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    Clinical Trial Results:
    IMMUNOGENICITY AND SAFETY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.

    Summary
    EudraCT number
    		 2018-003379-37
    Trial protocol
    		 DE   BE   AT  
    Global end of trial date
    02 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2022
    First version publication date
    24 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VLA15-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03769194
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Valneva Austria GmbH
    Sponsor organisation address
    Campus Vienna Biocenter 3, Vienna, Austria, 1030
    Public contact
    Valneva Clinical Operations, Valneva Austria GmbH, 43 120620, info@valneva.com
    Scientific contact
    Valneva Clinical Operations, Valneva Austria GmbH, 43 120620, info@valneva.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
    08 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the optimal dose of VLA15 in healthy adults aged 18 - 65 years up to Day 85.
    Protection of trial subjects
    Number of study visits and interventions was limited to the minimum required to generate the required safety and immunogenicity data. Participants were closely monitored for safety during the entire study period. Solicited adverse events were monitored by way of e-diaries for 7 consecutive days after each vaccination. An independent Data Safety Monitoring Board was established that continuously reviewed accruing safety information or ad-hoc safety data, as needed, to ensure participants' wellbeing.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2018
    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
    Belgium: 44
    Country: Number of subjects enrolled
    Germany: 173
    Country: Number of subjects enrolled
    United States: 355
    Worldwide total number of subjects
    572
    EEA total number of subjects
    217
    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)
    568
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between 21-Dec-2018 and 26-Sep-2019 at one study site in Belgium, two study sites in Germany and six study sites in the USA.

    Pre-assignment
    Screening details
    		 In total, 658 subjects were screened, 85 were screening failures. The most frequent reason for screening failure was subjects not meeting the inclusion or exclusion criteria (42 [49.4%] subjects); followed by other reasons (26 [30.6%] subjects) and withdrawal of consent (20 [23.5%] subjects).

    Period 1
    Period 1 title
    overall study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The study sponsor and trial statisticians were unblinded at the time of the Interim Analysis, after the respective database snapshot has been performed

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VLA15 90µg
    Arm description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 90 μg w/ alum
    Arm type
    		 Experimental

    Investigational medicinal product name
    VLA15 w/Alum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    VLA15 Drug Product w/ Alum consists of the three proteins Lip-D1B2B, Lip-D4Bva3B and Lip-D5B6B that are formulated in 1:1:1 ratio in buffer (10 mM L-Methionine, 10 mM NaH2PO4 dihydrate, 150 mM NaCl, 5% (w/v) Sucrose, 0.05% (v/v) Tween®20 at pH 6.7) to a concentration of 180 μg/mL total protein (i.e. 60 μg/mL for each protein). Depending on the assigned treatment group either 500 μl (treatment group VLA15 90 w/ Alum), 750μl (VLA15 135 w/ Alum) or 1ml (VLA15 180 w/ Alum) are administered per vaccination day

    Arm title
    		 VLA15 135 μg
    Arm description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 135 μg w/ alum
    Arm type
    		 Experimental

    Investigational medicinal product name
    VLA15 w/Alum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    VLA15 Drug Product w/ Alum consists of the three proteins Lip-D1B2B, Lip-D4Bva3B and Lip-D5B6B that are formulated in 1:1:1 ratio in buffer (10 mM L-Methionine, 10 mM NaH2PO4 dihydrate, 150 mM NaCl, 5% (w/v) Sucrose, 0.05% (v/v) Tween®20 at pH 6.7) to a concentration of 180 μg/mL total protein (i.e. 60 μg/mL for each protein). Depending on the assigned treatment group either 500 μl (treatment group VLA15 90 w/ Alum), 750μl (VLA15 135 w/ Alum) or 1ml (VLA15 180 w/ Alum) are administered per vaccination day

    Arm title
    		 VLA15 180 μg
    Arm description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 180 μg w/ alum
    Arm type
    		 Experimental

    Investigational medicinal product name
    VLA15 w/Alum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    VLA15 Drug Product w/ Alum consists of the three proteins Lip-D1B2B, Lip-D4Bva3B and Lip-D5B6B that are formulated in 1:1:1 ratio in buffer (10 mM L-Methionine, 10 mM NaH2PO4 dihydrate, 150 mM NaCl, 5% (w/v) Sucrose, 0.05% (v/v) Tween®20 at pH 6.7) to a concentration of 180 μg/mL total protein (i.e. 60 μg/mL for each protein). Depending on the assigned treatment group either 500 μl (treatment group VLA15 90 w/ Alum), 750μl (VLA15 135 w/ Alum) or 1ml (VLA15 180 w/ Alum) are administered per vaccination day

    Arm title
    		 Placebo
    Arm description
    		 At each vaccination day (Day 1, 29 and 57) treatment with Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The VLA Placebo is a PBS buffer based on Dulbecco’s PBS media formulation without Calcium and Magnesium. Placebo was administered at 1 mL injection of PBS

    Number of subjects in period 1
    		VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Started
    29
    214
    205
    124
    D85
    28
    204
    201
    121
    Completed
    25
    196
    197
    115
    Not completed
    4
    18
    8
    9
         Physician decision
    -
    1
    -
    -
         Consent withdrawn by subject
    -
    4
    2
    1
         Adverse event, non-fatal
    -
    2
    2
    -
         other
    1
    5
    1
    2
         Lost to follow-up
    3
    6
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study period
    Reporting group description
    		 -

    Reporting group values
    		 overall study period Total
    Number of subjects
    		 572 572
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 568 568
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.8 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 312 312
        Male
    		 260 260
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all subjects who entered into the study and received at least one vaccination. The Safety Population will be used for all safety analyses as well as demographic data. All analyses based on the Safety Population will be carried out using the actual treatment received.

    Subject analysis set title
    mITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population is defined to include all subjects enrolled who received at least one vaccination. Subjects will be analyzed according to the treatment group they had been allocated to, rather than by the actual treatment, they received.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP Population was the primary analysis population and will exclude all subjects from the mITT that fulfilled at least one of the major protocol deviation criteria

    Subject analysis sets values
    		 Safety Population mITT Population PP population
    Number of subjects
    572
    572
    536
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    568
    568
    532
        From 65-84 years
    4
    4
    4
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.8 ( 12.9 )
    40.8 ( 12.9 )
    41.1 ( 12.7 )
    Gender categorical
    Units: Subjects
        Female
    312
    312
    298
        Male
    260
    260
    238

    End points

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    End points reporting groups
    Reporting group title
    VLA15 90µg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 90 μg w/ alum

    Reporting group title
    VLA15 135 μg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 135 μg w/ alum

    Reporting group title
    VLA15 180 μg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 180 μg w/ alum

    Reporting group title
    Placebo
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with Placebo

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all subjects who entered into the study and received at least one vaccination. The Safety Population will be used for all safety analyses as well as demographic data. All analyses based on the Safety Population will be carried out using the actual treatment received.

    Subject analysis set title
    mITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population is defined to include all subjects enrolled who received at least one vaccination. Subjects will be analyzed according to the treatment group they had been allocated to, rather than by the actual treatment, they received.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP Population was the primary analysis population and will exclude all subjects from the mITT that fulfilled at least one of the major protocol deviation criteria

    Primary: GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6

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    End point title
    		 GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6
    End point description
    Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer surface protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 85
    End point type
    Primary
    End point timeframe
    Day 85
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    192
    194
    121
    Units: U/mL
    geometric mean (confidence interval 95%)
        ST1
    74.3 (46.4 to 119.0)
    101.9 (87.1 to 119.4)
    115.8 (98.8 to 135.7)
    21.7 (20.0 to 23.6)
        ST2
    180.9 (124.8 to 262.3)
    279.3 (247.1 to 315.8)
    303.7 (266.5 to 346.1)
    21.1 (20.0 to 22.3)
        ST3
    267.4 (194.8 to 367.1)
    283.2 (248.2 to 323.1)
    308.6 (266.8 to 356.8)
    20.8 (19.8 to 21.8)
        ST4
    117.0 (76.6 to 178.7)
    170.9 (150.5 to 194.2)
    190.7 (165.9 to 219.2)
    21.8 (20.4 to 23.4)
        ST5
    118.3 (78.3 to 178.9)
    176.0 (154.2 to 201.0)
    199.6 (172.5 to 230.9)
    21.4 (20.2 to 22.6)
        ST6
    115.6 (76.5 to 174.7)
    183.6 (161.7 to 208.4)
    208.7 (181.8 to 239.6)
    21.8 (20.3 to 23.4)
    Statistical analysis title
    		 Overall comparison between treatment groups
    Statistical analysis description
    GMTs were compared by applying an analysis of covariance (ANCOVA) including the factors treatment group and country. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 95% CIs.
    Comparison groups
    VLA15 135 μg v VLA15 90µg v VLA15 180 μg v Placebo
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6

