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    Clinical Trial Results:
    A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

    Summary
    EudraCT number
    		 2019-004503-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2022
    First version publication date
    26 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3772-CL-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04525599
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Affinivax
    Sponsor organisation address
    301 Binney Street, Suite 302, Cambridge, Massachusetts (MA), United States, 02142
    Public contact
    Affinivax, Affinivax, 1 617-465-0865, contact@affinivax.com
    Scientific contact
    Affinivax, Affinivax, 1 617-465-0865, contact@affinivax.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002641-PIP01-19
    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
    15 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of 3 dose levels of ASP3772, in comparison to the active comparator PCV13 in toddlers approximately 12 to 15 months of age who have previously been administered the routine 3-dose series of PCV13.
    Protection of trial subjects
    The toddlers were observed for safety reactogenicity events, including daily body temperature measurements and both local and systemic tolerability assessments. Oversight of safety and dose escalation was provided by Dose Escalation Committee.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    75
    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
    		 1 of 75 subjects was randomized to PCV13 group but administered ASP3772. Therefore, all the primary analysis and immunogenicity analysis were done on the Safety Analysis Set based on the treatment actually received, and the results are presented here.

    Pre-assignment
    Screening details
    		 Of 85 subjects with informed consent:7 were screen failures, 3 were withdrawn by their parent/guardian. 75 subjects were randomized and dosed. 1 subject randomized to PCV13 group received ASP3772 5µg dose instead of PCV13, thus contributed to ASP3772 5µg group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1, ASP3772 Low Dose
    Arm description
    		 Healthy toddlers aged approximately 12 to 15 months received a single intramuscular (IM) injection of low dose (1 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASP3772
    Investigational medicinal product code
    Other name
    AFX3772
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Low dose of ASP3772 was administered into anterolateral right or left thigh muscle on Day 1.

    Arm title
    		 Group 2, ASP3772 Medium Dose
    Arm description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of medium dose (2 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASP3772
    Investigational medicinal product code
    Other name
    AFX3772
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Medium dose of ASP3772 was administered into anterolateral right or left thigh muscle on Day 1.

    Arm title
    		 Group 3, ASP3772 High Dose
    Arm description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of high dose (5 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASP3772
    Investigational medicinal product code
    Other name
    AFX3772
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    High dose of ASP3772 was administered into anterolateral right or left thigh muscle on Day 1.

    Arm title
    		 Comparator PCV13
    Arm description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of the approved dose of PCV13 into anterolateral right or left thigh muscle on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PCV13
    Investigational medicinal product code
    Other name
    Prevnar 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PCV13 was administered into anterolateral right or left thigh muscle on Day 1.

    Number of subjects in period 1
    		Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Started
    15
    15
    16
    29
    Completed
    15
    14
    16
    29
    Not completed
    0
    1
    0
    0
         Lost to follow-up
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1, ASP3772 Low Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single intramuscular (IM) injection of low dose (1 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 2, ASP3772 Medium Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of medium dose (2 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 3, ASP3772 High Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of high dose (5 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Comparator PCV13
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of the approved dose of PCV13 into anterolateral right or left thigh muscle on Day 1.

    Reporting group values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13 Total
    Number of subjects
    		 15 15 16 29 75
    Age Categorical
    The Age characteristics analysis was performed on the Safety Analysis Set (SAF).
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 15 15 16 29 75
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    The Age characteristics analysis was performed on the Safety Analysis Set (SAF).
    Units: months
        arithmetic mean (standard deviation)
    		 13.3 ± 1.3 13.1 ± 0.8 13.3 ± 1.1 13.1 ± 1.1 -
    Gender Categorical
    The Gender categorical analysis was performed on the Safety Analysis Set (SAF).
    Units: Subjects
        Female
    		 7 11 6 13 37
        Male
    		 8 4 10 16 38
    Race/Ethnicity, Customized
    The Race/Ethnicity analysis was performed on the Safety Analysis Set (SAF).
    Units: Subjects
        White
    		 10 12 10 21 53
        Black or African American
    		 5 1 3 5 14
        American Indian or Alaska Native
    		 0 0 1 0 1
        Other
    		 0 2 2 3 7

    End points

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    End points reporting groups
    Reporting group title
    Group 1, ASP3772 Low Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single intramuscular (IM) injection of low dose (1 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 2, ASP3772 Medium Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of medium dose (2 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 3, ASP3772 High Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of high dose (5 μg) of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Comparator PCV13
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of the approved dose of PCV13 into anterolateral right or left thigh muscle on Day 1.

