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    Clinical Trial Results:
    A Phase 2, Non-Randomized, controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.

    Summary
    EudraCT number
    		 2015-003094-15
    Trial protocol
    		 BE  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    		 v3(current)
    This version publication date
    12 May 2019
    First version publication date
    15 Nov 2017
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Additional justification for missing anti-diphteria results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    205421
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02690181
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals S.A
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of a second dose of GBS Trivalent Vaccine (without adjuvant) administered approximately 4-6 years after the initial GBS vaccination, measured by ELISA. To assess the safety and tolerability of a second dose of GBS Trivalent Vaccine (without adjuvant) administered approximately 4-6 years after the initial dose.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and Japanese Ministry of Health, Labor, and Welfare, GSK codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 1 site in Belgium.

    Pre-assignment
    Screening details
    		 All enrolled subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GBS NoAdj/GBS NoAdj Group
    Arm description
    		 Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Arm title
    		 GBS Alum/GBS NoAdj Group
    Arm description
    		 Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Arm title
    		 GBS MF59 Half/GBS NoAdj Group
    Arm description
    		 Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Arm title
    		 GBS MF59 Full/GBS NoAdj Group
    Arm description
    		 Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Arm title
    		 Placebo/GBS NoAdj Group
    Arm description
    		 Subjects who had received placebo in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Arm title
    		 Naive/GBS NoAdj Group
    Arm description
    		 Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Group B Streptococcus Trivalent Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    GBS Trivalent Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the IM route, preferably the deltoid muscle in the non-dominant arm

    Number of subjects in period 1
    		GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Started
    14
    14
    15
    10
    6
    21
    Completed
    14
    14
    15
    10
    6
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GBS NoAdj/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS Alum/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Half/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Full/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Placebo/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received placebo in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Naive/GBS NoAdj Group
    Reporting group description
    		 Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group Total
    Number of subjects
    		 14 14 15 10 6 21 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 14 14 15 10 6 21 80
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.4 ± 6.91 31.6 ± 6.06 28.9 ± 4.68 29.7 ± 6.22 28.3 ± 5.39 29.2 ± 6.96 -
    Gender categorical
    Units: Subjects
        Female
    		 14 14 15 10 6 21 80
        Male
    		 0 0 0 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 14 14 15 10 6 21 80

    End points

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    End points reporting groups
    Reporting group title
    GBS NoAdj/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS Alum/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Half/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Full/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Placebo/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received placebo in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Naive/GBS NoAdj Group
    Reporting group description
    		 Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Primary: Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 61

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    End point title
    		 Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 61 [1]
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).
    End point type
    Primary
    End point timeframe
    At Day 61
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    14
    15
    10
    5
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    100 (83.2 to 100)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    95 (75.1 to 99.87)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    90 (68.3 to 98.8)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    80 (28.4 to 99.5)
    85 (62.1 to 96.8)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    60 (14.7 to 94.7)
    65 (40.8 to 84.6)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    93 (68.1 to 99.83)
    90 (55.5 to 99.75)
    60 (14.7 to 94.7)
    60 (36.1 to 80.9)
        ≥ 5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    93 (68.1 to 99.83)
    90 (55.5 to 99.75)
    60 (14.7 to 94.7)
    60 (36.1 to 80.9)
        ≥ 8 µg/mL
    92 (64 to 99.81)
    100 (76.8 to 100)
    93 (68.1 to 99.83)
    90 (55.5 to 99.75)
    60 (14.7 to 94.7)
    60 (36.1 to 80.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 61