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    End point title
    		 GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6
    End point description
    GMTs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 1, 29, 57, 180, 236, and Month 12
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 180, 236, and Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    192
    194
    121
    Units: U/ml
    geometric mean (confidence interval 95%)
        ST1 Day 1
    20.8 (19.2 to 22.5)
    20.5 (19.8 to 21.3)
    20.2 (19.8 to 20.6)
    21.6 (19.9 to 23.5)
        ST1 Day 29
    21.1 (18.9 to 23.5)
    21.8 (20.0 to 23.8)
    21.2 (20.1 to 22.4)
    21.7 (20.0 to 23.7)
        ST1 Day 57
    32.7 (25.1 to 42.6)
    37.5 (32.4 to 43.3)
    41.2 (35.7 to 47.5)
    21.9 (20.1 to 23.8)
        ST1 Day 180
    26.2 (19.9 to 34.5)
    32.8 (28.8 to 37.3)
    33.9 (30.0 to 38.3)
    21.0 (19.8 to 22.3)
        ST1 Day 236
    22.2 (18.8 to 26.1)
    25.7 (22.8 to 28.8)
    26.2 (23.1 to 29.7)
    21.5 (19.6 to 23.6)
        ST1 Day 365
    20.9 (19.1 to 22.9)
    23.4 (21.4 to 25.6)
    23.0 (21.3 to 24.9)
    21.4 (19.9 to 22.9)
        ST2 Day 1
    21.3 (18.7 to 24.2)
    20.0 (20.0 to 20.0)
    20.1 (19.9 to 20.2)
    20.7 (19.7 to 21.8)
        ST2 Day 29
    21.1 (18.9 to 23.7)
    21.1 (20.0 to 22.2)
    21.4 (20.5 to 22.4)
    21.0 (19.9 to 22.1)
        ST2 Day 57
    69.0 (47.7 to 99.8)
    89.2 (75.9 to 104.9)
    107.8 (92.7 to 125.2)
    21.3 (20.0 to 22.6)
        ST2 Day 180
    41.2 (29.3 to 57.9)
    62.5 (54.5 to 71.7)
    67.1 (58.3 to 77.1)
    20.6 (19.7 to 21.5)
        ST2 Day 236
    26.6 (21.2 to 33.4)
    36.8 (32.1 to 42.2)
    35.7 (30.9 to 41.2)
    20.5 (19.5 to 21.5)
        ST2 Day 365
    21.8 (19.2 to 24.7)
    24.6 (22.8 to 26.6)
    24.8 (23.1 to 26.6)
    20.6 (19.7 to 21.5)
        ST3 Day 1
    21.9 (19.1 to 25.1)
    20.4 (20.0 to 20.8)
    20.1 (19.9 to 20.4)
    20.4 (19.6 to 21.2)
        ST3 Day 29
    23.7 (20.0 to 28.0)
    21.7 (20.2 to 23.2)
    21.2 (20.3 to 22.1)
    20.8 (19.8 to 21.9)
        ST3 Day 57
    110.2 (71.1 to 171.0)
    123.8 (104.4 to 146.9)
    145.8 (122.8 to 173.0)
    21.2 (20.0 to 22.6)
        ST3 Day 180
    53.1 (35.6 to 79.1)
    63.1 (55.2 to 72.2)
    68.7 (59.5 to 79.2)
    20.5 (19.8 to 21.3)
        ST3 Day 236
    35.3 (25.7 to 48.6)
    35.8 (31.2 to 41.1)
    39.0 (33.3 to 45.8)
    20.6 (19.7 to 21.7)
        ST3 Day 365
    25.2 (19.9 to 31.8)
    25.6 (23.5 to 27.9)
    27.0 (24.5 to 29.8)
    20.5 (19.8 to 21.3)
        ST4 Day 1
    21.4 (18.7 to 24.4)
    21.0 (20.3 to 21.7)
    20.2 (19.9 to 20.6)
    21.7 (20.3 to 23.2)
        ST4 Day 29
    22.1 (19.1 to 25.6)
    21.9 (20.4 to 23.6)
    21.4 (20.4 to 22.4)
    22.0 (20.4 to 23.6)
        ST4 Day 57
    45.9 (32.8 to 64.2)
    57.4 (49.5 to 66.6)
    64.7 (55.5 to 75.5)
    22.0 (20.4 to 23.8)
        ST4 Day 180
    32.8 (24.1 to 44.6)
    48.1 (42.5 to 54.5)
    49.3 (43.1 to 56.3)
    21.5 (20.2 to 22.9)
        ST4 Day 236
    25.5 (20.6 to 31.5)
    32.8 (29.0 to 37.2)
    31.9 (27.7 to 36.6)
    21.7 (20.0 to 23.5)
        ST4 Day 365
    21.8 (19.2 to 24.7)
    26.5 (24.2 to 28.9)
    25.5 (23.2 to 27.9)
    21.7 (20.3 to 23.2)
        ST5 Day 1
    20.6 (19.4 to 21.8)
    20.7 (20.1 to 21.3)
    20.2 (19.8 to 20.5)
    21.4 (20.2 to 22.7)
        ST5 Day 29
    20.7 (19.2 to 22.4)
    21.2 (20.0 to 22.5)
    21.0 (20.2 to 21.9)
    21.4 (20.1 to 22.7)
        ST5 Day 57
    42.7 (29.8 to 61.3)
    57.9 (44.9 to 67.2)
    72.2 (61.6 to 84.7)
    21.5 (20.2 to 22.9)
        ST5 Day 180
    26.7 (20.7 to 34.3)
    44.0 (38.8 to 49.8)
    50.0 (43.5 to 57.4)
    21.1 (20.0 to 22.3)
        ST5 Day 236
    23.0 (19.6 to 27.0)
    31.0 (27.5 to 35.0)
    32.4 (28.0 to 37.4)
    21.5 (20.0 to 23.1)
        ST5 Day 365
    21.7 (19.3 to 24.3)
    24.0 (22.3 to 25.8)
    24.9 (22.7 to 27.2)
    21.1 (20.0 to 22.2)
        ST6 Day 1
    21.1 (18.9 to 23.5)
    21.3 (20.4 to 22.2)
    20.8 (20.1 to 21.6)
    21.6 (20.2 to 23.2)
        ST6 Day 29
    21.1 (18.9 to 23.6)
    22.7 (21.2 to 24.3)
    22.0 (20.9 to 23.2)
    22.0 (20.4 to 23.7)
        ST6 Day 57
    42.3 (29.8 to 60.1)
    55.5 (48.1 to 64.1)
    65.3 (55.6 to 76.7)
    22.1 (20.4 to 23.9)
        ST6 Day 180
    30.1 (22.6 to 40.2)
    48.4 (42.8 to 54.8)
    51.4 (44.7 to 59.0)
    21.4 (20.1 to 22.8)
        ST6 Day 236
    25.6 (20.7 to 31.8)
    33.4 (29.5 to 37.8)
    33.2 (28.6 to 38.6)
    22.1 (20.2 to 24.3)
        ST6 Day 365
    22.1 (19.2 to 25.5)
    25.7 (23.8 to 27.9)
    26.0 (23.6 to 28.7)
    21.8 (20.3 to 23.3)
    No statistical analyses for this end point

    Secondary: SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6)

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    End point title
    		 SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6)
    End point description
    Seroconversion for ELISA is defined as: • for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point. • for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. SCRs for each OspA serotype specific IgG (ST1 to ST6), determined by ELISA, at Day 29, 57, 85, 180, 236, and Month 12
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 180, 236 and Months 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    192
    194
    121
    Units: percentage of participants (%)
    number (confidence interval 95%)
        ST1 Day 29
    0.0 (0.0 to 11.7)
    3.7 (1.8 to 7.4)
    3.1 (1.4 to 6.6)
    0.8 (0.1 to 4.6)
        ST1 Day 57
    39.3 (23.6 to 57.6)
    37.2 (30.6 to 44.2)
    40.7 (34.1 to 47.8)
    1.7 (0.5 to 5.8)
        ST1 Day 85
    65.4 (46.2 to 80.6)
    81.3 (75.1 to 86.2)
    81.5 (75.3 to 86.4)
    0.8 (0.1 to 4.6)
        ST1 Day 180
    11.5 (4.0 to 29.0)
    32.8 (26.4 to 39.9)
    35.4 (29.0 to 42.5)
    0.9 (0.2 to 4.8)
        ST1 Day 236
    7.7 (2.1 to 24.1)
    17.2 (11.5 to 24.9)
    18.5 (12.5 to 26.4)
    2.6 (0.7 to 9.1)
        ST1 Day 365
    4.0 (0.7 to 19.5)
    10.9 (7.2 to 16.3)
    8.9 (5.6 to 13.8)
    1.8 (0.5 to 6.2)
        ST2 Day 29
    0.0 (0.0 to 11.7)
    2.6 (1.1 to 6.0)
    5.7 (3.2 to 9.9)
    0.8 (0.1 to 4.6)
        ST2 Day 57
    67.9 (49.3 to 82.1)
    72.3 (65.5 to 78.1)
    79.9 (73.7 to 84.9)
    1.7 (0.5 to 6.0)
        ST2 Day 85
    88.5 (71.0 to 96.0)
    98.4 (95.4 to 99.5)
    95.2 (91.2 to 97.5)
    1.7 (0.5 to 6.0)
        ST2 Day 180
    42.3 (25.5 to 61.1)
    66.1 (59.0 to 72.6)
    66.7 (59.7 to 73.0)
    0.9 (0.2 to 4.8)
        ST2 Day 236
    19.2 (8.5 to 37.9)
    42.6 (34.2 to 51.5)
    38.7 (30.4 to 47.6)
    0.0 (0.0 to 4.8)
        ST2 Day 365
    8.0 (2.2 to 25.0)
    15.3 (10.8 to 21.2)
    17.8 (13.0 to 23.8)
    0.9 (0.2 to 4.8)
        ST3 Day 29
    6.9 (1.9 to 22.0)
    4.2 (2.1 to 8.0)
    3.6 (1.8 to 7.3)
    1.7 (0.5 to 5.9)
        ST3 Day 57
    75.0 (56.6 to 87.3)
    80.1 (73.9 to 85.1)
    84.0 (78.2 to 88.5)
    2.5 (0.8 to 7.0)
        ST3 Day 85
    96.2 (81.1 to 99.3)
    97.3 (93.9 to 98.9)
    95.8 (91.9 to 97.8)
    1.7 (0.5 to 6.0)
        ST3 Day 180
    50.0 (32.1 to 67.9)
    68.9 (61.8 to 75.1)
    69.3 (62.4 to 75.4)
    1.8 (0.5 to 6.2)
        ST3 Day 236
    34.6 (19.4 to 53.8)
    39.3 (31.1 to 48.2)
    42.0 (33.5 to 51.0)
    2.6 (0.7 to 9.1)
        ST3 Day 365
    12.0 (4.2 to 30.0)
    17.5 (12.7 to 23.6)
    19.9 (14.9 to 26.1)
    1.8 (0.5 to 6.2)
        ST4 Day 29
    3.4 (0.6 to 17.2)
    2.6 (1.1 to 6.0)
    3.6 (1.8 to 7.3)
    0.8 (0.1 to 4.5)
        ST4 Day 57
    50.0 (32.6 to 67.4)
    58.6 (51.6 to 65.4)
    67.0 (60.1 to 73.2)
    0.8 (0.1 to 4.5)
        ST4 Day 85
    80.8 (62.1 to 91.5)
    94.1 (89.8 to 96.7)
    93.7 (89.2 to 96.3)
    0.8 (0.1 to 4.6)
        ST4 Day 180
    30.8 (16.5 to 50.0)
    57.4 (50.1 to 64.3)
    58.2 (51.1 to 65.0)
    0.9 (0.2 to 4.8)
        ST4 Day 236
    15.4 (6.2 to 33.5)
    36.1 (28.1 to 44.9)
    31.9 (24.2 to 40.8)
    1.3 (0.2 to 7.1)
        ST4 Day 365
    8.0 (2.2 to 25.0)
    19.7 (14.6 to 26.0)
    16.8 (12.1 to 22.7)
    2.7 (0.9 to 7.5)
        ST5 Day 29
    0.0 (0.0 to 11.7)
    1.6 (0.5 to 4.5)
    2.6 (1.1 to 5.9)
    0.0 (0.0 to 3.1)
        ST5 Day 57
    42.9 (26.5 to 60.9)
    58.1 (51.0 to 64.9)
    67.5 (60.7 to 73.7)
    0.0 (0.0 to 3.1)
        ST5 Day 85
    80.8 (62.1 to 91.5)
    91.4 (86.6 to 94.7)
    90.5 (85.4 to 93.9)
    0.0 (0.0 to 3.2)
        ST5 Day 180
    19.2 (8.5 to 37.9)
    49.7 (42.6 to 56.9)
    55.0 (47.9 to 61.9)
    0.9 (0.2 to 4.8)
        ST5 Day 236
    11.5 (4.0 to 29.0)
    32.0 (24.4 to 40.7)
    31.9 (24.2 to 40.8)
    1.3 (0.2 to 7.1)
        ST5 Day 365
    8.0 (2.2 to 25.0)
    13.1 (9.0 to 18.8)
    13.1 (9.0 to 18.6)
    0.9 (0.2 to 4.8)
        ST6 Day 29
    0.0 (0.0 to 11.7)
    6.3 (3.6 to 10.7)
    4.6 (2.5 to 8.6)
    1.7 (0.5 to 5.9)
        ST6 Day 57
    42.9 (26.5 to 60.9)
    54.4 (47.4 to 61.4)
    60.3 (53.3 to 66.9)
    1.7 (0.5 to 5.8)
        ST6 Day 85
    80.8 (62.1 to 91.5)
    93.0 (88.5 to 95.9)
    91.5 (86.7 to 94.7)
    0.8 (0.1 to 4.6)
        ST6 Day 180
    23.1 (11.0 to 42.1)
    54.1 (46.9 to 61.2)
    53.4 (46.3 to 60.4)
    2.6 (0.9 to 7.5)
        ST6 Day 236
    15.4 (6.2 to 33.5)
    35.2 (27.3 to 44.1)
    31.1 (23.5 to 39.9)
    3.9 (1.4 to 11.0)
        ST6 Day 365
    8.0 (2.2 to 25.0)
    16.9 (12.2 to 23.0)
    13.6 (9.5 to 19.2)
    3.5 (1.4 to 8.7)
    No statistical analyses for this end point

