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    Clinical Trial Results:
    A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine formulations when administered according to a 0-2-6 month schedule, in healthy children aged 12-23 months at the time of first vaccination.

    Summary
    EudraCT number
    		 2009-012701-19
    Trial protocol
    		 CZ  
    Global end of trial date
    02 Mar 2011

    Results information
    Results version number
    		 v3(current)
    This version publication date
    31 Oct 2020
    First version publication date
    01 Aug 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    113171
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00985751
    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
    25 Jul 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the two formulations of GSK Biologicals’ S. pneumoniae protein containing vaccine combined with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (pooled groups) versus GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with respect to the percentage of subjects reporting fever >40.0°C (rectal temperature) within 7 days after at least one dose of primary vaccination. To compare the two formulations of GSK Biologicals’ S. pneumoniae protein containing vaccine (pooled groups) versus GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with respect to the percentage of subjects reporting fever >40.0°C (rectal temperature) within 7 days after at least one dose of primary vaccination.
    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
    24 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 257
    Worldwide total number of subjects
    257
    EEA total number of subjects
    257
    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)
    257
    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 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    Serological data was not available to any investigator or any person involved in the conduct of the study (including data cleaning). Data were collected in an observer-blind manner: vaccine recipient and those responsible for evaluation of any endpoint (safety, reactogenicity, and immunogenicity) was unaware of which vaccine was administered. To do so, vaccine preparation and administration was done by authorised medical personnel who did not participate in any of the clinical evaluation assays

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 dPly-PhtD-LD Group
    Arm description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal protein vaccine (low dose formulation), adsorbed
    Investigational medicinal product code
    Other name
    GSK 2189242A , dPly/PhtD-LD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 2 dose schedule at Month 0 and Month 2 and a booster dose at Month 6, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

    Arm title
    		 dPly-PhtD-HD Group
    Arm description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal protein vaccine (high dose formulation), adsorbed
    Investigational medicinal product code
    Other name
    GSK 2189242A , dPly/PhtD-LD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 2 dose schedule at Month 0 and Month 2 and a booster dose at Month 6, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

    Arm title
    		 10Pn-dPly-PhtD-LD Group
    Arm description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10 valent pneumococcal conjugate vaccine combined with free pneumococcal proteins, adsorbed
    Investigational medicinal product code
    Other name
    10Pn/dPly/PhtD-LD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 2 dose schedule at Month 0 and Month 2 and a booster dose at Month 6, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

    Arm title
    		 10Pn-dPly-PhtD-HD Group
    Arm description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10 valent pneumococcal conjugate vaccine combined with free pneumococcal proteins, adsorbed
    Investigational medicinal product code
    Other name
    10Pn/dPly/PhtD-HD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 2 dose schedule at Month 0 and Month 2 and a booster dose at Month 6, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

    Arm title
    		 10Pn Group
    Arm description
    		 Subjects received 2 primary vaccination doses of10Pn-PD-DiT vaccine at Month 0 and Month 2 and a booster dose at Month 6.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Synflorix™
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 2 dose schedule at Month 0 and Month 2 and a booster dose at Month 6, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

    Number of subjects in period 1
    		dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Started
    51
    52
    52
    51
    51
    Completed
    51
    52
    52
    51
    50
    Not completed
    0
    0
    0
    0
    1
         Adverse event, non-fatal
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    dPly-PhtD-LD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    dPly-PhtD-HD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn-dPly-PhtD-LD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn-dPly-PhtD-HD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of10Pn-PD-DiT vaccine at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group Total
    Number of subjects
    		 51 52 52 51 51 257
    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)
    		 17 ( 3.6 ) 16.7 ( 3.81 ) 17.1 ( 4.03 ) 16.8 ( 3.96 ) 16.3 ( 4.18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 22 23 29 28 127
        Male
    		 26 30 29 22 23 130

    End points

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    End points reporting groups
    Reporting group title
    dPly-PhtD-LD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    dPly-PhtD-HD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn-dPly-PhtD-LD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn-dPly-PhtD-HD Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of 10Pn-PD-DiT vaccine combined with the pneumococcal protein vaccine containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6.

    Reporting group title
    10Pn Group
    Reporting group description
    		 Subjects received 2 primary vaccination doses of10Pn-PD-DiT vaccine at Month 0 and Month 2 and a booster dose at Month 6.

    Subject analysis set title
    dPly-PhtD Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled dPly-PhtD-LD and dPly-PhtD-HD groups

    Subject analysis set title
    10Pn-dPly-PhtD Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled 10Pn-dPly-PhtD-LD and 10Pn-dPly-PhtD-HD groups

    Primary: Number of subjects with fever > 40.0°C (rectal temperature)

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    End point title
    		 Number of subjects with fever > 40.0°C (rectal temperature) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Within 7 days (day 0-day 6) following at least one dose of the primary vaccination.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reporting the parameter for pooled groups containing the baseline groups.
    End point values
    		 10Pn Group 10Pn-dPly-PhtD Group
    Number of subjects analysed
    51
    103
    Units: Subjects
        Fever >40°C
    0
    1
    Statistical analysis title
    		 Fever >40°C -non-inferiority
    Statistical analysis description
    To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine combined with 10Pn-PD-DiT vaccine (pooled groups) versus 10Pn-PD-DiT vaccine (10Pn-dPly-PhtD Group minus 10Pn Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.
    Comparison groups
    10Pn Group v 10Pn-dPly-PhtD Group
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 5.32
    Notes
    [2] - The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the 10Pn-dPly-PhtD minus the 10Pn group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be expressed if the upper limit of the 2-sided 95% CI on the group difference < 10%.

