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    Clinical Trial Results:
    A phase IV, open-label, single-center study to evaluate long term immunogenicity up to 10 years after the first booster immunization with Tick Borne Encephalitis vaccine in adults who received 1 of 3 different primary vaccination schedules

    Summary
    EudraCT number
    2011-003255-19
    Trial protocol
    CZ  
    Global end of trial date
    30 Sep 2016

    Results information
    Results version number
    v3
    This version publication date
    14 Oct 2017
    First version publication date
    22 Feb 2015
    Other versions
    v1 (removed from public view) , v2 , v4
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    205335
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01562444
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity Objectives: To evaluate the persistence of antibody response to a booster vaccine starting 6 years after the booster administration and following subjects up to 10 years after first booster administration.
    Protection of trial subjects
    The clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki. Eligible subjects were included in the study after providing written (witnessed, where required by law or regulation), Independent Ethics Committee (IEC)-approved informed consent, or, if incapable of doing so, after such consent was provided by a legally acceptable representative of the subject.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 205
    Worldwide total number of subjects
    205
    EEA total number of subjects
    205
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    189
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects who completed V48P7E1 study having received primary vaccination according to rapid (R), conventional (C) or accelerated conventional (AC) schedule were included in the study. Since modified conventional (MC) had not been accepted by health authorities as primary vaccination schedule, this group from V48P7 was not enrolled in this study.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    205
    Number of subjects completed
    205

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    TBE_R Group
    Arm description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
    Arm type
    Blood draw

    Investigational medicinal product name
    Blood draw
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

    Arm title
    TBE_C Group
    Arm description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
    Arm type
    Blood draw

    Investigational medicinal product name
    Blood draw
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

    Arm title
    TBE_AC Group
    Arm description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
    Arm type
    Blood draw

    Investigational medicinal product name
    Blood draw
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

    Number of subjects in period 1
    TBE_R Group TBE_C Group TBE_AC Group
    Started
    48
    51
    106
    Completed
    43
    49
    99
    Not completed
    5
    2
    7
         Protocol forbidden medication
    1
    -
    -
         Did not meet entry criteria
    2
    -
    3
         Unavailable serological results
    -
    2
    2
         Did not comply with blood draw schedule
    1
    -
    1
         Protocol forbidden concomitant vaccine
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TBE_R Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).

    Reporting group title
    TBE_C Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.

    Reporting group title
    TBE_AC Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.

    Reporting group values
    TBE_R Group TBE_C Group TBE_AC Group Total
    Number of subjects
    48 51 106
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.7 ± 15.25 41.8 ± 14.34 42.4 ± 14.35 -
    Gender categorical
    Units: Subjects
        Female
    24 32 55 111
        Male
    24 19 51 94
    Race/Ethnicity, Customized
    Units: Subjects
        White
    48 51 106 205

    End points

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    End points reporting groups
    Reporting group title
    TBE_R Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).

    Reporting group title
    TBE_C Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.

    Reporting group title
    TBE_AC Group
    Reporting group description
    Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.

    Primary: Percentage of subjects with detectable TBE antibody titers greater than or equal to (≥) 2

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    End point title
    Percentage of subjects with detectable TBE antibody titers greater than or equal to (≥) 2 [1]
    End point description
    Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    95.83 (85.75 to 99.49)
    100 (93.02 to 100)
    97.17 (91.95 to 99.41)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 [2]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    93.75 (82.8 to 98.69)
    100 (93.02 to 100)
    95.28 (89.33 to 98.45)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 [3]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    98.04 (89.55 to 99.95)
    93.4 (86.87 to 97.3)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 [4]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    94.12 (83.76 to 98.77)
    92.45 (85.67 to 96.69)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 [5]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    96.08 (86.54 to 99.52)
    93.4 (86.87 to 97.3)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 [6]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    95.83 (85.75 to 99.49)
    100 (93.02 to 100)
    97.17 (91.95 to 99.41)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 [7]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    93.75 (82.8 to 98.69)
    100 (93.02 to 100)
    95.28 (89.33 to 98.45)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 [8]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    98.04 (89.55 to 99.95)
    92.45 (85.67 to 96.69)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 [9]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    94.12 (83.76 to 98.77)
    92.45 (85.67 to 96.69)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 [10]
    End point description
    Antibody titers were measured by GSK NT assay.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    89.58 (77.34 to 96.53)
    94.12 (83.76 to 98.77)
    93.4 (86.87 to 97.3)
    No statistical analyses for this end point