    Primary: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects with Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a subject administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A TEAE is defined as any AE with onset within 30 days from study vaccine administration (Day 1-Day 30). Analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 30
    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: This is a descriptive endpoint with no statistical analyses.
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Subjects
        Vaccine-Related TEAEs
    1
    1
    0
    2
        Serious TEAEs
    0
    0
    0
    2
        Always Serious TEAE
    0
    0
    0
    1
        Medically Attended TEAE
    5
    6
    9
    14
    No statistical analyses for this end point

    Primary: Maximum Body Temperature over 7 days Post-vaccination

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    End point title
    		 Maximum Body Temperature over 7 days Post-vaccination [2]
    End point description
    Body temperature was assessed by Grades range from 1 to 4. Grade 1= mild (38.0 – 38.4 Degrees Celsius [°C]); Grade 2 = moderate (38.5 – 38.9°C); Grade 3 = severe (39.0 – 40°C); Grade 4 = potentially life-threatening (> 40). Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Primary
    End point timeframe
    7 Days Post-vaccination
    Notes
    [2] - 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: This is a descriptive endpoint with no statistical analyses.
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Subjects
        No Fever
    14
    15
    15
    25
        38.0 – 38.4°C
    1
    0
    0
    2
        38.5 – 38.9°C
    0
    0
    1
    1
        39.0 – 40.0°C
    0
    0
    0
    1
        > 40.0°C
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Reactogenicity Assessed by Number of Solicited Local Reactions

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    End point title
    		 Reactogenicity Assessed by Number of Solicited Local Reactions [3]
    End point description
    Assessed solicited local reactions were tenderness, redness/erythema, induration, swelling and administration site movement restriction. Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a descriptive endpoint with no statistical analyses.
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Subjects
        Tenderness
    9
    7
    4
    8
        Erythema/Redness
    4
    7
    2
    8
        Induration
    4
    5
    3
    10
        Swelling
    3
    4
    2
    6
        Administration Site Movement Restriction
    0
    2
    2
    2
    No statistical analyses for this end point

    Primary: Reactogenicity assessed by Number of Solicited Systemic Reactions

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    End point title
    		 Reactogenicity assessed by Number of Solicited Systemic Reactions [4]
    End point description
    Assessed solicited systemic reactions were irritability, diarrhea, decrease of appetite, increase or decrease in sleep, vomiting, and fever. Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7
    Notes
    [4] - 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: This is a descriptive endpoint with no statistical analyses.
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Subjects
        Irritability
    10
    10
    8
    17
        Diarrhea
    4
    7
    7
    5
        Decrease of Appetite
    5
    5
    4
    9
        Increase in Sleep
    3
    4
    4
    9
        Decrease in Sleep
    4
    2
    2
    6
        Vomiting
    3
    4
    2
    6
        Fever
    1
    0
    1
    4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serotype-specific Immunoglobulin G (IgG) Concentration of greater than or equal to (>=) 0.35 microgram per millilitre (µg/mL)