    Primary: Number of subjects with fever > 40.0°C (rectal temperature)

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    End point title
    		 Number of subjects with fever > 40.0°C (rectal temperature) [3]
    End point description
    End point type
    Primary
    End point timeframe
    Within 7 days (day 0-day 6) following at least one dose of the primary vaccination.
    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: This endpoint is reporting the parameter for pooled groups containing the baseline groups.
    End point values
    		 10Pn Group dPly-PhtD Group
    Number of subjects analysed
    51
    103
    Units: Subjects
        Fever >40°C
    0
    1
    Statistical analysis title
    		 Fever >40°C -non-inferiority
    Statistical analysis description
    To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (pooled groups) versus 10Pn-PD-DiT vaccine (dPly-PhtD Group minus 10Pn Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.
    Comparison groups
    10Pn Group v dPly-PhtD Group
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 5.32
    Notes
    [4] - The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the dPly-PhtD minus the 10Pn group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be expressed if the upper limit of the 2-sided 95% CI on the group difference < 10%.

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

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    End point title
    		 Number of subjects reporting 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
    During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    51
    52
    52
    51
    51
    Units: Subjects
        Any Pain Dose 1 [N=51;52;52;51;51]
    18
    15
    31
    23
    26
        Grade 3 Pain Dose 1 [N=51;52;52;51;51]
    0
    0
    1
    2
    4
        Any Redness Dose 1 [N=51;52;52;51;51]
    17
    20
    32
    28
    25
        Grade 3 Redness Dose 1 [N=51;52;52;51;51]
    1
    0
    5
    4
    2
        Any Swelling Dose 1 [N=51;52;52;51;51]
    8
    5
    19
    17
    19
        Grade 3 Swelling Dose 1 [N=51;52;52;51;51]
    0
    0
    2
    2
    1
        Any Pain Dose 2 [N=51;52;52;51;50]
    15
    22
    24
    27
    27
        Grade 3 Pain Dose 2 [N=51;52;52;51;50]
    0
    0
    2
    2
    3
        Any Redness Dose 2 [N=51;52;52;51;50]
    21
    25
    23
    22
    24
        Grade 3 Redness Dose 2 [N=51;52;52;51;50]
    1
    1
    4
    1
    3
        Any Swelling Dose 2 [N=51;52;52;51;50]
    11
    9
    18
    11
    16
        Grade 3 Swelling Dose 2 [N=51;52;52;51;50]
    0
    0
    5
    1
    2
        Any Pain Booster [N=51;51;52;51;50]
    18
    22
    32
    26
    25
        Grade 3 Pain Booster [N=51;51;52;51;50]
    0
    0
    3
    2
    1
        Any Redness Booster [N=51;51;52;51;50]
    19
    20
    28
    22
    21
        Grade 3 Redness Booster [N=51;51;52;51;50]
    2
    2
    5
    4
    3
        Any Swelling Booster [N=51;51;52;51;50]
    11
    8
    18
    15
    13
        Grade 3 Swelling Booster [N=51;51;52;51;50]
    0
    3
    3
    1
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose ( Dose 1, Dose 2, Booster dose)
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    51
    52
    52
    51
    51
    Units: Subjects
        Any Drowsiness Dose 1 [N=51;52;52;51;51]
    16
    13
    24
    20
    26
        Grade 3 Drowsiness Dose 1 [N=51;52;52;51;51]
    0
    0
    0
    0
    0
        Related Drowsiness Dose 1 [N=51;52;52;51;51]
    6
    6
    13
    10
    16
        Any Irritability Dose 1 [N=51;52;52;51;51]
    21
    16
    31
    27
    23
        Grade 3 Irritability Dose 1 [N=51;52;52;51;51]
    0
    0
    0
    0
    0
        Related Irritability Dose 1 [N=51;52;52;51;51]
    6
    9
    17
    16
    14
        Any Loss of appetite Dose 1 [N=51;52;52;51;51]
    15
    7
    14
    12
    14
        Grade 3 Loss of appetite Dose 1 [N=51;52;52;51;51]
    2
    0
    1
    0
    0
        Related Loss of appetite Dose 1 [N=51;52;52;51;51]
    4
    5
    9
    3
    7
        Any Fever Dose 1 [N=51;52;52;51;51]
    7
    8
    14
    12
    12
        Grade 3 Fever Dose 1 [N=51;52;52;51;51]
    0
    1
    1
    0
    0
        Related Fever Dose 1 [N=51;52;52;51;51]
    3
    2
    7
    8
    9
        Any Drowsiness Dose 2 [N=51;52;52;51;50]
    12
    16
    17
    15
    23
        Grade 3 Drowsiness Dose 2 [N=51;52;52;51;50]
    0
    0
    0
    0
    0
        Related Drowsiness Dose 2 [N=51;52;52;51;50]
    6
    11
    11
    10
    18
        Any Irritability Dose 2 [N=51;52;52;51;50]
    12
    18
    22
    24
    27
        Grade 3 Irritability Dose 2 [N=51;52;52;51;50]
    0
    0
    0
    0
    1
        Related Irritability Dose 2 [N=51;52;52;51;50]
    3
    11
    17
    18
    21
        Any Loss of appetite Dose 2 [N=51;52;52;51;50]
    8
    10
    12
    9
    13
        Grade 3 Loss of appetite Dose 2 [N=51;52;52;51;50]
    1
    0
    0
    0
    0
        Related Loss of appetite Dose 2 [N=51;52;52;51;50]
    4
    5
    9
    5
    7
        Any Fever Dose 2 [N=51;52;52;51;50]
    9
    12
    8
    9
    7
        Grade 3 Fever Dose 2 [N=51;52;52;51;50]
    0
    0
    0
    0
    0
        Related Fever Dose 2 [N=51;52;52;51;50]
    2
    6
    5
    7
    7
        Any Drowsiness Booster [N=51;51;52;51;50]
    13
    13
    18
    12
    17
        Grade 3 Drowsiness Booster [N=51;51;52;51;50]
    0
    0
    0
    0
    0
        Related Drowsiness Booster [N=51;51;52;51;50]
    7
    9
    11
    10
    11
        Any Irritability Booster [N=51;51;52;51;50]
    15
    17
    26
    17
    19
        Grade 3 Irritability Booster [N=51;51;52;51;50]
    0
    0
    0
    1
    1
        Related Irritability Booster [N=51;51;52;51;50]
    9
    11
    15
    13
    13
        Any Loss of appetite Booster [N=51;51;52;51;50]
    6
    10
    13
    15
    8
        Grade 3 Loss of appetite Booster [N=51;51;52;51;50
    2
    0
    1
    1
    1
        Related Loss of appetite Booster [N=51;51;52;51;50
    4
    4
    7
    7
    6
        Any Fever Booster [N=51;51;52;51;50]
    8
    10
    10
    5
    7
        Grade 3 Fever Booster [N=51;51;52;51;50]
    0
    0
    0
    0
    0
        Related Fever Dose 3 Booster [N=51;51;52;51;50]
    5
    3
    7
    2
    3
    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
    During the 31-day (Days 0-30) follow-up period after each primary dose
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    51
    52
    52
    51
    51
    Units: Subjects
        Any AE(s)
    25
    24
    31
    24
    22
    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
    During the 31-day (Days 0-30) follow-up period after the booster dose
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    51
    51
    52
    51
    50
    Units: Subjects
        Any AE(s)
    14
    12
    13
    4
    9
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period starting at the administration of the first vaccine dose up to study end
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    51
    52
    52
    51
    51
    Units: Subjects
        Any SAE(s)
    5
    3
    5
    0
    4
    No statistical analyses for this end point

