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    Clinical Trial Results:
    Safety and Immunogenicity Study of VLA15, a Multivalent Recombinant OspA Based Vaccine Candidate Against Lyme Borreliosis: a Randomized, Controlled, Observer-Blind Phase 2 Study in a Healthy Pediatric and Adult Study Population

    Summary
    EudraCT number
    		 2025-000381-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Jul 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2026
    First version publication date
    01 Mar 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4601008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04801420
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003130-PIP02-23
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Oct 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the safety and tolerability profile of VLA15, given in a three- or two dose primary immunisation schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years up to Day 208 (Month 7) and to assess the immune response to VLA15, given in a three- or two dose primary immunisation schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years at Day 208 (Month 7).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. In addition, all the local regulatory requirements were followed, in particular, those affording greater protection to the safety of participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 625
    Worldwide total number of subjects
    625
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    155
    Adolescents (12-17 years)
    150
    Adults (18-64 years)
    312
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited for Part A and then continued into Part B

    Pre-assignment
    Screening details
    		 A total of 714 participants were screened of which 89 failed screening, and 625 participants were randomised into the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The study was an observer-blinded study, which was conducted in a blinded manner for the study investigators, the sponsor including laboratory personnel, and the participants.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: VLA15
    Arm description
    		 Participants aged 5 to 65 years received three intramuscular (IM) vaccinations of 180 microgram (mcg) VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07307405
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received VLA15 180 mcg IM injection at Months 0, 2 and 6. Eligible participants received booster dose at Months 18, 30 and 42.

    Arm title
    		 Group 2: VLA15 + Placebo
    Arm description
    		 Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.
    Arm type
    		 Experimental

    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
    Participants received normal saline 0.5 milliliter (mL) IM injection at Month 2.

    Investigational medicinal product name
    PF-07307405
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received VLA15 180 mcg IM injection at Months 0 and 6. Eligible participants received booster dose at Months 18, 30 and 42.

    Arm title
    		 Group 3: Placebo
    Arm description
    		 Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.
    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
    Participants received normal saline 0.5 mL IM injection at Months 0, 2 and 6. Eligible participants received booster dose at Months 18, 30 and 42.

    Number of subjects in period 1
    		Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Started
    208
    209
    208
    Completed
    128
    118
    113
    Not completed
    80
    91
    95
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    20
    17
    18
         Physician decision
    7
    9
    10
         Individual Stopping Criteria Reached
    -
    2
    -
         Adverse event, non-fatal
    1
    1
    4
         Unspecified
    18
    28
    24
         Lost to follow-up
    26
    27
    29
         Moved From Study Area
    7
    7
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: VLA15
    Reporting group description
    		 Participants aged 5 to 65 years received three intramuscular (IM) vaccinations of 180 microgram (mcg) VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 2: VLA15 + Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 3: Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Reporting group values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Total
    Number of subjects
    		 208 209 208
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.7 ( 19.09 ) 28.9 ( 19.56 ) 29.0 ( 19.72 ) -
    Gender categorical
    Units: Subjects
        Male
    		 96 101 107 304
        Female
    		 112 108 101 321
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 15 18 56
        Not Hispanic or Latino
    		 185 194 190 569
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 1
        Asian
    		 4 3 6 13
        Black or African American
    		 27 17 24 68
        White
    		 172 184 176 532
        Other
    		 4 5 2 11

    End points

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    End points reporting groups
    Reporting group title
    Group 1: VLA15
    Reporting group description
    		 Participants aged 5 to 65 years received three intramuscular (IM) vaccinations of 180 microgram (mcg) VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 2: VLA15 + Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 3: Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 1: VLA15
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received three IM vaccinations of 180 mcg VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 2: VLA15 + Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 3: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Received any VLA15
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years who received IM vaccination of 180 mcg VLA15 or placebo injections, but could not be assigned to Group 1, 2 or 3 as participants received wrong vaccination or missed a vaccination.

    Subject analysis set title
    All Participants
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years who received either IM vaccination of 180 mcg VLA15 or placebo injections during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.

    Subject analysis set title
    Group 1: VLA15
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 5 to 65 years received three IM vaccinations of 180 mcg VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 2: VLA15 + Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 3: Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 1: VLA15
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received three IM vaccinations of 180 mcg VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase. Participants in this subject analysis set received any vaccination.

    Subject analysis set title
    Group 2: VLA15 + Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Group 3: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Subject analysis set title
    Received any VLA15
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 5 to 65 years who received IM vaccination of 180 mcg VLA15 or placebo injections, but could not be assigned to Group 1, 2 or 3 as participants received wrong vaccination or missed a vaccination.

    Primary: Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1

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    End point title
    		 Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 [1]
    End point description
    Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method. Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “number analysed (n)” signifies number of participants evaluable for the specified rows.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after vaccination 1 at Month 0
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain (n=123, 108, 199, 403, 602)
    61.0 (52.1 to 69.1)
    52.8 (43.4 to 61.9)
    12.6 (8.7 to 17.9)
    60.3 (55.4 to 65.0)
    44.5 (40.6 to 48.5)
        Tenderness (n=123, 109, 199, 407, 606)
    80.5 (72.6 to 86.5)
    80.7 (72.3 to 87.0)
    19.6 (14.7 to 25.7)
    81.6 (77.5 to 85.0)
    61.2 (57.3 to 65.0)
        Erythema/​Redness MGS (n=120, 109, 198, 398, 596)
    10.0 (5.8 to 16.7)
    10.1 (5.7 to 17.2)
    2.5 (1.1 to 5.8)
    13.1 (10.1 to 16.7)
    9.6 (7.5 to 12.2)
        Swelling MGS (n=119, 109, 199, 395, 594)
    5.9 (2.9 to 11.6)
    4.6 (2.0 to 10.3)
    0.5 (0.1 to 2.8)
    9.1 (6.7 to 12.4)
    6.2 (4.6 to 8.5)
        Induration/Hardening MGS (n=119,109,198,396,594)
    9.2 (5.2 to 15.8)
    3.7 (1.4 to 9.1)
    1.0 (0.3 to 3.6)
    8.8 (6.4 to 12.0)
    6.2 (4.6 to 8.5)
        Headache (n=121, 108, 199, 397, 596)
    27.3 (20.1 to 35.8)
    23.1 (16.2 to 31.9)
    19.6 (14.7 to 25.7)
    23.4 (19.5 to 27.8)
    22.1 (19.0 to 25.7)
        Muscle pain (n=121, 109, 199, 402, 601)
    36.4 (28.3 to 45.2)
    33.0 (24.9 to 42.3)
    11.1 (7.4 to 16.2)
    35.6 (31.0 to 40.4)
    27.5 (24.0 to 31.2)
        Joint pain (n=121, 108, 199, 397, 596)
    10.7 (6.4 to 17.5)
    3.7 (1.4 to 9.1)
    6.0 (3.5 to 10.2)
    7.8 (5.6 to 10.9)
    7.2 (5.4 to 9.6)
        Nausea (n=119, 108, 199, 393, 592)
    2.5 (0.9 to 7.2)
    4.6 (2.0 to 10.4)
    6.0 (3.5 to 10.2)
    5.3 (3.5 to 8.0)
    5.6 (4.0 to 7.7)
        Vomiting (n=119, 108, 198, 393, 591)
    0.8 (0.1 to 4.6)
    0.0 (0.0 to 3.4)
    1.0 (0.3 to 3.6)
    0.8 (0.3 to 2.2)
    0.8 (0.4 to 2.0)
        Fatigue (n=120, 109, 200, 396, 596)
    20.0 (13.8 to 28.0)
    15.6 (10.0 to 23.6)
    16.5 (12.0 to 22.3)
    19.7 (16.1 to 23.9)
    18.6 (15.7 to 21.9)
        Fever (n=112, 98, 187, 364, 551)
    1.8 (0.5 to 6.3)
    0.0 (0.0 to 3.8)
    0.5 (0.1 to 3.0)
    1.1 (0.4 to 2.8)
    0.9 (0.4 to 2.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

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    End point title
    		 Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 [2]
    End point description
    Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method. SAS included all participants who entered into the study and received at least one vaccination. All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies number of participants evaluable for the specified rows.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after vaccination 2 at Month 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain (n=124, 105, 189, 392, 581)
    55.6 (46.9 to 64.1)
    4.8 (2.1 to 10.7)
    8.5 (5.3 to 13.3)
    31.9 (27.5 to 36.7)
    24.3 (21.0 to 27.9)
        Tenderness (n=126, 105, 191, 395, 586)
    81.0 (73.2 to 86.9)
    9.5 (5.3 to 16.6)
    14.7 (10.3 to 20.4)
    47.3 (42.5 to 52.3)
    36.7 (32.9 to 40.7)
        Erythema/Redness MGS (n=123, 105, 189, 390, 579)
    16.3 (10.8 to 23.8)
    0.0 (0.0 to 3.5)
    1.6 (0.5 to 4.6)
    7.4 (5.2 to 10.5)
    5.5 (3.9 to 7.7)
        Swelling MGS (n=123, 105, 189, 389, 578)
    13.8 (8.8 to 21.0)
    0.0 (0.0 to 3.5)
    0.5 (0.1 to 2.9)
    5.4 (3.6 to 8.1)
    3.8 (2.5 to 5.7)
        Induration/Hardening MGS (n=124,105,189,392,581)
    12.1 (7.5 to 19.0)
    0.0 (0.0 to 3.5)
    0.0 (0.0 to 2.0)
    5.4 (3.5 to 8.1)
    3.6 (2.4 to 5.5)
        Headache (n=123, 104, 190, 388, 578)
    20.3 (14.2 to 28.3)
    10.6 (6.0 to 18.0)
    12.6 (8.6 to 18.1)
    15.5 (12.2 to 19.4)
    14.5 (11.9 to 17.6)
        Muscle pain (n=124, 104, 189, 390, 579)
    25.8 (18.9 to 34.2)
    3.8 (1.5 to 9.5)
    3.7 (1.8 to 7.4)
    14.1 (11.0 to 17.9)
    10.7 (8.4 to 13.5)
        Joint pain (n=123, 104, 189, 388, 577)
    4.9 (2.3 to 10.2)
    2.9 (1.0 to 8.1)
    1.6 (0.5 to 4.6)
    4.6 (3.0 to 7.2)
    3.6 (2.4 to 5.5)
        Nausea (n=123, 104, 191, 387, 578)
    4.9 (2.3 to 10.2)
    1.9 (0.5 to 6.7)
    5.8 (3.2 to 10.0)
    3.6 (2.2 to 6.0)
    4.3 (2.9 to 6.3)
        Vomiting (n=123, 104, 189, 387, 576)
    0.0 (0.0 to 3.0)
    1.0 (0.2 to 5.2)
    0.0 (0.0 to 2.0)
    1.3 (0.6 to 3.0)
    0.9 (0.4 to 2.0)
        Fatigue (n=123, 104, 190, 387, 577)
    13.8 (8.8 to 21.0)
    8.7 (4.6 to 15.6)
    12.1 (8.2 to 17.5)
    11.9 (9.0 to 15.5)
    12.0 (9.6 to 14.9)
        Fever (n=118, 98, 181, 369, 550)
    2.5 (0.9 to 7.2)
    0.0 (0.0 to 3.8)
    0.0 (0.0 to 2.1)
    0.8 (0.3 to 2.4)
    0.5 (0.2 to 1.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3

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    End point title
    		 Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 [3]
    End point description
    Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method. SAS included all participants who entered into the study and received at least one vaccination. All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies number of participants evaluable for the specified rows.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after vaccination 3 at Month 6
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain (n=120, 105, 177, 365, 542)
    57.5 (48.6 to 66.0)
    60.0 (50.4 to 68.9)
    5.6 (3.1 to 10.1)
    59.2 (54.1 to 64.1)
    41.7 (37.6 to 45.9)
        Tenderness (n=121, 106, 177, 367, 544)
    73.6 (65.1 to 80.6)
    82.1 (73.7 to 88.2)
    13.0 (8.8 to 18.7)
    78.2 (73.7 to 82.1)
    57.0 (52.8 to 61.1)
        Erythema/Redness MGS (n=120, 106, 177, 364, 541)
    11.7 (7.1 to 18.6)
    7.5 (3.9 to 14.2)
    1.1 (0.3 to 4.0)
    9.6 (7.0 to 13.1)
    6.8 (5.0 to 9.3)
        Swelling MGS (n=119, 106, 177, 363, 540)
    8.4 (4.6 to 14.8)
    11.3 (6.6 to 18.8)
    0.6 (0.1 to 3.1)
    9.1 (6.5 to 12.5)
    6.3 (4.5 to 8.7)
        Induration/Hardening MGS (n=119,106,177,364,541)
    8.4 (4.6 to 14.8)
    6.6 (3.2 to 13.0)
    0.6 (0.1 to 3.1)
    8.2 (5.8 to 11.5)
    5.7 (4.1 to 8.0)
        Headache (n=117, 106, 178, 362, 540)
    15.4 (10.0 to 23.0)
    18.9 (12.6 to 27.4)
    9.0 (5.6 to 14.1)
    18.5 (14.8 to 22.8)
    15.4 (12.6 to 18.7)
        Muscle pain (n=118, 106, 177, 364, 541)
    27.1 (19.9 to 35.8)
    29.2 (21.4 to 38.5)
    7.3 (4.3 to 12.2)
    28.3 (23.9 to 33.1)
    21.4 (18.2 to 25.1)
        Joint pain (n=117, 106, 178, 362, 540)
    8.5 (4.7 to 15.0)
    2.8 (1.0 to 8.0)
    3.4 (1.6 to 7.2)
    5.0 (3.2 to 7.7)
    4.4 (3.0 to 6.5)
        Nausea (n=117, 105, 177, 361, 538)
    1.7 (0.5 to 6.0)
    2.9 (1.0 to 8.1)
    2.3 (0.9 to 5.7)
    3.0 (1.7 to 5.4)
    2.8 (1.7 to 4.5)
        Vomiting (n=117, 105, 177, 361, 538)
    0.9 (0.2 to 4.7)
    1.9 (0.5 to 6.7)
    0.0 (0.0 to 2.1)
    1.1 (0.4 to 2.8)
    0.7 (0.3 to 1.9)
        Fatigue (n=117, 106, 178, 362, 540)
    17.9 (12.0 to 25.9)
    16.0 (10.3 to 24.2)
    11.8 (7.8 to 17.4)
    17.1 (13.6 to 21.3)
    15.4 (12.6 to 18.7)
        Fever (n=114, 101, 171, 348, 519)
    0.0 (0.0 to 3.3)
    1.0 (0.2 to 5.4)
    0.6 (0.1 to 3.2)
    0.9 (0.3 to 2.5)
    0.8 (0.3 to 2.0)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

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    End point title
    		 Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase [4]
    End point description
    Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method. SAS included all participants who entered into the study and received at least one vaccination.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 All Participants Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15
    Number of subjects analysed
    625
    190
    187
    208
    417
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain
    57.0 (53.0 to 60.8)
    80.5 (74.3 to 85.5)
    77.0 (70.5 to 82.5)
    16.8 (12.4 to 22.5)
    77.0 (72.7 to 80.8)
        Tenderness
    69.9 (66.2 to 73.4)
    92.6 (88.0 to 95.6)
    92.5 (87.8 to 95.5)
    28.4 (22.7 to 34.8)
    90.6 (87.5 to 93.1)
        Erythema/Redness MGS
    15.7 (13.0 to 18.7)
    26.8 (21.0 to 33.6)
    18.7 (13.8 to 24.9)
    3.4 (1.6 to 6.8)
    21.8 (18.1 to 26.0)
        Swelling MGS
    12.5 (10.1 to 15.3)
    20.5 (15.4 to 26.8)
    16.6 (11.9 to 22.6)
    1.4 (0.5 to 4.2)
    18.0 (14.6 to 22.0)
        Induration/Hardening MGS
    11.5 (9.2 to 14.3)
    19.5 (14.5 to 25.7)
    14.4 (10.1 to 20.2)
    1.4 (0.5 to 4.2)
    16.5 (13.3 to 20.4)
        Headache
    34.6 (30.9 to 38.4)
    38.4 (31.8 to 45.5)
    36.4 (29.8 to 43.5)
    28.8 (23.1 to 35.3)
    37.4 (32.9 to 42.1)
        Muscle pain
    37.1 (33.4 to 41.0)
    45.8 (38.9 to 52.9)
    48.1 (41.1 to 55.3)
    17.8 (13.2 to 23.6)
    46.8 (42.0 to 51.6)
        Joint pain
    11.5 (9.2 to 14.3)
    15.3 (10.8 to 21.1)
    9.6 (6.2 to 14.7)
    8.2 (5.2 to 12.7)
    13.2 (10.3 to 16.8)
        Nausea
    9.6 (7.5 to 12.2)
    8.4 (5.2 to 13.2)
    11.2 (7.5 to 16.6)
    9.6 (6.3 to 14.4)
    9.6 (7.1 to 12.8)
        Vomiting
    2.2 (1.3 to 3.7)
    3.2 (1.5 to 6.7)
    3.2 (1.5 to 6.8)
    1.0 (0.3 to 3.4)
    2.9 (1.7 to 5.0)
        Fatigue
    30.4 (26.9 to 34.1)
    33.2 (26.9 to 40.1)
    29.9 (23.8 to 36.9)
    28.4 (22.7 to 34.8)
    31.4 (27.1 to 36.0)
        Fever
    1.9 (1.1 to 3.3)
    3.2 (1.5 to 6.7)
    1.6 (0.5 to 4.6)
    1.0 (0.3 to 3.4)
    2.4 (1.3 to 4.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase

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    End point title
    		 Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase [5]
    End point description
    GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure. Per-Protocol Analysis Set (PPAS) consisted of the Full Analysis Set (FAS, included all participants enrolled who received at least one vaccination) population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype.
    End point type
    Primary
    End point timeframe
    At Day 208 (Month 7)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Titers
    geometric mean (confidence interval 95%)
        ST1 (n=171, 158, 165)
    331.4 (273.5 to 401.5)
    197.3 (156.2 to 249.3)
    23.8 (21.6 to 26.2)
        ST2 (n=171, 158, 165)
    653.9 (557.9 to 766.3)
    460.3 (370.6 to 571.8)
    21.9 (20.2 to 23.7)
        ST3 (n=171, 158, 165)
    583.2 (494.4 to 688.0)
    436.2 (344.8 to 551.8)
    21.9 (20.2 to 23.9)
        ST4 (n=171, 158, 165)
    420.6 (353.2 to 500.9)
    245.8 (196.1 to 308.2)
    23.5 (21.3 to 25.9)
        ST5 (n=171, 158, 165)
    442.3 (374.2 to 522.7)
    239.4 (190.5 to 301.0)
    22.4 (20.6 to 24.4)
        ST6 (n=171, 158, 165)
    428.5 (358.8 to 511.8)
    222.0 (177.4 to 277.8)
    24.3 (22.2 to 26.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After 1st Booster Dose

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    End point title
    		 Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After 1st Booster Dose
    End point description
    Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method. SAS included all participants who entered into the study and received at least one vaccination. All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies number of participants evaluable for the specified rows.
    End point type
    Secondary
    End point timeframe
    Within 7 Days after 1st booster dose at Month 18
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain (n=121, 108, 133, 291, 424)
    53.7 (44.9 to 62.4)
    51.9 (42.5 to 61.0)
    6.0 (3.1 to 11.4)
    53.6 (47.9 to 59.3)
    38.7 (34.2 to 43.4)
        Tenderness (n=122, 110, 134, 296, 430)
    74.6 (66.2 to 81.5)
    76.4 (67.6 to 83.3)
    14.9 (9.9 to 21.9)
    75.7 (70.5 to 80.2)
    56.7 (52.0 to 61.3)
        Erythema/Redness MGS (n=119, 109, 135, 290, 425)
    7.6 (4.0 to 13.8)
    5.5 (2.5 to 11.5)
    2.2 (0.8 to 6.3)
    7.9 (5.3 to 11.6)
    6.1 (4.2 to 8.8)
        Swelling MGS (n=119, 108, 135, 289, 424)
    8.4 (4.6 to 14.8)
    6.5 (3.2 to 12.8)
    1.5 (0.4 to 5.2)
    8.7 (5.9 to 12.5)
    6.4 (4.4 to 9.1)
        Induration/Hardening MGS (n=121,108,135,291,426)
    5.0 (2.3 to 10.4)
    4.6 (2.0 to 10.4)
    1.5 (0.4 to 5.2)
    6.2 (3.9 to 9.6)
    4.7 (3.1 to 7.1)
        Headache (n=117, 109, 136, 288, 424)
    18.8 (12.8 to 26.8)
    11.9 (7.1 to 19.3)
    13.2 (8.5 to 20.0)
    15.3 (11.6 to 19.9)
    14.6 (11.6 to 18.3)
        Muscle pain (n=119, 108, 135, 291, 426)
    21.8 (15.4 to 30.1)
    33.3 (25.2 to 42.7)
    8.9 (5.2 to 14.9)
    28.9 (24.0 to 34.3)
    22.5 (18.8 to 26.7)
        Joint pain (n=118, 107, 135, 287, 422)
    5.9 (2.9 to 11.7)
    0.9 (0.2 to 5.1)
    1.5 (0.4 to 5.2)
    3.1 (1.7 to 5.9)
    2.6 (1.5 to 4.6)
        Nausea (n=118, 107, 135, 287, 422)
    5.1 (2.4 to 10.7)
    2.8 (1.0 to 7.9)
    1.5 (0.4 to 5.2)
    5.6 (3.5 to 8.9)
    4.3 (2.7 to 6.6)
        Vomiting (n=118, 107, 135, 287, 422)
    0.8 (0.1 to 4.6)
    0.9 (0.2 to 5.1)
    0.0 (0.0 to 2.8)
    1.0 (0.4 to 3.0)
    0.7 (0.2 to 2.1)
        Fatigue (n=118, 108, 135, 288, 423)
    13.6 (8.5 to 20.9)
    13.9 (8.6 to 21.7)
    7.4 (4.1 to 13.1)
    14.6 (11.0 to 19.1)
    12.3 (9.5 to 15.8)
        Fever (n=110, 105, 132, 272, 404)
    0.9 (0.2 to 5.0)
    0.0 (0.0 to 3.5)
    0.8 (0.1 to 4.2)
    0.4 (0.1 to 2.1)
    0.5 (0.1 to 1.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Serious Adverse Events (SAEs)
    End point description
    A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. SAS included all participants who entered into the study and received at least one vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 1 of vaccination up to Month 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 2.9)
    3.6 (1.4 to 8.8)
    6.8 (4.1 to 11.1)
    3.3 (2.0 to 5.5)
    4.5 (3.1 to 6.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Adverse Events of Special Interest (AESIs)