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    End point title
    		 Percentage of Subjects with Serotype-specific Immunoglobulin G (IgG) Concentration of greater than or equal to (>=) 0.35 microgram per millilitre (µg/mL)
    End point description
    Immunogenicity was measured in terms of percentage of subjects with serotype-specific IgG concentration >=0.35 µg/mL. Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 30
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 1, Day1 (N=12,14,10,22)
    80.0 (51.9 to 95.7)
    93.3 (68.1 to 99.8)
    62.5 (35.4 to 84.8)
    75.9 (56.5 to 89.7)
        Serotype 1, Day30 (N=14,15,15,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 3, Day1 (N=0,5,4,4)
    0 (0.0 to 21.8)
    33.3 (11.8 to 61.6)
    25.0 (7.3 to 52.4)
    13.8 (3.9 to 31.7)
        Serotype 3, Day30 (N=14,15,14,26)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    96.3 (81.0 to 99.9)
        Serotype 4, Day1 (N=6,8,9,11)
    40.0 (16.3 to 67.7)
    53.3 (26.6 to 78.7)
    56.3 (29.9 to 80.2)
    37.9 (20.7 to 57.7)
        Serotype 4, Day30 (N=14,15,14,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
        Serotype 5, Day1 (N=8,10,11,15)
    53.3 (26.6 to 78.7)
    66.7 (38.4 to 88.2)
    68.8 (41.3 to 89.0)
    51.7 (32.5 to 70.6)
        Serotype 5, Day30 (N=13,15,15,27)
    92.9 (66.1 to 99.8)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 6A, Day1 (N=14,13,12,23)
    93.3 (68.1 to 99.8)
    86.7 (59.5 to 98.3)
    75.0 (47.6 to 92.7)
    79.3 (60.3 to 92.0)
        Serotype 6A, Day30 (N=14,15,15,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 6B, Day1 (N=7,10,10,17)
    46.7 (21.3 to 73.4)
    66.7 (38.4 to 88.2)
    62.5 (35.4 to 84.8)
    58.6 (38.9 to 76.5)
        Serotype 6B, Day30 (N=14,15,15,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 7F, Day1 (N=15,13,14,29)
    100.0 (78.2 to 100.0)
    86.7 (59.5 to 98.3)
    87.5 (61.7 to 98.4)
    100.0 (88.1 to 100.0)
        Serotype 7F, Day30 (N=14,15,14,28)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
        Serotype 9V, Day1 (N=7,5,8,14)
    46.7 (21.3 to 73.4)
    33.3 (11.8 to 61.6)
    50.0 (24.7 to 75.3)
    48.3 (29.4 to 67.5)
        Serotype 9V, Day30 (N=14,15,15,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 14, Day1 (N=11,15,14,27)
    73.3 (44.9 to 92.2)
    100.0 (78.2 to 100.0)
    87.5 (61.7 to 98.4)
    93.1 (77.2 to 99.2)
        Serotype 14, Day30 (N=13,15,14,27)
    92.9 (66.1 to 99.8)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
        Serotype 18C, Day1 (N=8,11,11,19)
    53.3 (26.6 to 78.7)
    73.3 (44.9 to 92.2)
    68.8 (41.3 to 89.0)
    65.5 (45.7 to 82.1)
        Serotype 18C, Day30 (N=13,15,14,27)
    92.9 (66.1 to 99.8)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
        Serotype 19A, Day1 (N=3,7,8,15)
    20.0 (4.3 to 48.1)
    46.7 (21.3 to 73.4)
    50.0 (24.7 to 75.3)
    51.7 (32.5 to 70.6)
        Serotype 19A, Day30 (N=14,15,14,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
        Serotype 19F, Day1 (N=10,10,11,19)
    66.7 (38.4 to 88.2)
    66.7 (38.4 to 88.2)
    68.8 (41.3 to 89.0)
    65.5 (45.7 to 82.1)
        Serotype 19F, Day30 (N=14,15,15,27)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (87.2 to 100.0)
        Serotype 23F, Day1 (N=9,9,11,14)
    60.0 (32.3 to 83.7)
    60.0 (32.3 to 83.7)
    68.8 (41.3 to 89.0)
    48.3 (29.4 to 67.5)
        Serotype 23F, Day30 (N=13,15,14,27)
    92.9 (66.1 to 99.8)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (87.2 to 100.0)
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.7
         upper limit
    		 27.7
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    17.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 37.5
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -13.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.4
         upper limit
    		 13.7
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -13.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.8
         upper limit
    		 8
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 47.1
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    11.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 38.2
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.4
         upper limit
    		 32.1
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    15.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15
         upper limit
    		 43.7
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    18.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.9
         upper limit
    		 45.7
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.5
         upper limit
    		 30.9
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 41.8
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 43.1
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.9
         upper limit
    		 33.7
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.3
         upper limit
    		 28.8
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.3
         upper limit
    		 19.8
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.6
         upper limit
    		 18.5
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.7
         upper limit
    		 35.1
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 31.5
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.2
         upper limit
    		 -0.3
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.3
         upper limit
    		 0.4
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.9
         upper limit
    		 28.5
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.8
         upper limit
    		 16.2
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -19.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.5
         upper limit
    		 1.8
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 22.2
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.4
         upper limit
    		 12.5
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.2
         upper limit
    		 17.3
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.4
         upper limit
    		 33.5
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.3
         upper limit
    		 29.6
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -31.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55
         upper limit
    		 -0.8
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.2
         upper limit
    		 25.2
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.9
         upper limit
    		 27.6
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29
         upper limit
    		 28.3
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29
         upper limit
    		 28.3
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.3
         upper limit
    		 29.6
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.2
         upper limit
    		 39.7
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.2
         upper limit
    		 39.7
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    20.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2
         upper limit
    		 46.3
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.6
         upper limit
    		 18.5
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.4
         upper limit
    		 18.5
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27
         upper limit
    		 13.1
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.9
         upper limit
    		 6.2
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.9
         upper limit
    		 6.2
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.9
         upper limit
    		 6.2
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.9
         upper limit
    		 6.2
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 6.6
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettien and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.6
         upper limit
    		 30.9