    Secondary: Anti- pneumococcal dPly and PhtD proteins antibody concentrations

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    End point title
    		 Anti- pneumococcal dPly and PhtD proteins antibody concentrations
    End point description
    Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations >=599 Luminex Units per millilitre (LU/mL) and anti-pneumococcal PhtD antibody concentrations >=391 LU/mL .
    End point type
    Secondary
    End point timeframe
    one month post-dose 2, prior to the booster dose and one month post-booster:
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    45
    45
    47
    41
    41
    Units: LU/mL
    geometric mean (confidence interval 95%)
        Anti-dPly, Post-dose 2 [N=45;43;45;39;41]
    135703.5 (95376.62 to 193081.3)
    148447.5 (101599.9 to 216896.7)
    32436.07 (25523.77 to 41220.35)
    57149.83 (44908.69 to 72727.64)
    3759.82 (2376.77 to 5947.68)
        Anti-dPly, Pre-booster [N=44;45;46;40;40]
    100811.4 (74005.55 to 137326.8)
    96552.52 (73753.5 to 126399.3)
    19573.55 (14948.37 to 25629.82)
    29592.91 (22065.25 to 39688.66)
    4654.16 (2879.42 to 7522.78)
        Anti-dPly, Post-booster [N=44;43;47;41;41]
    224726.2 (178187.6 to 283419.8)
    305912.3 (248087.9 to 377214.4)
    44123.43 (34299.98 to 56760.29)
    85805.02 (67740.53 to 108686.8)
    4553.43 (2878.04 to 7204.12)
        Anti-PhtD, Post-dose 2 [N=45;43;45;39;41]
    30402.84 (20723.61 to 44602.88)
    35043.91 (24164.16 to 50822.19)
    23438.06 (16617.86 to 33057.36)
    22141.18 (15065.44 to 32540.15)
    3795.68 (2268.23 to 6351.73)
        Anti- PhtD, Pre-booster [N=44;45;46;40;40]
    24350.58 (17056.09 to 34764.74)
    23918.77 (17724.59 to 32277.63)
    14375.59 (9338.31 to 22130.1)
    12721.01 (8498 to 19042.62)
    4814.97 (2881.25 to 8046.46)
        Anti- PhtD, Post-booster [N=44;43;47;41;41]
    65584.24 (50985.27 to 84363.43)
    77312.07 (58589.49 to 102017.6)
    32609.19 (23615.58 to 45027.88)
    36098.18 (26620.97 to 48949.34)
    5072.43 (3023.97 to 8508.53)
    No statistical analyses for this end point

    Secondary: Anti-pneumococcal serotypes and cross-reactive serotypes antibody concentrations