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    End point title
    		 Percentage of Participants With Adverse Events of Special Interest (AESIs)
    End point description
    An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. SAS included all participants who entered into the study and received at least one vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 1 of vaccination up to Month 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
        number (confidence interval 95%)
    0.8 (0.1 to 4.3)
    2.7 (0.9 to 7.6)
    0.5 (0.1 to 2.7)
    3.3 (2.0 to 5.5)
    2.4 (1.5 to 3.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Unsolicited AE

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    End point title
    		 Percentage of Participants With Unsolicited AE
    End point description
    An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. SAS included all participants who entered into the study and received at least one vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days after vaccination
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
        number (confidence interval 95%)
    29.1 (21.9 to 37.6)
    36.6 (28.3 to 45.8)
    35.0 (28.8 to 41.7)
    30.8 (26.6 to 35.4)
    32.2 (28.6 to 35.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group

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    End point title
    		 Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
    End point description
    Percentage of participants with SAEs, AESIs, solicited & unsolicited AEs stratified by age group 5-11, 12-17 & 18-65 years (yrs) were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific & medical concern specific to the sponsor’s product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Safety set was analysed. Here, “n” signifies participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    SAEs and AESIs From Day 1 of vaccination up to Month 48; Solicited AEs: Within 7 Days after each booster vaccination; Unsolicited AEs: up to 28 Days after vaccination
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Received any VLA15 All Participants
    Number of subjects analysed
    127
    112
    206
    419
    625
    Units: Percentage of participants
    number (confidence interval 95%)
        18-65 yrs, SAEs (n=67, 63, 105, 215, 320)
    0.0 (0.0 to 5.4)
    4.8 (1.6 to 13.1)
    8.6 (4.6 to 15.5)
    3.7 (1.9 to 7.2)
    5.3 (3.3 to 8.3)
        18-65 yrs, AESIs (n=67, 63, 105, 215, 320)
    1.5 (0.3 to 8.0)
    1.6 (0.3 to 8.5)
    0.0 (0.0 to 3.5)
    4.2 (2.2 to 7.8)
    2.8 (1.5 to 5.3)
        18-65 yrs, Solicited AEs (n=67,63,105,215,320)
    98.5 (92.0 to 99.7)
    100 (94.3 to 100)
    68.6 (59.2 to 76.7)
    96.7 (93.4 to 98.4)
    87.5 (83.4 to 90.7)
        18-65 yrs, Unsolicited AEs (n=67,63,105,215,320)
    32.8 (22.8 to 44.7)
    44.4 (32.8 to 56.7)
    40.0 (31.1 to 49.6)
    39.1 (32.8 to 45.7)
    39.4 (34.2 to 44.8)
        12-17 yrs, SAEs (n=28, 24, 50, 100, 150)
    0.0 (0.0 to 12.1)
    0.0 (0.0 to 13.8)
    6.0 (2.1 to 16.2)
    3.0 (1.0 to 8.5)
    4.0 (1.8 to 8.5)
        12-17 yrs, AESIs (n=28, 24, 50, 100, 150)
    0.0 (0.0 to 12.1)
    0.0 (0.0 to 13.8)
    2.0 (0.4 to 10.5)
    2.0 (0.6 to 7.0)
    2.0 (0.7 to 5.7)
        12-17 yrs, Solicited AEs (n=28, 24, 50, 100, 150)
    96.4 (82.3 to 99.4)
    100 (86.2 to 100)
    64.0 (50.1 to 75.9)
    97.0 (91.5 to 99.0)
    86.0 (79.5 to 90.7)
        12-17 yrs, Unsolicited AEs (n=28,24,50,100,150)
    35.7 (20.7 to 54.2)
    20.8 (9.2 to 40.5)
    30.0 (19.1 to 43.8)
    25.0 (17.5 to 34.3)
    26.7 (20.2 to 34.3)
        5-11 yrs, SAEs (n=32, 25, 51, 104, 155)
    0.0 (0.0 to 10.7)
    4.0 (0.7 to 19.5)
    3.9 (1.1 to 13.2)
    2.9 (1.0 to 8.1)
    3.2 (1.4 to 7.3)
        5-11 yrs, AESIs (n=32, 25, 51, 104, 155)
    0.0 (0.0 to 10.7)
    8.0 (2.2 to 25.0)
    0.0 (0.0 to 7.0)
    2.9 (1.0 to 8.1)
    1.9 (0.7 to 5.5)
        5-11 yrs, Solicited AEs (n=32, 25, 51, 104, 155)
    93.8 (79.9 to 98.3)
    96.0 (80.5 to 99.3)
    76.5 (63.2 to 86.0)
    94.2 (88.0 to 97.3)
    88.4 (82.4 to 92.5)
        5-11 yrs, Unsolicited AEs (n=32,25,51,104,155)
    15.6 (6.9 to 31.8)
    32.0 (17.2 to 51.6)
    29.4 (18.7 to 43.0)
    19.2 (12.8 to 27.8)
    22.6 (16.7 to 29.8)
    No statistical analyses for this end point

    Secondary: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18 During the Main Study Phase

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    End point title
    		 GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18 During the Main Study Phase
    End point description
    GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Baseline, Days 85, 180, 365 and Month 18
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Titers
    geometric mean (confidence interval 95%)
        ST1: Baseline (n=175, 162, 175)
    21.2 (20.3 to 22.1)
    20.3 (19.9 to 20.7)
    21.9 (20.7 to 23.2)
        ST1: Day 85 (n=169, 155, 170)
    116.5 (96.4 to 140.8)
    20.8 (20.1 to 21.5)
    21.8 (20.5 to 23.3)
        ST1: Day 180 (n=172, 161, 172)
    38.2 (33.6 to 43.4)
    21.4 (20.5 to 22.3)
    22.0 (20.8 to 23.2)
        ST1: Day 365 (n=163, 156, 158)
    40.8 (35.3 to 47.1)
    30.2 (27.1 to 33.6)
    21.3 (20.3 to 22.4)
        ST1: Month 18 (n=158, 144, 156)
    27.3 (24.2 to 30.7)
    22.7 (21.3 to 24.2)
    21.2 (20.2 to 22.3)
        ST2: Baseline (n=175, 162, 175)
    20.8 (20.0 to 21.6)
    20.0 (20.0 to 20.0)
    21.3 (20.4 to 22.3)
        ST2: Day 85 (n=169, 155, 170)
    262.8 (217.6 to 317.3)
    21.8 (20.6 to 23.1)
    21.0 (19.9 to 22.1)
        ST2: Day 180 (n=172, 161, 172)
    70.4 (60.4 to 82.1)
    21.9 (20.8 to 23.1)
    21.1 (20.3 to 22.1)
        ST2: Day 365 (n=163, 156, 158)
    67.8 (58.2 to 78.9)
    54.1 (46.8 to 62.7)
    20.9 (20.1 to 21.7)
        ST2: Month 18 (n=157, 144, 156)
    35.4 (31.1 to 40.2)
    30.3 (27.2 to 33.8)
    20.3 (19.9 to 20.9)
        ST3: Baseline (n=175, 162, 175)
    20.6 (20.0 to 21.3)
    20.3 (19.9 to 20.7)
    20.9 (20.2 to 21.7)
        ST3: Day 85 (n=169, 155, 170)
    249.8 (205.1 to 304.2)
    22.7 (21.5 to 24.1)
    20.9 (19.8 to 22.2)
        ST3: Day 180 (n=172, 161, 172)
    65.4 (55.8 to 76.6)
    22.3 (21.2 to 23.6)
    21.1 (20.4 to 21.8)
        ST3: Day 365 (n=163, 156, 158)
    63.1 (53.8 to 74.0)
    58.1 (49.8 to 67.8)
    20.6 (20.0 to 21.1)
        ST3: Month 18 (n=158, 144, 156)
    34.3 (29.8 to 39.4)
    33.8 (30.1 to 37.9)
    20.1 (19.9 to 20.3)
        ST4: Baseline (n=175, 162, 175)
    20.8 (20.0 to 21.6)
    20.4 (20.0 to 20.9)
    21.7 (20.6 to 22.8)
        ST4: Day 85 (n=169, 155, 170)
    147.4 (122.6 to 177.3)
    21.7 (20.7 to 22.7)
    21.6 (20.3 to 23.0)
        ST4: Day 180 (n=172, 161, 172)
    47.5 (41.7 to 54.1)
    22.1 (21.1 to 23.2)
    22.4 (21.1 to 23.7)
        ST4: Day 365 (n=163, 156, 158)
    52.6 (45.5 to 60.8)
    37.2 (33.1 to 41.9)
    20.9 (20.0 to 21.8)
        ST4: Month 18 (n=158, 144, 156)
    32.3 (28.5 to 36.7)
    25.8 (23.7 to 28.1)
    21.0 (20.1 to 22.0)
        ST5: Baseline (n=175, 162, 175)
    20.6 (19.8 to 21.4)
    20.2 (19.9 to 20.6)
    20.7 (20.1 to 21.4)
        ST5: Day 85 (n=169, 155, 170)
    164.2 (135.7 to 198.8)
    21.2 (20.3 to 22.0)
    20.9 (19.9 to 22.1)
        ST5: Day 180 (n=172, 161, 172)
    52.3 (45.5 to 60.1)
    21.7 (20.7 to 22.7)
    20.8 (20.2 to 21.5)
        ST5: Day 365 (n=163, 156, 158)
    54.6 (47.0 to 63.5)
    38.4 (33.9 to 43.5)
    20.4 (19.9 to 20.9)
        ST5: Month 18 (n=157, 144, 156)
    29.3 (25.9 to 33.1)
    24.9 (23.0 to 27.0)
    20.2 (19.9 to 20.5)
        ST6: Baseline (n=176, 162, 175)
    22.5 (20.9 to 24.2)
    21.3 (20.4 to 22.2)
    22.1 (21.0 to 23.2)
        ST6: Day 85 (n=169, 155, 170)
    143.7 (119.2 to 173.1)
    22.5 (21.2 to 23.9)
    22.3 (20.9 to 23.9)
        ST6: Day 180 (n=172, 161, 172)
    49.3 (42.8 to 56.8)
    23.2 (21.9 to 24.7)
    22.5 (21.4 to 23.7)
        ST6: Day 365 (n=163, 156, 158)
    57.2 (49.2 to 66.6)
    38.1 (33.8 to 42.9)
    21.9 (20.9 to 23.1)
        ST6: Month 18 (n=158, 144, 156)
    32.2 (28.1 to 36.9)
    25.7 (23.5 to 28.0)
    21.2 (20.4 to 22.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroconversion at Days 85, 180, 208, 365 and Month 18 After Vaccination During the Main Study Phase

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    End point title
    		 Percentage of Participants With Seroconversion at Days 85, 180, 208, 365 and Month 18 After Vaccination During the Main Study Phase
    End point description
    Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA) were evaluated. Seroconversion for ELISA: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Days 85, 180, 208, 365 and Month 18
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Percentage of participants
    number (confidence interval 95%)
        ST1: Day 85 (n=168, 155, 170)
    75.0 (67.9 to 80.9)
    2.6 (1.0 to 6.4)
    1.8 (0.6 to 5.1)
        ST1: Day 180 (n=171, 161, 172)
    40.4 (33.3 to 47.8)
    5.0 (2.5 to 9.5)
    2.9 (1.2 to 6.6)
        ST1: Day 208 (n=170, 158, 165)
    92.9 (88.1 to 95.9)
    83.5 (77.0 to 88.5)
    6.7 (3.8 to 11.5)
        ST1: Day 365 (n=162, 156, 158)
    43.2 (35.8 to 50.9)
    28.8 (22.3 to 36.4)
    0.6 (0.1 to 3.5)
        ST1: Month 18 (n=157, 144, 156)
    16.6 (11.6 to 23.2)
    9.7 (5.9 to 15.7)
    0.0 (0.0 to 2.4)
        ST2: Day 85 (n=168, 155, 170)
    89.9 (84.4 to 93.6)
    6.5 (3.5 to 11.5)
    0.6 (0.1 to 3.3)
        ST2: Day 180 (n=171, 161, 172)
    66.7 (59.3 to 73.3)
    7.5 (4.3 to 12.6)
    1.2 (0.3 to 4.1)
        ST2: Day 208 (n=170, 158, 165)
    97.6 (94.1 to 99.1)
    94.3 (89.5 to 97.0)
    2.4 (0.9 to 6.1)
        ST2: Day 365 (n=162, 156, 158)
    64.8 (57.2 to 71.7)
    59.0 (51.1 to 66.4)
    1.3 (0.3 to 4.5)
        ST2: Month 18 (n=157, 144, 156)
    36.3 (29.2 to 44.1)
    31.3 (24.2 to 39.2)
    0.0 (0.0 to 2.4)
        ST3: Day 85 (n=168, 155, 170)
    90.5 (85.1 to 94.1)
    11.0 (7.0 to 16.9)
    0.6 (0.1 to 3.3)
        ST3: Day 180 (n=171, 161, 172)
    63.7 (56.3 to 70.6)
    8.7 (5.3 to 14.1)
    4.1 (2.0 to 8.2)
        ST3: Day 208 (n=170, 158, 165)
    98.8 (95.8 to 99.7)
    91.8 (86.4 to 95.1)
    4.2 (2.1 to 8.5)
        ST3: Day 365 (n=162, 156, 158)
    63.0 (55.3 to 70.0)
    61.5 (53.7 to 68.8)
    0.6 (0.1 to 3.5)
        ST3: Month 18 (n=157, 144, 156)
    31.2 (24.5 to 38.8)
    40.3 (32.6 to 48.4)
    0.6 (0.1 to 3.5)
        ST4: Day 85 (n=168, 155, 170)
    83.9 (77.6 to 88.7)
    5.2 (2.6 to 9.9)
    2.4 (0.9 to 5.9)
        ST4: Day 180 (n=171, 161, 172)
    55.0 (47.5 to 62.2)
    8.1 (4.8 to 13.3)
    6.4 (3.6 to 11.1)
        ST4: Day 208 (n=170, 158, 165)
    95.9 (91.7 to 98.0)
    88.6 (82.7 to 92.7)
    6.7 (3.8 to 11.5)
        ST4: Day 365 (n=162, 156, 158)
    57.4 (49.7 to 64.8)
    42.9 (35.4 to 50.8)
    1.3 (0.3 to 4.5)
        ST4: Month 18 (n=157, 144, 156)
    31.2 (24.5 to 38.8)
    19.4 (13.8 to 26.7)
    1.3 (0.4 to 4.6)
        ST5: Day 85 (n=168, 155, 170)
    82.7 (76.3 to 87.7)
    4.5 (2.2 to 9.0)
    2.4 (0.9 to 5.9)
        ST5: Day 180 (n=171, 161, 172)
    57.9 (50.4 to 65.0)
    5.6 (3.0 to 10.3)
    4.1 (2.0 to 8.2)
        ST5: Day 208 (n=170, 158, 165)
    97.1 (93.3 to 98.7)
    86.7 (80.5 to 91.1)
    6.7 (3.8 to 11.5)
        ST5: Day 365 (n=162, 156, 158)
    57.4 (49.7 to 64.8)
    43.6 (36.1 to 51.4)
    1.3 (0.3 to 4.5)
        ST5: Month 18 (n=157, 144, 156)
    23.6 (17.6 to 30.8)
    17.4 (12.0 to 24.4)
    1.3 (0.4 to 4.6)
        ST6: Day 85 (n=169, 155, 170)
    79.9 (73.2 to 85.2)
    4.5 (2.2 to 9.0)
    2.4 (0.9 to 5.9)
        ST6: Day 180 (n=172, 161, 172)
    50.0 (42.6 to 57.4)
    8.7 (5.3 to 14.1)
    5.2 (2.8 to 9.6)
        ST6: Day 208 (n=171, 158, 165)
    95.3 (91.0 to 97.6)
    85.4 (79.1 to 90.1)
    8.5 (5.1 to 13.7)
        ST6: Day 365 (n=163, 156, 158)
    57.1 (49.4 to 64.4)
    41.7 (34.2 to 49.5)
    3.2 (1.4 to 7.2)
        ST6: Month 18 (n=158, 144, 156)
    22.2 (16.4 to 29.2)
    16.7 (11.5 to 23.6)
    2.6 (1.0 to 6.4)
    No statistical analyses for this end point

    Secondary: Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208 During the Main Study Phase

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    End point title
    		 Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208 During the Main Study Phase
    End point description
    GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Days 85 and 208
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Fold rise
    geometric mean (confidence interval 95%)
        ST1: Day 85 (n=168, 155, 170)
    5.5 (4.5 to 6.6)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        ST1: Day 208 (n=170, 158, 165)
    15.5 (12.8 to 18.8)
    9.7 (7.7 to 12.3)
    1.1 (1.0 to 1.2)
        ST2: Day 85 (n=168, 155, 170)
    12.5 (10.4 to 15.2)
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.0)
        ST2: Day 208 (n=170, 158, 165)
    31.4 (26.6 to 36.9)
    23.0 (18.5 to 28.6)
    1.0 (1.0 to 1.1)
        ST3: Day 85 (n=168, 155, 170)
    12.0 (9.8 to 14.6)
    1.1 (1.1 to 1.2)
    1.0 (1.0 to 1.0)
        ST3: Day 208 (n=170, 158, 165)
    28.1 (23.8 to 33.2)
    21.7 (17.1 to 27.4)
    1.0 (1.0 to 1.1)
        ST4: Day 85 (n=168, 155, 170)
    7.0 (5.8 to 8.4)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        ST4: Day 208 (n=170, 158, 165)
    20.0 (16.8 to 23.9)
    12.0 (9.6 to 15.0)
    1.1 (1.0 to 1.2)
        ST5: Day 85 (n=168, 155, 170)
    7.9 (6.5 to 9.6)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
        ST5: Day 208 (n=170, 158, 165)
    21.3 (17.9 to 25.2)
    11.8 (9.4 to 14.8)
    1.1 (1.0 to 1.2)
        ST6: Day 85 (n=169, 155, 170)
    6.4 (5.3 to 7.7)
    1.1 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
        ST6: Day 208 (n=171, 158, 165)
    19.0 (15.9 to 22.8)
    10.4 (8.3 to 13.0)
    1.1 (1.0 to 1.2)
    No statistical analyses for this end point

    Secondary: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18 During the Main Study Phase