    Secondary: Percentage of Subjects with Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer >= Lower Limit of Quantification (LLOQ)

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    End point title
    		 Percentage of Subjects with Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer >= Lower Limit of Quantification (LLOQ)
    End point description
    Immunogenicity was measured in terms of percentage of subjects with OPA Antibody Titer >= LLOQ. Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 30
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 1, Day1 (N=6,6,10,7)
    40.0 (16.3 to 67.7)
    46.2 (19.2 to 74.9)
    62.5 (35.4 to 84.8)
    25.0 (10.7 to 44.9)
        Serotype 1, Day30 (N=11,13,12,26)
    78.6 (49.2 to 95.3)
    100.0 (75.3 to 100.0)
    92.3 (64.0 to 99.8)
    100.0 (86.8 to 100.0)
        Serotype 3, Day1 (N=14,13,16,27)
    93.3 (68.1 to 99.8)
    100.0 (75.3 to 100.0)
    100.0 (79.4 to 100.0)
    96.4 (81.7 to 99.9)
        Serotype 3, Day30 (N=13,15,14,25)
    100.0 (75.3 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (76.8 to 100.0)
    100.0 (86.3 to 100.0)
        Serotype 4, Day1 (N=10,9,14,22)
    71.4 (41.9 to 91.6)
    75.0 (42.8 to 94.5)
    87.5 (61.7 to 98.4)
    78.6 (59.0 to 91.7)
        Serotype 4, Day30 (N=12,15,15,25)
    100.0 (73.5 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (86.3 to 100.0)
        Serotype 5, Day1 (N=13,12,15,24)
    100.0 (75.3 to 100.0)
    85.7 (57.2 to 98.2)
    93.8 (69.8 to 99.8)
    82.8 (64.2 to 94.2)
        Serotype 5, Day30 (N=14,14,12,25)
    100.0 (76.8 to 100.0)
    100.0 (76.8 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (86.3 to 100.0)
        Serotype 6A, Day1 (N=13,13,15,28)
    100.0 (75.3 to 100.0)
    92.9 (66.1 to 99.8)
    93.8 (69.8 to 99.8)
    96.6 (82.2 to 99.9)
        Serotype 6A, Day30 (N=14,15,15,24)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (85.8 to 100.0)
        Serotype 6B, Day1 (N=13,12,13,21)
    86.7 (59.5 to 98.3)
    85.7 (57.2 to 98.2)
    81.3 (54.4 to 96.0)
    77.8 (57.7 to 91.4)
        Serotype 6B, Day30 (N=13,15,15,25)
    100.0 (75.3 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (86.3 to 100.0)
        Serotype 7F, Day1 (N=15,14,16,29)
    100.0 (78.2 to 100.0)
    100.0 (76.8 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (88.1 to 100.0)
        Serotype 7F, Day30 (N=11,15,15,22)
    100.0 (71.5 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (84.6 to 100.0)
        Serotype 9V, Day1 (12,10,14,21)
    100.0 (73.5 to 100.0)
    83.3 (51.6 to 97.9)
    93.3 (68.1 to 99.8)
    91.3 (72.0 to 98.9)
        Serotype 9V, Day30 (N=12,13,15,24)
    100.0 (73.5 to 100.0)
    100.0 (75.3 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (85.8 to 100.0)
        Serotype 14, Day1 (12,14,15,25)
    85.7 (57.2 to 98.2)
    100.0 (76.8 to 100.0)
    93.8 (69.8 to 99.8)
    92.6 (75.7 to 99.1)
        Serotype 14, Day30 (N=12,15,14,24)
    92.3 (64.0 to 99.8)
    100.0 (78.2 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (85.8 to 100.0)
        Serotype 18C, Day1 (N=14,10,14,24)
    100.0 (76.8 to 100.0)
    83.3 (51.6 to 97.9)
    87.5 (61.7 to 98.4)
    85.7 (67.3 to 96.0)
        Serotype 18C, Day30 (N=11,15,15,25)
    100.0 (71.5 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (86.3 to 100.0)
        Serotype 19A, Day1 (N=12,13,15,24)
    85.7 (57.2 to 98.2)
    100.0 (75.3 to 100.0)
    93.8 (69.8 to 99.8)
    85.7 (67.3 to 96.0)
        Serotype 19A, Day30 (N=14,15,15,26)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (86.8 to 100.0)
        Serotype 19F, Day1 (N=11,12,14,22)
    100.0 (71.5 to 100.0)
    85.7 (57.2 to 98.2)
    87.5 (61.7 to 98.4)
    81.5 (61.9 to 93.7)
        Serotype 19F, Day30 (N=14,14,15,23)
    100.0 (76.8 to 100.0)
    100.0 (76.8 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (85.2 to 100.0)
        Serotype 23F, Day1 (N=15,12,16,26)
    100.0 (78.2 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (79.4 to 100.0)
    89.7 (72.6 to 97.8)
        Serotype 23F, Day30 (N=13,15,15,23)
    100.0 (75.3 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (85.2 to 100.0)
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.2
         upper limit
    		 43.7
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 50.5
    Statistical analysis title
    		 Serotype 1, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    37.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.1
         upper limit
    		 62.1
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.1
         upper limit
    		 12.5