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    End point title
    		 Anti-pneumococcal serotypes and cross-reactive serotypes antibody concentrations
    End point description
    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations >= 0.05 microgram per millilitre (µg/mL).
    End point type
    Secondary
    End point timeframe
    One month post-dose 2, prior to the booster dose and one month post-booster
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    43
    44
    47
    41
    41
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1, Post-Dose 2 [N=40;36;46;40;41]
    0.04 (0.03 to 0.05)
    0.05 (0.04 to 0.06)
    2.5 (2.01 to 3.11)
    2.08 (1.56 to 2.77)
    2.13 (1.62 to 2.79)
        Anti-1, Pre-booster [N=43;42;45;40;40]
    0.05 (0.03 to 0.06)
    0.05 (0.04 to 0.07)
    0.87 (0.68 to 1.12)
    0.75 (0.57 to 0.99)
    0.73 (0.55 to 0.97)
        Anti-1, Post-booster [N=40;41;47;41;41]
    0.04 (0.03 to 0.06)
    0.05 (0.04 to 0.08)
    2.69 (2.13 to 3.39)
    2.47 (2.03 to 3)
    2.4 (1.85 to 3.12)
        Anti-4, Post-Dose 2 [N=37;37;46;40;41]
    0.05 (0.03 to 0.08)
    0.03 (0.02 to 0.03)
    6.42 (5.23 to 7.87)
    6.6 (5.12 to 8.52)
    5.67 (4.56 to 7.06)
        Anti-4, Pre-booster [N=41;41;46;41;40]
    0.05 (0.03 to 0.07)
    0.03 (0.03 to 0.03)
    2.3 (1.82 to 2.91)
    2.36 (1.79 to 3.11)
    2.11 (1.68 to 2.64)
        Anti-4, Post-booster [N=40;41;47;41;41]
    0.05 (0.03 to 0.07)
    0.04 (0.03 to 0.05)
    5.26 (4.14 to 6.69)
    5.61 (4.46 to 7.07)
    5.18 (4.05 to 6.63)
        Anti-5, Post-Dose 2 [N=31;34;44;39;41]
    0.06 (0.04 to 0.08)
    0.06 (0.05 to 0.08)
    2.42 (1.85 to 3.17)
    2.41 (1.85 to 3.13)
    2.36 (1.88 to 2.97)
        Anti-5, Pre-booster [N=42;43;45;41;40]
    0.07 (0.05 to 0.1)
    0.06 (0.05 to 0.08)
    1.08 (0.83 to 1.41)
    1.05 (0.81 to 1.36)
    1.18 (0.94 to 1.48)
        Anti-5, Post-booster [N=41;43;47;41;41]
    0.07 (0.05 to 0.09)
    0.07 (0.05 to 0.09)
    3.57 (2.79 to 4.57)
    3.45 (2.7 to 4.41)
    3.84 (2.98 to 4.95)
        Anti-6B, Post-Dose 2 [N=43;39;46;40;41]
    0.04 (0.03 to 0.05)
    0.03 (0.02 to 0.03)
    0.55 (0.37 to 0.81)
    0.48 (0.32 to 0.72)
    0.55 (0.39 to 0.78)
        Anti-6B, Pre-booster [N=42;41;44;40;40]
    0.04 (0.03 to 0.05)
    0.04 (0.03 to 0.05)
    0.39 (0.28 to 0.54)
    0.42 (0.3 to 0.59)
    0.46 (0.34 to 0.62)
        Anti-6B, Post-booster [N=41;42;47;41;40]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.06)
    1.08 (0.74 to 1.57)
    1.14 (0.83 to 1.57)
    1.08 (0.78 to 1.52)
        Anti-7F, Post-Dose 2 [N=37;38;46;40;41]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.04)
    5.03 (4.16 to 6.09)
    4.73 (3.89 to 5.74)
    3.72 (3.17 to 4.36)
        Anti-7F, Pre-booster [N=42;44;46;41;40]
    0.04 (0.03 to 0.06)
    0.03 (0.03 to 0.04)
    2.6 (2.14 to 3.15)
    2.36 (1.94 to 2.86)
    2.14 (1.82 to 2.51)
        Anti-7F, Post-booster [N=41;43;47;41;41]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.05)
    5.9 (4.83 to 7.2)
    5.25 (4.36 to 6.32)
    4.65 (3.77 to 5.72)
        Anti-9V, Post-Dose 2 [N=42;40;46;40;41]
    0.04 (0.03 to 0.06)
    0.03 (0.02 to 0.03)
    2.81 (2.24 to 3.51)
    2.49 (1.95 to 3.19)
    1.55 (1.21 to 2)
        Anti-9V, Pre-booster [N=41;42;45;41;40]
    0.04 (0.03 to 0.05)
    0.03 (0.03 to 0.04)
    1.44 (1.15 to 1.81)
    1.26 (0.94 to 1.67)
    0.95 (0.73 to 1.24)
        Anti-9V, Post-booster [N=39;40;47;41;40]
    0.04 (0.03 to 0.06)
    0.03 (0.02 to 0.04)
    3.13 (2.48 to 3.93)
    3.21 (2.45 to 4.19)
    2.18 (1.71 to 2.79)
        Anti-14, Post-Dose 2 [N=43;36;46;40;41]
    0.1 (0.07 to 0.14)
    0.09 (0.06 to 0.14)
    5.18 (3.91 to 6.86)
    3.78 (2.92 to 4.91)
    4.63 (3.71 to 5.77)
        Anti-14, Pre-booster [N=40;40;46;40;40]
    0.11 (0.08 to 0.17)
    0.11 (0.07 to 0.18)
    2.86 (2.25 to 3.65)
    2.3 (1.81 to 2.91)
    2.71 (2.17 to 3.38)
        Anti-14, Post-booster [N=42;43;47;41;41]
    0.13 (0.09 to 0.18)
    0.16 (0.1 to 0.26)
    7.74 (6.03 to 9.94)
    6.62 (5.22 to 8.4)
    5.98 (4.68 to 7.63)
        Anti-18C, Post-Dose 2 [N=39;39;45;40;41]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.05)
    13.92 (10.75 to 18.03)
    16.92 (13.61 to 21.03)
    12.56 (9.8 to 16.1)
        Anti-18C, Pre-booster [N=41;42;45;41;40]
    0.05 (0.03 to 0.07)
    0.04 (0.03 to 0.05)
    4.94 (3.83 to 6.38)
    5.51 (4.3 to 7.05)
    4.79 (3.69 to 6.21)
        Anti-18C, Post-booster [N=42;44;47;41;40]
    0.05 (0.03 to 0.07)
    0.05 (0.03 to 0.07)
    16.12 (12.2 to 21.32)
    21.98 (16.67 to 28.99)
    14.62 (10.9 to 19.6)
        Anti-19F, Post-Dose 2 [N=33;35;45;39;41]
    0.05 (0.03 to 0.08)
    0.06 (0.03 to 0.12)
    8.6 (6.37 to 11.63)
    10.08 (7.21 to 14.09)
    8.87 (6.2 to 12.7)
        Anti-19F, Pre-booster [N=38;40;46;41;40]
    0.06 (0.04 to 0.1)
    0.05 (0.03 to 0.09)
    4.15 (2.94 to 5.85)
    4.72 (3.54 to 6.3)
    4.33 (3.06 to 6.12)
        Anti-19F, Post-booster [N=41;40;47;41;41]
    0.06 (0.04 to 0.09)
    0.07 (0.04 to 0.13)
    10.46 (7.35 to 14.88)
    14.38 (10.53 to 19.63)
    11.32 (7.94 to 16.13)
        Anti-23F, Post-Dose 2 [N=38;38;45;39;41]
    0.03 (0.03 to 0.04)
    0.04 (0.03 to 0.05)
    1.19 (0.82 to 1.74)
    0.91 (0.62 to 1.33)
    0.73 (0.54 to 0.98)
        Anti-23F, Pre-booster [N=42;41;45;41;40]
    0.03 (0.03 to 0.04)
    0.04 (0.03 to 0.06)
    0.71 (0.5 to 0.99)
    0.62 (0.45 to 0.85)
    0.51 (0.39 to 0.67)
        Anti-23F, Post-booster [N=41;43;47;41;40]
    0.03 (0.03 to 0.04)
    0.05 (0.03 to 0.06)
    1.92 (1.42 to 2.6)
    2.04 (1.56 to 2.65)
    1.47 (1.04 to 2.06)
        Anti-6A, Post-Dose 2 [N=33;37;43;40;41]
    0.04 (0.03 to 0.07)
    0.03 (0.03 to 0.04)
    0.32 (0.2 to 0.51)
    0.27 (0.16 to 0.45)
    0.31 (0.2 to 0.48)
        Anti-6A, Pre-booster [N=42;42;44;41;40]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.04)
    0.24 (0.17 to 0.34)
    0.24 (0.15 to 0.38)
    0.27 (0.18 to 0.4)
        Anti-6A, Post-booster [N=42;40;47;41;40]
    0.04 (0.03 to 0.06)
    0.04 (0.03 to 0.06)
    0.53 (0.35 to 0.79)
    0.56 (0.36 to 0.87)
    0.58 (0.37 to 0.9)
        Anti-19A, Post-Dose 2 [N=33;35;43;39;41]
    0.07 (0.04 to 0.12)
    0.05 (0.03 to 0.06)
    1.08 (0.71 to 1.62)
    0.97 (0.63 to 1.48)
    0.93 (0.61 to 1.43)
        Anti-19A, Pre-booster [N=43;42;44;41;40]
    0.07 (0.04 to 0.1)
    0.05 (0.04 to 0.06)
    0.85 (0.61 to 1.17)
    0.68 (0.47 to 0.98)
    0.62 (0.42 to 0.93)
        Anti-19A, Post-booster [N=41;39;47;41;41]
    0.07 (0.05 to 0.11)
    0.05 (0.04 to 0.07)
    2.76 (1.92 to 3.96)
    2.98 (2.08 to 4.26)
    2.06 (1.3 to 3.25)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity (OPA) titers against pneumococcal serotypes and cross-reactive serotypes

