
    36
    72
    103
        Opsono-14 [N=36;73;112]
    36
    73
    110
        Opsono-18C [N=34;68;102]
    34
    65
    99
        Opsono-19F [N=35;74;110]
    31
    71
    105
        Opsono-23F [N=36;72;109]
    35
    70
    109
    No statistical analyses for this end point

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

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    End point title
    		 Opsonophagocytic activity against vaccine 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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    36
    74
    113
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-1 [N=34;72;110]
    23 (13 to 40.6)
    30.3 (20.5 to 44.8)
    46.3 (33.4 to 64.1)
        Opsono-4 [N=36;73;111]
    644.1 (474.6 to 874)
    500.9 (384.5 to 652.5)
    543.5 (450.6 to 655.5)
        Opsono-5 [N=34;74;109]
    45.2 (27.7 to 73.8)
    70.8 (52.3 to 95.7)
    94.8 (75.7 to 118.7)
        Opsono-6B [N=35;69;104]
    278.3 (125.5 to 617.3)
    305.1 (180.1 to 516.9)
    268.2 (167.5 to 429.4)
        Opsono-7F [N=36;74;113]
    4086.3 (2834.3 to 5891.3)
    3047.3 (2422.2 to 3833.7)
    2395.2 (1973.2 to 2907.5)
        Opsono-9V [N=36;72;103]
    930.5 (603.1 to 1435.6)
    837.9 (642.7 to 1092.3)
    1144.8 (922.3 to 1421)
        Opsono-14 [N=36;73;112]
    775.4 (539 to 1115.5)
    901.6 (699.8 to 1161.6)
    644.6 (514.9 to 807)
        Opsono-18C [N=34;68;102]
    262.5 (159.4 to 432.4)
    321.5 (220.9 to 467.7)
    251 (189 to 333.4)
        Opsono-19F [N=35;74;110]
    104.2 (61.5 to 176.5)
    201.1 (149.7 to 270.1)
    182.7 (139.2 to 239.7)
        Opsono-23F [N=36;72;109]
    1659.4 (975.1 to 2824)
    1147.2 (843 to 1561.2)
    1558.8 (1302.6 to 1865.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A equal to or above (≥) 0.05 microgram per milliliter (μg/mL)

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    End point title
    		 Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A equal to or above (≥) 0.05 microgram per milliliter (μg/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    81
    131
    Units: Subjects
        Anti-6A [N=42;81;129]
    32
    68
    114
        Anti-19A [N=42;81;131]
    26
    72
    120
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

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    End point title
    		 Concentrations of antibodies against cross-reactive pneumococcal 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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    81
    131
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A [N=42;81;129]
    0.14 (0.09 to 0.2)
    0.21 (0.15 to 0.28)
    0.2 (0.16 to 0.25)
        Anti-19A [N=42;81;131]
    0.08 (0.06 to 0.11)
    0.21 (0.16 to 0.28)
    0.26 (0.21 to 0.32)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A equal to or above (≥) 8
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    33
    69
    105
    Units: Subjects
        Opsono-6A [N=33;66;96]
    25
    54
    58
        Opsono-19A [N=31;69;105]
    2
    10
    17
    No statistical analyses for this end point

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

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    End point title
    		 Opsonophagocytic activity against cross-reactive pneumococcal 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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    33
    69
    105
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-6A [N=33;66;96]
    114.5 (52.8 to 248.5)
    157.3 (95.8 to 258.4)
    49.5 (31.8 to 76.9)
        Opsono-19A [N=31;69;105]
    4.5 (3.8 to 5.4)
    7.1 (4.9 to 10.1)
    7 (5.4 to 9.2)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with concentrations of antibodies against protein D (Anti-PD) equal to or above (≥) 100 ELISA units per milliliter (EL.U/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    82
    130
    Units: Subjects
        Anti-PD
    42
    82
    130
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations of antibodies against protein D (Anti-PD)
    End point description
    Seropositivity status, defined as anti-PD antibody concentrations >= 100 ELISA units per milliliter ( EL.U/mL)
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine.
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    42
    82
    130
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD
    1688.6 (1320.1 to 2159.8)
    1415.4 (1167.1 to 1716.5)
    1496.8 (1283.4 to 1745.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (Anti DT) and anti-tetanus toxoids (Anti TT) antibody concentrations equal to or above 0.1 international units per milliliter (IU/mL)