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 18
    Statistical analysis title
    		 Serotype 3, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.4
         upper limit
    		 18
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.9
         upper limit
    		 18.7
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.3
         upper limit
    		 22
    Statistical analysis title
    		 Serotype 4, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.9
         upper limit
    		 30.5
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 34.8
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 24.3
    Statistical analysis title
    		 Serotype 5, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 30.1
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.1
         upper limit
    		 17.4
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.8
         upper limit
    		 11.7
    Statistical analysis title
    		 Serotype 6A, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.7
         upper limit
    		 12.3
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.1
         upper limit
    		 31.2
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.2
         upper limit
    		 30.6
    Statistical analysis title
    		 Serotype 6B, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.4
         upper limit
    		 27
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.9
         upper limit
    		 27.1
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38
         upper limit
    		 14.6
    Statistical analysis title
    		 Serotype 9V, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.8
         upper limit
    		 21.9
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Group 3, ASP3772 High Dose
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34
         upper limit
    		 12.7
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 23.6
    Statistical analysis title
    		 Serotype 14, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.3
         upper limit
    		 18.7
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 31.7
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.9
         upper limit
    		 19.7
    Statistical analysis title
    		 Serotype 18C, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.1
         upper limit
    		 22.3
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28
         upper limit
    		 21.2
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 31.7
    Statistical analysis title
    		 Serotype 19A, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 27
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 37
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.4
         upper limit
    		 26.5
    Statistical analysis title
    		 Serotype 19F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.5
         upper limit
    		 27.6
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 26.6
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -21.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.9
         upper limit
    		 -6.5
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 1, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.7
         upper limit
    		 6.2
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 3, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 4, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 5, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6A, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 6B, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 7F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 9V, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.8
         upper limit
    		 7.2
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 14, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 8
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 18C, Day 30
    Comparison groups
    Comparator PCV13 v Group 3, ASP3772 High Dose
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19A, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 19F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 1, ASP3772 Low Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 30
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 2, ASP3772 Medium Dose v Comparator PCV13
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 26.6
    Statistical analysis title
    		 Serotype 23F, Day 1
    Comparison groups
    Group 3, ASP3772 High Dose v Comparator PCV13
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportion
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 26.6