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    End point title
    		 Opsonophagocytic activity (OPA) titers against pneumococcal serotypes and cross-reactive serotypes
    End point description
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A >= 8
    End point type
    Secondary
    End point timeframe
    one month post-dose 2, prior to the booster dose and one month post-booster
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    35
    36
    37
    36
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        OPSONO-1, Post-Dose 2 [N=27;33;35;30;30]
    4 (4 to 4)
    5.4 (3.8 to 7.8)
    71.8 (40.9 to 126.1)
    48.2 (26.5 to 87.6)
    90 (52.9 to 153)
        OPSONO-1, Pre-booster [N=35;35;33;35;34]
    4 (4 to 4)
    4.3 (3.7 to 5)
    23 (13.1 to 40.3)
    12.4 (7.6 to 20.3)
    19.3 (11.1 to 33.6)
        OPSONO-1, Post-booster [N=31;35;37;36;37]
    5.2 (4 to 6.9)
    8.1 (4.8 to 13.7)
    169.5 (96.1 to 298.8)
    200 (138.2 to 289.4)
    206.9 (123.1 to 347.5)
        OPSONO-4, Post-Dose 2 [N=20;29;32;29;29]
    7 (3.1 to 15.6)
    8.9 (4.5 to 17.6)
    1260.2 (856.1 to 1855.2)
    1197.9 (784.1 to 1830.2)
    1220.4 (913.8 to 1629.9)
        OPSONO-4, Pre-booster [N=28;29;29;33;30]
    12.6 (5.6 to 28.4)
    16.2 (7 to 37.2)
    247.9 (117.4 to 523.2)
    259.9 (120.6 to 560)
    478.9 (309.3 to 741.3)
        OPSONO-4, Post-booster [N=24;31;35;32;34]
    15.5 (6.1 to 39.5)
    17.8 (7.3 to 43.4)
    1206.2 (888.9 to 1636.8)
    1385 (974.5 to 1968.4)
    1476 (1076 to 2024.6)
        OPSONO-5, Post-Dose 2 [N=27;33;33;30;31]
    4 (4 to 4)
    4.7 (3.4 to 6.5)
    43.8 (27.1 to 70.8)
    37.3 (21.7 to 64)
    42 (26.6 to 66.4)
        OPSONO-5, Pre-booster [N=34;35;34;33;34]
    4.5 (3.5 to 5.8)
    4 (4 to 4)
    12.8 (8.2 to 19.9)
    14.8 (9.6 to 23)
    17 (10.9 to 26.4)
        OPSONO-5, Post-booster [N=30;36;37;34;36]
    4 (4 to 4)
    5.1 (3.8 to 6.7)
    99.3 (62.1 to 158.8)
    110.4 (73.1 to 166.8)
    160.7 (113 to 228.7)
        OPSONO-6B, Post-Dose 2 [N=16;21;27;25;28]
    15 (4.2 to 53.1)
    23.4 (6.1 to 90.3)
    361.9 (120 to 1091.7)
    527.5 (202.6 to 1372.9)
    915.3 (543.4 to 1541.8)
        OPSONO-6B, Pre-booster [N=23;27;30;30;30]
    56.7 (16.2 to 198.4)
    61.6 (19.2 to 197.3)
    213.8 (79 to 578.1)
    513.1 (243.9 to 1079.6)
    371.9 (172.5 to 801.8)
        OPSONO-6B, Post-booster [N=24;33;33;34;35]
    26.1 (7.7 to 88.7)
    30.8 (11.2 to 84.7)
    804.6 (343.5 to 1884.9)
    982.7 (527.6 to 1830.4)
    1523.1 (875.8 to 2649)
        OPSONO-7F, Post-Dose 2 [N=27;33;33;29;30]
    734.6 (369.7 to 1459.6)
    807.4 (445 to 1465.2)
    5703.7 (4143.6 to 7851.2)
    4936.6 (3320.7 to 7338.7)
    6154.4 (4244.4 to 8923.7)
        OPSONO-7F, Pre-booster [N=33;30;32;34;33]
    670.4 (317.5 to 1415.6)
    462.3 (187.5 to 1139.8)
    2450.1 (1637.4 to 3666.2)
    2713.5 (1836.1 to 4010.1)
    3844.5 (2725.7 to 5422.4)
        OPSONO-7F, Post-booster [N=30;35;35;33;36]
    936.8 (510 to 1720.7)
    785.5 (428 to 1441.6)
    4109.3 (3086.9 to 5470.3)
    5730.4 (4262 to 7704.7)
    7404.7 (5271.1 to 10401.8)
        OPSONO-9V, Post-Dose 2 [N=22;29;34;29;30]
    26.5 (8.2 to 85.9)
    50.1 (17.5 to 143.7)
    4455 (2803.3 to 7079.9)
    3542.8 (2271.5 to 5525.5)
    3947.2 (2612.7 to 5963.5)
        OPSONO--9V, Pre-booster [N=30;28;32;33;32]
    172.4 (68.9 to 431.4)
    172 (57.6 to 513.2)
    2126.1 (1140.2 to 3964.4)
    2622.4 (1786.7 to 3849)
    3450 (2357.5 to 5048.7)
        OPSONO-9V, Post-booster [N=26;32;37;34;36]
    173.5 (59.1 to 509.8)
    137.6 (51.7 to 366)
    4643.1 (3418.3 to 6306.9)
    5802.4 (4453 to 7560.8)
    6016.6 (4617.2 to 7840)
        OPSONO-14, Post-Dose 2 [N=18;23;33;29;31]
    21.1 (6.7 to 66.8)
    11.9 (4.7 to 30.4)
    3324.8 (2324.8 to 4754.8)
    2580.7 (1788.4 to 3724)
    2487.6 (1703.4 to 3632.7)
        OPSONO-14, Pre-booster [N=30;30;32;34;33]