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    End point title
    		 GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18 During the Main Study Phase
    End point description
    GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 & 18-65 yrs) were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Baseline, Days 85, 180, 194 (18 to 65 years only), 365 and Month 18
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Titers
    geometric mean (confidence interval 95%)
        18-65 yrs, ST1: Baseline (n=96, 84, 93)
    21.4 (20.0 to 23.0)
    20.0 (20.0 to 20.0)
    21.9 (20.1 to 23.8)
        18-65 yrs, ST1: Day 85 (n=93, 81, 93)
    66.4 (51.8 to 85.1)
    20.3 (19.7 to 20.8)
    21.9 (20.2 to 23.7)
        18-65 yrs, ST1: Day 180 (n=95, 83, 92)
    29.4 (25.0 to 34.6)
    20.4 (19.8 to 21.1)
    22.3 (20.5 to 24.2)
        18-65 yrs, ST1: Day 194 (n=51, 44, 44)
    360.8 (238.2 to 546.6)
    91.6 (60.0 to 139.6)
    20.8 (19.7 to 22.0)
        18-65 yrs, ST1: Day 365 (n=92, 81, 87)
    33.4 (27.8 to 40.0)
    23.1 (21.0 to 25.4)
    21.8 (20.1 to 23.6)
        18-65 yrs, ST1: Month 18 (n=86, 73, 85)
    24.6 (21.2 to 28.4)
    21.6 (20.2 to 23.2)
    21.6 (19.9 to 23.4)
        18-65 yrs, ST2: Baseline (n=96, 84, 93)
    21.2 (19.8 to 22.7)
    20.0 (20.0 to 20.0)
    21.3 (20.0 to 22.7)
        18-65 yrs, ST2: Day 85 (n=93, 81, 93)
    152.4 (120.0 to 193.6)
    20.4 (19.8 to 21.0)
    21.0 (19.9 to 22.1)
        18-65 yrs, ST2: Day 180 (n=95, 83, 92)
    44.5 (37.3 to 53.1)
    21.0 (19.8 to 22.1)
    21.3 (20.0 to 22.6)
        18-65 yrs, ST2: Day 194 (n=51, 44, 44)
    691.5 (519.0 to 921.3)
    216.7 (143.9 to 326.2)
    21.0 (19.5 to 22.7)
        18-65 yrs, ST2: Day 365 (n=92, 81, 87)
    50.9 (42.3 to 61.4)
    35.9 (30.6 to 42.3)
    21.3 (20.0 to 22.8)
        18-65 yrs, ST2: Month 18 (n=86, 73, 85)
    29.5 (25.6 to 34.0)
    23.5 (21.4 to 25.9)
    20.6 (19.7 to 21.6)
        18-65 yrs, ST3: Baseline (n=96, 84, 93)
    20.8 (19.7 to 22.0)
    20.3 (19.7 to 20.9)
    20.7 (19.9 to 21.5)
        18-65 yrs, ST3: Day 85 (n=93, 81, 93)
    135.2 (106.4 to 171.9)
    21.2 (20.1 to 22.3)
    20.5 (19.8 to 21.3)
        18-65 yrs, ST3: Day 180 (n=95, 83, 92)
    40.2 (33.8 to 47.9)
    21.2 (20.0 to 22.6)
    21.3 (20.3 to 22.4)
        18-65 yrs, ST3: Day 194 (n=51, 44, 44)
    589.2 (428.7 to 809.9)
    196.6 (129.9 to 297.6)
    21.2 (19.8 to 22.8)
        18-65 yrs, ST3: Day 365 (n=92, 81, 87)
    46.6 (38.6 to 56.3)
    34.6 (29.4 to 40.6)
    20.5 (19.8 to 21.3)
        18-65 yrs, ST3: Month 18 (n=86, 73, 85)
    27.0 (23.5 to 31.1)
    24.2 (22.0 to 26.6)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST4: Baseline (n=96, 84, 93)
    21.3 (19.9 to 22.8)
    20.0 (20.0 to 20.0)
    21.6 (20.0 to 23.4)
        18-65 yrs, ST4: Day 85 (n=93, 81, 93)
    81.8 (65.3 to 102.6)
    20.5 (19.8 to 21.1)
    21.5 (20.0 to 23.2)
        18-65 yrs, ST4: Day 180 (n=95, 83, 92)
    32.5 (28.1 to 37.6)
    21.4 (20.3 to 22.7)
    22.9 (20.9 to 25.0)
        18-65 yrs, ST4: Day 194 (n=51, 44, 44)
    434.4 (306.2 to 616.3)
    112.4 (75.7 to 166.9)
    22.5 (19.7 to 25.7)
        18-65 yrs, ST4: Day 365 (n=92, 81, 87)
    39.9 (33.5 to 47.6)
    25.9 (23.1 to 29.0)
    21.4 (19.9 to 23.2)
        18-65 yrs, ST4: Month 18 (n=86, 73, 85)
    26.8 (23.4 to 30.8)
    22.3 (20.5 to 24.3)
    21.5 (19.9 to 23.3)
        18-65 yrs, ST5: Baseline (n=96, 84, 93)
    21.1 (19.7 to 22.6)
    20.0 (20.0 to 20.0)
    20.2 (19.8 to 20.6)
        18-65 yrs, ST5: Day 85 (n=93, 81, 93)
    88.6 (70.4 to 111.4)
    20.2 (19.8 to 20.6)
    20.2 (19.8 to 20.7)
        18-65 yrs, ST5: Day 180 (n=95, 83, 92)
    34.1 (29.5 to 39.5)
    20.6 (19.8 to 21.5)
    20.8 (20.0 to 21.7)
        18-65 yrs, ST5: Day 194 (n=51, 44, 44)
    450.5 (328.9 to 617.2)
    117.1 (78.1 to 175.7)
    21.1 (19.9 to 22.4)
        18-65 yrs, ST5: Day 365 (n=92, 81, 87)
    39.2 (32.9 to 46.7)
    27.2 (24.0 to 30.7)
    20.4 (19.8 to 21.1)
        18-65 yrs, ST5: Month 18 (n=86, 73, 85)
    24.2 (21.4 to 27.4)
    21.7 (20.3 to 23.1)
    20.2 (19.8 to 20.5)
        18-65 yrs, ST6: Baseline (n=96, 84, 93)
    21.7 (20.0 to 23.6)
    20.5 (19.8 to 21.1)
    21.0 (20.0 to 21.9)
        18-65 yrs, ST6: Day 85 (n=93, 81, 93)
    79.3 (63.5 to 98.9)
    20.8 (19.9 to 21.9)
    21.4 (20.3 to 22.6)
        18-65 yrs, ST6: Day 180 (n=95, 83, 92)
    33.4 (28.7 to 38.9)
    21.1 (20.0 to 22.3)
    21.8 (20.5 to 23.1)
        18-65 yrs, ST6: Day 194 (n=51, 44, 44)
    405.5 (289.5 to 568.1)
    104.8 (70.1 to 156.5)
    21.7 (20.0 to 23.5)
        18-65 yrs, ST6: Day 365 (n=92, 81, 87)
    41.4 (34.5 to 49.7)
    26.2 (23.4 to 29.2)
    22.0 (20.5 to 23.6)
        18-65 yrs, ST6: Month 18 (n=86, 73, 85)
    26.5 (23.0 to 30.6)
    21.8 (20.3 to 23.3)
    21.1 (20.0 to 22.3)
        12-17 yrs, ST1: Baseline (n=40, 40, 42)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    21.0 (19.6 to 22.6)
        12-17 yrs, ST1: Day 85 (n=37, 40, 39)
    198.4 (136.9 to 287.7)
    20.8 (19.7 to 21.9)
    20.6 (19.4 to 21.9)
        12-17 yrs, ST1: Day 180 (n=39, 40, 41)
    48.3 (36.8 to 63.5)
    22.6 (20.3 to 25.2)
    21.9 (20.0 to 24.1)
        12-17 yrs, ST1: Day 365 (n=35, 38, 36)
    43.9 (31.8 to 60.5)
    36.5 (28.7 to 46.4)
    20.6 (19.4 to 22.0)
        12-17 yrs, ST1: Month 18 (n=36, 37, 34)
    31.0 (22.8 to 42.1)
    24.6 (20.9 to 28.9)
    20.6 (19.4 to 22.0)
        12-17 yrs, ST2: Baseline (n=40, 40, 42)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Day 85 (n=37, 40, 39)
    414.3 (284.2 to 604.1)
    23.7 (19.9 to 28.2)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Day 180 (n=39, 40, 41)
    102.3 (74.0 to 141.4)
    24.6 (21.0 to 28.9)
    21.2 (19.5 to 22.9)
        12-17 yrs, ST2: Day 365 (n=35, 38, 36)
    68.6 (47.9 to 98.2)
    72.8 (53.6 to 98.8)
    20.7 (19.3 to 22.2)
        12-17 yrs, ST2: Month 18 (n=36, 37, 34)
    39.8 (28.2 to 56.2)
    39.3 (30.4 to 50.9)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Baseline (n=40, 40, 42)
    20.0 (20.0 to 20.0)
    20.5 (19.5 to 21.5)
    20.4 (19.6 to 21.2)
        12-17 yrs, ST3: Day 85 (n=37, 40, 39)
    426.3 (288.0 to 631.2)
    24.8 (21.5 to 28.6)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Day 180 (n=39, 40, 41)
    104.5 (75.8 to 143.9)
    25.1 (21.5 to 29.4)
    21.5 (19.8 to 23.5)
        12-17 yrs, ST3: Day 365 (n=35, 38, 36)
    73.2 (50.8 to 105.5)
    86.1 (63.4 to 116.8)
    20.7 (19.3 to 22.3)
        12-17 yrs, ST3: Month 18 (n=36, 37, 34)
    41.5 (28.3 to 61.0)
    44.8 (34.4 to 58.3)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST4: Baseline (n=40, 40, 42)
    20.0 (20.0 to 20.0)
    21.8 (20.0 to 23.7)
    21.4 (19.8 to 23.1)
        12-17 yrs, ST4: Day 85 (n=37, 40, 39)
    256.6 (181.0 to 363.7)
    23.7 (20.7 to 27.0)
    21.1 (19.5 to 22.8)
        12-17 yrs, ST4: Day 180 (n=39, 40, 41)
    68.0 (52.3 to 88.5)
    24.1 (21.3 to 27.2)
    22.2 (20.0 to 24.7)
        12-17 yrs, ST4: Day 365 (n=35, 38, 36)
    58.6 (42.6 to 80.7)
    52.4 (40.0 to 68.6)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST4: Month 18 (n=36, 37, 34)
    38.0 (27.7 to 52.2)
    33.6 (26.8 to 42.0)
    21.0 (19.6 to 22.5)
        12-17 yrs, ST5: Baseline (n=40, 40, 42)
    20.0 (20.0 to 20.0)
    21.0 (19.6 to 22.6)
    21.0 (19.6 to 22.5)
        12-17 yrs, ST5: Day 85 (n=37, 40, 39)
    237.7 (190.5 to 393.4)
    22.8 (20.1 to 25.9)
    21.0 (19.6 to 22.5)
        12-17 yrs, ST5: Day 180 (n=39, 40, 41)
    71.7 (53.2 to 96.7)
    24.2 (21.1 to 27.7)
    20.6 (19.4 to 21.8)
        12-17 yrs, ST5: Day 365 (n=35, 38, 36)
    60.0 (42.6 to 84.4)
    56.4 (43.1 to 73.8)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST5: Month 18 (n=36, 37, 34)
    35.8 (25.5 to 50.1)
    29.5 (23.9 to 36.4)
    20.6 (19.4 to 21.9)
        12-17 yrs, ST6: Baseline (n=40, 40, 42)
    20.9 (19.6 to 22.4)
    23.6 (20.4 to 27.2)
    23.2 (20.4 to 26.4)
        12-17 yrs, ST6: Day 85 (n=37, 40, 39)
    229.4 (157.8 to 333.4)
    26.3 (21.6 to 31.8)
    22.8 (20.1 to 26.0)
        12-17 yrs, ST6: Day 180 (n=39, 40, 41)
    66.2 (49.0 to 89.4)
    27.3 (23.0 to 32.5)
    23.8 (20.9 to 27.0)
        12-17 yrs, ST6: Day 365 (n=35, 38, 36)
    66.5 (47.4 to 93.2)
    51.2 (39.4 to 66.5)
    21.7 (19.7 to 23.8)
        12-17 yrs, ST6: Month 18 (n=36, 37, 34)
    37.5 (26.8 to 52.3)
    31.9 (25.2 to 40.5)
    22.3 (20.1 to 24.9)
        5-11 yrs, ST1: Baseline (n=39, 38, 40)
    21.8 (19.7 to 24.0)
    21.3 (19.4 to 23.4)
    22.9 (20.1 to 26.2)
        5-11 yrs, ST1: Day 85 (n=39, 34, 38)
    269.5 (219.8 to 330.5)
    22.2 (19.7 to 25.1)
    23.0 (18.6 to 28.6)
        5-11 yrs, ST1: Day 180 (n=38, 38, 39)
    57.6 (44.8 to 74.0)
    22.3 (19.6 to 25.3)
    21.4 (19.4 to 23.6)
        5-11 yrs, ST1: Day 365 (n=36, 37, 35)
    63.4 (46.7 to 86.1)
    44.3 (33.5 to 58.6)
    20.8 (19.2 to 22.5)
        5-11 yrs, ST1: Month 18 (n=36, 34, 37)
    30.8 (23.6 to 40.1)
    23.2 (20.0 to 26.9)
    20.8 (19.2 to 22.6)
        5-11 yrs, ST2: Baseline (n=39, 38, 40)
    20.6 (19.4 to 22.0)
    20.0 (20.0 to 20.0)
    22.9 (20.0 to 26.3)
        5-11 yrs, ST2: Day 85 (n=39, 34, 38)
    625.2 (482.4 to 810.3)
    23.1 (20.0 to 26.6)
    22.0 (18.1 to 26.7)
        5-11 yrs, ST2: Day 180 (n=38, 38, 39)
    151.0 (117.2 to 194.5)
    21.3 (19.5 to 23.3)
    20.8 (19.2 to 22.7)
        5-11 yrs, ST2: Day 365 (n=36, 37, 35)
    138.9 (107.7 to 179.2)
    98.0 (73.2 to 131.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 18 (n=35, 34, 37)
    48.7 (36.4 to 65.1)
    39.5 (30.5 to 51.0)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST3: Baseline (n=39, 38, 40)
    20.8 (19.7 to 22.1)
    20.0 (20.0 to 20.0)
    22.2 (19.7 to 24.9)
        5-11 yrs, ST3: Day 85 (n=39, 34, 38)
    649.6 (494.7 to 853.1)
    24.4 (20.8 to 28.5)
    23.0 (18.1 to 29.3)
        5-11 yrs, ST3: Day 180 (n=38, 38, 39)
    135.9 (100.2 to 184.5)
    22.0 (20.0 to 24.3)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST3: Day 365 (n=36, 37, 35)
    118.6 (85.0 to 165.5)
    120.6 (91.1 to 159.6)
    20.4 (19.6 to 21.4)
        5-11 yrs, ST3: Month 18 (n=36, 34, 37)
    50.0 (36.4 to 68.8)
    50.9 (39.6 to 65.6)
    20.5 (19.5 to 21.5)
        5-11 yrs, ST4: Baseline (n=39, 38, 40)
    20.5 (19.5 to 21.6)
    20.0 (20.0 to 20.0)
    22.1 (19.7 to 24.9)
        5-11 yrs, ST4: Day 85 (n=39, 34, 38)
    354.9 (275.2 to 457.7)
    22.5 (20.0 to 25.2)
    22.6 (18.4 to 27.8)
        5-11 yrs, ST4: Day 180 (n=38, 38, 39)
    84.7 (65.3 to 109.8)
    21.6 (19.8 to 23.6)
    21.3 (19.5 to 23.3)
        5-11 yrs, ST4: Day 365 (n=36, 37, 35)
    96.1 (71.8 to 128.4)
    58.0 (46.0 to 73.1)
    20.5 (19.5 to 21.4)
        5-11 yrs, ST4: Month 18 (n=36, 34, 37)
    42.9 (31.3 to 58.8)
    26.6 (22.5 to 31.3)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Baseline (n=39, 38, 40)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    21.9 (19.7 to 24.2)
        5-11 yrs, ST5: Day 85 (n=39, 34, 38)
    441.2 (339.3 to 573.7)
    21.6 (19.7 to 23.6)
    22.8 (18.3 to 28.4)
        5-11 yrs, ST5: Day 180 (n=38, 38, 39)
    109.9 (84.1 to 143.6)
    21.5 (19.3 to 23.9)
    21.2 (19.5 to 22.9)
        5-11 yrs, ST5: Day 365 (n=36, 37, 35)
    116.6 (87.9 to 154.7)
    55.1 (41.6 to 73.0)
    20.8 (19.2 to 22.4)
        5-11 yrs, ST5: Month 18 (n=35, 34, 37)
    38.1 (28.6 to 50.8)
    28.1 (23.2 to 34.1)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST6: Baseline (n=40, 38, 40)
    26.2 (20.6 to 33.4)
    20.9 (19.7 to 22.2)
    23.8 (20.7 to 27.3)
        5-11 yrs, ST6: Day 85 (n=39, 34, 38)
    380.4 (293.3 to 493.5)
    22.6 (20.1 to 25.4)
    24.2 (19.0 to 30.9)
        5-11 yrs, ST6: Day 180 (n=38, 38, 39)
    96.6 (71.4 to 130.6)
    24.1 (21.1 to 27.5)
    23.0 (20.3 to 26.0)
        5-11 yrs, ST6: Day 365 (n=36, 37, 35)
    113.1 (84.7 to 151.1)
    64.0 (50.3 to 81.4)
    22.0 (19.6 to 24.7)
        5-11 yrs, ST6: Month 18 (n=36, 34, 37)
    44.2 (31.1 to 62.8)
    28.8 (23.6 to 35.2)
    20.5 (19.5 to 21.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroconversion Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18 After Vaccination During the Main Study Phase