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    End point title
    		 Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 61 [2]
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Primary
    End point timeframe
    At Day 61
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    14
    15
    10
    5
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    85 (62.1 to 96.8)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    80 (56.3 to 94.3)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    80 (28.4 to 99.5)
    70 (45.7 to 88.1)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    60 (14.7 to 94.7)
    65 (40.8 to 84.6)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    60 (14.7 to 94.7)
    50 (27.2 to 72.8)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    93 (66.1 to 99.82)
    100 (78.2 to 100)
    100 (69.2 to 100)
    60 (14.7 to 94.7)
    50 (27.2 to 72.8)
        ≥ 5 µg/mL
    85 (54.6 to 98.1)
    93 (66.1 to 99.82)
    100 (78.2 to 100)
    100 (69.2 to 100)
    60 (14.7 to 94.7)
    45 (23.1 to 68.5)
        ≥ 8 µg/mL
    85 (54.6 to 98.1)
    93 (66.1 to 99.82)
    93 (68.1 to 99.83)
    100 (69.2 to 100)
    20 (0.5 to 71.6)
    40 (19.1 to 63.9)
    No statistical analyses for this end point

    Primary: Percentage of All Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 61

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    End point title
    		 Percentage of All Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 61 [3]
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Primary
    End point timeframe
    At Day 61
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    13
    15
    10
    5
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    100 (83.2 to 100)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (47.8 to 100)
    80 (56.3 to 94.3)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    80 (28.4 to 99.5)
    80 (56.3 to 94.3)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    40 (5.3 to 85.3)
    75 (50.9 to 91.3)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    40 (5.3 to 85.3)
    65 (40.8 to 84.6)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    40 (5.3 to 85.3)
    65 (40.8 to 84.6)
        ≥ 5 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    40 (5.3 to 85.3)
    50 (27.2 to 72.8)
        ≥ 8 µg/mL
    100 (75.3 to 100)
    92 (64 to 99.81)
    100 (78.2 to 100)
    100 (69.2 to 100)
    40 (5.3 to 85.3)
    50 (27.2 to 72.8)
    No statistical analyses for this end point

    Primary: Numbers of subjects with solicited local and systemic Adverse Events (AEs)

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    End point title
    		 Numbers of subjects with solicited local and systemic Adverse Events (AEs) [4]
    End point description
    Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    14
    15
    10
    5
    21
    Units: Participants
        Any Local (N=14,14,15,10,5,21)
    11
    12
    10
    6
    3
    11
        Pain (N=14,14,15,10,5,21)
    10
    9
    9
    6
    3
    11
        Erythema (N=14,14,15,10,5,21)
    1
    4
    2
    1
    1
    3
        Swelling (N=14,14,15,10,5,20)
    0
    2
    4
    1
    1
    0
        Warmth (N=14,14,15,10,5,21)
    1
    4
    4
    2
    2
    2
        Induration (N=14,14,15,10,5,20)
    2
    2
    5
    2
    1
    0
        Ecchymosis (N=14,14,15,10,5,20)
    0
    0
    1
    0
    0
    1
        Any Systemic (N=14,14,15,10,5,21)
    5
    11
    7
    5
    2
    5
        Chills (N=14,14,15,10,5,21)
    0
    0
    1
    1
    1
    0
        Nausea (N=14,14,15,10,5,21)
    0
    2
    2
    0
    0
    1
        Malaise (N=14,14,15,10,5,21)
    0
    2
    2
    2
    1
    1
        Generalized Myalgia (N=14,14,15,10,5,21)
    2
    2
    2
    1
    1
    1
        Generalized Arthralgia (N=14,14,15,10,5,21)
    0
    1
    2
    0
    0
    0
        Headache (N=14,14,15,10,5,21)
    4
    4
    5
    2
    2
    4
        Fatigue (N=14,14,15,10,5,21)
    3
    10
    4
    4
    1
    2
        Body Rash (N=14,14,15,10,5,21)
    0
    1
    0
    0
    0
    0
        Fever (≥ 38°C) (N=14,14,15,10,5,21)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any unsolicited Adverse Events (AEs)