    Secondary: Geometric Mean Titer (GMT) for Serotype-specific OPA

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    End point title
    		 Geometric Mean Titer (GMT) for Serotype-specific OPA
    End point description
    Immunogenicity was measured in terms of OPA GMTs and expressed as titers. Analysis was performed on SAF which consisted of all randomized subjects who received a vaccination in this study with either ASP3772 or PCV13, per treatment actually received.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 30
    End point values
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose Comparator PCV13
    Number of subjects analysed
    15
    15
    16
    29
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 1, Day1 (N=15,13,16,28)
    10.2 (5.7 to 18.2)
    15.9 (6.5 to 39.4)
    20.7 (9.9 to 42.9)
    10.1 (6.0 to 17.3)
        Serotype 1, Day30 (N=14,13,13,26)
    54.7 (21.0 to 142.4)
    170.5 (67.2 to 432.1)
    172.8 (70.3 to 424.8)
    188.6 (120.5 to 295.1)
        Serotype 3, Day1 (N=15,13,16,28)
    55.4 (32.8 to 93.4)
    101.7 (51.8 to 199.7)
    118.4 (70.2 to 199.8)
    125.0 (81.9 to 191.0)
        Serotype 3, Day30 (N=13,15,14,25)
    339.1 (273.6 to 420.1)
    467.1 (318.1 to 686.1)
    692.5 (386.3 to 1241.4)
    450.1 (338.4 to 598.6)
        Serotype 4, Day1 (N=14,12,16,28)
    32.6 (11.6 to 91.3)
    83.9 (24.2 to 290.7)
    130.4 (46.9 to 363.2)
    51.5 (26.2 to 101.4)
        Serotype 4, Day30 (N=12,15,15,25)
    427.5 (230.2 to 794.0)
    1142.5 (725.1 to 1800.1)
    1071.8 (541.2 to 2122.6)
    2217.0 (1685.4 to 2916.3)
        Serotype 5, Day1 (N=13,14,16,29)
    119.0 (76.9 to 184.1)
    158.2 (48.0 to 521.3)
    192.5 (81.3 to 455.9)
    52.9 (28.4 to 98.5)
        Serotype 5, Day30 (N=14,14,12,25)
    694.4 (336.7 to 1432.1)
    978.1 (385.3 to 2483.2)
    984.3 (410.9 to 2357.7)
    797.8 (503.7 to 1263.5)
        Serotype 6A, Day1 (N=13,14,16,29)
    1664.2 (1005.7 to 2753.9)
    983.7 (402.5 to 2404.3)
    938.2 (373.1 to 2359.5)
    816.7 (490.6 to 1359.6)
        Serotype 6A, Day30 (N=14,15,15,24)
    2790.1 (1995.2 to 3901.6)
    3312.4 (2221.4 to 4939.3)
    2471.5 (1219.7 to 5008.1)
    9502.0 (6137.0 to 14712.1)
        Serotype 6B, Day1 (N=15,14,16,27)
    412.3 (148.9 to 1141.1)
    241.4 (82.3 to 707.8)
    236.2 (73.0 to 764.9)
    150.5 (65.3 to 347.1)
        Serotype 6B, Day30 (N=13,15,15,25)
    1955.8 (1128.5 to 3389.3)
    1489.5 (999.2 to 2220.6)
    1387.4 (582.6 to 3304.3)
    5134.9 (3428.0 to 7691.9)
        Serotype 7F, Day1 (N=15,14,16,29)
    1409.4 (829.6 to 2394.6)
    1075.6 (526.7 to 2196.3)
    1077.1 (640.3 to 1811.7)
    1436.1 (1003.0 to 2056.3)
        Serotype 7F, Day30 (N=11,15,15,22)
    2326.1 (1260.9 to 4291.2)
    2615.8 (1539.4 to 4444.9)
    2563.5 (1338.0 to 4911.3)
    8442.5 (4987.7 to 14290.3)
        Serotype 9V, Day1 (N=12,12,15,23)
    2311.2 (872.7 to 6120.6)
    360.7 (60.3 to 2158.4)
    602.2 (219.2 to 1654.6)
    345.0 (134.4 to 885.3)
        Serotype 9V, Day30 (N=12,13,15,24)
    4080.3 (2654.5 to 6271.9)
    3636.3 (1908.0 to 6930.2)
    2347.9 (1429.3 to 3856.9)
    5142.6 (3544.9 to 7460.3)
        Serotype 14, Day1 (N=14,14,16,27)
    259.6 (90.5 to 744.6)
    650.6 (302.7 to 1398.2)
    489.4 (187.5 to 1277.7)
    476.8 (270.1 to 841.7)
        Serotype 14, Day30 (N=13,15,15,24)
    556.9 (201.3 to 1540.8)
    1842.4 (1124.2 to 3019.6)
    1090.4 (440.0 to 2702.7)
    2922.4 (1985.7 to 4300.8)
        Serotype 18C, Day1 (N=14,12,16,28)
    249.4 (93.6 to 664.9)