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    End point title
    		 Percentage of Participants With Seroconversion Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18 After Vaccination During the Main Study Phase
    End point description
    Seroconversion rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (5-11, 12-17 & 18-65 yrs) were evaluated. Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Days 85, 180, 194 (18 to 65 years only), 208, 365 and Month 18
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Percentage of participants
    number (confidence interval 95%)
        18-65 yrs, ST1: Day 85 (n=93, 81, 93)
    59.1 (49.0 to 68.6)
    1.2 (0.2 to 6.7)
    2.2 (0.6 to 7.5)
        18-65 yrs, ST1: Day 180 (n=95, 83, 92)
    22.1 (14.9 to 31.4)
    2.4 (0.7 to 8.4)
    2.2 (0.6 to 7.6)
        18-65 yrs, ST1: Day 194 (n=51, 44, 44)
    92.2 (81.5 to 96.9)
    65.9 (51.1 to 78.1)
    4.5 (1.3 to 15.1)
        18-65 yrs, ST1: Day 208 (n=93, 81, 88)
    89.2 (81.3 to 94.1)
    70.4 (59.7 to 79.2)
    9.1 (4.7 to 16.9)
        18-65 yrs, ST1: Day 365 (n=92, 81, 87)
    32.6 (23.9 to 42.7)
    11.1 (6.0 to 19.8)
    1.1 (0.2 to 6.2)
        18-65 yrs, ST1: Month 18 (n=86, 73, 85)
    10.5 (5.6 to 18.7)
    6.8 (3.0 to 15.1)
    0.0 (0.0 to 4.3)
        18-65 yrs, ST2: Day 85 (n=93, 81, 93)
    84.9 (76.3 to 90.8)
    2.5 (0.7 to 8.6)
    0.0 (0.0 to 4.0)
        18-65 yrs, ST2: Day 180 (n=95, 83, 92)
    49.5 (39.6 to 59.4)
    3.6 (1.2 to 10.1)
    0.0 (0.0 to 4.0)
        18-65 yrs, ST2: Day 194 (n=51, 44, 44)
    100 (93.0 to 100)
    88.6 (76.0 to 95.0)
    2.3 (0.4 to 11.8)
        18-65 yrs, ST2: Day 208 (n=93, 81, 88)
    96.8 (90.9 to 98.9)
    90.1 (81.7 to 94.9)
    2.3 (0.6 to 7.9)
        18-65 yrs, ST2: Day 365 (n=92, 81, 87)
    54.3 (44.2 to 64.1)
    42.0 (31.8 to 52.8)
    1.1 (0.2 to 6.2)
        18-65 yrs, ST2: Month 18 (n=86, 73, 85)
    25.6 (17.5 to 35.7)
    13.7 (7.6 to 23.4)
    0.0 (0.0 to 4.3)
        18-65 yrs, ST3: Day 85 (n=93, 81, 93)
    86.0 (77.5 to 91.6)
    4.9 (1.9 to 12.0)
    0.0 (0.0 to 4.0)
        18-65 yrs, ST3: Day 180 (n=95, 83, 92)
    45.3 (35.6 to 55.3)
    3.6 (1.2 to 10.1)
    4.3 (1.7 to 10.7)
        18-65 yrs, ST3: Day 194 (n=51, 44, 44)
    100 (93.0 to 100)
    86.4 (73.3 to 93.6)
    4.5 (1.3 to 15.1)
        18-65 yrs, ST3: Day 208 (n=93, 81, 88)
    98.9 (94.2 to 99.8)
    85.2 (75.9 to 91.3)
    3.4 (1.2 to 9.5)
        18-65 yrs, ST3: Day 365 (n=92, 81, 87)
    53.3 (43.1 to 63.1)
    39.5 (29.6 to 50.4)
    1.1 (0.2 to 6.2)
        18-65 yrs, ST3: Month 18 (n=86, 73, 85)
    18.6 (11.8 to 28.1)
    19.2 (11.8 to 29.7)
    0.0 (0.0 to 4.3)
        18-65 yrs, ST4: Day 85 (n=93, 81, 93)
    73.1 (63.3 to 81.1)
    2.5 (0.7 to 8.6)
    2.2 (0.6 to 7.5)
        18-65 yrs, ST4: Day 180 (n=95, 83, 92)
    31.6 (23.1 to 41.5)
    7.2 (3.4 to 14.9)
    7.6 (3.7 to 14.9)
        18-65 yrs, ST4: Day 194 (n=51, 44, 44)
    98.0 (89.7 to 99.7)
    77.3 (63.0 to 87.2)
    6.8 (2.3 to 18.2)
        18-65 yrs, ST4: Day 208 (n=93, 81, 88)
    93.5 (86.6 to 97.0)
    79.0 (68.9 to 86.5)
    6.8 (3.2 to 14.1)
        18-65 yrs, ST4: Day 365 (n=92, 81, 87)
    43.5 (33.8 to 53.7)
    22.2 (14.5 to 32.4)
    2.3 (0.6 to 8.0)
        18-65 yrs, ST4: Month 18 (n=86, 73, 85)
    18.6 (11.8 to 28.1)
    9.6 (4.7 to 18.5)
    2.4 (0.6 to 8.2)
        18-65 yrs, ST5: Day 85 (n=93, 81, 93)
    72.0 (62.2 to 80.1)
    1.2 (0.2 to 6.7)
    1.1 (0.2 to 5.8)
        18-65 yrs, ST5: Day 180 (n=95, 83, 92)
    37.9 (28.8 to 47.9)
    2.4 (0.7 to 8.4)
    4.3 (1.7 to 10.7)
        18-65 yrs, ST5: Day 194 (n=51, 44, 44)
    98.0 (89.7 to 99.7)
    77.3 (63.0 to 87.2)
    4.5 (1.3 to 15.1)
        18-65 yrs, ST5: Day 208 (n=93, 81, 88)
    95.7 (89.5 to 98.3)
    75.3 (64.9 to 83.4)
    6.8 (3.2 to 14.1)
        18-65 yrs, ST5: Day 365 (n=92, 81, 87)
    41.3 (31.8 to 51.5)
    24.7 (16.6 to 35.1)
    2.3 (0.6 to 8.0)
        18-65 yrs, ST5: Month 18 (n=86, 73, 85)
    11.6 (6.4 to 20.1)
    8.2 (3.8 to 16.8)
    1.2 (0.2 to 6.4)
        18-65 yrs, ST6: Day 85 (n=93, 81, 93)
    68.8 (58.8 to 77.3)
    2.5 (0.7 to 8.6)
    3.2 (1.1 to 9.1)
        18-65 yrs, ST6: Day 180 (n=95, 83, 92)
    31.6 (23.1 to 41.5)
    3.6 (1.2 to 10.1)
    4.3 (1.7 to 10.7)
        18-65 yrs, ST6: Day 194 (n=51, 44, 44)
    98.0 (89.7 to 99.7)
    77.3 (63.0 to 87.2)
    6.8 (2.3 to 18.2)
        18-65 yrs, ST6: Day 208 (n=93, 81, 88)
    93.5 (86.6 to 97.0)
    74.1 (63.6 to 82.4)
    8.0 (3.9 to 15.5)
        18-65 yrs, ST6: Day 365 (n=92, 81, 87)
    42.4 (32.8 to 52.6)
    22.2 (14.5 to 32.4)
    4.6 (1.8 to 11.2)
        18-65 yrs, ST6: Month 18 (n=86, 73, 85)
    15.1 (9.1 to 24.2)
    6.8 (3.0 to 15.1)
    3.5 (1.2 to 9.9)
        12-17 yrs, ST1: Day 85 (n=37, 40, 39)
    91.9 (78.7 to 97.2)
    5.0 (1.4 to 16.5)
    0.0 (0.0 to 9.0)
        12-17 yrs, ST1: Day 180 (n=39, 40, 41)
    59.0 (43.4 to 72.9)
    12.5 (5.5 to 26.1)
    7.3 (2.5 to 19.4)
        12-17 yrs, ST1: Day 208 (n=39, 40, 38)
    97.4 (86.8 to 99.5)
    97.5 (87.1 to 99.6)
    5.3 (1.5 to 17.3)
        12-17 yrs, ST1: Day 365 (n=35, 38, 36)
    48.6 (33.0 to 64.4)
    44.7 (30.1 to 60.3)
    0.0 (0.0 to 9.6)
        12-17 yrs, ST1: Month 18 (n=36, 37, 34)
    27.8 (15.8 to 44.0)
    16.2 (7.7 to 31.1)
    0.0 (0.0 to 10.2)
        12-17 yrs, ST2: Day 85 (n=37, 40, 39)
    94.6 (82.3 to 98.5)
    10.0 (4.0 to 23.1)
    0.0 (0.0 to 9.0)
        12-17 yrs, ST2: Day 180 (n=39, 40, 41)
    82.1 (67.3 to 91.0)
    17.5 (8.7 to 31.9)
    4.9 (1.3 to 16.1)
        12-17 yrs, ST2: Day 208 (n=39, 40, 38)
    100 (91.0 to 100)
    97.5 (87.1 to 99.6)
    2.6 (0.5 to 13.5)
        12-17 yrs, ST2: Day 365 (n=35, 38, 36)
    65.7 (49.2 to 79.2)
    71.1 (55.2 to 83.0)
    2.8 (0.5 to 14.2)
        12-17 yrs, ST2: Month 18 (n=36, 37, 34)
    41.7 (27.1 to 57.8)
    48.6 (33.4 to 64.1)
    0.0 (0.0 to 10.2)
        12-17 yrs, ST3: Day 85 (n=37, 40, 39)
    94.6 (82.3 to 98.5)
    17.5 (8.7 to 31.9)
    0.0 (0.0 to 9.0)
        12-17 yrs, ST3: Day 180 (n=39, 40, 41)
    84.6 (70.3 to 92.8)
    17.5 (8.7 to 31.9)
    7.3 (2.5 to 19.4)
        12-17 yrs, ST3: Day 208 (n=39, 40, 38)
    100 (91.0 to 100)
    97.5 (87.1 to 99.6)
    7.9 (2.7 to 20.8)
        12-17 yrs, ST3: Day 365 (n=35, 38, 36)
    71.4 (54.9 to 83.7)
    78.9 (63.7 to 88.9)
    0.0 (0.0 to 9.6)
        12-17 yrs, ST3: Month 18 (n=36, 37, 34)
    38.9 (24.8 to 55.1)
    54.1 (38.4 to 69.0)
    0.0 (0.0 to 10.2)
        12-17 yrs, ST4: Day 85 (n=37, 40, 39)
    97.3 (86.2 to 99.5)
    5.0 (1.4 to 16.5)
    0.0 (0.0 to 9.0)
        12-17 yrs, ST4: Day 180 (n=39, 40, 41)
    79.5 (64.5 to 89.2)
    10.0 (4.0 to 23.1)
    4.9 (1.3 to 16.1)
        12-17 yrs, ST4: Day 208 (n=39, 40, 38)
    100 (91.0 to 100)
    97.5 (87.1 to 99.6)
    7.9 (2.7 to 20.8)
        12-17 yrs, ST4: Day 365 (n=35, 38, 36)
    65.7 (49.2 to 79.2)
    55.3 (39.7 to 69.9)
    0.0 (0.0 to 9.6)
        12-17 yrs, ST4: Month 18 (n=36, 37, 34)
    44.4 (29.5 to 60.4)
    29.7 (17.5 to 45.8)
    0.0 (0.0 to 10.2)
        12-17 yrs, ST5: Day 85 (n=37, 40, 39)
    94.6 (82.3 to 98.5)
    7.5 (2.6 to 19.9)
    2.6 (0.5 to 13.2)
        12-17 yrs, ST5: Day 180 (n=39, 40, 41)
    74.4 (58.9 to 85.4)
    12.5 (5.5 to 26.1)
    2.4 (0.4 to 12.6)
        12-17 yrs, ST5: Day 208 (n=39, 40, 38)
    100 (91.0 to 100)
    97.5 (87.1 to 99.6)
    5.3 (1.5 to 17.3)
        12-17 yrs, ST5: Day 365 (n=35, 38, 36)
    65.7 (49.2 to 79.2)
    63.2 (47.3 to 76.6)
    0.0 (0.0 to 9.6)
        12-17 yrs, ST5: Month 18 (n=36, 37, 34)
    33.3 (20.2 to 49.7)
    24.3 (13.4 to 40.1)
    2.9 (0.5 to 14.9)
        12-17 yrs, ST6: Day 85 (n=37, 40, 39)
    91.9 (78.7 to 97.2)
    5.0 (1.4 to 16.5)
    0.0 (0.0 to 9.0)
        12-17 yrs, ST6: Day 180 (n=39, 40, 41)
    66.7 (51.0 to 79.4)
    15.0 (7.1 to 29.1)
    7.3 (2.5 to 19.4)
        12-17 yrs, ST6: Day 208 (n=39, 40, 38)
    100 (91.0 to 100)
    95.0 (83.5 to 98.6)
    10.5 (4.2 to 24.1)
        12-17 yrs, ST6: Day 365 (n=35, 38, 36)
    68.6 (52.0 to 81.4)
    52.6 (37.3 to 67.5)
    2.8 (0.5 to 14.2)
        12-17 yrs, ST6: Month 18 (n=36, 37, 34)
    33.3 (20.2 to 49.7)
    21.6 (11.4 to 37.2)
    2.9 (0.5 to 14.9)
        5-11 yrs, ST1: Day 85 (n=38, 34, 38)
    97.4 (86.5 to 99.5)
    2.9 (0.5 to 14.9)
    2.6 (0.5 to 13.5)
        5-11 yrs, ST1: Day 180 (n=37, 38, 39)
    67.6 (51.5 to 80.4)
    2.6 (0.5 to 13.5)
    0.0 (0.0 to 9.0)
        5-11 yrs, ST1: Day 208 (n=38, 37, 39)
    97.4 (86.5 to 99.5)
    97.3 (86.2 to 99.5)
    2.6 (0.5 to 13.2)
        5-11 yrs, ST1: Day 365 (n=35, 37, 35)
    65.7 (49.2 to 79.2)
    51.4 (35.9 to 66.6)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST1: Month 18 (n=35, 34, 37)
    20.0 (10.0 to 35.9)
    8.8 (3.0 to 23.0)
    0.0 (0.0 to 9.4)
        5-11 yrs, ST2: Day 85 (n=38, 34, 38)
    97.4 (86.5 to 99.5)
    11.8 (4.7 to 26.6)
    2.6 (0.5 to 13.5)
        5-11 yrs, ST2: Day 180 (n=37, 38, 39)
    94.6 (82.3 to 98.5)
    5.3 (1.5 to 17.3)
    0.0 (0.0 to 9.0)
        5-11 yrs, ST2: Day 208 (n=38, 37, 39)
    97.4 (86.5 to 99.5)
    100 (90.6 to 100)
    2.6 (0.5 to 13.2)
        5-11 yrs, ST2: Day 365 (n=35, 37, 35)
    91.4 (77.6 to 97.0)
    83.8 (68.9 to 92.3)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST2: Month 18 (n=35, 34, 37)
    57.1 (40.9 to 72.0)
    50.0 (34.1 to 65.9)
    0.0 (0.0 to 9.4)
        5-11 yrs, ST3: Day 85 (n=38, 34, 38)
    97.4 (86.5 to 99.5)
    17.6 (8.3 to 33.5)
    2.6 (0.5 to 13.5)
        5-11 yrs, ST3: Day 180 (n=37, 38, 39)
    89.2 (75.3 to 95.7)
    10.5 (4.2 to 24.1)
    0.0 (0.0 to 9.0)
        5-11 yrs, ST3: Day 208 (n=38, 37, 39)
    97.4 (86.5 to 99.5)
    100 (90.6 to 100)
    2.6 (0.5 to 13.2)
        5-11 yrs, ST3: Day 365 (n=35, 37, 35)
    80.0 (64.1 to 90.0)
    91.9 (78.7 to 97.2)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST3: Month 18 (n=35, 34, 37)
    54.3 (38.2 to 69.5)
    70.6 (53.8 to 83.2)
    2.7 (0.5 to 13.8)
        5-11 yrs, ST4: Day 85 (n=38, 34, 38)
    97.4 (86.5 to 99.5)
    11.8 (4.7 to 26.6)
    5.3 (1.5 to 17.3)
        5-11 yrs, ST4: Day 180 (n=37, 38, 39)
    89.2 (75.3 to 95.7)
    7.9 (2.7 to 20.8)
    5.1 (1.4 to 16.9)
        5-11 yrs, ST4: Day 208 (n=38, 37, 39)
    97.4 (86.5 to 99.5)
    100 (90.6 to 100)
    5.1 (1.4 to 16.9)
        5-11 yrs, ST4: Day 365 (n=35, 37, 35)
    85.7 (70.6 to 93.7)
    75.7 (59.9 to 86.6)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST4: Month 18 (n=35, 34, 37)
    48.6 (33.0 to 64.4)
    29.4 (16.8 to 46.2)
    0.0 (0.0 to 9.4)
        5-11 yrs, ST5: Day 85 (n=38, 34, 38)
    97.4 (86.5 to 99.5)
    8.8 (3.0 to 23.0)
    5.3 (1.5 to 17.3)
        5-11 yrs, ST5: Day 180 (n=37, 38, 39)
    91.9 (78.7 to 97.2)
    5.3 (1.5 to 17.3)
    5.1 (1.4 to 16.9)
        5-11 yrs, ST5: Day 208 (n=38, 37, 39)
    97.4 (86.5 to 99.5)
    100 (90.6 to 100)
    7.7 (2.7 to 20.3)
        5-11 yrs, ST5: Day 365 (n=35, 37, 35)
    91.4 (77.6 to 97.0)
    64.9 (48.8 to 78.2)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST5: Month 18 (n=35, 34, 37)
    42.9 (28.0 to 59.1)
    29.4 (16.8 to 46.2)
    0.0 (0.0 to 9.4)
        5-11 yrs, ST6: Day 85 (n=39, 34, 38)
    94.9 (83.1 to 98.6)
    8.8 (3.0 to 23.0)
    2.6 (0.5 to 13.5)
        5-11 yrs, ST6: Day 180 (n=38, 38, 39)
    78.9 (63.7 to 88.9)
    13.2 (5.8 to 27.3)
    5.1 (1.4 to 16.9)
        5-11 yrs, ST6: Day 208 (n=39, 37, 39)
    94.9 (83.1 to 98.6)
    100 (90.6 to 100)
    7.7 (2.7 to 20.3)
        5-11 yrs, ST6: Day 365 (n=36, 37, 35)
    83.3 (68.1 to 92.1)
    73.0 (57.0 to 84.6)
    0.0 (0.0 to 9.9)
        5-11 yrs, ST6: Month 18 (n=36, 34, 37)
    27.8 (15.8 to 44.0)
    32.4 (19.1 to 49.2)
    0.0 (0.0 to 9.4)
    No statistical analyses for this end point

    Secondary: GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208 During the Main Study Phase

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    End point title
    		 GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208 During the Main Study Phase
    End point description
    GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 & 18-65 yrs) determined by IgG binding assay at Day 85 and Day 208 were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Days 85 and 208
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Fold rise
    geometric mean (confidence interval 95%)
        18-65 yrs, ST1: Day 85 (n=93, 81, 93)
    3.1 (2.4 to 3.9)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST1: Day 208 (n=93, 81, 88)
    9.4 (7.2 to 12.2)
    4.0 (3.1 to 5.3)
    1.1 (1.0 to 1.3)
        18-65 yrs, ST2: Day 85 (n=93, 81, 93)
    7.2 (5.7 to 9.1)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST2: Day 208 (n=93, 81, 88)
    19.7 (15.9 to 24.4)
    10.6 (8.1 to 13.7)
    1.0 (0.9 to 1.1)
        18-65 yrs, ST3: Day 85 (n=93, 81, 93)
    6.5 (5.1 to 8.2)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST3: Day 208 (n=93, 81, 88)
    17.7 (14.3 to 22.0)
    9.0 (6.8 to 11.8)
    1.1 (1.0 to 1.2)
        18-65 yrs, ST4: Day 85 (n=93, 81, 93)
    3.8 (3.1 to 4.8)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST4: Day 208 (n=93, 81, 88)
    11.9 (9.5 to 15.0)
    5.2 (4.0 to 6.7)
    1.1 (1.0 to 1.2)
        18-65 yrs, ST5: Day 85 (n=93, 81, 93)
    4.2 (3.3 to 5.2)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST5: Day 208 (n=93, 81, 88)
    12.7 (10.3 to 15.8)
    4.9 (3.8 to 6.4)
    1.1 (1.0 to 1.2)
        18-65 yrs, ST6: Day 85 (n=93, 81, 93)
    3.6 (2.9 to 4.5)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
        18-65 yrs, ST6: Day 208 (n=93, 81, 88)
    11.6 (9.2 to 14.7)
    4.6 (3.6 to 5.9)
    1.1 (1.0 to 1.2)
        12-17 yrs, ST1: Day 85 (n=37, 40, 39)
    9.9 (6.8 to 14.4)
    1.0 (1.0 to 1.1)
    1.0 (0.9 to 1.0)
        12-17 yrs, ST1: Day 208 (n=39, 40, 38)
    25.4 (18.1 to 35.7)
    23.4 (15.7 to 34.8)
    1.1 (1.0 to 1.2)
        12-17 yrs, ST2: Day 85 (n=37, 40, 39)
    20.7 (14.2 to 30.2)
    1.2 (1.0 to 1.4)
    1.0 (1.0 to 1.0)
        12-17 yrs, ST2: Day 208 (n=39, 40, 38)
    45.2 (34.8 to 58.8)
    45.3 (31.0 to 66.4)
    1.0 (1.0 to 1.1)
        12-17 yrs, ST3: Day 85 (n=37, 40, 39)
    21.3 (14.4 to 31.6)
    1.2 (1.1 to 1.4)
    1.0 (0.9 to 1.0)
        12-17 yrs, ST3: Day 208 (n=39, 40, 38)
    43.9 (32.5 to 59.3)
    46.9 (31.3 to 70.2)
    1.0 (1.0 to 1.1)
        12-17 yrs, ST4: Day 85 (n=37, 40, 39)
    12.8 (9.1 to 18.2)
    1.1 (1.0 to 1.2)
    1.0 (0.9 to 1.0)
        12-17 yrs, ST4: Day 208 (n=39, 40, 38)
    32.0 (23.8 to 43.0)
    26.1 (17.7 to 38.4)
    1.1 (1.0 to 1.2)
        12-17 yrs, ST5: Day 85 (n=37, 40, 39)
    13.7 (9.5 to 19.7)
    1.1 (1.0 to 1.2)
    1.0 (0.9 to 1.1)
        12-17 yrs, ST5: Day 208 (n=39, 40, 38)
    31.7 (24.1 to 41.7)
    25.8 (17.7 to 37.7)
    1.0 (0.9 to 1.2)
        12-17 yrs, ST6: Day 85 (n=37, 40, 39)
    11.2 (7.8 to 16.2)
    1.1 (1.0 to 1.2)
    1.0 (0.9 to 1.0)
        12-17 yrs, ST6: Day 208 (n=39, 40, 38)
    30.0 (22.5 to 39.9)
    19.7 (13.4 to 28.8)
    1.1 (1.0 to 1.3)
        5-11 yrs, ST1: Day 85 (n=38, 34, 38)
    12.3 (9.8 to 15.3)
    1.0 (1.0 to 1.1)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST1: Day 208 (n=38, 37, 39)
    32.3 (24.3 to 42.9)
    25.7 (17.8 to 37.1)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST2: Day 85 (n=38, 34, 38)
    30.2 (23.4 to 39.0)
    1.2 (1.0 to 1.3)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST2: Day 208 (n=38, 37, 39)
    66.9 (50.5 to 88.6)
    60.7 (44.9 to 81.9)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST3: Day 85 (n=38, 34, 38)
    30.7 (23.1 to 40.8)
    1.2 (1.0 to 1.4)
    1.0 (0.9 to 1.2)
        5-11 yrs, ST3: Day 208 (n=38, 37, 39)
    54.7 (40.5 to 74.0)
    65.1 (47.1 to 89.9)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST4: Day 85 (n=38, 34, 38)
    16.9 (13.0 to 22.1)
    1.1 (1.0 to 1.3)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST4: Day 208 (n=38, 37, 39)
    43.9 (33.0 to 58.6)
    33.1 (23.7 to 46.4)
    1.0 (0.8 to 1.3)
        5-11 yrs, ST5: Day 85 (n=38, 34, 38)
    21.7 (16.6 to 28.4)
    1.1 (1.0 to 1.2)
    1.0 (0.9 to 1.3)
        5-11 yrs, ST5: Day 208 (n=38, 37, 39)
    49.6 (37.3 to 65.9)
    34.5 (24.9 to 47.7)
    1.1 (0.9 to 1.3)
        5-11 yrs, ST6: Day 85 (n=39, 34, 38)
    14.4 (10.9 to 19.0)
    1.1 (1.0 to 1.2)
    1.0 (0.8 to 1.2)
        5-11 yrs, ST6: Day 208 (n=39, 37, 39)
    38.8 (26.9 to 56.0)
    31.5 (22.4 to 44.3)
    1.1 (0.9 to 1.4)
    No statistical analyses for this end point

    Secondary: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 During the Booster Phase