    Secondary: GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6),

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    End point title
    		 GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6),
    End point description
    GMFR (Geometric Mean of the fold rise as compared to Day 1) for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 29, 57, 85, 180, 236 and Month 12
    End point type
    Secondary
    End point timeframe
    Day 29,57,85,180,236 and Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    192
    194
    121
    Units: Geometric Mean of the Fold Rise
    number (confidence interval 95%)
        ST1 Day 29
    1.0 (1.0 to 1.0)
    1.1 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST1 Day 57
    1.6 (1.2 to 2.1)
    1.8 (1.6 to 2.1)
    2.0 (1.8 to 2.4)
    1.0 (1.0 to 1.0)
        ST1 Day 85
    3.6 (2.2 to 5.6)
    5.0 (4.3 to 5.8)
    5.7 (4.9 to 6.7)
    1.0 (1.0 to 1.0)
        ST1 Day 180
    1.3 (1.0 to 1.6)
    1.6 (1.4 to 1.8)
    1.7 (1.5 to 1.9)
    1.0 (1.0 to 1.0)
        ST1 Day 236
    1.1 (0.9 to 1.3)
    1.3 (1.1 to 1.4)
    1.3 (1.2 to 1.5)
    1.0 (1.0 to 1.1)
        ST1 Day 365
    1.0 (0.9 to 1.1)
    1.1 (1.1 to 1.2)
    1.1 (1.1 to 1.2)
    1.0 (1.0 to 1.1)
        ST2 Day 29
    1.0 (1.0 to 1.0)
    1.1 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST2 Day 57
    3.2 (2.2 to 4.7)
    4.5 (3.8 to 5.2)
    5.4 (4.6 to 6.2)
    1.0 (1.0 to 1.1)
        ST2 Day 85
    8.4 (5.7 to 12.4)
    14.0 (12.4 to 15.8)
    15.1 (13.3 to 17.3)
    1.0 (1.0 to 1.0)
        ST2 Day 180
    1.9 (1.4 to 2.7)
    3.1 (2.7 to 3.6)
    3.3 (2.9 to 3.8)
    1.0 (1.0 to 1.0)
        ST2 Day 236
    1.2 (1.0 to 1.6)
    1.8 (1.6 to 2.1)
    1.8 (1.5 to 2.1)
    1.0 (1.0 to 1.0)
        ST2 Day 365
    1.1 (1.0 to 1.2)
    1.2 (1.1 to 1.3)
    1.2 (1.1 to 1.3)
    1.0 (1.0 to 1.0)
        ST3 Day 29
    1.1 (1.0 to 1.2)
    1.1 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
        ST3 Day 57
    5.0 (3.2 to 7.8)
    6.1 (5.1 to 7.2)
    7.2 (6.1 to 8.6)
    1.0 (1.0 to 1.1)
        ST3 Day 85
    12.1 (8.6 to 17.0)
    13.9 (12.3 to 15.9)
    15.3 (13.3 to 17.7)
    1.0 (1.0 to 1.1)
        ST3 Day 180
    2.4 (1.6 to 3.6)
    3.1 (2.7 to 3.5)
    3.4 (3.0 to 3.9)
    1.0 (1.0 to 1.1)
        ST3 Day 236
    1.6 (1.2 to 2.2)
    1.8 (1.5 to 2.0)
    1.9 (1.6 to 2.3)
    1.0 (1.0 to 1.1)
        ST3 Day 365
    1.2 (1.0 to 1.4)
    1.3 (1.2 to 1.4)
    1.3 (1.2 to 1.5)
    1.0 (1.0 to 1.1)
        ST4 Day 29
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST4 Day 57
    2.1 (1.5 to 3.0)
    2.7 (2.4 to 3.2)
    3.2 (2.7 to 3.7)
    1.0 (1.0 to 1.0)
        ST4 Day 85
    5.4 (3.5 to 8.5)
    8.2 (7.2 to 9.3)
    9.4 (8.2 to 10.8)
    1.0 (1.0 to 1.0)
        ST4 Day 180
    1.5 (1.1 to 2.1)
    2.3 (2.0 to 2.6)
    2.4 (2.1 to 2.8)
    1.0 (1.0 to 1.1)
        ST4 Day 236
    1.2 (0.9 to 1.5)
    1.6 (1.4 to 1.8)
    1.6 (1.4 to 1.8)
    1.0 (1.0 to 1.1)
        ST4 Day 365
    1.1 (1.0 to 1.2)
    1.3 (1.2 to 1.4)
    1.3 (1.1 to 1.4)
    1.0 (1.0 to 1.1)
        ST5 Day 29
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST5 Day 57
    2.1 (1.5 to 3.0)
    2.8 (2.4 to 3.2)
    3.6 (3.1 to 4.2)
    1.0 (1.0 to 1.0)
        ST5 Day 85
    5.7 (3.8 to 8.7)
    8.6 (7.5 to 9.8)
    9.9 (8.5 to 11.4)
    1.0 (1.0 to 1.0)
        ST5 Day 180
    1.3 (1.0 to 1.7)
    2.1 (1.9 to 2.4)
    2.5 (2.2 to 2.8)
    1.0 (1.0 to 1.0)
        ST5 Day 236
    1.1 (0.9 to 1.3)
    1.5 (1.4 to 1.7)
    1.6 (1.4 to 1.8)
    1.0 (1.0 to 1.0)
        ST5 Day 365
    1.1 (1.0 to 1.2)
    1.2 (1.1 to 1.2)
    1.2 (1.1 to 1.3)
    1.0 (1.0 to 1.0)
        ST6 Day 29
    1.0 (1.0 to 1.0)
    1.1 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST6 Day 57
    2.0 (1.4 to 2.8)
    2.6 (2.3 to 3.0)
    3.1 (2.7 to 3.7)
    1.0 (1.0 to 1.0)
        ST6 Day 85
    5.4 (3.6 to 8.3)
    8.7 (7.7 to 9.8)
    10.0 (8.7 to 11.5)
    1.0 (1.0 to 1.0)
        ST6 Day 180
    1.4 (1.1 to 1.9)
    2.3 (2.0 to 2.6)
    2.5 (2.1 to 2.8)
    1.0 (1.0 to 1.1)
        ST6 Day 236
    1.2 (1.0 to 1.5)
    1.6 (1.4 to 1.8)
    1.6 (1.4 to 1.9)
    1.0 (1.0 to 1.1)
        ST6 Day 365
    1.1 (1.0 to 1.3)
    1.2 (1.1 to 1.3)
    1.2 (1.1 to 1.4)
    1.0 (1.0 to 1.1)
    No statistical analyses for this end point

    Secondary: GMTs for IgG against each OspA serotype (ST1 to ST6) - group 18 to 49 years