    267.4 (67.3 to 1061.6)
    276.6 (105.2 to 726.8)
    229.4 (118.6 to 443.6)
        Serotype 18C, Day30 (N=11,15,15,25)
    1481.9 (935.7 to 2347.0)
    1772.6 (1132.9 to 2773.4)
    1935.4 (1042.9 to 3591.9)
    5268.2 (3876.1 to 7160.3)
        Serotype 19A, Day1 (N=14,13,16,28)
    177.7 (59.9 to 526.6)
    241.8 (80.3 to 728.1)
    320.0 (137.5 to 744.7)
    176.3 (88.6 to 350.6)
        Serotype 19A, Day30 (N=14,15,15,26)
    1851.6 (1055.9 to 3246.7)
    2621.7 (1802.2 to 3813.8)
    1919.7 (1040.0 to 3543.5)
    5801.8 (4546.2 to 7404.1)
        Serotype 19F, Day1 (N=11,14,16,27)
    373.2 (175.9 to 791.9)
    326.3 (97.5 to 1091.4)
    315.6 (118.1 to 843.4)
    230.3 (111.0 to 477.7)
        Serotype 19F, Day30 (N=14,14,15,23)
    1998.7 (1328.7 to 3006.4)
    2601.4 (1776.3 to 3809.6)
    2704.6 (1412.0 to 5180.5)
    4678.9 (3559.7 to 6150.1)
        Serotype 23F, Day1 (N=15,12,16,29)
    760.1 (310.7 to 1859.1)
    766.4 (260.2 to 2257.6)
    1005.8 (423.8 to 2386.8)
    410.5 (189.4 to 889.5)
        Serotype 23F, Day30 (N=13,15,15,23)
    1711.8 (1118.0 to 2620.9)
    1702.5 (1104.1 to 2625.3)
    3462.8 (1320.2 to 9082.4)
    12510.5 (7488.7 to 20900.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events were collected from Day 1 to Day 30.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Group 1, ASP3772 Low Dose
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single intramuscular (IM) injection of low dose of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 2, ASP3772 Medium Dose
    Reporting group description
    		 Healthy toddlers approximately 12 to 15 months received a single IM injection of medium dose of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    Group 3, ASP3772 High Dose
    Reporting group description
    		 Healthy toddlers approximately 12 to 15 months received a single IM injection of high dose of ASP3772 into anterolateral right or left thigh muscle on Day 1.

    Reporting group title
    PCV13 Comparator
    Reporting group description
    		 Healthy toddlers aged approximately 12 to 15 months received a single IM injection of approved dose of PCV13 into anterolateral right or left thigh muscle on Day 1.

    Serious adverse events
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose PCV13 Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    2 / 29 (6.90%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1, ASP3772 Low Dose Group 2, ASP3772 Medium Dose Group 3, ASP3772 High Dose PCV13 Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    4 / 15 (26.67%)
    9 / 16 (56.25%)
    9 / 29 (31.03%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Exposure to SARS-CoV-2
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    1
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    1
    1
    Teething
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    1
    0
    2
    Flatulence
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    0
    1
    Vomiting projectile
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2020
    • The objectives were reorganized such that comparison of the GMT for functional OPA for each serotype post-vaccination was moved from the exploratory to the secondary list of objectives. • The list of exclusion criteria was updated to include the exclusion of subjects who had previously received an approved (other than PCV13) or investigational pneumococcal vaccine.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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