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    End point title
    		 GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 During the Booster Phase
    End point description
    GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 23, 26, 30, 31, 39, 42, 43 and 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Titers
    geometric mean (confidence interval 95%)
        ST1: Month 19 (n=127, 111, 123)
    1057.0 (843.1 to 1325.1)
    830.0 (621.3 to 1108.9)
    20.9 (20.0 to 21.9)
        ST1: Month 23 (n=115, 109, 118)
    178.2 (142.9 to 222.2)
    136.9 (107.3 to 174.6)
    21.4 (20.1 to 22.9)
        ST1 Month 26 (n=110, 103, 112)
    91.0 (74.4 to 111.4)
    71.1 (56.3 to 89.8)
    21.9 (20.5 to 23.4)
        ST1: Month 30 (n=107, 97, 97)
    61.1 (49.0 to 76.2)
    52.6 (42.0 to 65.7)
    20.3 (19.7 to 20.9)
        ST1: Month 31 (n=113, 98, 97)
    1193.1 (967.1 to 1471.8)
    941.4 (729.8 to 1214.4)
    21.0 (19.0 to 23.3)
        ST1: Month 39 (n=107, 83, 86)
    97.3 (81.5 to 116.2)
    89.5 (69.7 to 114.8)
    21.2 (19.6 to 23.1)
        ST1: Month 42 (n=105, 82, 85)
    78.3 (66.1 to 92.6)
    68.6 (54.6 to 86.2)
    20.6 (19.7 to 21.6)
        ST1: Month 43 (n=112, 91, 88)
    1044.8 (888.5 to 1228.5)
    969.8 (768.9 to 1223.2)
    21.5 (19.1 to 24.2)
        ST1: Month 48 (n=92, 79, 75)
    201.1 (159.9 to 252.8)
    173.8 (136.8 to 220.9)
    20.0 (20.0 to 20.0)
        ST2: Month 19 (n=127, 111, 123)
    1807.9 (1486.2 to 2199.3)
    1603.1 (1239.7 to 2073.0)
    20.5 (19.8 to 21.2)
        ST2: Month 23 (n=115, 109, 118)
    350.5 (294.0 to 417.9)
    282.6 (228.2 to 349.9)
    20.9 (19.8 to 22.1)
        ST2: Month 26 (n=110, 103, 112)
    177.1 (148.6 to 211.0)
    140.6 (112.7 to 175.6)
    21.5 (20.3 to 22.8)
        ST2: Month 30 (n=107, 97, 97)
    106.9 (85.8 to 133.2)
    95.2 (76.4 to 118.5)
    20.3 (19.7 to 20.8)
        ST2: Month 31 (n=113, 98, 97)
    1788.6 (1501.0 to 2131.2)
    1489.7 (1197.1 to 1853.8)
    21.4 (19.2 to 23.9)
        ST2: Month 39 (n=107, 83, 86)
    172.5 (144.4 to 206.0)
    150.3 (118.7 to 190.3)
    20.8 (19.5 to 22.2)
        ST2: Month 42 (n=105, 82, 85)
    132.9 (110.9 to 159.3)
    115.5 (92.7 to 143.9)
    20.5 (19.5 to 21.6)
        ST2: Month 43 (n=112, 91, 88)
    1622.3 (1407.9 to 1869.4)
    1555.9 (1253.9 to 1930.7)
    21.2 (18.9 to 23.9)
        ST2: Month 48 (n=92, 79, 75)
    324.6 (264.4 to 398.5)
    306.0 (250.4 to 373.8)
    20.0 (20.0 to 20.0)
        ST3: Month 19 (n=127, 111, 123)
    1628.0 (1331.6 to 1990.2)
    1418.0 (1094.3 to 1837.4)
    20.8 (20.1 to 21.6)
        ST3: Month 23 (n=115, 109, 118)
    319.5 (261.3 to 390.8)
    283.6 (225.2 to 357.2)
    21.0 (19.7 to 22.4)
        ST3: Month 26 (n=110, 103, 112)
    160.9 (133.7 to 193.5)
    143.9 (114.7 to 180.6)
    21.6 (20.3 to 23.0)
        ST3: Month 30 (n=107, 97, 97)
    97.9 (77.6 to 123.6)
    102.6 (82.0 to 128.2)
    21.2 (20.2 to 22.2)
        ST3: Month 31 (n=113, 98, 97)
    1592.0 (1327.3 to 1909.6)
    1396.0 (1099.7 to 1772.2)
    21.9 (19.6 to 24.5)
        ST3: Month 39 (n=107, 83, 86)
    155.5 (129.6 to 186.6)
    151.9 (117.7 to 196.0)
    21.5 (19.3 to 23.9)
        ST3: Month 42 (n=105, 82, 85)
    118.6 (99.0 to 142.0)
    119.1 (95.4 to 148.7)
    20.7 (19.7 to 21.8)
        ST3: Month 43 (n=112, 91, 88)
    1388.1 (1192.5 to 1615.9)
    1393.0 (1104.4 to 1756.9)
    21.8 (19.3 to 24.5)
        ST3: Month 48 (n=92, 79, 75)
    320.2 (258.0 to 397.5)
    317.4 (253.5 to 397.4)
    20.7 (19.7 to 21.8)
        ST4: Month 19 (n=127, 111, 123)
    1334.1 (1086.0 to 1639.0)
    1032.9 (786.1 to 1357.3)
    21.7 (20.5 to 23.0)
        ST4: Month 23 (n=115, 109, 118)
    227.5 (185.0 to 279.8)
    170.4 (135.1 to 215.0)
    22.0 (20.3 to 23.8)
        ST4: Month 26 (n=110, 103, 112)
    122.9 (102.6 to 147.2)
    90.6 (72.4 to 113.5)
    22.7 (21.0 to 24.6)
        ST4: Month 30 (n=107, 97, 97)
    81.1 (65.3 to 100.7)
    63.9 (51.4 to 79.5)
    21.4 (20.0 to 22.9)
        ST4: Month 31 (n=113, 98, 97)
    1493.2 (1242.7 to 1794.2)
    1123.3 (877.9 to 1437.2)
    23.2 (20.5 to 26.3)
        ST4: Month 39 (n=107, 83, 86)
    125.1 (104.5 to 149.7)
    113.6 (89.1 to 144.9)
    21.9 (19.7 to 24.4)
        ST4: Month 42 (n=105, 82, 85)
    101.8 (85.6 to 121.1)
    88.0 (70.1 to 110.4)
    21.9 (20.2 to 23.8)
        ST4: Month 43 (n=112, 91, 88)
    1327.6 (1143.7 to 1541.0)
    1199.4 (964.0 to 1492.3)
    22.5 (19.8 to 25.6)
        ST4: Month 48 (n=92, 79, 75)
    260.0 (209.3 to 323.0)
    226.7 (184.2 to 279.1)
    20.6 (19.5 to 21.7)
        ST5: Month 19 (n=127, 111, 123)
    1266.2 (1024.3 to 1565.2)
    980.1 (745.0 to 1289.4)
    20.2 (19.8 to 20.7)
        ST5: Month 23 (n=115, 109, 118)
    226.5 (186.1 to 275.7)
    150.6 (117.6 to 193.0)
    21.0 (19.8 to 22.2)
        ST5: Month 26 (n=110, 103, 112)
    121.5 (101.1 to 146.1)
    86.6 (69.2 to 108.4)
    21.6 (20.3 to 23.0)
        ST5: Month 30 (n=107, 97, 97)
    72.6 (57.8 to 91.2)
    65.7 (52.8 to 81.7)
    20.3 (19.7 to 20.9)
        ST5: Month 31 (n=113, 98, 97)
    1354.6 (1130.8 to 1622.7)
    1044.5 (829.9 to 1314.7)
    22.1 (19.7 to 24.9)
        ST5: Month 39 (n=107, 83, 86)
    119.8 (100.7 to 142.7)
    106.7 (84.5 to 134.9)
    21.4 (19.6 to 23.4)
        ST5: Month 42 (n=105, 82, 85)
    91.8 (77.1 to 109.3)
    83.7 (67.7 to 103.5)
    20.3 (19.7 to 20.9)
        ST5: Month 43 (n=112, 91, 88)
    1195.4 (1030.9 to 1386.3)
    1097.4 (884.8 to 1361.1)
    21.5 (19.1 to 24.2)
        ST5: Month 48 (n=92, 79, 75)
    226.0 (181.5 to 281.4)
    181.2 (141.0 to 232.9)
    20.3 (19.7 to 21.0)
        ST6: Month 19 (n=127, 111, 123)
    1254.9 (1020.7 to 1542.8)
    957.2 (726.8 to 1260.5)
    22.3 (21.0 to 23.7)
        ST6: Month 23 (n=115, 109, 118)
    226.3 (184.3 to 277.8)
    165.7 (131.3 to 209.0)
    22.2 (20.7 to 23.9)
        ST6: Month 26 (n=110, 103, 112)
    128.0 (106.5 to 153.9)
    88.6 (70.9 to 110.7)
    22.6 (21.0 to 24.2)
        ST6: Month 30 (n=107, 97, 97)
    76.3 (60.7 to 95.9)
    67.3 (54.3 to 83.5)
    22.1 (20.6 to 23.7)
        ST6: Month 31 (n=113, 98, 97)
    1358.1 (1132.7 to 1628.3)
    1026.8 (813.9 to 1295.3)
    23.5 (20.7 to 26.7)
        ST6: Month 39 (n=107, 83, 86)
    124.0 (103.4 to 148.8)
    103.7 (81.8 to 131.4)
    22.1 (20.0 to 24.5)
        ST6: Month 42 (n=105, 82, 85)
    98.2 (81.8 to 118.0)
    82.7 (66.2 to 103.5)
    20.8 (19.7 to 22.0)
        ST6: Month 43 (n=112, 91, 88)
    1195.8 (1028.0 to 1391.0)
    1072.7 (862.9 to 1333.6)
    22.4 (19.8 to 25.4)
        ST6: Month 48 (n=92, 79, 75)
    240.9 (192.4 to 301.7)
    203.7 (164.6 to 252.2)
    21.0 (19.8 to 22.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroconversion at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 After Vaccination During the Booster Phase

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    End point title
    		 Percentage of Participants With Seroconversion at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 After Vaccination During the Booster Phase
    End point description
    SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA were evaluated. Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 23, 26, 30, 31, 39, 42, 43 and 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Percentage of participants
    number (confidence interval 95%)
        ST1: Month 19 (n=126, 111, 123)
    96.8 (92.1 to 98.8)
    94.6 (88.7 to 97.5)
    0.0 (0.0 to 3.0)
        ST1: Month 23 (n=115, 109, 118)
    87.8 (80.6 to 92.6)
    80.7 (72.3 to 87.0)
    1.7 (0.5 to 6.0)
        ST1: Month 26 (n=110, 103, 112)
    75.5 (66.6 to 82.5)
    62.1 (52.5 to 70.9)
    3.6 (1.4 to 8.8)
        ST1: Month 30 (n=107, 97, 97)
    57.9 (48.5 to 66.9)
    49.5 (39.7 to 59.3)
    0.0 (0.0 to 3.8)
        ST1: Month 31 (n=113, 98, 97)
    97.3 (92.5 to 99.1)
    98.0 (92.9 to 99.4)
    1.0 (0.2 to 5.6)
        ST1: Month 39 (n=107, 83, 86)
    80.4 (71.9 to 86.8)
    71.1 (60.6 to 79.7)
    2.3 (0.6 to 8.1)
        ST1: Month 42 (n=105, 82, 85)
    77.1 (68.2 to 84.1)
    67.1 (56.3 to 76.3)
    2.4 (0.6 to 8.2)
        ST1: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    2.3 (0.6 to 7.9)
        ST1: Month 48 (n=92, 79, 75)
    92.4 (85.1 to 96.3)
    93.7 (86.0 to 97.3)
    0.0 (0.0 to 4.9)
        ST2: Month 19 (n=126, 111, 123)
    97.6 (93.2 to 99.2)
    96.4 (91.1 to 98.6)
    0.0 (0.0 to 3.0)
        ST2: Month 23 (n=115, 109, 118)
    96.5 (91.4 to 98.6)
    92.7 (86.2 to 96.2)
    0.8 (0.1 to 4.6)
        ST2: Month 26 (n=110, 103, 112)
    91.8 (85.2 to 95.6)
    81.6 (73.0 to 87.9)
    4.5 (1.9 to 10.0)
        ST2: Month 30 (n=107, 97, 97)
    78.5 (69.8 to 85.2)
    74.2 (64.7 to 81.9)
    1.0 (0.2 to 5.6)
        ST2: Month 31 (n=113, 98, 97)
    99.1 (95.2 to 99.8)
    99.0 (94.4 to 99.8)
    2.1 (0.6 to 7.2)
        ST2: Month 39 (n=107, 83, 86)
    90.7 (83.6 to 94.8)
    84.3 (75.0 to 90.6)
    2.3 (0.6 to 8.1)
        ST2: Month 42 (n=105, 82, 85)
    85.7 (77.8 to 91.1)
    81.7 (72.0 to 88.6)
    1.2 (0.2 to 6.4)
        ST2: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    1.1 (0.2 to 6.2)
        ST2: Month 48 (n=92, 79, 75)
    94.6 (87.9 to 97.7)
    97.5 (91.2 to 99.3)
    0.0 (0.0 to 4.9)
        ST3: Month 19 (n=126, 111, 123)
    97.6 (93.2 to 99.2)
    96.4 (91.1 to 98.6)
    2.4 (0.8 to 6.9)
        ST3: Month 23 (n=115, 109, 118)
    93.0 (86.9 to 96.4)
    91.7 (85.0 to 95.6)
    1.7 (0.5 to 6.0)
        ST3: Month 26 (n=110, 103, 112)
    90.0 (83.0 to 94.3)
    85.4 (77.4 to 91.0)
    5.4 (2.5 to 11.2)
        ST3: Month 30 (n=107, 97, 97)
    74.8 (65.8 to 82.0)
    78.4 (69.2 to 85.4)
    6.2 (2.9 to 12.8)
        ST3: Month 31 (n=113, 98, 97)
    99.1 (95.2 to 99.8)
    99.0 (94.4 to 99.8)
    4.1 (1.6 to 10.1)
        ST3: Month 39 (n=107, 83, 86)
    90.7 (83.6 to 94.8)
    84.3 (75.0 to 90.6)
    2.3 (0.6 to 8.1)
        ST3: Month 42 (n=105, 82, 85)
    88.6 (81.1 to 93.3)
    86.6 (77.6 to 92.3)
    2.4 (0.6 to 8.2)
        ST3: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    3.4 (1.2 to 9.5)
        ST3: Month 48 (n=92, 79, 75)
    95.7 (89.3 to 98.3)
    96.2 (89.4 to 98.7)
    2.7 (0.7 to 9.2)
        ST4: Month 19 (n=126, 111, 123)
    97.6 (93.2 to 99.2)
    94.6 (88.7 to 97.5)
    3.3 (1.3 to 8.1)
        ST4: Month 23 (n=115, 109, 118)
    91.3 (84.7 to 95.2)
    88.1 (80.7 to 92.9)
    2.5 (0.9 to 7.2)
        ST4: Month 26 (n=110, 103, 112)
    86.4 (78.7 to 91.6)
    72.8 (63.5 to 80.5)
    7.1 (3.7 to 13.5)
        ST4: Month 30 (n=107, 97, 97)
    72.9 (63.8 to 80.4)
    60.8 (50.9 to 69.9)
    1.0 (0.2 to 5.6)
        ST4: Month 31 (n=113, 98, 97)
    99.1 (95.2 to 99.8)
    98.0 (92.9 to 99.4)
    3.1 (1.1 to 8.7)
        ST4: Month 39 (n=107, 83, 86)
    85.0 (77.1 to 90.6)
    80.7 (71.0 to 87.8)
    2.3 (0.6 to 8.1)
        ST4: Month 42 (n=105, 82, 85)
    82.9 (74.5 to 88.9)
    74.4 (64.0 to 82.6)
    4.7 (1.8 to 11.5)
        ST4: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    4.5 (1.8 to 11.1)
        ST4: Month 48 (n=92, 79, 75)
    94.6 (87.9 to 97.7)
    98.7 (93.2 to 99.8)
    0.0 (0.0 to 4.9)
        ST5: Month 19 (n=126, 111, 123)
    96.8 (92.1 to 98.8)
    94.6 (88.7 to 97.5)
    0.8 (0.1 to 4.5)
        ST5: Month 23 (n=115, 109, 118)
    91.3 (84.7 to 95.2)
    78.0 (69.3 to 84.7)
    2.5 (0.9 to 7.2)
        ST5: Month 26 (n=110, 103, 112)
    85.5 (77.7 to 90.8)
    68.0 (58.4 to 76.2)
    5.4 (2.5 to 11.2)
        ST5: Month 30 (n=107, 97, 97)
    61.7 (52.2 to 70.3)
    60.8 (50.9 to 69.9)
    1.0 (0.2 to 5.6)
        ST5: Month 31 (n=113, 98, 97)
    99.1 (95.2 to 99.8)
    99.0 (94.4 to 99.8)
    4.1 (1.6 to 10.1)
        ST5: Month 39 (n=107, 83, 86)
    86.0 (78.2 to 91.3)
    80.7 (71.0 to 87.8)
    3.5 (1.2 to 9.8)
        ST5: Month 42 (n=105, 82, 85)
    80.0 (71.4 to 86.5)
    79.3 (69.3 to 86.6)
    1.2 (0.2 to 6.4)
        ST5: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    2.3 (0.6 to 7.9)
        ST5: Month 48 (n=92, 79, 75)
    92.4 (85.1 to 96.3)
    87.3 (78.2 to 93.0)
    1.3 (0.2 to 7.2)
        ST6: Month 19 (n=127, 111, 123)
    96.9 (92.2 to 98.8)
    94.6 (88.7 to 97.5)
    4.1 (1.7 to 9.2)
        ST6: Month 23 (n=115, 109, 118)
    90.4 (83.7 to 94.6)
    83.5 (75.4 to 89.3)
    2.5 (0.9 to 7.2)
        ST6: Month 26 (n=110, 103, 112)
    86.4 (78.7 to 91.6)
    66.0 (56.4 to 74.4)
    7.1 (3.7 to 13.5)
        ST6: Month 30 (n=107, 97, 97)
    59.8 (50.3 to 68.6)
    59.8 (49.8 to 69.0)
    4.1 (1.6 to 10.1)
        ST6 :Month 31 (n=113, 98, 97)
    99.1 (95.2 to 99.8)
    98.0 (92.9 to 99.4)
    3.1 (1.1 to 8.7)
        ST6: Month 39 (n=107, 83, 86)
    85.0 (77.1 to 90.6)
    77.1 (67.0 to 84.8)
    4.7 (1.8 to 11.4)
        ST6: Month 42 (n=105, 82, 85)
    79.0 (70.3 to 85.7)
    70.7 (60.1 to 79.5)
    2.4 (0.6 to 8.2)
        ST6: Month 43 (n=112, 91, 88)
    100 (96.7 to 100)
    98.9 (94.0 to 99.8)
    3.4 (1.2 to 9.5)
        ST6: Month 48 (n=92, 79, 75)
    92.4 (85.1 to 96.3)
    93.7 (86.0 to 97.3)
    1.3 (0.2 to 7.2)
    No statistical analyses for this end point

    Secondary: GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 18 (M18)-M19, M30-M31, M42-M43 During the Booster Phase

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    End point title
    		 GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 18 (M18)-M19, M30-M31, M42-M43 During the Booster Phase
    End point description
    GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1–ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints (Months 18, 30, and 42, respectively). PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 31 and 43
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Fold rise
    geometric mean (confidence interval 95%)
        ST1: Month 19 (n=127, 110, 123)
    38.4 (31.0 to 47.7)
    36.5 (27.7 to 48.1)
    1.0 (1.0 to 1.0)
        ST1: Month 31 (n=113, 97, 96)
    19.3 (15.0 to 25.0)
    19.1 (15.0 to 24.5)
    1.0 (0.9 to 1.2)
        ST1: Month 43 (n=111, 90, 87)
    13.3 (11.3 to 15.7)
    14.3 (11.5 to 17.7)
    1.0 (0.9 to 1.2)
        ST2: Month 19 (n=126, 110, 123)
    50.6 (41.7 to 61.5)
    53.7 (42.3 to 68.2)
    1.0 (1.0 to 1.0)
        ST2: Month 31 (n=113, 97, 96)
    16.2 (12.9 to 20.3)
    15.9 (12.9 to 19.5)
    1.1 (1.0 to 1.2)
        ST2: Month 43 (n=111, 90, 87)
    12.2 (10.3 to 14.4)
    13.6 (10.8 to 17.0)
    1.0 (0.9 to 1.2)
        ST3: Month 19 (n=127, 110, 123)
    46.7 (38.3 to 57.1)
    44.9 (35.6 to 56.6)
    1.0 (1.0 to 1.1)
        ST3: Month 31 (n=113, 97, 96)
    16.6 (13.2 to 21.1)
    14.1 (11.5 to 17.2)
    1.0 (0.9 to 1.2)
        ST3: Month 43 (n=111, 90, 87)
    11.6 (10.0 to 13.5)
    11.6 (9.4 to 14.3)
    1.1 (0.9 to 1.2)
        ST4: Month 19 (n=127, 110, 123)
    40.1 (32.6 to 49.2)
    40.9 (31.5 to 53.0)
    1.0 (1.0 to 1.1)
        ST4: Month 31 (n=113, 97, 96)
    18.1 (14.3 to 23.0)
    18.1 (14.6 to 22.5)
    1.1 (1.0 to 1.2)
        ST4: Month 43 (n=111, 90, 87)
    13.1 (11.1 to 15.4)
    13.6 (11.0 to 17.0)
    1.1 (0.9 to 1.2)
        ST5: Month 19 (n=126, 110, 123)
    41.3 (33.5 to 50.9)
    40.5 (31.3 to 52.4)
    1.0 (1.0 to 1.0)
        ST5: Month 31 (n=113, 97, 96)
    18.5 (14.6 to 23.5)
    16.5 (13.4 to 20.4)
    1.1 (1.0 to 1.2)
        ST5: Month 43 (n=111, 90, 87)
    13.0 (11.1 to 15.2)
    13.1 (10.6 to 16.1)
    1.1 (1.0 to 1.2)
        ST6: Month 19 (n=127, 110, 123)
    37.2 (30.2 to 45.8)
    37.4 (28.9 to 48.5)
    1.0 (1.0 to 1.1)
        ST6: Month 31 (n=113, 97, 96)
    18.2 (14.4 to 23.1)
    15.4 (12.5 to 19.0)
    1.1 (0.9 to 1.2)
        ST6: Month 43 (n=111, 90, 87)
    12.0 (10.3 to 14.0)
    13.0 (10.5 to 16.1)
    1.1 (0.9 to 1.2)
    No statistical analyses for this end point

    Secondary: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 During the Booster Phase