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    End point title
    		 GMTs for IgG against each OspA serotype (ST1 to ST6) - group 18 to 49 years
    End point description
    GMTs IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 1, 29, 57, 85, 180, 236, and Month 12, stratified by age group ( 18- 49 years)
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 180, 236 and Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    133
    136
    88
    Units: U/ml
    geometric mean (confidence interval 95%)
        ST1 Day 1
    20.8 (19.2 to 22.5)
    20.3 (19.7 to 21.0)
    20.3 (19.7 to 20.8)
    22.0 (19.6 to 24.6)
        ST1 Day 29
    21.1 (18.9 to 23.5)
    20.9 (19.7 to 22.1)
    21.4 (19.9 to 23.0)
    22.0 (19.6 to 24.6)
        ST1 Day 57
    32.7 (25.1 to 42.6)
    34.8 (30.0 to 40.3)
    43.6 (36.5 to 52.0)
    22.4 (19.9 to 25.2)
        ST1 Day 85
    74.3 (46.4 to 119.0)
    105.2 (88.8 to 124.5)
    129.6 (107.6 to 156.2)
    21.9 (19.6 to 24.5)
        ST1 Day 180
    26.2 (19.9 to 34.5)
    31.7 (27.5 to 36.4)
    34.7 (29.7 to 40.5)
    21.0 (19.5 to 22.7)
        ST1 Day 236
    22.2 (18.8 to 26.1)
    26.1 (22.5 to 30.3)
    26.4 (22.4 to 31.2)
    21.7 (19.3 to 24.4)
        ST1 Day 365
    20.9 (19.1 to 22.9)
    23.0 (21.1 to 25.1)
    23.8 (21.4 to 26.5)
    21.7 (19.7 to 23.9)
        ST2 Day 1
    21.3 (18.7 to 24.2)
    20.0 (20.0 to 20.0)
    20.1 (19.9 to 20.3)
    21.0 (19.6 to 22.5)
        ST2 Day 29
    21.1 (18.9 to 23.7)
    20.7 (19.9 to 21.5)
    21.4 (20.5 to 22.3)
    21.0 (19.6 to 22.4)
        ST2 Day 57
    69.0 (47.7 to 99.8)
    89.5 (74.2 to 107.9)
    121.4 (102.4 to 143.9)
    21.4 (19.8 to 23.2)
        ST2 Day 85
    180.9 (124.8 to 262.3)
    296.5 (258.6 to 339.9)
    322.1 (277.1 to 374.4)
    21.2 (19.8 to 22.7)
        ST2 Day 180
    41.2 (29.3 to 57.9)
    64.5 (54.7 to 76.0)
    71.8 (60.8 to 84.7)
    20.5 (19.5 to 21.6)
        ST2 Day 236
    26.6 (21.2 to 33.4)
    39.6 (33.5 to 46.8)
    37.0 (31.2 to 43.9)
    20.6 (19.4 to 22.0)
        ST2 Day 365
    21.8 (19.2 to 24.7)
    24.5 (22.4 to 26.8)
    25.1 (23.0 to 27.4)
    20.5 (19.5 to 21.6)
        ST3 Day 1
    21.9 (19.1 to 25.1)
    20.3 (19.9 to 20.7)
    20.2 (19.8 to 20.5)
    20.6 (19.5 to 21.7)
        ST3 Day 29
    23.7 (20.0 to 28.0)
    21.0 (20.1 to 21.9)
    21.7 (20.5 to 23.0)
    20.7 (19.6 to 21.9)
        ST3 Day 57
    110.2 (71.1 to 171.0)
    122.6 (101.3 to 148.3)
    159.4 (130.1 to 195.2)
    21.3 (19.7 to 22.9)
        ST3 Day 85
    267.4 (194.8 to 367.1)
    295.1 (255.6 to 340.8)
    334.2 (282.1 to 395.9)
    20.7 (19.6 to 21.8)
        ST3 Day 180
    53.1 (35.6 to 79.1)
    60.7 (51.7 to 71.2)
    73.0 (61.3 to 86.9)
    20.0 (20.0 to 20.0)
        ST3 Day 236
    35.3 (25.7 to 48.6)
    35.8 (30.4 to 42.2)
    39.9 (33.0 to 48.3)
    20.2 (19.8 to 20.7)
        ST3 Day 365
    25.2 (19.9 to 31.8)
    25.4 (23.2 to 27.8)
    28.0 (24.7 to 31.8)
    20.2 (19.8 to 20.7)
        ST4 Day 1
    21.4 (18.7 to 24.4)
    20.8 (20.0 to 21.6)
    20.3 (19.9 to 20.8)
    22.0 (20.2 to 24.0)
        ST4 Day 29
    22.1 (19.1 to 25.6)
    21.5 (20.4 to 22.8)
    21.5 (20.3 to 22.8)
    22.3 (20.4 to 24.4)
        ST4 Day 57
    45.9 (32.8 to 64.2)
    56.9 (48.3 to 67.1)
    71.4 (59.1 to 86.3)
    22.4 (20.4 to 24.6)
        ST4 Day 85
    117.0 (76.6 to 178.7)
    177.1 (154.5 to 203.1)
    206.8 (175.0 to 244.3)
    22.1 (20.3 to 24.1)
        ST4 Day 180
    32.8 (24.1 to 44.6)
    48.2 (41.8 to 55.6)
    53.2 (44.9 to 63.0)
    21.7 (20.0 to 23.5)
        ST4 Day 236
    25.5 (20.6 to 31.5)
    34.9 (29.9 to 40.8)
    33.6 (28.1 to 40.1)
    21.2 (19.5 to 23.2)
        ST4 Day 365
    21.8 (19.2 to 24.7)
    26.7 (24.2 to 29.5)
    26.7 (23.5 to 30.3)
    21.4 (19.9 to 23.0)
        ST5 Day 1
    20.6 (19.4 to 21.8)
    20.4 (19.9 to 20.9)
    20.2 (19.8 to 20.8)
    21.5 (20.0 to 23.1)
        ST5 Day 29
    20.7 (19.2 to 22.4)
    20.6 (19.9 to 21.3)
    21.1 (20.1 to 22.1)
    21.4 (20.0 to 22.9)
        ST5 Day 57
    42.7 (29.8 to 61.3)
    56.6 (47.8 to 67.0)
    80.7 (66.3 to 98.1)
    21.6 (20.0 to 23.3)
        ST5 Day 85
    118.3 (78.3 to 178.9)
    180.7 (156.8 to 208.2)
    218.3 (183.6 to 259.7)
    21.4 (20.0 to 22.9)
        ST5 Day 180
    26.7 (20.7 to 34.3)
    42.5 (36.7 to 49.1)
    54.6 (45.9 to 64.8)
    20.8 (19.7 to 21.9)
        ST5 Day 236
    23.0 (19.6 to 27.0)
    31.9 (27.5 to 37.1)
    33.4 (27.7 to 40.2)
    21.0 (19.6 to 22.6)
        ST5 Day 365
    21.7 (19.3 to 24.3)
    24.0 (22.2 to 26.0)
    26.0 (23.0 to 29.5)
    20.8 (19.7 to 21.9)
        ST6 Day 1
    21.1 (18.9 to 23.5)
    20.8 (20.0 to 21.5)
    21.2 (20.1 to 22.4)
    21.7 (20.0 to 23.6)
        ST6 Day 29
    21.1 (18.9 to 23.6)
    22.3 (21.0 to 23.7)
    22.2 (20.8 to 23.7)
    22.1 (20.3 to 24.0)
        ST6 Day 57
    42.3 (29.8 to 60.1)
    54.5 (46.2 to 64.3)
    72.3 (59.2 to 88.3)
    22.3 (20.3 to 24.4)
        ST6 Day 85
    115.6 (76.5 to 174.7)
    185.8 (162.2 to 213.0)
    225.6 (191.9 to 265.3)
    21.8 (20.1 to 23.7)
        ST6 Day 180
    30.1 (22.6 to 40.2)
    46.7 (40.4 to 53.9)
    54.2 (45.5 to 64.4)
    20.6 (19.7 to 21.4)
        ST6 Day 236
    25.6 (20.7 to 31.8)
    34.6 (29.8 to 40.2)
    34.6 (28.7 to 41.9)
    21.4 (19.7 to 23.2)
        ST6 Day 365
    22.1 (19.2 to 25.5)
    25.5 (23.3 to 27.9)
    27.7 (24.3 to 31.6)
    21.4 (20.1 to 22.7)
    No statistical analyses for this end point

    Secondary: GMTs for IgG against each OspA serotype (ST1 to ST6) - group 50 to 65 years

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    End point title
    		 GMTs for IgG against each OspA serotype (ST1 to ST6) - group 50 to 65 years [1]
    End point description
    GMTs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 1, 29, 57, 85, 180, 236, and Month 12, stratified by age group. ( 50-65 years)
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 180, 236 and Month 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    59
    58
    33
    Units: U/ml
    geometric mean (confidence interval 95%)
        ST1 Day 1
    21.0 (19.0 to 23.3)
    20.0 (20.0 to 20.0)
    20.6 (19.4 to 22.0)
        ST1 Day 29
    24.2 (18.7 to 31.4)
    20.9 (19.5 to 22.5)
    21.0 (19.6 to 22.6)
        ST1 Day 57
    44.5 (31.7 to 62.3)
    36.2 (28.6 to 45.8)
    20.5 (19.5 to 21.6)
        ST1 Day 85
    95.3 (67.2 to 135.1)
    89.2 (66.0 to 120.4)
    21.2 (19.5 to 23.1)
        ST1 Day 180
    35.4 (26.8 to 46.9)
    32.1 (26.4 to 39.0)
    21.0 (19.6 to 22.5)
        ST1 Day 236
    24.5 (20.4 to 29.4)
    25.6 (21.4 to 30.5)
    20.9 (19.1 to 22.9)
        ST1 Day 365
    24.3 (19.6 to 30.1)
    21.4 (19.6 to 23.2)
    20.5 (19.4 to 21.7)
        ST2 Day 1
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        ST2 Day 29
    22.0 (18.9 to 25.7)
    21.6 (19.4 to 24.0)
    20.9 (19.1 to 22.8)
        ST2 Day 57
    88.7 (64.1 to 122.5)
    81.5 (60.4 to 110.2)
    20.9 (19.1 to 22.8)
        ST2 Day 85
    245.5 (190.3 to 316.6)
    265.0 (204.2 to 344.0)
    20.8 (19.2 to 22.4)
        ST2 Day 180
    58.5 (45.4 to 75.3)
    57.4 (44.1 to 74.5)
    20.8 (19.2 to 22.4)
        ST2 Day 236
    30.5 (24.1 to 38.7)
    32.7 (24.8 to 43.1)
    20.0 (20.0 to 20.0)
        ST2 Day 365
    24.9 (21.3 to 29.2)
    24.1 (21.3 to 27.3)
    20.9 (19.1 to 22.7)
        ST3 Day 1
    20.7 (19.7 to 21.7)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        ST3 Day 29
    23.3 (18.9 to 28.7)
    20.0 (20.0 to 20.0)
    21.2 (18.8 to 23.8)
        ST3 Day 57
    126.7 (88.0 to 182.4)
    118.3 (85.7 to 163.1)
    21.1 (18.9 to 23.6)
        ST3 Day 85
    258.9 (194.9 to 343.8)
    256.5 (193.5 to 340.0)
    21.1 (19.0 to 23.4)
        ST3 Day 180
    68.8 (53.5 to 88.4)
    59.7 (46.4 to 76.7)
    21.9 (19.1 to 25.0)
        ST3 Day 236
    35.7 (27.3 to 46.8)
    36.9 (27.2 to 50.1)
    22.0 (18.0 to 26.9)
        ST3 Day 365
    26.0 (21.5 to 31.5)
    24.8 (21.6 to 28.4)
    21.3 (18.7 to 24.2)
        ST4 Day 1
    21.3 (19.8 to 23.0)
    20.0 (20.0 to 20.0)
    20.9 (19.1 to 22.9)
        ST4 Day 29
    22.9 (18.7 to 28.0)
    21.0 (19.4 to 22.8)
    21.2 (18.8 to 23.8)
        ST4 Day 57
    58.6 (42.6 to 80.6)
    51.4 (39.8 to 66.4)
    21.2 (18.8 to 23.9)
        ST4 Day 85
    158.2 (119.5 to 209.4)
    158.1 (122.5 to 203.9)
    21.1 (18.9 to 23.4)
        ST4 Day 180
    48.0 (37.5 to 61.5)
    41.3 (33.6 to 50.9)
    21.1 (18.9 to 23.6)
        ST4 Day 236
    28.0 (23.1 to 33.8)
    28.0 (22.7 to 34.7)
    23.1 (18.7 to 28.5)
        ST4 Day 365
    26.0 (21.7 to 31.1)
    22.9 (20.9 to 25.1)
    22.5 (19.4 to 26.1)
        ST5 Day 1
    21.4 (19.8 to 23.0)
    20.0 (20.0 to 20.0)
    21.0 (19.0 to 23.4)
        ST5 Day 29
    22.7 (19.0 to 27.1)
    20.8 (19.2 to 22.6)
    21.3 (18.7 to 24.3)
        ST5 Day 57
    61.0 (44.9 to 82.9)
    55.7 (42.5 to 72.8)
    21.3 (18.7 to 24.2)
        ST5 Day 85
    166.4 (124.1 to 223.0)
    162.1 (124.0 to 211.9)
    21.2 (18.8 to 23.9)
        ST5 Day 180
    47.4 (37.2 to 60.5)
    40.8 (32.6 to 51.1)
    21.9 (19.1 to 25.2)
        ST5 Day 236
    28.8 (23.4 to 35.6)
    30.2 (24.1 to 37.7)
    23.1 (18.6 to 28.7)
        ST5 Day 365
    23.9 (20.5 to 27.8)
    22.4 (20.2 to 24.7)
    21.9 (19.1 to 25.2)
        ST6 Day 1
    22.6 (20.3 to 25.1)
    20.0 (20.0 to 20.0)
    21.4 (18.7 to 24.4)
        ST6 Day 29
    23.6 (19.9 to 28.1)
    21.6 (19.6 to 23.9)
    21.7 (18.3 to 25.8)
        ST6 Day 57
    58.0 (43.2 to 77.7)
    51.4 (39.3 to 67.1)
    21.7 (18.4 to 25.6)
        ST6 Day 85
    178.7 (135.2 to 236.3)
    174.3 (133.9 to 226.9)
    21.6 (18.5 to 25.3)
        ST6 Day 180
    52.3 (41.1 to 66.5)
    45.5 (36.1 to 57.3)
    23.6 (19.2 to 28.8)
        ST6 Day 236
    30.3 (24.1 to 38.1)
    30.1 (23.6 to 38.3)
    24.6 (18.0 to 33.6)
        ST6 Day 385
    26.2 (22.2 to 30.9)
    22.5 (20.2 to 25.0)
    22.8 (18.7 to 27.8)
    No statistical analyses for this end point