    21 (8.5 to 51.6)
    27.9 (10.4 to 75.1)
    1390.5 (615.7 to 3140.4)
    1725.8 (972.1 to 3064)
    1776.6 (1009.5 to 3126.5)
        OPSONO-14, Post-booster [N=27;33;34;36;37]
    32.3 (11.5 to 90.9)
    46.7 (17 to 127.8)
    2911.6 (1841.3 to 4604)
    3729.8 (2693.2 to 5165.4)
    3094 (2353.3 to 4068)
        OPSONO-18C, Post-Dose 2 [N=24;29;33;28;27]
    4 (4 to 4)
    7.4 (3.7 to 15.1)
    1398.3 (810.6 to 2412)
    2538.4 (1787.3 to 3605)
    1905.4 (1271.4 to 2855.6)
        OPSONO-18C, Pre-booster [N=33;33;31;34;34]
    5.4 (3.4 to 8.3)
    5 (3.7 to 6.8)
    420.1 (192.8 to 915.3)
    1041 (699.6 to 1548.9)
    766.4 (468.4 to 1253.8)
        OPSONO-18C, Post-booster [N=26;32;34;32;33]
    6 (3.3 to 10.7)
    8 (4.4 to 14.6)
    1764.6 (1243.6 to 2503.8)
    2640.6 (2083.3 to 3346.8)
    2123.4 (1493 to 3020.1)
        OPSONO-19F, Pre-booster [N=31;34;30;34;34]
    5 (3.1 to 8.2)
    8 (4.3 to 14.7)
    794.3 (476.6 to 1324)
    420.7 (197.4 to 896.4)
    625.4 (266.5 to 1467.7)
        OPSONO-19F, Post-booster [N=30;36;36;34;34]
    4.9 (3.5 to 6.8)
    4.4 (3.7 to 5.2)
    173.3 (86.1 to 349)
    210.1 (118.4 to 373)
    260.7 (138 to 492.5)
        OPSONO-19F, Post-Dose 2 [N=17;28;32;28;27]
    5.6 (3.4 to 9.1)
    7.3 (4.3 to 12.6)
    1248.5 (740.4 to 2105.3)
    1823.7 (1252.9 to 2654.5)
    1625.3 (931.7 to 2835.3)
        OPSONO-23F, Post-Dose 2 [N=20;28;34;28;29]
    17.9 (5.1 to 62.9)
    107.8 (28.1 to 412.8)
    1735.5 (833.6 to 3613.3)
    3621.8 (2431.4 to 5395.2)
    2502.5 (1610.5 to 3888.6)
        OPSONO-23F, Pre-booster [N=30;33;32;33;33]
    23.2 (7.6 to 70.3)
    136.3 (36.1 to 514.6)
    989.7 (419.2 to 2336.8)
    1635.9 (691.7 to 3868.8)
    897.4 (381.6 to 2110.4)
        OPSONO-23F, Post-booster [N=25;33;35;35;36]
    68.6 (17.3 to 271.2)
    106.7 (28.5 to 399.4)
    3598.5 (2422.2 to 5345.9)
    6108 (4335.9 to 8604.5)
    5296.1 (3857.9 to 7270.4)
        OPSONO-6A, Post-Dose 2 [N=19;26;31;21;27]
    9.3 (3.5 to 24.7)
    5.7 (3.4 to 9.5)
    225.3 (83.3 to 608.8)
    186.2 (55.3 to 627.2)
    364.5 (158.7 to 837.1)
        OPSONO-6A, Pre-booster [N=27;30;31;33;32]
    18.4 (7.6 to 44.5)
    9.4 (4.5 to 19.5)
    58.9 (21.6 to 160.3)
    99.4 (39.9 to 247.8)
    221.7 (93.8 to 524)
        OPSONO-6A, Post-booster [N=22;32;34;31;32]
    11.8 (4.7 to 29.5)
    17.3 (7.9 to 37.9)
    308 (141 to 672.9)
    348.2 (154.9 to 782.5)
    554.3 (248.3 to 1237.6)
        OPSONO-19A, Post-Dose 2 [N=25;31;34;28;29]
    5.8 (3.4 to 9.9)
    4.6 (3.7 to 5.6)
    246 (109.7 to 551.7)
    363.2 (202.1 to 652.8)
    349.9 (177.1 to 691.6)
        OPSONO-19A, Pre-booster [N=35;35;33;35;32]
    6 (4 to 9.1)
    4.5 (3.8 to 5.3)
    56.7 (25.2 to 127.9)
    76.4 (36.3 to 160.7)
    87.8 (40.6 to 189.7)
        OPSONO-19A, Post-booster [N=30;36;34;34;34]
    6.7 (4.3 to 10.3)
    6.3 (4.4 to 9.1)
    746.3 (407.8 to 1365.6)
    989.3 (652.5 to 1500)
    725.9 (367.8 to 1432.6)
    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 millilitre (EL.U/mL)
    End point type
    Secondary
    End point timeframe
    One month post-dose 2, prior to the booster dose and one month post-booster
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    45
    45
    47
    41
    41
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD Post-Dose 2 [N=45;43;45;39;41]
    90.9 (71.1 to 116.3)
    100.4 (76.3 to 132.1)
    1105.4 (833.7 to 1465.7)
    600.2 (426.5 to 844.7)
    860 (659.2 to 1121.9)
        Anti-PD Pre-booster [N=44;45;46;40;40]
    89.1 (71.8 to 110.7)
    118.2 (89.6 to 155.9)
    734.6 (523.9 to 1030.1)
    463 (330.2 to 649.3)
    691.8 (527.6 to 907.1)
        Anti-PD Post-booster [N=44;43;47;41;41]
    97.9 (78 to 122.9)
    130.6 (93.1 to 183.3)
    1882.6 (1407.4 to 2518.1)
    1474.6 (1103.7 to 1970.3)
    1963.8 (1560.1 to 2472)
    No statistical analyses for this end point