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    End point title
    		 GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 During the Booster Phase
    End point description
    GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 & 18-65 yrs) were evaluated. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 23, 26, 30, 31, 39, 42, 43 and 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Titers
    geometric mean (confidence interval 95%)
        18-65 yrs, ST1: Month 19 (n=72, 65, 67)
    768.3 (565.5 to 1043.9)
    499.6 (356.4 to 700.4)
    21.3 (19.7 to 23.1)
        18-65 yrs, ST1: Month 23 (n=62, 60, 69:)
    130.8 (95.7 to 178.8)
    97.8 (71.2 to 134.1)
    22.1 (19.9 to 24.5)
        18-65 yrs, ST1: Month 26 (n=63, 61, 67)
    72.9 (55.5 to 95.8)
    56.4 (42.6 to 74.8)
    22.8 (20.5 to 25.2)
        18-65 yrs, ST1: Month 30 (n=60, 55, 54)
    41.1 (33.0 to 51.3)
    41.3 (31.8 to 53.6)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST1: Month 31 (n=66, 55, 53)
    818.5 (635.6 to 1054.0)
    606.0 (456.3 to 804.7)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST1: Month 39 (n=61, 49, 53)
    79.9 (63.6 to 100.4)
    59.9 (44.3 to 80.8)
    20.7 (19.7 to 21.7)
        18-65 yrs, ST1: Month 42 (n=61, 49, 53)
    62.7 (50.4 to 77.9)
    54.7 (40.6 to 73.6)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST1: Month 43 (n=63, 53, 54)
    791.7 (651.3 to 962.3)
    589.1 (450.7 to 770.0)
    22.0 (18.2 to 26.5)
        18-65 yrs, ST1: Month 48 (n=52, 46, 43)
    169.2 (126.6 to 226.1)
    138.4 (103.5 to 185.2)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST2: Month 19 (n=72, 65, 67)
    1441.7 (1128.9 to 1841.1)
    1144.1 (856.8 to 1527.8)
    20.9 (19.6 to 22.2)
        18-65 yrs, ST2: Month 23 (n=62, 60, 69)
    277.1 (219.6 to 349.7)
    219.3 (166.8 to 288.4)
    21.6 (19.7 to 23.6)
        18-65 yrs, ST2: Month 26 (n=63, 61, 67)
    134.3 (105.3 to 171.3)
    101.1 (75.9 to 134.6)
    22.2 (20.2 to 24.4)
        18-65 yrs, ST2: Month 30 (n=60, 55, 54)
    72.7 (56.5 to 93.5)
    70.3 (53.4 to 92.4)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST2: Month 31 (n=66, 55, 53)
    1322.1 (1109.9 to 1575.0)
    1028.1 (818.4 to 1291.5)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST2: Month 39 (n=61, 49, 53)
    143.2 (114.4 to 179.2)
    100.0 (72.9 to 137.0)
    20.3 (19.7 to 20.9)
        18-65 yrs, ST2: Month 42 (n=61, 49, 53)
    111.6 (88.3 to 141.0)
    88.8 (66.6 to 118.4)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST2: Month 43 (n=63, 53, 54)
    1331.8 (1146.3 to 1547.4)
    975.7 (759.7 to 1253.2)
    22.0 (18.2 to 26.7)
        18-65 yrs, ST2: Month 48 (n=52, 46, 43)
    297.4 (231.2 to 382.5)
    234.3 (188.6 to 291.0)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST3: Month 19 (n=72, 65, 67)
    1237.2 (963.1 to 1589.4)
    948.9 (710.6 to 1267.1)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST3: Month 23 (n=62, 60, 69)
    237.3 (178.4 to 315.6)
    200.7 (148.8 to 270.7)
    21.7 (19.5 to 24.2)
        18-65 yrs, ST3: Month 26 (n=63, 61, 67)
    124.6 (97.2 to 159.6)
    101.3 (75.5 to 135.9)
    22.1 (20.1 to 24.3)
        18-65 yrs, ST3: Month 30 (n=60, 55, 54)
    66.8 (51.9 to 86.0)
    72.6 (54.9 to 96.1)
    20.8 (19.6 to 22.1)
        18-65 yrs, ST3: Month 31 (n=66, 55, 53)
    1157.5 (956.5 to 1400.7)
    912.8 (702.6 to 1186.0)
    20.6 (19.5 to 21.7)
        18-65 yrs, ST3: Month 39 (n=61, 49, 53)
    133.1 (106.1 to 166.9)
    97.6 (71.3 to 133.5)
    20.7 (19.3 to 22.3)
        18-65 yrs, ST3: Month 42 (n=61, 49, 53)
    96.0 (75.9 to 121.4)
    88.9 (66.6 to 118.5)
    20.6 (19.4 to 22.0)
        18-65 yrs, ST3: Month 43 (n=63, 53, 54)
    1104.0 (925.1 to 1317.4)
    820.3 (627.5 to 1072.4)
    22.0 (18.2 to 26.6)
        18-65 yrs, ST3: Month 48 (n=52, 46, 43)
    279.3 (212.3 to 367.3)
    232.1 (178.2 to 302.3)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST4: Month 19 (n=72, 65, 67)
    994.2 (762.2 to 1296.8)
    668.9 (487.6 to 917.5)
    21.2 (19.6 to 23.0)
        18-65 yrs, ST4: Month 23 (n=62, 60, 69)
    159.1 (118.9 to 212.9)
    121.5 (90.0 to 164.1)
    22.5 (19.9 to 25.5)
        18-65 yrs, ST4: Month 26 (n=63, 61, 67)
    95.6 (75.3 to 121.4)
    67.8 (51.0 to 90.1)
    23.6 (20.9 to 26.6)
        18-65 yrs, ST4: Month 30 (n=60, 55, 54)
    55.5 (44.4 to 69.3)
    47.1 (36.4 to 60.9)
    21.5 (19.4 to 23.9)
        18-65 yrs, ST4: Month 31 (n=66, 55, 53)
    1058.7 (866.2 to 1294.1)
    747.9 (570.9 to 979.8)
    22.3 (19.7 to 25.4)
        18-65 yrs, ST4: Month 39 (n=61, 49, 53)
    106.0 (84.3 to 133.1)
    79.3 (59.3 to 106.0)
    21.6 (19.4 to 24.1)
        18-65 yrs, ST4: Month 42 (n=61, 49, 53)
    82.3 (65.6 to 103.4)
    72.3 (53.6 to 97.5)
    22.0 (19.6 to 24.7)
        18-65 yrs, ST4: Month 43 (n=63, 53, 54)
    1051.5 (882.2 to 1253.2)
    754.6 (585.5 to 972.5)
    23.2 (18.9 to 28.4)
        18-65 yrs, ST4: Month 48 (n=52, 46, 43)
    223.0 (169.9 to 292.7)
    176.3 (139.2 to 223.3)
    21.0 (19.0 to 23.1)
        18-65 yrs, ST5: Month 19 (n=72, 65, 67)
    930.5 (702.6 to 1232.3)
    637.0 (460.8 to 880.6)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST5: Month 23 (n=62, 60, 69)
    164.9 (126.3 to 215.4)
    105.8 (76.3 to 146.8)
    21.3 (19.5 to 23.3)
        18-65 yrs, ST5: Month 26 (n=63, 61, 67)
    95.1 (75.0 to 120.6)
    62.6 (46.9 to 83.6)
    22.4 (20.3 to 24.7)
        18-65 yrs, ST5: Month 30 (n=60, 55, 54)
    47.7 (37.4 to 60.8)
    48.3 (37.1 to 63.0)
    20.5 (19.5 to 21.6)
        18-65 yrs, ST5: Month 31 (n=66, 55, 53)
    974.1 (797.9 to 1189.3)
    696.3 (546.3 to 887.5)
    20.6 (19.4 to 22.0)
        18-65 yrs, ST5: Month 39 (n=61, 49, 53)
    102.2 (82.5 to 126.7)
    70.9 (53.0 to 95.0)
    20.9 (19.6 to 22.3)
        18-65 yrs, ST5: Month 42 (n=61, 49, 53)
    72.3 (57.6 to 90.9)
    69.9 (53.3 to 91.8)
    20.5 (19.5 to 21.4)
        18-65 yrs, ST5: Month 43 (n=63, 53, 54)
    937.6 (789.8 to 1113.1)
    688.1 (540.9 to 875.3)
    22.0 (18.2 to 26.7)
        18-65 yrs, ST5: Month 48 (n=52, 46, 43)
    194.9 (146.5 to 259.3)
    142.0 (104.3 to 193.4)
    20.0 (20.0 to 20.0)
        18-65 yrs, ST6: Month 19 (n=72, 65, 67)
    913.7 (700.2 to 1192.2)
    621.8 (447.7 to 863.8)
    21.3 (20.0 to 22.7)
        18-65 yrs, ST6: Month 23 (n=62, 60, 69)
    166.9 (126.6 to 220.0)
    123.7 (92.5 to 165.4)
    21.5 (19.6 to 23.6)
        18-65 yrs, ST6: Month 26 (n=63, 61, 67)
    99.8 (77.7 to 128.2)
    65.9 (49.9 to 87.2)
    23.2 (20.9 to 25.7)
        18-65 yrs, ST6: Month 30 (n=60, 55, 54)
    52.0 (40.3 to 67.0)
    50.2 (38.9 to 64.7)
    21.0 (19.6 to 22.4)
        18-65 yrs, ST6: Month 31 (n=66, 55, 53)
    962.8 (791.1 to 1171.8)
    679.3 (531.4 to 868.5)
    21.1 (19.5 to 22.9)
        18-65 yrs, ST6: Month 39 (n=61, 49, 53)
    100.9 (79.2 to 128.6)
    71.2 (52.9 to 95.9)
    21.6 (19.6 to 23.7)
        18-65 yrs, ST6: Month 42 (n=61, 49, 53)
    80.2 (62.8 to 102.4)
    68.3 (51.1 to 91.4)
    20.8 (19.3 to 22.4)
        18-65 yrs, ST6: Month 43 (n=63, 53, 54)
    939.6 (785.9 to 1123.3)
    676.9 (526.3 to 870.5)
    22.7 (18.7 to 27.5)
        18-65 yrs, ST6: Month 48 (n=52, 46, 43)
    210.1 (155.5 to 283.8)
    161.2 (124.7 to 208.5)
    20.4 (19.6 to 21.3)
        12-17 yrs, ST1: Month 19 (n=27, 26, 26)
    1442.0 (899.5 to 2311.5)
    1958.4 (1111.1 to 3451.7)
    20.8 (19.1 to 22.7)
        12-17 yrs, ST1: Month 23 (n=25, 27, 21)
    288.3 (189.7 to 438.2)
    220.0 (131.9 to 367.1)
    21.3 (18.7 to 24.3)
        12-17 yrs, ST1: Month 26 (n=24, 25, 21)
    122.1 (77.2 to 193.1)
    109.8 (61.4 to 196.4)
    21.4 (18.6 to 24.7)
        12-17 yrs, ST1: Month 30 (n=21, 21, 19)
    86.8 (47.9 to 157.4)
    84.4 (47.2 to 150.9)
    21.5 (18.4 to 25.1)
        12-17 yrs, ST1: Month 31 (n=20, 21, 21)
    2125.7 (1487.7 to 3037.3)
    2040.7 (1326.0 to 3140.8)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST1: Month 39 (n=21, 23, 13)
    135.2 (92.8 to 196.8)
    143.0 (87.4 to 234.1)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST1: Month 42 (n=23, 20, 15)
    100.2 (69.4 to 144.5)
    89.2 (53.6 to 148.7)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST1: Month 43 (n=23, 21, 16)
    1244.9 (839.2 to 1846.9)
    1638.9 (1037.2 to 2589.6)
    21.8 (18.2 to 26.0)
        12-17 yrs, ST1: Month 48 (n=20, 19, 17)
    185.1 (109.9 to 311.7)
    207.4 (120.3 to 357.6)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 19 (n=27, 26, 26)
    1963.1 (1226.3 to 3142.5)
    3149.2 (1904.3 to 5207.9)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 23 (n=25, 27, 21)
    468.8 (316.7 to 694.1)
    412.2 (277.3 to 612.7)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 26 (n=24, 25, 21)
    241.4 (164.1 to 355.1)
    278.2 (203.5 to 380.2)
    21.1 (18.8 to 23.7)
        12-17 yrs, ST2: Month 30 (n=21, 21, 19)
    135.3 (73.2 to 250.1)
    169.7 (113.0 to 254.6)
    21.4 (18.6 to 24.6)
        12-17 yrs, ST2: Month 31 (n=20, 21, 21)
    2644.4 (1812.2 to 3858.8)
    2678.0 (1924.1 to 3727.3)
    21.6 (18.4 to 25.4)
        12-17 yrs, ST2: Month 39 (n=21, 23, 13)
    225.1 (151.3 to 335.1)
    265.7 (194.0 to 363.7)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 42 (n=23, 20, 15)
    155.8 (102.5 to 236.8)
    160.6 (102.2 to 252.4)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 43 (n=23, 21, 16)
    1611.9 (1055.2 to 2462.4)
    2400.5 (1558.0 to 3698.8)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST2: Month 48 (n=20, 19, 17)
    231.7 (135.2 to 397.0)
    366.6 (227.4 to 591.1)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Month 19 (n=27, 26, 26)
    2052.5 (1312.9 to 3208.6)
    2919.2 (1746.8 to 4878.4)
    21.9 (19.2 to 24.9)
        12-17 yrs, ST3: Month 23 (n=25, 27, 21)
    496.9 (345.7 to 714.4)
    447.1 (282.0 to 708.9)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Month 26 (n=24, 25, 21)
    237.1 (164.5 to 341.7)
    283.1 (194.3 to 412.5)
    21.3 (18.7 to 24.3)
        12-17 yrs, ST3: Month 30 (n=21, 21, 19)
    143.5 (77.9 to 264.5)
    167.0 (103.1 to 270.7)
    23.0 (19.6 to 26.9)
        12-17 yrs, ST3: Month 31 (n=20, 21, 21)
    2483.0 (1787.8 to 3448.5)
    2690.2 (1785.0 to 4054.4)
    22.5 (18.9 to 26.9)
        12-17 yrs, ST3: Month 39 (n=21, 23, 13)
    207.7 (142.7 to 302.3)
    253.9 (162.3 to 397.1)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Month 42 (n=23, 20, 15)
    142.1 (99.1 to 203.8)
    182.2 (115.6 to 287.1)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST3: Month 43 (n=23, 21, 16)
    1530.5 (1046.5 to 2238.4)
    2339.8 (1523.4 to 3593.8)
    21.1 (18.8 to 23.7)
        12-17 yrs, ST3: Month 48 (n=20, 19, 17)
    264.8 (156.3 to 448.6)
    392.2 (237.5 to 647.7)
    21.3 (18.6 to 24.5)
        12-17 yrs, ST4: Month 19 (n=27, 26, 26)
    1738.3 (1100.8 to 2745.2)
    2295.9 (1323.2 to 3983.7)
    22.8 (19.5 to 26.7)
        12-17 yrs, ST4: Month 23 (n=25, 27, 21)
    377.6 (255.6 to 557.9)
    285.3 (175.9 to 462.5)
    23.2 (19.5 to 27.6)
        12-17 yrs, ST4: Month 26 (n=24, 25, 21)
    169.2 (109.9 to 260.5)
    178.1 (114.5 to 277.0)
    23.4 (19.5 to 28.0)
        12-17 yrs, ST4: Month 30 (n=21, 21, 19)
    113.4 (64.3 to 200.0)
    112.7 (66.7 to 190.5)
    21.5 (18.4 to 25.1)
        12-17 yrs, ST4: Month 31 (n=20, 21, 21)
    2527.9 (1857.0 to 3441.0)
    2274.1 (1492.7 to 3464.6)
    22.6 (18.9 to 26.9)
        12-17 yrs, ST4: Month 39 (n=21, 23, 13)
    166.1 (108.9 to 253.3)
    180.2 (109.8 to 295.7)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST4: Month 42 (n=23, 20, 15)
    119.4 (80.9 to 176.2)
    121.5 (75.9 to 194.4)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST4: Month 43 (n=23, 21, 16)
    1583.8 (1088.2 to 2305.2)
    1895.2 (1210.3 to 2967.8)
    23.2 (18.5 to 29.0)
        12-17 yrs, ST4: Month 48 (n=20, 19, 17)
    227.3 (135.2 to 382.1)
    269.4 (164.3 to 442.0)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST5: Month 19 (n=27, 26, 26)
    1549.7 (988.0 to 2430.9)
    2065.7 (1230.6 to 3467.7)
    21.2 (18.8 to 23.7)
        12-17 yrs, ST5: Month 23 (n=25, 27, 21)
    334.5 (226.5 to 493.9)
    244.7 (153.9 to 389.0)
    21.3 (18.7 to 24.2)
        12-17 yrs, ST5: Month 26 (n=24, 25, 21)
    145.4 (89.0 to 237.5)
    160.9 (107.5 to 240.6)
    21.2 (18.8 to 23.9)
        12-17 yrs, ST5: Month 30 (n=21, 21, 19)
    100.5 (53.8 to 187.6)
    106.8 (63.4 to 179.8)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST5: Month 31 (n=20, 21, 21)
    2084.9 (1527.0 to 2846.7)
    2062.9 (1375.2 to 3094.5)
    23.0 (18.8 to 28.3)
        12-17 yrs, ST5: Month 39 (n=21, 23, 13)
    160.1 (108.7 to 236.0)
    181.6 (124.5 to 264.8)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST5: Month 42 (n=23, 20, 15)
    114.4 (77.0 to 169.8)
    106.1 (66.1 to 170.2)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST5: Month 43 (n=23, 21, 16)
    1285.8 (891.4 to 1854.6)
    1802.3 (1124.4 to 2889.0)
    21.5 (18.4 to 25.2)
        12-17 yrs, ST5: Month 48 (n=20, 19, 17)
    191.5 (117.1 to 313.2)
    228.7 (130.2 to 401.9)
    21.5 (18.5 to 25.0)
        12-17 yrs, ST6: Month 19 (n=27, 26, 26)
    1588.3 (1008.8 to 2500.9)
    1975.8 (1187.5 to 3287.4)
    24.4 (20.0 to 29.8)
        12-17 yrs, ST6: Month 23 (n=25, 27, 21)
    336.9 (215.1 to 527.7)
    237.4 (148.0 to 380.7)
    25.8 (20.1 to 33.1)
        12-17 yrs, ST6: Month 26 (n=24, 25, 21)
    176.2 (113.7 to 273.2)
    150.7 (97.9 to 232.0)
    22.6 (18.9 to 27.0)
        12-17 yrs, ST6: Month 30 (n=21, 21, 19)
    110.6 (60.2 to 203.2)
    97.2 (55.3 to 170.6)
    27.7 (20.9 to 36.8)
        12-17 yrs, ST6: Month 31 (n=20, 21, 21)
    2242.3 (1627.7 to 3089.0)
    1987.0 (1371.5 to 2878.8)
    25.1 (19.3 to 32.6)
        12-17 yrs, ST6: Month 39 (n=21, 23, 13)
    174.9 (111.7 to 273.8)
    161.4 (108.0 to 241.4)
    21.7 (18.2 to 25.9)
        12-17 yrs, ST6: Month 42 (n=23, 20, 15)
    131.2 (87.4 to 197.2)
    106.1 (66.3 to 169.7)
    20.0 (20.0 to 20.0)
        12-17 yrs, ST6: Month 43 (n=23, 21, 16)
    1318.7 (907.0 to 1917.3)
    1613.1 (1014.0 to 2566.2)
    23.3 (18.6 to 29.2)
        12-17 yrs, ST6: Month 48 (n=20, 19, 17)
    209.1 (125.3 to 349.0)
    235.2 (141.3 to 391.5)
    23.8 (18.5 to 30.5)
        5-11 yrs, ST1: Month 19 (n=28, 20, 30)
    1778.9 (1154.1 to 2742.0)
    1415.6 (657.0 to 3049.9)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST1: Month 23 (n=28, 22, 28)
    230.2 (151.2 to 350.4)
    191.4 (112.3 to 326.4)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST1: Month 26 (n=23, 17, 24)
    123.0 (83.8 to 180.4)
    85.9 (50.1 to 147.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST1: Month 30 (n=26, 21, 24)
    115.0 (68.6 to 192.7)
    61.6 (36.5 to 103.9)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST1: Month 31 (n=27, 22, 23)
    1954.0 (1198.9 to 3184.7)
    1353.1 (669.2 to 2736.0)
    24.8 (15.9 to 38.5)
        5-11 yrs, ST1: Month 39 (n=25, 11, 20)
    119.6 (79.5 to 179.7)
    200.9 (119.8 to 336.9)
    23.6 (16.7 to 33.6)
        5-11 yrs, ST1: Month 42 (n=21, 13, 17)
    113.8 (79.6 to 162.7)
    107.3 (67.7 to 170.0)
    23.5 (18.5 to 29.7)
        5-11 yrs, ST1: Month 43 (n=26, 17, 18)
    1752.4 (1280.9 to 2397.4)
    2399.3 (1610.6 to 3574.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST1: Month 48 (n=20, 14, 15)
    342.2 (200.1 to 585.1)
    289.2 (151.4 to 552.7)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 19 (n=28, 20, 30)
    2988.8 (1955.7 to 4567.7)
    1994.9 (872.8 to 4559.5)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 23 (n=28, 22, 28)
    455.0 (318.2 to 650.6)
    354.9 (199.4 to 631.7)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 26 (n=23, 17, 24)
    273.5 (220.7 to 338.9)
    168.7 (90.0 to 316.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 30 (n=26, 21, 24)
    215.5 (145.6 to 319.0)
    118.3 (68.2 to 205.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 31 (n=27, 22, 23)
    2802.1 (1724.3 to 4553.5)
    2151.1 (1095.7 to 4223.3)
    25.0 (15.7 to 39.6)
        5-11 yrs, ST2: Month 39 (n=25, 11, 20)
    217.0 (142.5 to 330.4)
    280.2 (162.7 to 482.6)
    22.9 (17.2 to 30.5)
        5-11 yrs, ST2: Month 42 (n=21, 13, 17)
    185.8 (124.5 to 277.4)
    187.7 (120.3 to 292.8)
    22.8 (17.3 to 30.0)
        5-11 yrs, ST2: Month 43 (n=26, 17, 18)
    2631.6 (1989.6 to 3480.7)
    3900.7 (2855.5 to 5328.4)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST2: Month 48 (n=20, 14, 15)
    570.7 (384.9 to 846.1)
    575.7 (337.1 to 983.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST3: Month 19 (n=28, 20, 30)
    2637.1 (1667.7 to 4170.0)
    2046.5 (927.0 to 4518.1)
    21.8 (19.7 to 24.1)
        5-11 yrs, ST3: Month 23 (n=28, 22, 28)
    416.4 (281.1 to 616.8)
    417.0 (248.2 to 700.7)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST3: Month 26 (n=23, 17, 24)
    216.1 (147.4 to 316.8)
    187.6 (107.3 to 327.7)
    20.6 (19.4 to 21.9)
        5-11 yrs, ST3: Month 30 (n=26, 21, 24)
    173.9 (102.0 to 296.4)
    155.4 (96.4 to 250.5)
    20.6 (19.3 to 22.1)
        5-11 yrs, ST3: Month 31 (n=27, 22, 23)
    2496.3 (1509.5 to 4128.2)
    2158.8 (1109.1 to 4201.9)
    24.9 (15.8 to 39.0)
        5-11 yrs, ST3: Month 39 (n=25, 11, 20)
    178.4 (111.2 to 286.2)
    372.4 (215.1 to 644.8)
    24.7 (15.9 to 38.5)
        5-11 yrs, ST3: Month 42 (n=21, 13, 17)
    179.7 (117.3 to 275.2)
    186.8 (121.1 to 288.2)
    21.6 (18.4 to 25.3)
        5-11 yrs, ST3: Month 43 (n=26, 17, 18)
    2217.9 (1600.7 to 3073.0)
    3824.8 (2719.1 to 5380.1)
    21.8 (19.2 to 24.6)
        5-11 yrs, ST3: Month 48 (n=20, 14, 15)
    552.8 (350.8 to 871.1)
    665.8 (396.9 to 1117.0)
    22.1 (17.8 to 27.5)
        5-11 yrs, ST4: Month 19 (n=28, 20, 30)
    2201.9 (1439.7 to 3367.7)
    1501.4 (705.0 to 3197.4)
    21.9 (19.7 to 24.4)
        5-11 yrs, ST4: Month 23 (n=28, 22, 28)
    319.4 (221.9 to 459.8)
    227.8 (137.3 to 378.2)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST4: Month 26 (n=23, 17, 24)
    174.9 (130.3 to 234.8)
    95.1 (55.5 to 163.0)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST4: Month 30 (n=26, 21, 24)
    148.7 (89.6 to 246.7)
    80.5 (49.1 to 132.0)
    21.1 (18.9 to 23.6)
        5-11 yrs, ST4: Month 31 (n=27, 22, 23)
    2343.1 (1449.4 to 3787.7)
    1583.6 (780.5 to 3212.9)
    26.0 (16.7 to 40.5)
        5-11 yrs, ST4: Month 39 (n=25, 11, 20)
    147.8 (97.9 to 223.2)
    215.1 (117.8 to 392.5)
    24.0 (16.4 to 35.1)
        5-11 yrs, ST4: Month 42 (n=21, 13, 17)
    158.6 (114.1 to 220.5)
    112.3 (63.5 to 198.4)
    23.5 (18.6 to 29.6)
        5-11 yrs, ST4: Month 43 (n=26, 17, 18)
    1998.3 (1458.7 to 2737.5)
    2890.2 (2074.0 to 4027.5)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST4: Month 48 (n=20, 14, 15)
    443.6 (273.2 to 720.3)
    410.0 (240.3 to 699.5)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 19 (n=28, 20, 30)
    2300.8 (1523.2 to 3475.4)
    1508.5 (689.1 to 3302.0)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 23 (n=28, 22, 28)
    323.0 (219.7 to 474.7)
    217.6 (121.4 to 390.0)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 26 (n=23, 17, 24)
    197.2 (152.7 to 254.5)
    111.2 (63.8 to 193.6)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 30 (n=26, 21, 24)
    147.1 (91.6 to 236.2)
    90.5 (56.1 to 146.0)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 31 (n=27, 22, 23)
    2203.7 (1378.3 to 3523.3)
    1503.5 (776.7 to 2910.5)
    25.1 (15.7 to 40.0)
        5-11 yrs, ST5: Month 39 (n=25, 11, 20)
    138.4 (89.1 to 215.1)
    216.9 (120.3 to 391.3)
    23.8 (16.5 to 34.3)
        5-11 yrs, ST5: Month 42 (n=21, 13, 17)
    144.2 (104.5 to 198.8)
    114.4 (67.2 to 194.7)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 43 (n=26, 17, 18)
    2019.2 (1494.0 to 2729.1)
    2548.2 (1845.4 to 3518.6)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST5: Month 48 (n=20, 14, 15)
    391.6 (243.3 to 630.3)
    293.9 (149.8 to 576.8)
    20.0 (20.0 to 20.0)
        5-11 yrs, ST6: Month 19 (n=28, 20, 30)
    2260.9 (1496.1 to 3416.6)
    1515.5 (691.7 to 3320.4)
    22.8 (20.0 to 25.9)
        5-11 yrs, ST6: Month 23 (n=28, 22, 28)
    311.2 (210.4 to 460.5)
    236.5 (129.7 to 431.4)
    21.6 (19.4 to 24.0)
        5-11 yrs, ST6: Month 26 (n=23, 17, 24)
    181.3 (139.3 to 236.1)
    117.0 (64.7 to 211.5)
    20.9 (19.1 to 22.8)
        5-11 yrs, ST6: Month 30 (n=26, 21, 24)
    137.4 (84.0 to 224.6)
    100.6 (63.5 to 159.5)
    20.9 (19.1 to 22.8)
        5-11 yrs, ST6: Month 31 (n=27, 22, 23)
    2172.0 (1355.4 to 3480.6)
    1535.5 (773.0 to 3049.8)
    28.3 (17.7 to 45.3)
        5-11 yrs, ST6: Month 39 (n=25, 11, 20)
    153.7 (109.6 to 215.5)
    219.1 (119.2 to 402.6)
    23.9 (16.5 to 34.7)
        5-11 yrs, ST6: Month 42 (n=21, 13, 17)
    129.0 (89.0 to 186.9)
    116.4 (65.2 to 207.9)
    21.6 (18.3 to 25.5)
        5-11 yrs, ST6: Month 43 (n=26, 17, 18)
    1967.4 (1448.4 to 2672.4)
    2723.5 (2059.6 to 3601.6)
    20.9 (19.1 to 22.9)
        5-11 yrs, ST6: Month 48 (n=20, 14, 15)
    396.3 (249.0 to 630.9)
    361.5 (220.5 to 592.5)
    20.0 (20.0 to 20.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroconversion Stratified by Age Group at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 After Vaccination During the Booster Phase