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    End point title
    		 Number of subjects with any unsolicited Adverse Events (AEs) [5]
    End point description
    The number of subjects with any unsolicited AEs from the day of vaccination in study V98_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 31
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    14
    15
    10
    6
    21
    Units: Participants
        Any AE
    4
    5
    4
    4
    4
    9
        At least possibly or probably related AEs
    1
    1
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of subjects with Serious Adverse Events (SAEs), medically attended AEs, and AEs leading to study withdrawal

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    End point title
    		 Number of subjects with Serious Adverse Events (SAEs), medically attended AEs, and AEs leading to study withdrawal [6]
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. “Medically attended adverse event” is defined as an adverse event that leads to a visit to a healthcare provider and “AEs leading to withdrawal” are defined as adverse events leading to study or vaccine withdrawal.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 181
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    14
    15
    10
    6
    21
    Units: Participants
        SAEs
    0
    0
    0
    0
    0
    0
        Medically attended AEs
    5
    5
    7
    0
    2
    5
        AEs leading to withdrawal
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 31

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    End point title
    		 Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 31
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    14
    15
    10
    6
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    100 (83.2 to 100)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    85 (62.1 to 96.8)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    80 (56.3 to 94.3)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    83 (35.9 to 99.58)
    75 (50.9 to 91.3)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    67 (22.3 to 95.7)
    60 (36.1 to 80.9)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    67 (22.3 to 95.7)
    60 (36.1 to 80.9)
        ≥ 5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    93 (68.1 to 99.83)
    90 (55.5 to 99.75)
    67 (22.3 to 95.7)
    60 (36.1 to 80.9)
        ≥ 8 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    93 (68.1 to 99.83)
    90 (55.5 to 99.75)
    67 (22.3 to 95.7)
    60 (36.1 to 80.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 31

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    End point title
    		 Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 31
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    14
    15
    10
    6
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    75 (50.9 to 91.3)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    70 (45.7 to 88.1)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    83 (35.9 to 99.58)
    60 (36.1 to 80.9)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    83 (35.9 to 99.58)
    45 (23.1 to 68.5)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (76.8 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    45 (23.1 to 68.5)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    93 (66.1 to 99.82)
    100 (78.2 to 100)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    45 (23.1 to 68.5)
        ≥ 5 µg/mL
    92 (64 to 99.81)
    93 (66.1 to 99.82)
    100 (78.2 to 100)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    45 (23.1 to 68.5)
        ≥ 8 µg/mL
    85 (54.6 to 98.1)
    93 (66.1 to 99.82)
    93 (68.1 to 99.83)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    45 (23.1 to 68.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 31

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    End point title
    		 Percentage of Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 31
    End point description
    Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    13
    13
    15
    10
    6
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 0.1 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    100 (54.1 to 100)
    100 (83.2 to 100)
        ≥ 0.2 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    67 (22.3 to 95.7)
    75 (50.9 to 91.3)
        ≥ 0.5 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    67 (22.3 to 95.7)
    70 (45.7 to 88.1)
        ≥ 1 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    65 (40.8 to 84.6)
        ≥ 2 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    50 (11.8 to 88.2)
    60 (36.1 to 80.9)
        ≥ 3 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    33 (4.3 to 77.7)
    55 (31.5 to 76.9)
        ≥ 5 µg/mL
    100 (75.3 to 100)
    100 (75.3 to 100)
    100 (78.2 to 100)
    100 (69.2 to 100)
    33 (4.3 to 77.7)
    55 (31.5 to 76.9)
        ≥ 8 µg/mL
    100 (75.3 to 100)
    92 (64 to 99.81)
    100 (78.2 to 100)
    100 (69.2 to 100)
    33 (4.3 to 77.7)
    50 (27.2 to 72.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia

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    End point title
    		 Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
    End point description
    The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    14
    15
    10
    6
    20
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype Ia-Day 1(V98_06E1), (N=14;14;15;10;6;20)
    9.32 (3.03 to 29)
    5.50 (1.79 to 17)
    3.44 (1.16 to 10)
    2.18 (0.58 to 8.24)
    1.05 (0.19 to 5.86)
    0.32 (0.13 to 0.83)
        Serotype Ia-Day 31, (N=13;14;15;10;6;20)
    61.13 (23 to 165)
    81.61 (31 to 213)
    64.19 (25 to 162)
    57.54 (19 to 179)
    19.25 (4.46 to 83)
    10.06 (4.52 to 22)
        Serotype Ia-Day 61, (N=13;14;15;10;5;20)
    51.53 (21 to 129)
    65.30 (27 to 158)
    44.69 (19 to 105)
    50.67 (18 to 145)
    21.36 (4.85 to 94)
    10.02 (4.77 to 21)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype Ib

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype Ib
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    14
    15
    10
    6
    20
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1, (N = 14; 14; 15, 10; 4; 20)
    0.19 (0.093 to 0.41)
    0.15 (0.073 to 0.32)
    0.10 (0.049 to 0.20)
    0.16 (0.068 to 0.39)
    0.14 (0.035 to 0.55)
    0.17 (0.093 to 0.32)
        Day 31, (N = 13; 14; 15; 10; 6; 20)
    80.62 (28 to 232)
    74.96 (27 to 207)
    89.59 (33 to 241)
    85.9 (26 to 286)
    6.61 (0.99 to 44)
    3.55 (1.52 to 8.34)
        Day 61, (N = 13; 14; 15; 10; 5; 20)
    56.32 (22 to 145)
    57.82 (23 to 143)
    59.13 (24 to 143)
    65.53 (22 to 192)
    5.51 (1.01 to 30)
    4.47 (2.09 to 9.58)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype III

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype III
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    14
    13
    15
    10
    6
    20
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1, (N = 14; 13; 15; 10; 4; 20)
    0.41 (0.20 to 0.82)
    0.17 (0.085 to 0.36)
    0.25 (0.13 to 0.49)
    0.17 (0.076 to 0.39)
    0.15 (0.040 to 0.54)
    0.31 (0.17 to 0.55)
        Day 31, (N = 13; 13; 15; 10; 6; 20)
    111.3 (42 to 294)
    104.55 (40 to 277)
    109.23 (44 to 269)
    216.39 (71 to 655)
    2.66 (0.46 to 15)
    5.33 (2.43 to 12)
        Day 61, (N = 13; 13; 15; 10; 5; 20)
    91.3 (39 to 214)
    80.94 (34 to 190)
    81.71 (37 to 180)
    200.78 (76 to 531)
    2.67 (0.57 to 12)
    5.82 (2.92 to 12)
    No statistical analyses for this end point

    Secondary: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than the Lower Limit of Quantitation (LLQ)

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    End point title
    		 Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than the Lower Limit of Quantitation (LLQ)
    End point description
    The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than LLQ, were estimated for at Day 1, Day 31 and Day 61.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    7
    10
    9
    7
    4
    15
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype Ia-Day 1 (V98_06E1), (N=7;10;9;7;4;15)
    1.36 (0.43 to 4.27)
    2.59 (0.99 to 6.75)
    0.81 (0.30 to 2.24)
    1.12 (0.36 to 3.52)
    0.45 (0.099 to 2.05)
    0.16 (0.074 to 0.36)
        Serotype Ia-Day 31, (N=7;10;9;7;4;15)
    32.25 (8.59 to 121)
    62.54 (21 to 189)
    35.47 (11 to 114)
    46.11 (12 to 173)
    6.34 (1.10 to 36)
    3.98 (1.61 to 9.84)
        Serotype Ia-Day 61, (N=7;10;9;7;3;15)
    26.33 (8.12 to 85)
    49.01 (18 to 131)
    24.89 (8.82 to 70)
    39.56 (12 to 128)
    5.79 (0.96 to 35)
    4.25 (1.90 to 9.48)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ, were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    10
    9
    14
    8
    3
    15
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1
    0.078 (0.078 to 0.078)
    0.078 (0.078 to 0.078)
    0.078 (0.078 to 0.078)
    0.078 (0.078 to 0.078)
    0.078 (0.078 to 0.078)
    0.078 (0.078 to 0.078)
        Day 31
    60.78 (20 to 182)
    69.05 (22 to 220)
    53.01 (21 to 134)
    65.50 (19 to 224)
    1.47 (0.2 to 11)
    0.79 (0.32 to 1.95)
        Day 61
    40.59 (15 to 111)
    47.71 (16 to 138)
    34.12 (15 to 80)
    47.58 (15 to 147)
    1.32 (0.21 to 8.37)
    1.19 (0.52 to 2.71)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ, were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    10
    12
    11
    9
    4
    15
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
        Day 31
    109.31 (40 to 301)
    77.97 (31 to 197)
    126.89 (48 to 333)
    188.63 (65 to 549)
    1.9 (0.38 to 9.44)
    2.12 (0.93 to 4.84)
        Day 61
    83.19 (33 to 208)
    60.01 (26 to 138)
    87.4 (37 to 209)
    169.45 (65 to 444)
    1.92 (0.45 to 8.16)
    2.52 (1.2 to 5.32)
    No statistical analyses for this end point