    Secondary: SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6) group 18-49 years

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    End point title
    		 SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6) group 18-49 years
    End point description
    Seroconversion for ELISA is defined as: • for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point. • for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. SCRs for each OspA serotype specific IgG (ST1 to ST6), determined by ELISA, at Day 1, 29, 57, 85, 180, 236, and Month 12, stratified by age group ( 18-49 years)
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 180, 236 and Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    133
    136
    88
    Units: percentage of participants (%)
    number (confidence interval 95%)
        ST1 Day 29
    0.0 (0.0 to 11.7)
    2.3 (0.8 to 6.4)
    2.9 (1.1 to 7.3)
    0.0 (0.0 to 4.2)
        ST1 Day 57
    39.3 (23.6 to 57.6)
    36.1 (28.4 to 44.5)
    43.4 (35.3 to 51.8)
    1.1 (0.2 to 6.2)
        ST1 Day 85
    65.4 (46.2 to 80.6)
    85.9 (78.9 to 90.0)
    85.6 (78.6 to 90.6)
    0.0 (0.0 to 4.3)
        ST1 Day 180
    11.5 (4.0 to 29.0)
    31.2 (23.7 to 39.8)
    36.4 (28.7 to 44.8)
    0.0 (0.0 to 4.5)
        ST1 Day 236
    7.7 (2.1 to 24.1)
    18.2 (11.5 to 27.5)
    17.9 (11.1 to 27.4)
    1.7 (0.3 to 9.1)
        ST1 Day 365
    4.0 (0.7 to 19.5)
    11.3 (6.8 to 18.1)
    10.5 (6.4 to 16.9)
    1.2 (0.2 to 6.6)
        ST2 Day 29
    0.0 (0.0 to 0.0)
    2.3 (0.8 to 6.4)
    6.6 (3.5 to 12.1)
    0.0 (0.0 to 4.2)
        ST2 Day 57
    67.9 (49.3 to 82.1)
    72.9 (64.8 to 79.8)
    85.3 (78.4 to 90.3)
    1.1 (0.2 to 6.4)
        ST2 Day 85
    88.5 (71.0 to 96.0)
    100 (97.1 to 100)
    96.2 (91.4 to 98.4)
    1.2 (0.2 to 6.4)
        ST2 Day 180
    42.3 (25.5 to 61.1)
    68.0 (59.4 to 75.5)
    69.7 (61.4 to 76.9)
    0.0 (0.0 to 4.5)
        ST2 Day 236
    19.2 (8.5 to 37.9)
    47.7 (37.6 to 58.0)
    41.7 (41.7 to 52.3)
    0.0 (0.0 to 6.2)
        ST2 Day 365
    8.0 (2.2 to 25.0)
    15.3 (10.0 to 22.7)
    18.8 (13.1 to 26.3)
    0.0 (0.0 to 4.5)
        ST3 Day 29
    6.9 (1.9 to 22.0)
    3.0 (1.2 to 7.5)
    5.1 (2.5 to 10.2)
    1.1 (0.2 to 6.2)
        ST3 Day 57
    75.0 (56.6 to 87.3)
    81.2 (73.7 to 86.9)
    85.3 (78.4 to 90.3)
    2.3 (0.2 to 6.4)
        ST3 Day 85
    96.2 (81.1 to 99.3)
    98.4 (94.5 to 99.6)
    97.0 (92.5 to 98.8)
    1.2 (0.2 to 6.4)
        ST3 Day 180
    50.0 (32.1 to 67.9)
    66.4 (57.7 to 74.1)
    70.5 (66.2 to 77.6)
    0.0 (0.0 to 4.5)
        ST3 Day 236
    34.6 (19.4 to 53.8)
    39.8 (30.2 to 50.2)
    44.0 (33.9 to 54.7)
    1.7 (0.3 to 9.1)
        ST3 Day 365
    12.0 (4.2 to 30.0)
    19.4 (13.4 to 27.2)
    21.8 (15.6 to 29.6)
    1.2 (0.2 to 6.6)
        ST4 Day 29
    3.4 (0.6 to 17.2)
    2.3 (0.8 to 6.5)
    3.7 (1.6 to 8.3)
    1.1 (0.2 to 6.2)
        ST4 Day 57
    50.0 (32.6 to 67.4)
    60.2 (51.7 to 68.1)
    71.3 (63.2 to 78.3)
    1.1 (0.2 to 6.2)
        ST4 Day 85
    80.8 (62.1 to 91.5)
    96.1 (91.2 to 98.3)
    94.7 (89.5 to 97.4)
    1.2 (0.2 to 6.4)
        ST4 Day 180
    30.8 (16.5 to 50.0)
    58.4 (49.6 to 66.7)
    60.6 (52.1 to 68.5)
    1.2 (0.2 to 6.6)
        ST4 Day 236
    15.4 (6.2 to 33.5)
    38.6 (29.1 to 49.1)
    34.5 (25.2 to 45.2)
    0.0 (0.0 to 6.2)
        ST4 Day 365
    8.0 (2.2 to 25.0)
    21.0 (14.7 to 29.0)
    18.0 (12.4 to 25.4)
    1.2 (0.2 to 6.6)
        ST5 Day 29
    0.0 (0.0 to 11.7)
    0.8 (0.1 to 4.1)
    2.9 (1.1 to 7.3)
    0.0 (0.0 to 4.2)
        ST5 Day 57
    42.9 (26.5 to 60.9)
    59.4 (50.9 to 67.4)
    72.8 (64.8 to 79.6)
    0.0 (0.0 to 4.2)
        ST5 Day 85
    80.8 (62.1 to 91.5)
    94.5 (89.1 to 97.3)
    91.7 (85.7 to 95.3)
    0.0 (0.0 to 4.3)
        ST5 Day 180
    19.2 (8.5 to 37.9)
    48.8 (40.2 to 57.5)
    59.1 (50.6 to 67.1)
    0.0 (0.0 to 4.3)
        ST5 Day 236
    11.5 (4.0 to 29.0)
    33.0 (24.0 to 43.3)
    32.1 (23.1 to 42.7)
    0.0 (0.0 to 4.5)
        ST5 Day 365
    8.0 (2.2 to 25.0)
    15.3 (10.0 to 22.7)
    15.0 (10.0 to 22.1)
    0.0 (0.0 to 4.5)
        ST6 Day 29
    0.0 (0.0 to 11.7)
    6.8 (3.6 to 12.4)
    4.4 (2.0 to 9.3)
    2.3 (0.6 to 7.9)
        ST6 Day 57
    42.9 (26.5 to 60.9)
    55.6 (47.2 to 63.8)
    64.0 (55.6 to 71.6)
    2.3 (0.6 to 7.9)
        ST6 Day 85
    80.8 (62.1 to 91.5)
    95.3 (90.2 to 97.8)
    92.4 (86.6 to 95.8)
    1.2 (0.2 to 6.4)
        ST6 Day 180
    23.1 (11.0 to 42.1)
    54.4 (45.7 to 62.9)
    53.8 (45.3 to 62.1)
    1.2 (0.2 to 6.6)
        ST6 Day 236
    15.4 (6.2 to 33.5)
    38.6 (29.1 to 49.1)
    32.1 (23.1 to 42.7)
    3.4 (1.0 to 11.7)
        ST6 Day 365
    8.0 (2.2 to 25.0)
    17.7 (12.0 to 25.4)
    15.8 (10.6 to 22.9)
    3.7 (1.3 to 10.2)
    No statistical analyses for this end point

    Secondary: SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6) group 50-65 years