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    End point title
    		 Percentage of Participants With Seroconversion Stratified by Age Group at Months 19, 23, 26, 30, 31, 39, 42, 43 and 48 After Vaccination During the Booster Phase
    End point description
    SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (5-11, 12-17 & 18-65 yrs) were evaluated. Seroconversion for ELISA: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening. PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 23, 26, 30, 31, 39, 42, 43 and 48
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Percentage of participants
    number (confidence interval 95%)
        18-65 yrs, ST1: Month 19 (n=72, 65, 67)
    97.2 (90.4 to 99.2)
    95.4 (87.3 to 98.4)
    0.0 (0.0 to 5.4)
        18-65 yrs, ST1: Month 23 (n=62, 60, 69)
    82.3 (71.0 to 89.8)
    75.0 (62.8 to 84.2)
    2.9 (0.8 to 10.0)
        18-65 yrs, ST1: Month 26 (n=63, 61, 67)
    68.3 (56.0 to 78.4)
    57.4 (44.9 to 69.0)
    6.0 (2.3 to 14.4)
        18-65 yrs, ST1: Month 30 (n=60, 55, 54)
    45.0 (33.1 to 57.5)
    41.8 (29.7 to 55.0)
    0.0 (0.0 to 6.6)
        18-65 yrs, ST1: Month 31 (n=66, 55, 53)
    97.0 (89.6 to 99.2)
    100 (93.5 to 100)
    0.0 (0.0 to 6.8)
        18-65 yrs, ST1: Month 39 (n=61, 49, 53)
    73.8 (61.6 to 83.2)
    59.2 (45.2 to 71.8)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST1: Month 42 (n=61, 49, 53)
    70.5 (58.1 to 80.4)
    57.1 (43.3 to 70.0)
    0.0 (0.0 to 6.8)
        18-65 yrs, ST1: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST1: Month 48 (n=52, 46, 43)
    90.4 (79.4 to 95.8)
    93.5 (82.5 to 97.8)
    0.0 (0.0 to 8.2)
        18-65 yrs, ST2: Month 19 (n=72, 65, 67)
    98.6 (92.5 to 99.8)
    98.5 (91.8 to 99.7)
    0.0 (0.0 to 5.4)
        18-65 yrs, ST2: Month 23 (n=62, 60, 69)
    95.2 (86.7 to 98.3)
    91.7 (81.9 to 96.4)
    1.4 (0.3 to 7.8)
        18-65 yrs, ST2: Month 26 (n=63, 61, 67)
    85.7 (75.0 to 92.3)
    73.8 (61.6 to 83.2)
    6.0 (2.3 to 14.4)
        18-65 yrs, ST2: Month 30 (n=60, 55, 54)
    68.3 (55.8 to 78.7)
    65.5 (52.3 to 76.6)
    0.0 (0.0 to 6.6)
        18-65 yrs, ST2: Month 31 (n=66, 55, 53)
    100 (94.5 to 100)
    100 (93.5 to 100)
    0.0 (0.0 to 6.8)
        18-65 yrs, ST2: Month 39 (n=61, 49, 53)
    86.9 (76.2 to 93.2)
    73.5 (59.7 to 83.8)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST2: Month 42 (n=61, 49, 53)
    82.0 (70.5 to 89.6)
    73.5 (59.7 to 83.8)
    0.0 (0.0 to 6.8)
        18-65 yrs, ST2: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST2: Month 48 (n=52, 46, 43)
    94.2 (84.4 to 98.0)
    97.8 (88.7 to 99.6)
    0.0 (0.0 to 8.2)
        18-65 yrs, ST3: Month 19 (n=72, 65, 67)
    98.6 (92.5 to 99.8)
    98.5 (91.8 to 99.7)
    0.0 (0.0 to 5.4)
        18-65 yrs, ST3: Month 23 (n=62, 60, 69)
    88.7 (78.5 to 94.4)
    88.3 (77.8 to 94.2)
    2.9 (0.8 to 10.0)
        18-65 yrs, ST3: Month 26 (n=63, 61, 67)
    84.1 (73.2 to 91.1)
    77.0 (65.1 to 85.8)
    7.5 (3.2 to 16.3)
        18-65 yrs, ST3: Month 30 (n=60, 55, 54)
    66.7 (54.1 to 77.3)
    69.1 (56.0 to 79.7)
    3.7 (1.0 to 12.5)
        18-65 yrs, ST3: Month 31 (n=66, 55, 53)
    100 (94.5 to 100)
    100 (93.5 to 100)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST3: Month 39 (n=61, 49, 53)
    88.5 (78.2 to 94.3)
    75.5 (61.9 to 85.4)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST3: Month 42 (n=61, 49, 53)
    83.6 (72.4 to 90.8)
    79.6 (66.4 to 88.5)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST3: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST3: Month 48 (n=52, 46, 43)
    96.2 (87.0 to 98.9)
    95.7 (85.5 to 98.8)
    0.0 (0.0 to 8.2)
        18-65 yrs, ST4: Month 19 (n=72, 65, 67)
    98.6 (92.5 to 99.8)
    95.4 (87.3 to 98.4)
    3.0 (0.8 to 10.2)
        18-65 yrs, ST4: Month 23 (n=62, 60, 69)
    85.5 (74.7 to 92.2)
    83.3 (72.0 to 90.7)
    2.9 (0.8 to 10.0)
        18-65 yrs, ST4: Month 26 (n=63, 61, 67)
    81.0 (69.6 to 88.8)
    63.9 (51.4 to 74.8)
    10.4 (5.2 to 20.0)
        18-65 yrs, ST4: Month 30 (n=60, 55, 54)
    65.0 (52.4 to 75.8)
    52.7 (39.8 to 65.3)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST4: Month 31 (n=66, 55, 53)
    100 (94.5 to 100)
    100 (93.5 to 100)
    3.8 (1.0 to 12.8)
        18-65 yrs, ST4: Month 39 (n=61, 49, 53)
    83.6 (72.4 to 90.8)
    73.5 (59.7 to 83.8)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST4: Month 42 (n=61, 49, 53)
    77.0 (65.1 to 85.8)
    69.4 (55.5 to 80.5)
    3.8 (1.0 to 12.8)
        18-65 yrs, ST4: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    3.7 (1.0 to 12.5)
        18-65 yrs, ST4: Month 48 (n=52, 46, 43)
    94.2 (84.4 to 98.0)
    100 (92.3 to 100)
    0.0 (0.0 to 8.2)
        18-65 yrs, ST5: Month 19 (n=72, 65, 67)
    97.2 (90.4 to 99.2)
    95.4 (87.3 to 98.4)
    0.0 (0.0 to 5.4)
        18-65 yrs, ST5: Month 23 (n=62, 60, 69)
    87.1 (76.6 to 93.3)
    70.0 (57.5 to 80.1)
    2.9 (0.8 to 10.0)
        18-65 yrs, ST5: Month 26 (n=63, 61, 67)
    81.0 (69.6 to 88.8)
    55.7 (43.3 to 67.5)
    7.5 (3.2 to 16.3)
        18-65 yrs, ST5: Month 30 (n=60, 55, 54)
    48.3 (36.2 to 60.7)
    49.1 (36.4 to 61.9)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST5: Month 31 (n=66, 55, 53)
    100 (94.5 to 100)
    100 (93.5 to 100)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST5: Month 39 (n=61, 49, 53)
    83.6 (72.4 to 90.8)
    67.3 (53.4 to 78.8)
    3.8 (1.0 to 12.8)
        18-65 yrs, ST5: Month 42 (n=61, 49, 53)
    72.1 (59.8 to 81.8)
    75.5 (61.9 to 85.4)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST5: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    1.9 (0.3 to 9.8)
        18-65 yrs, ST5: Month 48 (n=52, 46, 43)
    90.4 (79.4 to 95.8)
    84.8 (71.8 to 92.4)
    0.0 (0.0 to 8.2)
        18-65 yrs, ST6: Month 19 (n=72, 65, 67)
    98.6 (92.5 to 99.8)
    95.4 (87.3 to 98.4)
    4.5 (1.5 to 12.4)
        18-65 yrs, ST6: Month 23 (n=62, 60, 69)
    87.1 (76.6 to 93.3)
    81.7 (70.1 to 89.4)
    4.3 (1.5 to 12.0)
        18-65 yrs, ST6: Month 26 (n=63, 61, 67)
    79.4 (67.8 to 87.5)
    57.4 (44.9 to 69.0)
    11.9 (6.2 to 21.8)
        18-65 yrs, ST6: Month 30 (n=60, 55, 54)
    50.0 (37.7 to 62.3)
    50.9 (38.1 to 63.6)
    3.7 (1.0 to 12.5)
        18-65 yrs, ST6: Month 31 (n=66, 55, 53)
    100 (94.5 to 100)
    100 (93.5 to 100)
    3.8 (1.0 to 12.8)
        18-65 yrs, ST6: Month 39 (n=61, 49, 53)
    78.7 (66.9 to 87.1)
    65.3 (51.3 to 77.1)
    5.7 (1.9 to 15.4)
        18-65 yrs, ST6: Month 42 (n=61, 49, 53)
    72.1 (59.8 to 81.8)
    65.3 (51.3 to 77.1)
    1.9 (0.3 to 9.9)
        18-65 yrs, ST6: Month 43 (n=63, 53, 54)
    100 (94.3 to 100)
    98.1 (90.1 to 99.7)
    3.7 (1.0 to 12.5)
        18-65 yrs, ST6: Month 48 (n=52, 46, 43)
    92.3 (81.8 to 97.0)
    95.7 (85.5 to 98.8)
    2.3 (0.4 to 12.1)
        12-17 yrs, ST1: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    0.0 (0.0 to 12.9)
        12-17 yrs, ST1: Month 23 (n=25, 27, 21)
    100 (86.7 to 100)
    92.6 (76.6 to 97.9)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST1: Month 26 (n=24, 25, 21)
    83.3 (64.1 to 93.3)
    68.0 (48.4 to 82.8)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST1: Month 30 (n=21, 21, 19)
    71.4 (50.0 to 86.2)
    66.7 (45.4 to 82.8)
    0.0 (0.0 to 16.8)
        12-17 yrs, ST1: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST1: Month 39 (n=21, 23, 13)
    95.2 (77.3 to 99.2)
    87.0 (67.9 to 95.5)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST1: Month 42 (n=23, 20, 15)
    87.0 (67.9 to 95.5)
    75.0 (53.1 to 88.8)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST1: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    6.3 (1.1 to 28.3)
        12-17 yrs, ST1: Month 48 (n=20, 19, 17)
    90.0 (69.9 to 97.2)
    94.7 (75.4 to 99.1)
    0.0 (0.0 to 18.4)
        12-17 yrs, ST2: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    0.0 (0.0 to 12.9)
        12-17 yrs, ST2: Month 23 (n=25, 27, 21)
    100 (86.7 to 100)
    96.3 (81.7 to 99.3)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST2: Month 26 (n=24, 25, 21)
    100 (86.2 to 100)
    100 (86.7 to 100)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST2: Month 30 (n=21, 21, 19)
    81.0 (60.0 to 92.3)
    95.2 (77.3 to 99.2)
    5.3 (0.9 to 24.6)
        12-17 yrs, ST2: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST2: Month 39 (n=21, 23, 13)
    100 (84.5 to 100)
    100 (85.7 to 100)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST2: Month 42 (n=23, 20, 15)
    91.3 (73.2 to 97.6)
    90.0 (69.9 to 97.2)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST2: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    0.0 (0.0 to 19.4)
        12-17 yrs, ST2: Month 48 (n=20, 19, 17)
    90.0 (69.9 to 97.2)
    94.7 (75.4 to 99.1)
    0.0 (0.0 to 18.4)
        12-17 yrs, ST3: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    3.8 (0.7 to 18.9)
        12-17 yrs, ST3: Month 23 (n=25, 27, 21)
    100 (86.7 to 100)
    96.3 (81.7 to 99.3)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST3: Month 26 (n=24, 25, 21)
    100 (86.2 to 100)
    100 (86.7 to 100)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST3: Month 30 (n=21, 21, 19)
    85.7 (65.4 to 95.0)
    95.2 (77.3 to 99.2)
    15.8 (5.5 to 37.6)
        12-17 yrs, ST3: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    9.5 (2.7 to 28.9)
        12-17 yrs, ST3: Month 39 (n=21, 23, 13)
    100 (84.5 to 100)
    95.7 (79.0 to 99.2)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST3: Month 42 (n=23, 20, 15)
    95.7 (79.0 to 99.2)
    95.0 (76.4 to 99.1)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST3: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    6.3 (1.1 to 28.3)
        12-17 yrs, ST3: Month 48 (n=20, 19, 17)
    90.0 (69.9 to 97.2)
    94.7 (75.4 to 99.1)
    5.9 (1.0 to 27.0)
        12-17 yrs, ST4: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    3.8 (0.7 to 18.9)
        12-17 yrs, ST4: Month 23 (n=25, 27, 21)
    100 (86.7 to 100)
    96.3 (81.7 to 99.3)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST4: Month 26 (n=24, 25, 21)
    91.7 (74.2 to 97.7)
    92.0 (75.0 to 97.8)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST4: Month 30 (n=21, 21, 19)
    81.0 (60.0 to 92.3)
    71.4 (50.0 to 86.2)
    0.0 (0.0 to 16.8)
        12-17 yrs, ST4: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST4: Month 39 (n=21, 23, 13)
    90.5 (71.1 to 97.3)
    87.0 (67.9 to 95.5)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST4: Month 42 (n=23, 20, 15)
    87.0 (67.9 to 95.5)
    80.0 (58.4 to 91.9)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST4: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    12.5 (3.5 to 36.0)
        12-17 yrs, ST4: Month 48 (n=20, 19, 17)
    90.0 (69.9 to 97.2)
    94.7 (75.4 to 99.1)
    0.0 (0.0 to 18.4)
        12-17 yrs, ST5: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    3.8 (0.7 to 18.9)
        12-17 yrs, ST5: Month 23 (n=25, 27, 21)
    100 (86.7 to 100)
    92.6 (76.6 to 97.9)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST5: Month 26 (n=24, 25, 21)
    83.3 (64.1 to 93.3)
    92.0 (75.0 to 97.8)
    4.8 (0.8 to 22.7)
        12-17 yrs, ST5: Month 30 (n=21, 21, 19)
    66.7 (45.4 to 82.8)
    76.2 (54.9 to 89.4)
    0.0 (0.0 to 16.8)
        12-17 yrs, ST5: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    9.5 (2.7 to 28.9)
        12-17 yrs, ST5: Month 39 (n=21, 23, 13)
    95.2 (77.3 to 99.2)
    100 (85.7 to 100)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST5: Month 42 (n=23, 20, 15)
    87.0 (67.9 to 95.5)
    80.0 (58.4 to 91.9)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST5: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    6.3 (1.1 to 28.3)
        12-17 yrs, ST5: Month 48 (n=20, 19, 17)
    90.0 (69.9 to 97.2)
    89.5 (68.6 to 97.1)
    5.9 (1.0 to 27.0)
        12-17 yrs, ST6: Month 19 (n=27, 26, 26)
    96.3 (81.7 to 99.3)
    96.2 (81.1 to 99.3)
    0.0 (0.0 to 12.9)
        12-17 yrs, ST6: Month 23 (n=25, 27, 21)
    96.0 (80.5 to 99.3)
    88.9 (71.9 to 96.1)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST6: Month 26 (n=24, 25, 21)
    95.8 (79.8 to 99.3)
    80.0 (60.9 to 91.1)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST6: Month 30 (n=21, 21, 19)
    66.7 (45.4 to 82.8)
    61.9 (40.9 to 79.2)
    10.5 (2.9 to 31.4)
        12-17 yrs, ST6: Month 31 (n=20, 21, 21)
    100 (83.9 to 100)
    100 (84.5 to 100)
    0.0 (0.0 to 15.5)
        12-17 yrs, ST6: Month 39 (n=21, 23, 13)
    95.2 (77.3 to 99.2)
    91.3 (73.2 to 97.6)
    0.0 (0.0 to 22.8)
        12-17 yrs, ST6: Month 42 (n=23, 20, 15)
    87.0 (67.9 to 95.5)
    80.0 (58.4 to 91.9)
    0.0 (0.0 to 20.4)
        12-17 yrs, ST6: Month 43 (n=23, 21, 16)
    100 (85.7 to 100)
    100 (84.5 to 100)
    0.0 (0.0 to 19.4)
        12-17 yrs, ST6: Month 48 (n=20, 19, 17)
    85.0 (64.0 to 94.8)
    89.5 (68.6 to 97.1)
    0.0 (0.0 to 18.4)
        5-11 yrs, ST1: Month 19 (n=27, 20, 30)
    96.3 (81.7 to 99.3)
    90.0 (69.9 to 97.2)
    0.0 (0.0 to 11.4)
        5-11 yrs, ST1: Month 23 (n=28, 22, 28)
    89.3 (72.8 to 96.3)
    81.8 (61.5 to 92.7)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST1: Month 26 (n=23, 17, 24)
    87.0 (67.9 to 95.5)
    70.6 (46.9 to 86.7)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST1: Month 30 (n=26, 21, 24)
    76.9 (57.9 to 89.0)
    52.4 (32.4 to 71.7)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST1: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    90.9 (72.2 to 97.5)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST1: Month 39 (n=25, 11, 20)
    84.0 (65.3 to 93.6)
    90.9 (62.3 to 98.4)
    5.0 (0.9 to 23.6)
        5-11 yrs, ST1: Month 42 (n=21, 13, 17)
    85.7 (65.4 to 95.0)
    92.3 (66.7 to 98.6)
    11.8 (3.3 to 34.3)
        5-11 yrs, ST1: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    0.0 (0.0 to 17.6)
        5-11 yrs, ST1: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    92.9 (68.5 to 98.7)
    0.0 (0.0 to 20.4)
        5-11 yrs, ST2: Month 19 (n=27, 20, 30)
    96.3 (81.7 to 99.3)
    90.0 (69.9 to 97.2)
    0.0 (0.0 to 11.4)
        5-11 yrs, ST2: Month 23 (n=28, 22, 28)
    96.4 (82.3 to 99.4)
    90.9 (72.2 to 97.5)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST2: Month 26 (n=23, 17, 24)
    100 (85.7 to 100)
    82.4 (59.0 to 93.8)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST2: Month 30 (n=26, 21, 24)
    100 (87.1 to 100)
    76.2 (54.9 to 89.4)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST2: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    95.5 (78.2 to 99.2)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST2: Month 39 (n=25, 11, 20)
    92.0 (75.0 to 97.8)
    100 (74.1 to 100)
    1 (0.9 to 23.6)
        5-11 yrs, ST2: Month 42 (n=21, 13, 17)
    90.5 (71.1 to 97.3)
    100 (77.2 to 100)
    5.9 (1.0 to 27.0)
        5-11 yrs, ST2: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    0.0 (0.0 to 17.6)
        5-11 yrs, ST2: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    100 (78.5 to 100)
    0.0 (0.0 to 20.4)
        5-11 yrs, ST3: Month 19 (n=27, 20, 30)
    96.3 (81.7 to 99.3)
    90.0 (69.9 to 97.2)
    6.7 (1.8 to 21.3)
        5-11 yrs, ST3: Month 23 (n=28, 22, 28)
    96.4 (82.3 to 99.4)
    95.5 (78.2 to 99.2)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST3: Month 26 (n=23, 17, 24)
    95.7 (79.0 to 99.2)
    94.1 (73.0 to 99.0)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST3: Month 30 (n=26, 21, 24)
    84.6 (66.5 to 93.8)
    85.7 (65.4 to 95.0)
    4.2 (0.7 to 20.2)
        5-11 yrs, ST3: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    95.5 (78.2 to 99.2)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST3: Month 39 (n=25, 11, 20)
    88.0 (70.0 to 95.8)
    100 (74.1 to 100)
    5.0 (0.9 to 23.6)
        5-11 yrs, ST3: Month 42 (n=21, 13, 17)
    95.2 (77.3 to 99.2)
    100 (77.2 to 100)
    5.9 (1.0 to 27.0)
        5-11 yrs, ST3: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    5.6 (1.0 to 25.8)
        5-11 yrs, ST3: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    100 (78.5 to 100)
    6.7 (1.2 to 29.8)
        5-11 yrs, ST4: Month 19 (n=27, 20, 30)
    96.3 (81.7 to 99.3)
    90.0 (69.9 to 97.2)
    3.3 (0.6 to 16.7)
        5-11 yrs, ST4: Month 23 (n=28, 22, 28)
    96.4 (82.3 to 99.4)
    90.9 (72.2 to 97.5)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST4: Month 26 (n=23, 17, 24)
    95.7 (79.0 to 99.2)
    76.5 (52.7 to 90.4)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST4: Month 30 (n=26, 21, 24)
    84.6 (66.5 to 93.8)
    71.4 (50.0 to 86.2)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST4: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    90.9 (72.2 to 97.5)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST4: Month 39 (n=25, 11, 20)
    84.0 (65.3 to 93.6)
    100 (74.1 to 100)
    5.0 (0.9 to 23.6)
        5-11 yrs, ST4: Month 42 (n=21, 13, 17)
    95.2 (77.3 to 99.2)
    84.6 (57.8 to 95.7)
    11.8 (3.3 to 34.3)
        5-11 yrs, ST4: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    0.0 (0.0 to 17.6)
        5-11 yrs, ST4: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    100 (78.5 to 100)
    0.0 (0.0 to 20.4)
        5-11 yrs, ST5: Month 19 (n=27, 20, 30)
    96.3 (81.7 to 99.3)
    90.0 (69.9 to 97.2)
    0.0 (0.0 to 11.4)
        5-11 yrs, ST5: Month 23 (n=28, 22, 28)
    92.9 (77.4 to 98)
    81.8 (61.5 to 92.7)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST5: Month 26 (n=23, 17, 24)
    100 (85.7 to 100)
    76.5 (52.7 to 90.4)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST15: Month 30 (n=26, 21, 24)
    88.5 (71.0 to 96.0)
    76.2 (54.9 to 89.4)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST5: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    95.5 (78.2 to 99.2)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST5: Month 39 (n=25, 11, 20)
    84.0 (65.3 to 93.6)
    100 (74.1 to 100)
    5.0 (0.9 to 23.6)
        5-11 yrs, ST5: Month 42 (n=21, 13, 17)
    95.2 (77.3 to 99.2)
    92.3 (66.7 to 98.6)
    0.0 (0.0 to 18.4)
        5-11 yrs, ST5: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    0.0 (0.0 to 17.6)
        5-11 yrs, ST5: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    92.9 (68.5 to 98.7)
    0.0 (0.0 to 20.4)
        5-11 yrs, ST6: Month 19 (n=28, 20, 30)
    92.9 (77.4 to 98.0)
    90.0 (69.9 to 97.2)
    6.7 (1.8 to 21.3)
        5-11 yrs, ST6: Month 23 (n=28, 22, 28)
    92.9 (77.4 to 98.0)
    81.8 (61.5 to 92.7)
    0.0 (0.0 to 12.1)
        5-11 yrs, ST6: Month 26 (n=23, 17, 24)
    95.7 (79.0 to 99.2)
    76.5 (52.7 to 90.4)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST6: Month 30 (n=26, 21, 24)
    76.9 (57.9 to 89.0)
    81.0 (60.0 to 92.3)
    0.0 (0.0 to 13.8)
        5-11 yrs, ST6: Month 31 (n=27, 22, 23)
    96.3 (81.7 to 99.3)
    90.9 (72.2 to 97.5)
    4.3 (0.8 to 21.0)
        5-11 yrs, ST6: Month 39 (n=25, 11, 20)
    92.0 (75.0 to 97.8)
    100 (74.1 to 100)
    5.0 (0.9 to 23.6)
        5-11 yrs, ST6: Month 42 (n=21, 13, 17)
    90.5 (71.1 to 97.3)
    76.9 (49.7 to 91.8)
    5.9 (1.0 to 27.0)
        5-11 yrs, ST6: Month 43 (n=26, 17, 18)
    100 (87.1 to 100)
    100 (81.6 to 100)
    5.6 (1.0 to 25.8)
        5-11 yrs, ST6: Month 48 (n=20, 14, 15)
    100 (83.9 to 100)
    92.9 (68.5 to 98.7)
    0.0 (0.0 to 20.4)
    No statistical analyses for this end point