    Secondary: Level of anti-dPly antibodies inhibiting Ply haemolysis activity

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    End point title
    		 Level of anti-dPly antibodies inhibiting Ply haemolysis activity
    End point description
    Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titres (for inhibition of haemolytic activity) >=140
    End point type
    Secondary
    End point timeframe
    one month post-dose 2, prior to the booster dose and one month post-booster
    End point values
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Number of subjects analysed
    43
    38
    43
    39
    40
    Units: % of inhibition
    geometric mean (confidence interval 95%)
        Anti-Hem-dPly Post-Dose 2 [N=43;38;43;39;40]
    3080 (2555.3 to 3712.5)
    2988.7 (2410.1 to 3706.2)
    1278.9 (1048.2 to 1560.3)
    1814 (1495.3 to 2200.8)
    913.2 (699.1 to 1192.8)
        Anti- Hem-dPly Pre-booster [N=37;37;37;34;35]
    2441.1 (1867.1 to 3191.7)
    2193.7 (1737.3 to 2770)
    1141.5 (950.6 to 1370.6)
    1344.2 (1087.6 to 1661.3)
    995.9 (788.3 to 1258.2)
        Anti- Hem-dPly Post-booster [N=31;32;36;32;30]
    4332.4 (3327.6 to 5640.4)
    5931.9 (4744.5 to 7416.4)
    1346.2 (1068.2 to 1696.5)
    2388.3 (1830.6 to 3115.9)
    818.6 (662.5 to 1011.5)
    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-primary and post booster vaccination period; Unsolicited AEs during the 31-day post-primary and post-booster vaccination period; 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
    14.0
    Reporting groups
    Reporting group title
    dPly-PhtD-LD Group
    Reporting group description
    		 -