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    End point title
    		 SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) Serotype Specific IgG (ST1 to ST6) group 50-65 years [2]
    End point description
    Seroconversion for ELISA is defined as: • for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point. • for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. SCRs for each OspA serotype specific IgG (ST1 to ST6), determined by ELISA, at Day 1, 29, 57, 85, 180, 236, and Month 12, stratified by age group (50-65 years)
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 180 and Month 12
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    59
    58
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        ST1 Day 29
    6.9 (2.7 to 16.4)
    3.4 (1.0 to 11.7)
    3.1 (0.6 to 15.7)
        ST1 Day 57
    39.7 (28.1 to 52.5)
    34.5 (23.6 to 47.3)
    3.0 (0.5 to 15.3)
        ST1 Day 85
    71.2 (58.6 to 81.2)
    71.9 (59.2 to 81.9)
    3.0 (0.5 to 15.3)
        ST1 Day 180
    36.2 (25.1 to 49.1)
    33.3 (22.5 to 46.3)
    3.1 (0.6 to 15.7)
        ST1 Day 236
    14.7 (6.4 to 30.1)
    20.0 (10.0 to 35.9)
    5.6 (1.0 to 25.8)
        ST1 Day 365
    10.2 (4.7 to 20.5)
    5.2 (1.8 to 14.1)
    3.2 (0.6 to 16.2)
        ST2 Day 29
    3.4 (1.0 to 11.7)
    3.4 (1.0 to 11.7)
    3.1 (0.6 to 15.7)
        ST2 Day 57
    70.7 (58.0 to 80.8)
    67.2 (54.4 to 77.9)
    3.0 (0.5 to 15.3)
        ST2 Day 85
    94.9 (86.1 to 98.3)
    93.0 (83.3 to 97.2)
    3.0 (0.5 to 15.3)
        ST2 Day 180
    62.1 (49.2 to 73.4)
    59.6 (46.7 to 71.4)
    3.1 (0.6 to 15.7)
        ST2 Day 236
    29.4 (16.8 to 46.2)
    31.4 (18.6 to 48.0)
    0.0 (0.0 to 17.6)
        ST2 Day 365
    15.3 (8.2 to 26.5)
    15.5 (8.4 to 26.9)
    3.2 (0.6 to 16.2)
        ST3 Day 29
    6.9 (2.7 to 16.4)
    0.0 (0.0 to 6.2)
    3.1 (0.6 to 15.7)
        ST3 Day 57
    77.6 (65.3 to 86.4)
    81.0 (69.1 to 89.1)
    3.0 (0.5 to 15.3)
        ST3 Day 85
    94.9 (86.1 to 98.3)
    93.0 (83.3 to 97.2)
    3.0 (0.5 to 15.3)
        ST3 Day 180
    74.1 (61.6 to 83.7)
    66.7 (53.7 to 77.5)
    6.3 (1.7 to 20.1)
        ST3 Day 236
    38.2 (23.9 to 55.0)
    37.1 (23.2 to 53.7)
    5.6 (1.0 to 25.8)
        ST3 Day 365
    13.6 (7.0 to 24)
    15.5 (8.4 to 26.9)
    3.2 (0.6 to 16.2)
        ST4 Day 29
    3.4 (1.0 to 11.7)
    3.4 (1.0 to 11.7)
    0.0 (0.0 to 10.7)
        ST4 Day 57
    55.2 (42.5 to 67.3)
    56.9 (44.1 to 68.8)
    0.0 (0.0 to 10.4)
        ST4 Day 85
    89.8 (79.5 to 95.3)
    91.2 (81.1 to 96.2)
    0.0 (0.0 to 10.4)
        ST4 Day 180
    55.2 (42.5 to 67.3)
    52.6 (39.9 to 65.0)
    0.0 (0.0 to 10.7)
        ST4 Day 236
    29.4 (16.8 to 46.2)
    25.7 (14.2 to 42.1)
    5.6 (1.0 to 25.8)
        ST4 Day 365
    16.9 (9.5 to 28.5)
    13.8 (7.2 to 24.9)
    6.5 (1.8 to 20.7)
        ST5 Day 29
    3.4 (1.0 to 11.7)
    1.7 (0.3 to 9.1)
    0.0 (0.0 to 10.7)
        ST5 Day 57
    55.2 (42.5 to 67.3)
    55.2 (42.5 to 67.3)
    0 (0.0 to 10.4)
        ST5 Day 85
    84.7 (73.5 to 91.8)
    87.7 (76.8 to 93.9)
    0.0 (0.0 to 10.4)
        ST5 Day 180
    51.7 (39.2 to 64.1)
    45.6 (33.4 to 58.4)
    3.1 (0.6 to 15.7)
        ST5 Day 236
    29.4 (16.8 to 46.2)
    31.4 (18.6 to 48.0)
    5.6 (1.0 to 25.8)
        ST5 Day 365
    8.5 (3.7 to 18.4)
    8.6 (3.7 to 18.6)
    3.2 (0.6 to 16.2)
        ST6 Day 29
    5.2 (1.8 to 14.1)
    5.2 (1.8 to 14.1)
    0.0 (0.0 to 10.7)
        ST6 Day 57
    51.7 (39.2 to 64.1)
    51.7 (39.2 to 64.1)
    0.0 (0.0 to 10.4)
        ST6 Day 85
    88.1 (77.5 to 94.1)
    89.5 (78.9 to 95.1)
    0.0 (0.0 to 10.4)
        ST6 Day 180
    53.4 (40.8 to 65.7)
    52.6 (39.9 to 65.0)
    6.3 (1.7 to 20.1)
        ST6 Day 236
    26.5 (14.6 to 43.1)
    28.6 (16.3 to 45.1)
    5.6 (1.0 to 25.8)
        ST6 Day 365
    15.3 (8.2 to 26.5)
    8.6 (3.7 to 18.6)
    3.2 (0.6 to 16.2)
    No statistical analyses for this end point

    Secondary: GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6) group 18-49 years

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    End point title
    		 GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6) group 18-49 years
    End point description
    GMFR (Geometric Mean of the fold rise as compared to Day 1) for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 29, 57, 85, 180, 236 and Month 12; stratified by age ( 18-49 years)
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 180, 236 and Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    133
    136
    88
    Units: Geometric Mean of the Fold Rise
    number (confidence interval 95%)
        ST1 Day 29
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST1 Day 57
    1.6 (1.2 to 2.1)
    1.7 (1.5 to 2.0)
    2.2 (1.8 to 2.6)
    1.0 (1.0 to 1.1)
        ST1 Day 85
    3.6 (2.2 to 5.6)
    5.3 (4.4 to 6.2)
    6.4 (5.3 to 7.7)
    1.0 (1.0 to 1.0)
        ST1 Day 180
    1.3 (1.0 to 1.6)
    1.6 (1.4 to 1.8)
    1.7 (1.5 to 2.0)
    1.0 (1.0 to 1.0)
        ST1 Day 236
    1.1 (0.9 to 1.3)
    1.3 (1.1 to 1.4)
    1.3 (1.1 to 1.6)
    1.0 (1.0 to 1.1)
        ST1 Day 365
    1.0 (0.9 to 1.1)
    1.1 (1.1 to 1.2)
    1.2 (1.1 to 1.3)
    1.0 (1.0 to 1.1)
        ST2 Day 29
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST2 Day 57
    3.2 (2.2 to 4.7)
    4.5 (3.7 to 5.4)
    6.0 (5.1 to 7.2)
    1.0 (1.0 to 1.1)
        ST2 Day 85
    8.4 (5.7 to 12.4)
    14.8 (12.9 to 17.0)
    16.0 (13.8 to 18.6)
    1.0 (1.0 to 1.0)
        ST2 Day 180
    1.9 (1.4 to 2.7)
    3.2 (2.7 to 3.8)
    3.6 (3.0 to 4.2)
    1.0 (1.0 to 1.0)
        ST2 Day 236
    1.2 (1.0 to 1.6)
    2.0 (1.7 to 2.3)
    1.8 (1.5 to 2.2)
    1.0 (1.0 to 1.0)
        ST2 Day 365
    1.1 (1.0 to 1.2)
    1.2 (1.1 to 1.3)
    1.2 (1.1 to 1.4)
    1.0 (1.0 to 1.0)
        ST3 Day 29
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST3 Day 57
    5.0 (3.2 to 7.8)
    6.0 (5.0 to 7.3)
    7.9 (6.4 to 9.7)
    1.0 (1.0 to 1.1)
        ST3 Day 85
    12.1 (8.6 to 17.0)
    14.7 (12.7 to 16.9)
    16.6 (14.0 to 19.6)
    1.0 (1.0 to 1.0)
        ST3 Day 180
    2.4 (1.6 to 3.6)
    3.0 (2.6 to 3.5)
    3.6 (3.0 to 4.3)
    1.0 (1.0 to 1.0)
        ST3 Day 236
    1.6 (1.2 to 2.2)
    1.8 (1.5 to 2.1)
    2.0 (1.6 to 2.4)
    1.0 (1.0 to 1.0)
        ST3 Day 365
    1.2 (1.0 to 1.4)
    1.3 (1.2 to 1.4)
    1.4 (1.2 to 1.4)
    1.0 (1.0 to 1.0)
        ST4 Day 29
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST4 Day 57
    2.1 (1.5 to 3.0)
    2.7 (2.3 to 3.2)
    3.5 (2.9 to 4.2)
    1.0 (1.0 to 1.0)
        ST4 Day 85
    5.4 (3.5 to 8.5)
    8.6 (7.5 to 9.8)
    10.2 (8.6 to 12.0)
    1.0 (1.0 to 1.0)
        ST4 Day 180
    1.5 (1.1 to 2.1)
    2.3 (2.0 to 2.7)
    2.6 (2.2 to 3.1)
    1.0 (1.0 to 1.1)
        ST4 Day 236
    1.2 (0.9 to 1.5)
    1.7 (1.4 to 2.0)
    1.7 (1.4 to 2.0)
    1.0 (1.0 to 1.0)
        ST4 Day 365
    1.1 (1.0 to 1.2)
    1.3 (1.2 to 1.4)
    1.3 (1.2 to 1.5)
    1.0 (1.0 to 1.0)
        ST5 Day 29
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST5 Day 57
    2.1 (1.5 to 3.0)
    2.8 (2.4 to 3.3)
    4.0 (3.3 to 4.8)
    1.0 (1.0 to 1.0)
        ST5 Day 85
    5.7 (3.8 to 8.7)
    9.0 (7.8 to 10.3)
    10.8 (9.1 to 12.8)
    1.0 (1.0 to 1.0)
        ST5 Day 180
    1.3 (1.0 to 1.7)
    2.1 (1.8 to 2.4)
    2.7 (2.3 to 3.2)
    1.0 (1.0 to 1.0)
        ST5 Day 236
    1.1 (0.9 to 1.3)
    1.6 (1.4 to 1.8)
    1.6 (1.4 to 2.0)
    1.0 (1.0 to 1.0)
        ST5 Day 365
    1.1 (1.0 to 1.2)
    1.2 (1.1 to 1.3)
    1.3 (1.1 to 1.4)
    1.0 (1.0 to 1.0)
        ST6 Day 29
    1.0 (1.0 to 1.0)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST6 Day 57
    2.0 (1.4 to 2.8)
    2.6 (2.2 to 3.1)
    3.4 (2.8 to 4.2)
    1.0 (1.0 to 1.1)
        ST6 Day 85
    5.4 (3.6 to 8.3)
    9.1 (7.9 to 10.4)
    10.6 (9.0 to 12.5)
    1.0 (1.0 to 1.0)
        ST6 Day 180
    1.4 (1.1 to 1.9)
    2.3 (2.0 to 2.6)
    2.5 (2.2 to 3.0)
    1.0 (1.0 to 1.0)
        ST6 Day 236
    1.2 (1.0 to 1.5)
    1.7 (1.5 to 2.0)
    1.7 (1.4 to 2.0)
    1.0 (1.0 to 1.1)
        ST6 Day 365
    1.1 (1.0 to 1.3)
    1.2 (1.1 to 1.4)
    1.3 (1.2 to 1.5)
    1.0 (1.0 to 1.1)
    No statistical analyses for this end point

    Secondary: GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6) group 50-65 years