    Secondary: GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at M18-M19, M30-M31, M42-M43 During the Booster Phase

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    End point title
    		 GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at M18-M19, M30-M31, M42-M43 During the Booster Phase
    End point description
    GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1–ST6), stratified by age group (5-11, 12-17 & 18-65 yrs) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints (Months 18, 30, and 42, respectively). PPAS consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, “n” signifies participants with available results for each serotype at specified time points.
    End point type
    Secondary
    End point timeframe
    At Months 19, 31 and 43
    End point values
    		 Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
    Number of subjects analysed
    176
    162
    175
    Units: Fold rise
    geometric mean (confidence interval 95%)
        18-65 yrs, ST1: Month 19 (n=72, 65, 67)
    32.2 (24.1 to 42.9)
    23.4 (16.8 to 32.5)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST1: Month 31 (n=66, 55, 53)
    18.5 (14.1 to 24.4)
    15.1 (11.6 to 19.5)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST1: Month 43 (n=63, 53, 54)
    12.6 (10.2 to 15.4)
    11.1 (8.5 to 14.5)
    1.1 (0.9 to 1.3)
        18-65 yrs, ST2: Month 19 (n=72, 65, 67)
    48.3 (38.1 to 61.2)
    48.5 (36.6 to 64.3)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST2: Month 31 (n=66, 55, 53)
    16.4 (13.1 to 20.6)
    14.5 (11.7 to 18.0)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST2: Month 43 (n=63, 53, 54)
    12.1 (9.8 to 14.9)
    11.7 (8.6 to 15.8)
    1.1 (0.9 to 1.3)
        18-65 yrs, ST3: Month 19 (n=72, 65, 67)
    44.9 (34.8 to 57.9)
    39.5 (30.4 to 51.5)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST3: Month 31 (n=66, 55, 53)
    17.0 (13.4 to 21.5)
    13.1 (10.7 to 15.9)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST3: Month 43 (n=63, 53, 54)
    11.5 (9.6 to 13.8)
    9.5 (7.3 to 12.2)
    1.1 (0.9 to 1.3)
        18-65 yrs, ST4: Month 19 (n=72, 65, 67)
    36.0 (27.7 to 46.9)
    29.8 (21.8 to 40.9)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST4: Month 31 (n=66, 55, 53)
    17.9 (14.0 to 22.8)
    15.7 (12.4 to 19.9)
    1.0 (1.0 to 1.1)
        18-65 yrs, ST4: Month 43 (n=63, 53, 54)
    13.0 (10.5 to 16.1)
    10.8 (8.3 to 14.0)
    1.1 (0.9 to 1.3)
        18-65 yrs, ST5: Month 19 (n=72, 65, 67)
    37.0 (28.0 to 48.8)
    29.6 (21.6 to 40.5)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST5: Month 31 (n=66, 55, 53)
    19.2 (15.0 to 24.6)
    14.2 (11.4 to 17.7)
    1.0 (1.0 to 1.0)
        18-65 yrs, ST5: Month 43 (n=63, 53, 54)
    13.4 (10.9 to 16.4)
    10.3 (8.0 to 13.4)
    1.1 (0.9 to 1.3)
        18-65 yrs, ST6: Month 19 (n=72, 65, 67)
    32.6 (25.3 to 42.1)
    28.3 (20.3 to 39.5)
    1.0 (1.0 to 1.1)
        18-65 yrs, ST6: Month 31 (n=66, 55, 53)
    18.2 (14.3 to 23.2)
    12.9 (10.3 to 16.0)
    1.0 (1.0 to 1.1)
        18-65 yrs, ST6: Month 43 (n=63, 53, 54)
    11.8 (9.7 to 14.4)
    10.4 (8.0 to 13.5)
    1.1 (0.9 to 1.3)
        12-17 yrs, ST1: Month 19 (n=27, 26, 26)
    43.4 (25.8 to 73.0)
    78.4 (46.7 to 131.5)
    1.0 (1.0 to 1.0)
        12-17 yrs, ST1: Month 31 (n=20, 21, 21)
    25.7 (14.3 to 46.0)
    29.8 (18.2 to 49.0)
    0.9 (0.8 to 1.1)
        12-17 yrs, ST1: Month 43 (n=23, 21, 16)
    12.4 (8.0 to 19.2)
    18.1 (11.2 to 29.1)
    1.1 (0.9 to 1.3)
        12-17 yrs, ST2: Month 19 (n=27, 26, 26)
    46.2 (27.8 to 76.7)
    73.9 (47.0 to 116.3)
    1.0 (1.0 to 1.0)
        12-17 yrs, ST2: Month 31 (n=20, 21, 21)
    19.8 (11.0 to 35.5)
    16.8 (12.0 to 23.6)
    1.0 (1.0 to 1.1)
        12-17 yrs, ST2: Month 43 (n=23, 21, 16)
    10.3 (6.8 to 15.8)
    14.4 (8.8 to 23.4)
    1.0 (1.0 to 1.0)
        12-17 yrs, ST3: Month 19 (n=27, 26, 26)
    45.0 (27.3 to 74.2)
    70.6 (43.7 to 113.9)
    1.1 (1.0 to 1.2)
        12-17 yrs, ST3: Month 31 (n=20, 21, 21)
    18.5 (10.2 to 33.4)
    16.7 (12.6 to 22.3)
    1.0 (0.8 to 1.2)
        12-17 yrs, ST3: Month 43 (n=23, 21, 16)
    10.8 (7.3 to 15.9)
    12.8 (8.1 to 20.0)
    1.1 (0.9 to 1.2)
        12-17 yrs, ST4: Month 19 (n=27, 26, 26)
    42.4 (26.0 to 69.0)
    68.1 (41.8 to 110.9)
    1.1 (1.0 to 1.2)
        12-17 yrs, ST4: Month 31 (n=20, 21, 21)
    22.2 (12.7 to 38.6)
    22.7 (14.8 to 34.9)
    1.1 (0.9 to 1.2)
        12-17 yrs, ST4: Month 43 (n=23, 21, 16)
    13.3 (8.8 to 19.9)
    15.1 (9.3 to 24.8)
    1.2 (0.9 to 1.5)
        12-17 yrs, ST5: Month 19 (n=27, 26, 26)
    40.0 (24.5 to 65.3)
    71.8 (43.9 to 117.4)
    1.0 (1.0 to 1.1)
        12-17 yrs, ST5: Month 31 (n=20, 21, 21)
    21.1 (11.8 to 37.9)
    23.5 (15.1 to 36.5)
    1.2 (0.9 to 1.4)
        12-17 yrs, ST5: Month 43 (n=23, 21, 16)
    11.2 (7.4 to 17.1)
    16.3 (10.4 to 25.6)
    1.1 (0.9 to 1.3)
        12-17 yrs, ST6: Month 19 (n=27, 26, 26)
    39.1 (24.0 to 63.9)
    59.1 (37.0 to 94.3)
    1.1 (0.9 to 1.2)
        12-17 yrs, ST6: Month 31 (n=20, 21, 21)
    21.8 (12.5 to 38.0)
    23.9 (15.6 to 36.5)
    0.9 (0.8 to 1.1)
        12-17 yrs, ST6: Month 43 (n=23, 21, 16)
    10.0 (6.7 to 15.1)
    14.4 (8.8 to 23.6)
    1.1 (0.9 to 1.2)
        5-11 yrs, ST1: Month 19 (n=28, 19, 30)
    54.0 (35.4 to 82.5)
    58.7 (27.2 to 126.5)
    1.0 (1.0 to 1.0)
        5-11 yrs, ST1: Month 31 (n=27, 21, 22)
    17.4 (8.1 to 37.4)
    23.0 (10.3 to 51.3)
    1.2 (0.8 to 2.0)
        5-11 yrs, ST1: Month 43 (n=25, 16, 17)
    16.5 (11.6 to 23.3)
    24.3 (14.6 to 40.7)
    0.9 (0.7 to 1.1)
        5-11 yrs, ST2: Month 19 (n=27, 19, 30)
    63.1 (39.7 to 100.3)
    49.0 (20.7 to 115.7)
    1.0 (1.0 to 1.0)
        5-11 yrs, ST2: Month 31 (n=27, 21, 22)
    13.4 (6.7 to 27.1)
    18.9 (9.2 to 39.2)
    1.3 (0.8 to 2.0)
        5-11 yrs, ST2: Month 43 (n=25, 16, 17)
    14.3 (9.8 to 20.8)
    20.4 (11.6 to 35.8)
    0.9 (0.7 to 1.2)
        5-11 yrs, ST3: Month 19 (n=28, 19, 30)
    53.8 (33.9 to 85.4)
    37.4 (17.0 to 82.7)
    1.1 (1.0 to 1.2)
        5-11 yrs, ST3: Month 31 (n=27, 21, 22)
    14.6 (7.1 to 30.4)
    14.4 (6.7 to 30.9)
    1.2 (0.7 to 2.0)
        5-11 yrs, ST3: Month 43 (n=25, 16, 17)
    12.6 (8.6 to 18.4)
    20.1 (11.3 to 35.8)
    1.0 (0.8 to 1.3)
        5-11 yrs, ST4: Month 19 (n=28, 19, 30)
    49.8 (30.6 to 81.1)
    59.6 (26.6 to 133.7)
    1.1 (1.0 to 1.2)
        5-11 yrs, ST4: Month 31 (n=27, 21, 22)
    16.2 (7.8 to 33.7)
    21.0 (10.2 to 43.1)
    1.2 (0.8 to 2.0)
        5-11 yrs, ST4: Month 43 (n=25, 16, 17)
    13.2 (9.2 to 19.0)
    26.0 (15.0 to 45.3)
    0.9 (0.7 to 1.1)
        5-11 yrs, ST5: Month 19 (n=27, 19, 30)
    57.1 (36.2 to 90.3)
    54.0 (24.9 to 117.3)
    1.0 (1.0 to 1.0)
        5-11 yrs, ST5: Month 31 (n=27, 21, 22)
    15.3 (7.4 to 31.7)
    17.4 (8.6 to 35.0)
    1.3 (0.8 to 2.1)
        5-11 yrs, ST5: Month 43 (n=25, 16, 17)
    13.8 (10.1 to 18.9)
    21.5 (12.7 to 36.6)
    1.0 (1.0 to 1.0)
        5-11 yrs, ST6: Month 19 (n=28, 19, 30)
    49.8 (29.4 to 84.6)
    52.0 (24.6 to 110.0)
    1.1 (1.0 to 1.3)
        5-11 yrs, ST6: Month 31 (n=27, 21, 22)
    16.1 (7.8 to 33.0)
    16.1 (8.1 to 31.9)
    1.4 (0.8 to 2.2)
        5-11 yrs, ST6: Month 43 (n=25, 16, 17)
    14.9 (10.8 to 20.5)
    23.4 (14.1 to 39.0)
    1.0 (0.8 to 1.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Systematic assessment(SA): solicited AEs were assessed for up to 7 Days after each vaccination;non-SA: unsolicited AEs were assessed for up to 28 Days after each vaccination,all-cause mortality,SAEs and AESIs were assessed up to Month 48 after vaccination
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAS include all participants who entered into the study and received at least one vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.1
    Reporting groups
    Reporting group title
    Group 2: VLA15 + Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received two IM vaccinations of 180 mcg VLA15 at Months 0 and 6 and a placebo injection at Month 2 during the Main Study Phase and received three IM vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 3: Placebo
    Reporting group description
    		 Participants aged 5 to 65 years received three IM injections of placebo at Months 0, 2 and 6 during the Main Study Phase and received three IM injections of placebo at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    Group 1: VLA15
    Reporting group description
    		 Participants aged 5 to 65 years received three IM vaccinations of 180 mcg VLA15 at Months 0, 2 and 6 during the Main Study Phase and received three intramuscular vaccinations of 180 mcg VLA15 at Months 18, 30 and 42 during the Booster Phase.

    Reporting group title
    All Participants
    Reporting group description
    		 Participants aged 5 to 65 years who received either IM vaccination of 180 mcg VLA15 or placebo injections during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.

    Reporting group title
    Received any VLA15
    Reporting group description
    		 Participants aged 5 to 65 years who received IM vaccination of 180 mcg VLA15 or placebo injections, but could not be assigned to Group 1, 2 or 3 as participants received wrong vaccination or missed a vaccination.

    Serious adverse events
    		 Group 2: VLA15 + Placebo Group 3: Placebo Group 1: VLA15 All Participants Received any VLA15
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 112 (3.57%)
    14 / 206 (6.80%)
    0 / 127 (0.00%)
    28 / 625 (4.48%)
    14 / 419 (3.34%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 206 (0.97%)
    0 / 127 (0.00%)
    2 / 625 (0.32%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    2 / 625 (0.32%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Concussion
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Klinefelter's syndrome
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Tooth loss
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    2 / 625 (0.32%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reactive attachment disorder
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emotional distress
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    1 / 419 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 206 (0.49%)
    0 / 127 (0.00%)
    1 / 625 (0.16%)
    0 / 419 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 206 (0.00%)
    0 / 127 (0.00%)
    2 / 625 (0.32%)
    2 / 419 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 2: VLA15 + Placebo Group 3: Placebo Group 1: VLA15 All Participants Received any VLA15
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 112 (99.11%)
    145 / 206 (70.39%)
    124 / 127 (97.64%)
    548 / 625 (87.68%)
    403 / 419 (96.18%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    51 / 112 (45.54%)
    81 / 206 (39.32%)
    75 / 127 (59.06%)
    277 / 625 (44.32%)
    196 / 419 (46.78%)
         occurrences all number
    103
    139
    151
    499
    360
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    110 / 112 (98.21%)
    80 / 206 (38.83%)
    122 / 127 (96.06%)
    476 / 625 (76.16%)
    396 / 419 (94.51%)
         occurrences all number
    741
    213
    999
    2660
    2447
    Injection site swelling
         subjects affected / exposed
    46 / 112 (41.07%)
    18 / 206 (8.74%)
    70 / 127 (55.12%)
    199 / 625 (31.84%)
    181 / 419 (43.20%)
         occurrences all number
    81
    27
    147
    350
    323
    Injection site induration
         subjects affected / exposed
    46 / 112 (41.07%)
    16 / 206 (7.77%)
    62 / 127 (48.82%)
    190 / 625 (30.40%)
    174 / 419 (41.53%)
         occurrences all number
    80
    21
    126
    330
    309
    Pyrexia
         subjects affected / exposed
    4 / 112 (3.57%)
    7 / 206 (3.40%)
    11 / 127 (8.66%)
    27 / 625 (4.32%)
    20 / 419 (4.77%)
         occurrences all number
    4
    8
    11
    28
    20
    Fatigue
         subjects affected / exposed
    53 / 112 (47.32%)
    64 / 206 (31.07%)
    59 / 127 (46.46%)
    236 / 625 (37.76%)
    172 / 419 (41.05%)
         occurrences all number
    100
    104
    116
    417
    313
    Injection site erythema
         subjects affected / exposed
    45 / 112 (40.18%)
    23 / 206 (11.17%)
    73 / 127 (57.48%)
    215 / 625 (34.40%)
    192 / 419 (45.82%)
         occurrences all number
    90
    34
    162
    408
    374
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    23 / 112 (20.54%)
    28 / 206 (13.59%)
    21 / 127 (16.54%)
    99 / 625 (15.84%)
    71 / 419 (16.95%)
         occurrences all number
    26
    38
    25
    125
    87
    Vomiting
         subjects affected / exposed
    6 / 112 (5.36%)
    3 / 206 (1.46%)
    4 / 127 (3.15%)
    23 / 625 (3.68%)
    20 / 419 (4.77%)
         occurrences all number
    6
    3
    5
    24
    21
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    71 / 112 (63.39%)
    50 / 206 (24.27%)
    81 / 127 (63.78%)
    288 / 625 (46.08%)
    238 / 419 (56.80%)
         occurrences all number
    166
    68
    197
    588
    520
    Arthralgia
         subjects affected / exposed
    12 / 112 (10.71%)
    22 / 206 (10.68%)
    36 / 127 (28.35%)
    100 / 625 (16.00%)
    78 / 419 (18.62%)
         occurrences all number
    18
    30
    55
    142
    112
    Infections and infestations
    COVID-19
         subjects affected / exposed
    7 / 112 (6.25%)
    2 / 206 (0.97%)
    3 / 127 (2.36%)
    15 / 625 (2.40%)
    13 / 419 (3.10%)
         occurrences all number
    7
    2
    3
    15
    13

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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