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    End point title
    		 Number of subjects with anti-diphtheria (Anti DT) and anti-tetanus toxoids (Anti TT) antibody concentrations equal to or above 0.1 international units per milliliter (IU/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    61
    Units: Subjects
        Anti-diphtheria
    18
    41
    61
        Anti-tetanus
    18
    41
    61
    No statistical analyses for this end point

    Secondary: Antibody concentrations for anti-diphtheria and tetanus toxoids

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    End point title
    		 Antibody concentrations for anti-diphtheria and tetanus toxoids
    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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    61
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria
    2.495 (1.664 to 3.741)
    3.23 (2.628 to 3.969)
    3.077 (2.481 to 3.817)
        Anti-tetanus
    7.745 (6.284 to 9.545)
    8.617 (7.216 to 10.29)
    7.695 (6.838 to 8.66)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 0.15 microgram per milliliter (µg/mL)

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 0.15 microgram per milliliter (µg/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    63
    Units: Subjects
        Anti-PRP
    18
    41
    63
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1.0 microgram per milliliter (μg/mL)

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1.0 microgram per milliliter (μg/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    63
    Units: Subjects
        Anti-PRP
    16
    38
    60
    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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    63
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    4.031 (2.261 to 7.184)
    5.804 (4.12 to 8.178)
    7.952 (5.839 to 10.831)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations above or equal to 5 ELISA unit per milli-liter (EL.U/mL)

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    End point title
    		 Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations above or equal to 5 ELISA unit per milli-liter (EL.U/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    61
    Units: Subjects
        Anti-PT [N=18;41;61]
    18
    41
    61
        Anti-FHA [N=18;41;61]
    18
    41
    61
        Anti-PRN [N=17;40;60]
    17
    40
    60
    No statistical analyses for this end point

    Secondary: Antibody concentration for anti-pertussis toxoid (anti-PT) , anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Antibody concentration for anti-pertussis toxoid (anti-PT) , anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
    End point description
    Seropositivity status, defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    41
    61
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT [N=18;41;61]
    41.9 (27.6 to 63.7)
    37.9 (30.7 to 46.7)
    47.3 (40.2 to 55.7)
        Anti-FHA [N=18;41;61]
    188.6 (133.4 to 266.6)
    169 (139.6 to 204.7)
    163.1 (138.3 to 192.3)
        Anti-PRN [N=17;40;60]
    127.6 (81.5 to 199.6)
    109.1 (85.7 to 139)
    119.1 (101.1 to 140.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations equal to or above 10 milli-international units per milliliter (mIU/mL)

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    End point title
    		 Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations equal to or above 10 milli-international units per milliliter (mIU/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    8
    26
    12
    Units: Subjects
        Anti-HBs
    8
    26
    12
    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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    8
    26
    12
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    431.9 (240.7 to 775.2)
    356 (221.1 to 573.4)
    462.9 (221.1 to 969.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polio type 1, 2 and 3 antibody titres

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    End point title
    		 Number of subjects with anti-polio type 1, 2 and 3 antibody titres
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    12
    22
    29
    Units: Subjects
        Anti-Polio 1 [N= 12;22;29]
    12
    22
    29
        Anti-Polio 2 [N= 12;22;29]
    12
    22
    29
        Anti-Polio 3 [N= 11;21;29]
    10
    21
    29
    No statistical analyses for this end point