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    End point title
    		 GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6) group 50-65 years [3]
    End point description
    GMFR (Geometric Mean of the fold rise as compared to Day 1) for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, at Day 29, 57, 85, 180, 236 and Month 12, stratified by age ,group 50-65 years
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 180, 236 and Month 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    59
    58
    33
    Units: Geometric Mean of the Fold Rise
    number (confidence interval 95%)
        ST1 Day 29
    1.2 (1.0 to 1.4)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
        ST1 Day 57
    2.1 (1.6 to 2.8)
    1.8 (1.4 to 2.3)
    1.0 (0.9 to 1.1)
        ST1 Day 85
    4.5 (3.3 to 6.1)
    4.5 (3.3 to 6.0)
    1.0 (1.0 to 1.1)
        ST1 Day 180
    1.7 (1.4 to 2.1)
    1.6 (1.3 to 1.9)
    1.0 (1.0 to 1.1)
        ST1 Day 236
    1.2 (1.0 to 1.5)
    1.3 (1.1 to 1.5)
    1.0 (1.0 to 1.1)
        ST1 Day 365
    1.2 (1.0 to 1.3)
    1.1 (1.0 to 1.2)
    1.0 (0.9 to 1.1)
        ST2 Day 29
    1.1 (0.9 to 1.3)
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.1)
        ST2 Day 57
    4.4 (3.2 to 6.1)
    4.1 (3.0 to 5.5)
    1.0 (1.0 to 1.1)
        ST2 Day 85
    12.3 (9.5 to 15.8)
    13.3 (10.2 to 17.2)
    1.0 (1.0 to 1.1)
        ST2 Day 180
    2.9 (2.3 to 3.8)
    2.9 (2.2 to 3.7)
    1.0 (1.0 to 1.1)
        ST2 Day 236
    1.5 (1.2 to 1.9)
    1.6 (1.2 to 2.2)
    1.0 (1.0 to 1.0)
        ST2 Day 365
    1.2 (1.1 to 1.5)
    1.2 (1.1 to 1.4)
    1.0 (1.0 to 1.1)
        ST3 Day 29
    1.1 (1.0 to 1.4)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.2)
        ST3 Day 57
    6.1 (4.3 to 8.7)
    5.9 (4.3 to 8.2)
    1.1 (0.9 to 1.2)
        ST3 Day 85
    12.5 (9.6 to 16.4)
    12.8 (9.7 to 17.0)
    1.1 (0.9 to 1.2)
        ST3 Day 180
    3.3 (2.6 to 4.2)
    3.0 (2.3 to 3.8)
    1.1 (1.0 to 1.2)
        ST3 Day 236
    1.7 (1.3 to 2.2)
    1.8 (1.4 to 2.5)
    1.1 (0.9 to 1.3)
        ST3 Day 365
    1.3 (1.1 to 1.5)
    1.2 (1.1 to 1.4)
    1.1 (0.9 to 1.2)
        ST4 Day 29
    1.1 (0.9 to 1.3)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST4 Day 57
    2.7 (2.0 to 3.7)
    2.6 (2.0 to 3.3)
    1.0 (1.0 to 1.0)
        ST4 Day 85
    7.4 (5.7 to 9.7)
    7.9 (6.1 to 10.2)
    1.0 (1.0 to 1.0)
        ST4 Day 180
    2.2 (1.8 to 2.8)
    2.1 (1.7 to 2.5)
    1.0 (1.0 to 1.0)
        ST4 Day 236
    1.4 (1.2 to 1.7)
    1.4 (1.1 to 1.7)
    1.1 (0.9 to 1.2)
        ST4 Day 365
    1.2 (1.0 to 1.4)
    1.1 (1.0 to 1.3)
    1.1 (1.0 to 1.2)
        ST5 Day 29
    1.1 (0.9 to 1.2)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST5 Day 57
    2.9 (2.1 to 3.8)
    2.8 (2.1 to 3.6)
    1.0 (1.0 to 1.0)
        ST5 Day 85
    7.8 (5.9 to 10.3)
    8.1 (6.2 to 10.6)
    1.0 (1.0 to 1.0)
        ST5 Day 180
    2.2 (1.8 to 2.8)
    2.0 (1.6 to 2.6)
    1.0 (1.0 to 1.1)
        ST5 Day 236
    1.4 (1.2 to 1.8)
    1.5 (1.2 to 1.9)
    1.1 (0.9 to 1.2)
        ST5 Day 365
    1.1 (1.0 to 1.3)
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.1)
        ST6 Day 29
    1.1 (0.9 to 1.2)
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.0)
        ST6 Day 57
    2.6 (1.9 to 3.4)
    2.6 (2.0 to 3.4)
    1.0 (1.0 to 1.0)
        ST6 Day 85
    7.9 (6.1 to 10.4)
    8.7 (6.7 to 11.3)
    1.0 (1.0 to 1.0)
        ST6 Day 180
    2.3 (1.9 to 2.9)
    2.3 (1.8 to 2.9)
    1.1 (1.0 to 1.2)
        ST6 Day 236
    1.4 (1.1 to 1.7)
    1.5 (1.2 to 1.9)
    1.1 (0.9 to 1.3)
        ST6 Day 365
    1.2 (1.0 to 1.3)
    1.1 (1.0 to 1.3)
    1.1 (1.0 to 1.2)
    No statistical analyses for this end point

    Secondary: Frequency of SAEs during the entire study

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    End point title
    		 Frequency of SAEs during the entire study
    End point description
    Frequency of SAEs during the entire study
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        SAEs
    0.0 (0.0 to 11.7)
    1.9 (0.7 to 4.7)
    2.4 (1.0 to 5.6)
    2.4 (0.8 to 6.9)
    No statistical analyses for this end point

    Secondary: Frequency of related SAEs during the entire study

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    End point title
    		 Frequency of related SAEs during the entire study
    End point description
    Frequency of related SAE during the entire study
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Related SAEs
    0.0 (0.0 to 11.7)
    0.0 (0.0 to 1.8)
    0.0 (0.0 to 1.8)
    0.0 (0.0 to 3.0)
    No statistical analyses for this end point

    Secondary: Frequency of AESIs during the entire study

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    End point title
    		 Frequency of AESIs during the entire study
    End point description
    Frequency of AESIs during the entire study
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        AESIs
    0.0 (0.0 to 11.7)
    1.9 (0.7 to 4.7)
    0.5 (0.1 to 2.7)
    0.0 (0.0 to 3.0)
    No statistical analyses for this end point

    Secondary: Frequency of related AESIs during the entire study

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    End point title
    		 Frequency of related AESIs during the entire study
    End point description
    Frequency of related AESIs during the entire study
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Related AESIs
    0.0 (0.0 to 11.7)
    0.5 (0.1 to 2.6)
    0.0 (0.0 to 1.8)
    0.0 (0.0 to 3.0)
    No statistical analyses for this end point

    Secondary: Frequency of unsolicited AEs during the entire study

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    End point title
    		 Frequency of unsolicited AEs during the entire study
    End point description
    Frequency of unsolicited AEs during the entire study (incl. clinically relevant laboratory parameters)
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Unsolicited AEs
    27.6 (14.7 to 45.7)
    51.9 (45.2 to 58.5)
    56.6 (49.7 to 63.2)
    51.6 (42.9 to 60.2)
    No statistical analyses for this end point

    Secondary: Frequency of related unsolicited AEs during the entire study

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    End point title
    		 Frequency of related unsolicited AEs during the entire study
    End point description
    Frequency of related unsolicited AEs during the entire study (incl. clinically relevant laboratory parameters)
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Related unsolicited AEs
    6.9 (1.9 to 22.0)
    9.3 (6.1 to 14.0)
    14.6 (10.4 to 20.1)
    8.9 (5.0 to 15.2)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AEs within 7 days after 1st Vaccination

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    End point title
    		 Frequency of solicited local AEs within 7 days after 1st Vaccination
    End point description
    Frequency of solicited local AEs within 7 days after 1st Vaccination, percentages are based on N.
    End point type
    Secondary
    End point timeframe
    7 days after first vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AEs
    89.7 (73.6 to 96.4)
    92.1 (87.6 to 95.0)
    94.1 (90.0 to 96.6)
    21.0 (14.7 to 29.0)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AE within 7 days after 2nd Vaccination

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    End point title
    		 Frequency of solicited local AE within 7 days after 2nd Vaccination
    End point description
    Frequency of solicited local AE within 7 days after 2nd Vaccination, percentages are based on N.
    End point type
    Secondary
    End point timeframe
    within 7 days after 2nd Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AE
    72.4 (54.3 to 85.3)
    78.5 (72.5 to 83.5)
    85.9 (80.4 to 90.0)
    13.7 (8.7 to 20.9)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AE within 7 days after 3rd Vaccination

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    End point title
    		 Frequency of solicited local AE within 7 days after 3rd Vaccination
    End point description
    Frequency of solicited local AE within 7 days after 3rd Vaccination, percentages are based on N.
    End point type
    Secondary
    End point timeframe
    within 7 days after 3rd vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AE
    62.1 (44.0 to 77.3)
    74.8 (68.5 to 80.1)
    76.1 (69.8 to 81.4)
    11.3 (6.8 to 18.1)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AE within 7 days after any Vaccination

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    End point title
    		 Frequency of solicited local AE within 7 days after any Vaccination
    End point description
    Frequency of solicited local AE within 7 days after any Vaccination, percentages are based on N
    End point type
    Secondary
    End point timeframe
    within 7 days after any vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AE
    89.7 (73.6 to 96.4)
    93.0 (88.8 to 95.7)
    96.1 (92.5 to 98.0)
    29.8 (22.5 to 38.4)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after 1st Vaccination

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    End point title
    		 Frequency of solicited systemic AE within 7 days after 1st Vaccination
    End point description
    Frequency of solicited systemic AE within 7 days after 1st Vaccination, percentages are based on N.
    End point type
    Secondary
    End point timeframe
    within 7 days after 1st Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    55.2 (37.5 to 71.6)
    52.8 (46.1 to 59.4)
    59.0 (52.2 to 65.5)
    29.8 (22.5 to 38.4)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after 2nd Vaccination

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    End point title
    		 Frequency of solicited systemic AE within 7 days after 2nd Vaccination
    End point description
    Frequency of solicited systemic AE within 7 days after 2nd Vaccination, percentages are based on N
    End point type
    Secondary
    End point timeframe
    within 7 days after 2nd Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    31.0 (17.3 to 49.2)
    37.9 (31.6 to 44.5)
    41.0 (34.5 to 47.8)
    17.7 (12.0 to 25.4)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after 3rd Vaccination

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    End point title
    		 Frequency of solicited systemic AE within 7 days after 3rd Vaccination
    End point description
    Frequency of solicited systemic AE within 7 days after 3rd Vaccination, percentages are based on N.
    End point type
    Secondary
    End point timeframe
    within 7 days after 3rd Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    27.6 (14.7 to 45.7)
    30.4 (24.6 to 36.8)
    30.2 (24.4 to 36.8)
    17.7 (12.0 to 25.4)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after any Vaccination

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    End point title
    		 Frequency of solicited systemic AE within 7 days after any Vaccination
    End point description
    Frequency of solicited systemic AE within 7 days after any Vaccination, percentages are based on N
    End point type
    Secondary
    End point timeframe
    within 7 days after any Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    214
    205
    124
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    62.1 (44.0 to 77.3)
    67.8 (61.2 to 73.7)
    71.7 (65.2 to 77.4)
    42.7 (34.4 to 51.5)
    No statistical analyses for this end point