    Secondary: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ

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    End point title
    		 Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ
    End point description
    The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ, were estimated for at Day 1, Day 31 and Day 61.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    7
    3
    6
    2
    2
    5
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype Ia - Day 1 (V98_06E1), (N=7;3;6;2;2;5)
    64.06 (23 to 178)
    98.43 (21 to 469)
    29.83 (9.89 to 90)
    39.57 (5.84 to 268)
    5.76 (0.85 to 39)
    2.54 (0.76 to 8.50)
        Serotype Ia - Day 31, (N=6;3;6;2;2;5)
    128.91 (71 to 234)
    196.32 (85 to 456)
    156.26 (86 to 284)
    85.63 (31 to 240)
    177.38 (63 to 498)
    161.99 (84 to 311)
        Serotype Ia - Day 61, (N=6;3;6;2;2;5)
    112.78 (57 to 222)
    197.67 (76 to 515)
    107.57 (55 to 212)
    93.02 (29 to 300)
    151.27 (47 to 488)
    131.48 (63 to 276)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ, were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    4
    5
    1
    2
    1
    5
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1, (N = 4; 5; 1; 2; 1; 5)
    1.96 (0.56 to 6.85)
    0.52 (0.17 to 1.6)
    3.42 (0.28 to 42)
    3.12 (0.53 to 18)
    0.82 (0.067 to 10)
    1.92 (0.63 to 5.89)
        Day 31, (N = 3; 5; 1; 2; 1; 5)
    287.34 (90 to 917)
    121.6 (44 to 333)
    373.02 (48 to 2877)
    338.8 (78 to 1469)
    557.46 (75 to 4142)
    557.03 (225 to 1379)
        Day 61, (N = 4; 5; 1; 2; 1; 5)
    228.26 (72 to 726)
    118.94 (43 to 326)
    367.26 (48 to 2818)
    300.1 (69 to 1296)
    378.7 (51 to 2800)
    403.16 (163 to 996)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ

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    End point title
    		 Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ
    End point description
    The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ, were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31 and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    4
    1
    4
    1
    0 [7]
    5
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Day 1, (N = 4; 1; 4; 1; 0; 5)
    5.33 (0.76 to 37)
    1.41 (0.029 to 68)
    1.07 (0.15 to 7.46)
    0.74 (0.015 to 36)
    ( to )
    2.79 (0.49 to 16)
        Day 31, (N = 3; 1; 4; 1; 0; 5)
    171.67 (13 to 2214)
    270.01 (3.46 to 21064)
    120.0 (13 to 1113)
    149.93 (1.81 to 12454)
    ( to )
    136.68 (19 to 979)
        Day 61, (N = 3; 1; 4; 1; 0; 5)
    186.63 (24 to 1439)
    231.17 (7.12 to 7509)
    107.21 (18 to 635)
    180.29 (5.28 to 6158)
    ( to )
    116.43 (24 to 561)
    Notes
    [7] - No particpants analyzed in this group
    No statistical analyses for this end point