    Reporting group title
    dPly-PhtD-HD Group
    Reporting group description
    		 -

    Reporting group title
    10Pn-dPly-PhtD-LD Group
    Reporting group description
    		 -

    Reporting group title
    10Pn-dPly-PhtD-HD Group
    Reporting group description
    		 -

    Reporting group title
    10Pn Group
    Reporting group description
    		 -

    Serious adverse events
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 51 (9.80%)
    3 / 52 (5.77%)
    5 / 52 (9.62%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open wound
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngo-tonsillitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 dPly-PhtD-LD Group dPly-PhtD-HD Group 10Pn-dPly-PhtD-LD Group 10Pn-dPly-PhtD-HD Group 10Pn Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 51 (92.16%)
    49 / 52 (94.23%)
    49 / 52 (94.23%)
    49 / 51 (96.08%)
    49 / 51 (96.08%)
    General disorders and administration site conditions
    Pain Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 51 (52.94%)
    28 / 52 (53.85%)
    34 / 52 (65.38%)
    33 / 51 (64.71%)
    34 / 51 (66.67%)
         occurrences all number
    27
    28
    34
    33
    34
    Redness Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 51 (47.06%)
    30 / 52 (57.69%)
    36 / 52 (69.23%)
    33 / 51 (64.71%)
    30 / 51 (58.82%)
         occurrences all number
    24
    30
    36
    33
    30
    Swelling Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 51 (33.33%)
    11 / 52 (21.15%)
    25 / 52 (48.08%)
    21 / 51 (41.18%)
    26 / 51 (50.98%)
         occurrences all number
    17
    11
    25
    21
    26
    Pain Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 51 (35.29%)
    22 / 52 (42.31%)
    32 / 52 (61.54%)
    26 / 51 (50.98%)
    25 / 51 (49.02%)
         occurrences all number
    18
    22
    32
    26
    25
    Redness Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 51 (37.25%)
    20 / 52 (38.46%)
    28 / 52 (53.85%)
    22 / 51 (43.14%)
    21 / 51 (41.18%)
         occurrences all number
    19
    20
    28
    22
    21
    Swelling Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 51 (21.57%)
    8 / 52 (15.38%)
    18 / 52 (34.62%)
    15 / 51 (29.41%)
    13 / 51 (25.49%)
         occurrences all number
    11
    8
    18
    15
    13
    Drowsiness Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    25 / 51 (49.02%)
    21 / 52 (40.38%)
    34 / 52 (65.38%)
    28 / 51 (54.90%)
    35 / 51 (68.63%)
         occurrences all number
    25
    21
    34
    28
    35
    Irritability Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 51 (50.98%)
    23 / 52 (44.23%)
    35 / 52 (67.31%)
    36 / 51 (70.59%)
    35 / 51 (68.63%)
         occurrences all number
    26
    23
    35
    36
    35
    Loss of appetite Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 51 (37.25%)
    15 / 52 (28.85%)
    20 / 52 (38.46%)
    19 / 51 (37.25%)
    23 / 51 (45.10%)
         occurrences all number
    19
    15
    20
    19
    23
    Temperature/Rectally Primary
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 51 (25.49%)
    16 / 52 (30.77%)
    18 / 52 (34.62%)
    18 / 51 (35.29%)
    17 / 51 (33.33%)
         occurrences all number
    13
    16
    18
    18
    17
    Drowsiness Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 51 (25.49%)
    13 / 52 (25.00%)
    18 / 52 (34.62%)
    12 / 51 (23.53%)
    17 / 51 (33.33%)
         occurrences all number
    13
    13
    18
    12
    17
    Irritability Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 51 (29.41%)
    17 / 52 (32.69%)
    26 / 52 (50.00%)
    17 / 51 (33.33%)
    19 / 51 (37.25%)
         occurrences all number
    15
    17
    26
    17
    19
    Loss of appetite Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 51 (11.76%)
    10 / 52 (19.23%)
    13 / 52 (25.00%)
    15 / 51 (29.41%)
    8 / 51 (15.69%)
         occurrences all number
    6
    10
    13
    15
    8
    Temperature/Rectally Booster
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 51 (15.69%)
    10 / 52 (19.23%)
    10 / 52 (19.23%)
    5 / 51 (9.80%)
    7 / 51 (13.73%)
         occurrences all number
    8
    10
    10
    5
    7
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 51 (11.76%)
    3 / 52 (5.77%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    4 / 51 (7.84%)
         occurrences all number
    6
    3
    2
    1
    4
    Infections and infestations
    Nasopharyngitis Primary
         subjects affected / exposed
    4 / 51 (7.84%)
    8 / 52 (15.38%)
    9 / 52 (17.31%)
    4 / 51 (7.84%)
    7 / 51 (13.73%)
         occurrences all number
    4
    8
    9
    4
    7
    Nasopharyngitis Booster
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 52 (5.77%)
    2 / 52 (3.85%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    3
    3
    2
    0
    2
    Rhinitis Primary
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 52 (1.92%)
    4 / 52 (7.69%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    4
    1
    1
    Rhinitis Booster
         subjects affected / exposed
    4 / 51 (7.84%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    4
    1
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 52 (5.77%)
    4 / 52 (7.69%)
    4 / 51 (7.84%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    4
    4
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    2
    2
    3
    0
    1
    Viral infection
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
    4 / 52 (7.69%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    4
    3
    1
    Laryngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    1
    4
    2
    Varicella
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    1
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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