    Secondary: Frequency of SAEs during the entire study group 18-49 years

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    End point title
    		 Frequency of SAEs during the entire study group 18-49 years
    End point description
    Frequency of SAEs during the entire study group 18-49 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants (%)
    number (confidence interval 95%)
        SAEs
    0.0 (0.0 to 11.7)
    2.0 (0.7 to 5.8)
    2.1 (0.7 to 5.9)
    1.1 (0.2 to 6.0)
    No statistical analyses for this end point

    Secondary: Frequency of SAEs during the entire study group 50-65 years

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    End point title
    		 Frequency of SAEs during the entire study group 50-65 years [4]
    End point description
    Frequency of SAEs during the entire study group 50-65 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        SAEs
    1.5 (0.3 to 8.0)
    3.3 (0.9 to 11.4)
    6.1 (1.7 to 19.6)
    No statistical analyses for this end point

    Secondary: Frequency of AESIs during the entire study group 18-49 years

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    End point title
    		 Frequency of AESIs during the entire study group 18-49 years
    End point description
    Frequency of AESIs during the entire study group 18-49 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants
    number (confidence interval 95%)
        AESIs
    0.0 (0.0 to 11.7)
    0.7 (0.1 to 3.8)
    0.0 (0.0 to 2.6)
    0.0 (0.0 to 4.1)
    No statistical analyses for this end point

    Secondary: Frequency of AESIs during the entire study group 50-65 years

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    End point title
    		 Frequency of AESIs during the entire study group 50-65 years [5]
    End point description
    Frequency of AESIs during the entire study group 50-65 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        AESIs
    4.5 (1.5 to 12.4)
    1.7 (0.3 to 8.9)
    0.0 (0.0 to 10.4)
    No statistical analyses for this end point

    Secondary: Frequency of unsolicited AEs during the entire study group 18-49 years

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    End point title
    		 Frequency of unsolicited AEs during the entire study group 18-49 years
    End point description
    Frequency of unsolicited AEs during the entire study group 18-49 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Unsolicited AEs
    27.6 (14.7 to 45.7)
    49.0 (41.0 to 57.0)
    55.2 (47.0 to 63.0)
    50.5 (40.5 to 60.6)
    No statistical analyses for this end point

    Secondary: Frequency of unsolicited AEs during the entire study group 50-65 years

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    End point title
    		 Frequency of unsolicited AEs during the entire study group 50-65 years [6]
    End point description
    Frequency of unsolicited AEs during the entire study group 50-65 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Unsolicited AEs
    58.2 (46.3 to 69.3)
    60.0 (47.4 to 71.4)
    54.5 (38.0 to 70.2)
    No statistical analyses for this end point

    Secondary: Frequency of related unsolicited AEs during the entire study group 18-49 years

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    End point title
    		 Frequency of related unsolicited AEs during the entire study group 18-49 years
    End point description
    Frequency of related unsolicited AEs during the entire study group 18-49 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Related unsolicited AEs
    6.9 (1.9 to 22.0)
    8.8 (5.2 to 14.5)
    14.5 (9.7 to 21.1)
    7.7 (3.8 to 15.0)
    No statistical analyses for this end point

    Secondary: Frequency of related unsolicited AEs during the entire study group 50-65 years

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    End point title
    		 Frequency of related unsolicited AEs during the entire study group 50-65 years [7]
    End point description
    Frequency of related unsolicited AEs during the entire study group 50-65 years
    End point type
    Secondary
    End point timeframe
    Up to Month 12
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Related unsolicited AEs
    10.4 (5.2 to 20.0)
    15.0 (8.1 to 26.1)
    12.1 (4.8 to 27.3)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AE within 7 days after any Vaccination group 18-49 years

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    End point title
    		 Frequency of solicited local AE within 7 days after any Vaccination group 18-49 years
    End point description
    Frequency of solicited local AE within 7 days after any Vaccination group 18-49 years
    End point type
    Secondary
    End point timeframe
    within 7 days after any Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AE
    89.7 (73.6 to 96.4)
    93.2 (87.9 to 96.3)
    96.6 (92.2 to 98.5)
    29.7 (21.3 to 39.7)
    No statistical analyses for this end point

    Secondary: Frequency of solicited local AE within 7 days after any Vaccination group 50-65 years

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    End point title
    		 Frequency of solicited local AE within 7 days after any Vaccination group 50-65 years [8]
    End point description
    Frequency of solicited local AE within 7 days after any Vaccination group 50-65 years
    End point type
    Secondary
    End point timeframe
    Within 7 days after any Vaccination
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited local AE
    92.5 (83.7 to 96.8)
    95.0 (86.3 to 98.3)
    30.3 (17.4 to 47.3)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after any Vaccination group 18-49 years

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    End point title
    		 Frequency of solicited systemic AE within 7 days after any Vaccination group 18-49 years
    End point description
    Frequency of solicited systemic AE within 7 days after any Vaccination group 18-49 years
    End point type
    Secondary
    End point timeframe
    Within 7 days after any Vaccination
    End point values
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    29
    147
    145
    91
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    62.1 (44.0 to 77.3)
    70.1 (62.2 to 76.9)
    71.7 (63.9 to 78.4)
    42.9 (33.2 to 53.1)
    No statistical analyses for this end point

    Secondary: Frequency of solicited systemic AE within 7 days after any Vaccination group 50-65 years

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    End point title
    		 Frequency of solicited systemic AE within 7 days after any Vaccination group 50-65 years [9]
    End point description
    Frequency of solicited systemic AE within 7 days after any Vaccination group 50-65 years
    End point type
    Secondary
    End point timeframe
    Within 7 days after any Vaccination
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The 90μg arm was only applicable in the run in phase for subjects aged 18-40 years
    End point values
    		 VLA15 135 μg VLA15 180 μg Placebo
    Number of subjects analysed
    67
    60
    33
    Units: percentage of participants (%)
    number (confidence interval 95%)
        Solicited systemic AE
    62.7 (50.7 to 73.3)
    71.7 (59.2 to 81.5)
    42.4 (27.2 to 59.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Event (AE) collection started at the time of first study vaccination. AEs were captured until the last study visit. Solicited local and systemic AEs were captured in a diary during 7 consecutive days after each vaccination
    Adverse event reporting additional description
    In addition memory aids were used for documentation of AEs up to Visit 7/Month 12 (Day 365) during Main Study Phase . Diary and memory aid were returned to and reviewed with site staff at the next visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    VLA15 90µg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 90 μg w/ alum

    Reporting group title
    VLA15 135 μg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 135 μg w/ alum

    Reporting group title
    VLA15 180 μg
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with VLA15 180 μg w/ alum

    Reporting group title
    Placebo
    Reporting group description
    		 At each vaccination day (Day 1, 29 and 57) treatment with Placebo

    Serious adverse events
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 214 (1.87%)
    5 / 205 (2.44%)
    3 / 124 (2.42%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    1 / 205 (0.49%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple injuries
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    1 / 205 (0.49%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    1 / 205 (0.49%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    1 / 205 (0.49%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    0 / 205 (0.00%)
    1 / 124 (0.81%)
         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
    Hepatobiliary disorders
    Biliary colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    0 / 205 (0.00%)
    1 / 124 (0.81%)
         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
    Psychiatric disorders
    Psychotic disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 214 (0.47%)
    0 / 205 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 214 (0.47%)
    0 / 205 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 214 (0.47%)
    0 / 205 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 214 (0.47%)
    0 / 205 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    0 / 205 (0.00%)
    1 / 124 (0.81%)
         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
    Herpes zoster
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    1 / 205 (0.49%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 214 (0.00%)
    0 / 205 (0.00%)
    1 / 124 (0.81%)
         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
    		 VLA15 90µg VLA15 135 μg VLA15 180 μg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 29 (89.66%)
    203 / 214 (94.86%)
    202 / 205 (98.54%)
    86 / 124 (69.35%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 29 (34.48%)
    73 / 214 (34.11%)
    84 / 205 (40.98%)
    33 / 124 (26.61%)
         occurrences all number
    19
    115
    135
    46
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    26 / 29 (89.66%)
    198 / 214 (92.52%)
    196 / 205 (95.61%)
    30 / 124 (24.19%)
         occurrences all number
    111
    924
    941
    57
    Fatigue
         subjects affected / exposed
    8 / 29 (27.59%)
    66 / 214 (30.84%)
    81 / 205 (39.51%)
    29 / 124 (23.39%)
         occurrences all number
    14
    111
    130
    40
    Injection site erythema
         subjects affected / exposed
    8 / 29 (27.59%)
    68 / 214 (31.78%)
    72 / 205 (35.12%)
    12 / 124 (9.68%)
         occurrences all number
    10
    116
    123
    18
    Injection site induration
         subjects affected / exposed
    3 / 29 (10.34%)
    64 / 214 (29.91%)
    65 / 205 (31.71%)
    2 / 124 (1.61%)
         occurrences all number
    6
    108
    108
    3
    Injection site swelling
         subjects affected / exposed
    4 / 29 (13.79%)
    57 / 214 (26.64%)
    68 / 205 (33.17%)
    4 / 124 (3.23%)
         occurrences all number
    6
    84
    104
    6
    Influenza like illness
         subjects affected / exposed
    3 / 29 (10.34%)
    32 / 214 (14.95%)
    42 / 205 (20.49%)
    20 / 124 (16.13%)
         occurrences all number
    3
    44
    49
    25
    Pyrexia
         subjects affected / exposed
    2 / 29 (6.90%)
    9 / 214 (4.21%)
    7 / 205 (3.41%)
    3 / 124 (2.42%)
         occurrences all number
    2
    10
    7
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 29 (17.24%)
    23 / 214 (10.75%)
    32 / 205 (15.61%)
    11 / 124 (8.87%)
         occurrences all number
    5
    31
    36
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    15 / 29 (51.72%)
    106 / 214 (49.53%)
    97 / 205 (47.32%)
    21 / 124 (16.94%)
         occurrences all number
    22
    173
    156
    29
    Arthralgia
         subjects affected / exposed
    2 / 29 (6.90%)
    42 / 214 (19.63%)
    37 / 205 (18.05%)
    12 / 124 (9.68%)
         occurrences all number
    4
    67
    55
    23
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    14 / 214 (6.54%)
    10 / 205 (4.88%)
    7 / 124 (5.65%)
         occurrences all number
    1
    16
    12
    8
    Nasopharyngitis
         subjects affected / exposed
    0 / 29 (0.00%)
    9 / 214 (4.21%)
    10 / 205 (4.88%)
    9 / 124 (7.26%)
         occurrences all number
    0
    10
    11
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2020
    Global Amendment 1 to CSP v4.0

    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
    For support, Contact us.
    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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