    Secondary: Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects

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    End point title
    		 Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
    End point description
    Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98_06 study or V98_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98_06E1. Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other Cross Reactive Material(CRM)-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.
    End point type
    Secondary
    End point timeframe
    At Day 1 (V98_06 or V98_06E1) and Day 61
    End point values
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: µg/mL
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [8] - Analysis was not performed.
    [9] - Analysis was not performed.
    [10] - Analysis was not performed.
    [11] - Analysis was not performed.
    [12] - Analysis was not performed.
    [13] - Analysis was not performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    GBS NoAdj/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS Alum/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Half/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    GBS MF59 Full/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Placebo/GBS NoAdj Group
    Reporting group description
    		 Subjects who had received placebo in parent study V98_06 (205468 – NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Reporting group title
    Naive/GBS NoAdj Group
    Reporting group description
    		 Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

    Serious adverse events
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GBS NoAdj/GBS NoAdj Group GBS Alum/GBS NoAdj Group GBS MF59 Half/GBS NoAdj Group GBS MF59 Full/GBS NoAdj Group Placebo/GBS NoAdj Group Naive/GBS NoAdj Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 14 (92.86%)
    13 / 14 (92.86%)
    13 / 15 (86.67%)
    7 / 10 (70.00%)
    4 / 6 (66.67%)
    17 / 21 (80.95%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    Fatigue
         subjects affected / exposed
    3 / 14 (21.43%)
    10 / 14 (71.43%)
    4 / 15 (26.67%)
    4 / 10 (40.00%)
    1 / 6 (16.67%)
    2 / 21 (9.52%)
         occurrences all number
    11
    13
    9
    6
    3
    2
    Feeling hot
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 14 (28.57%)
    2 / 15 (13.33%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    3 / 21 (14.29%)
         occurrences all number
    3
    6
    2
    1
    8
    5
    Injection site haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    3
    0
    0
    3
    Injection site induration
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 14 (14.29%)
    5 / 15 (33.33%)
    2 / 10 (20.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    3
    3
    10
    6
    5
    0
    Injection site pain
         subjects affected / exposed
    10 / 14 (71.43%)
    9 / 14 (64.29%)
    9 / 15 (60.00%)
    6 / 10 (60.00%)
    3 / 6 (50.00%)
    11 / 21 (52.38%)
         occurrences all number
    20
    15
    19
    10
    12
    23
    Injection site swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    4 / 15 (26.67%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    6
    3
    5
    0
    Injection site warmth
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 14 (28.57%)
    4 / 15 (26.67%)
    2 / 10 (20.00%)
    2 / 6 (33.33%)
    2 / 21 (9.52%)
         occurrences all number
    2
    5
    7
    3
    8
    2
    Malaise
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    2 / 15 (13.33%)
    2 / 10 (20.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
         occurrences all number
    0
    3
    3
    3
    1
    1
    Hangover
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    0
    0
    1
    0
    2
    Nasal congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Stress fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    5 / 14 (35.71%)
    6 / 14 (42.86%)
    5 / 15 (33.33%)
    3 / 10 (30.00%)
    2 / 6 (33.33%)
    4 / 21 (19.05%)
         occurrences all number
    12
    12
    9
    3
    4
    6
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tinnitus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eye disorders
    Conjunctival irritation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastric disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 14 (21.43%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    4
    3
    0
    0
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Myalgia
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 14 (14.29%)
    3 / 15 (20.00%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
         occurrences all number
    4
    3
    4
    1
    1
    1
    Tendonitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    Infections and infestations
    Chlamydial infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    0
    1
    0
    0
    3
    Gingivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    More information

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

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

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

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