    Secondary: Antibody titers for polio type 1, 2 and 3

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    End point title
    		 Antibody titers for polio type 1, 2 and 3
    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
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    12
    22
    29
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 [N= 12;22;29]
    271.3 (132.9 to 554)
    189.5 (109.9 to 326.8)
    230.1 (166 to 319)
        Anti-Polio 2 [N= 12;22;29]
    341.7 (214 to 545.6)
    319 (172.5 to 589.8)
    194.4 (121.7 to 310.7)
        Anti-Polio 3 [N= 11;21;29]
    248.4 (67.9 to 908.7)
    344.7 (192.2 to 618.3)
    384.8 (245.3 to 603.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response to anti-pertussis toxoid, anti-filamentous haemagglutinin and anti-pertactin

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    End point title
    		 Number of subjects with vaccine response to anti-pertussis toxoid, anti-filamentous haemagglutinin and anti-pertactin
    End point description
    Vaccine response to PT, FHA and PRN: defined as appearance of antibodies in subjects who are initially seronegative (S-) (i.e., with concentrations < 5 EL.U/mL), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+) (i.e., with concentrations ≥ 5 EL.U/mL).
    End point type
    Secondary
    End point timeframe
    One month after the administration of the 3rd dose of the primary vaccination course with 10Pn vaccine co-administered with DTPa-HBV-IPV/Hib vaccine
    End point values
    		 PT1 Group PT2 Group FT Group
    Number of subjects analysed
    18
    27
    45
    Units: Subjects
        Anti-PT, S- [N=18;27;45]
    18
    27
    45
        Anti-PT, S+ [N=0;10;13]
    0
    8
    12
        Anti-FHA, S- [N=15;22;18]
    15
    22
    18
        Anti-FHA, S+ [N=3;17;41]
    3
    17
    41
        Anti-PRN, S- [N= 17;34;45]
    17
    34
    45
        Anti-PRN, S+ [N=0;4;12]
    0
    4
    12
    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 post vaccination Unsolicited AEs: during the 31-day post vaccination; SAEs:during the whole study 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
    11.0
    Reporting groups
    Reporting group title
    PT Group
    Reporting group description
    		 Pooled PT1 and PT2 groups

    Reporting group title
    FT Group
    Reporting group description
    		 Infants born after a gestation period of more than 36 weeks (more than 258 days)

    Serious adverse events
    		 PT Group FT Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 137 (21.17%)
    19 / 149 (12.75%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Skull fracture
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritability
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocythaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Choking
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachypnoea
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    5 / 137 (3.65%)
    3 / 149 (2.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 137 (2.19%)
    3 / 149 (2.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PT Group FT Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 137 (54.74%)
    102 / 149 (68.46%)
    General disorders and administration site conditions
    Injection site nodule
         subjects affected / exposed
    4 / 137 (2.92%)
    10 / 149 (6.71%)
         occurrences all number
    4
    10
    Pyrexia
         subjects affected / exposed
    3 / 137 (2.19%)
    10 / 149 (6.71%)
         occurrences all number
    3
    10
    Any Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    65 / 135 (48.15%)
    84 / 146 (57.53%)
         occurrences all number
    65
    84
    Any Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    73 / 135 (54.07%)
    102 / 146 (69.86%)
         occurrences all number
    73
    102
    Any Swelling
         subjects affected / exposed [3]
    55 / 135 (40.74%)
    98 / 146 (67.12%)
         occurrences all number
    55
    98
    Any Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    64 / 135 (47.41%)
    65 / 146 (44.52%)
         occurrences all number
    64
    65
    Fever/(Rectally)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    66 / 135 (48.89%)
    64 / 146 (43.84%)
         occurrences all number
    66
    64
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    75 / 135 (55.56%)
    100 / 146 (68.49%)
         occurrences all number
    75
    100
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    65 / 135 (48.15%)
    51 / 146 (34.93%)
         occurrences all number
    65
    51
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 137 (8.03%)
    10 / 149 (6.71%)
         occurrences all number
    11
    10
    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? 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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