    Primary: Evaluation of Geometric Mean Antibody Titers (GMTs)

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    End point title
    Evaluation of Geometric Mean Antibody Titers (GMTs) [11]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;51;104)
    76 (28 to 208)
    228 (149 to 348)
    228 (170 to 307)
        Baseline GMT post booster (N=48;51;105)
    467 (325 to 670)
    1135 (799 to 1611)
    985 (771 to 1257)
        GMT Year 6
    292 (184 to 463)
    293 (187 to 458)
    221 (162 to 302)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs

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    End point title
    Evaluation of GMTs [12]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;51;104)
    76 (28 to 208)
    228 (149 to 348)
    228 (170 to 307)
        Baseline GMT post booster (N=48;51;105)
    467 (325 to 670)
    1135 (799 to 1611)
    985 (771 to 1257)
        GMT Year 7
    295 (180 to 484)
    343 (212 to 555)
    254 (182 to 355)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs

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    End point title
    Evaluation of GMTs [13]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At year 8
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;51;104)
    76 (28 to 208)
    228 (149 to 348)
    228 (170 to 307)
        Baseline GMT post booster (N=48;51;105)
    467 (325 to 670)
    1135 (799 to 1611)
    985 (771 to 1257)
        GMT Year 8
    134 (79 to 227)
    211 (127 to 352)
    155 (109 to 221)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs

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    End point title
    Evaluation of GMTs [14]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;51;104)
    76 (28 to 208)
    228 (149 to 348)
    228 (170 to 307)
        Baseline GMT post booster (N=48;51;105)
    467 (325 to 670)
    1135 (799 to 1611)
    985 (771 to 1257)
        GMT Year 9
    211 (119 to 375)
    214 (122 to 374)
    194 (131 to 285)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs

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    End point title
    Evaluation of GMTs [15]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;51;104)
    76 (28 to 208)
    228 (149 to 348)
    228 (170 to 307)
        Baseline GMT post booster (N=48;51;105)
    467 (325 to 670)
    1135 (799 to 1611)
    985 (771 to 1257)
        GMT Year 10
    166 (94 to 295)
    245 (140 to 428)
    180 (122 to 265)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratios (GMRs) calculated to pre booster baselines

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    End point title
    Geometric Mean Ratios (GMRs) calculated to pre booster baselines [16]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    51
    104
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    6.73 (3.23 to 14.02)
    1.28 (0.94 to 1.75)
    0.99 (0.8 to 1.23)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines

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    End point title
    GMRs calculated to pre booster baselines [17]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    51
    104
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    3.85 (1.48 to 10)
    1.51 (1.01 to 2.25)
    1.13 (0.85 to 1.5)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines

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    End point title
    GMRs calculated to pre booster baselines [18]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    51
    104
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.67 (0.23 to 1.91)
    0.93 (0.6 to 1.44)
    0.69 (0.51 to 0.95)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines

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    End point title
    GMRs calculated to pre booster baselines [19]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    51
    104
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.08 (0.33 to 3.53)
    0.94 (0.57 to 1.54)
    0.85 (0.6 to 1.21)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines

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    End point title
    GMRs calculated to pre booster baselines [20]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    51
    104
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.76 (0.26 to 2.24)
    1.08 (0.68 to 1.69)
    0.8 (0.59 to 1.1)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines

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    End point title
    GMRs calculated to post booster baselines [21]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    105
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.63 (0.46 to 0.86)
    0.26 (0.19 to 0.35)
    0.22 (0.18 to 0.28)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines

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    End point title
    GMRs calculated to post booster baselines [22]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    105
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.63 (0.41 to 0.96)
    0.3 (0.2 to 0.46)
    0.25 (0.19 to 0.34)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines

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    End point title
    GMRs calculated to post booster baselines [23]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    105
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.29 (0.18 to 0.47)
    0.19 (0.12 to 0.3)
    0.16 (0.11 to 0.22)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines

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    End point title
    GMRs calculated to post booster baselines [24]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    105
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.45 (0.27 to 0.77)
    0.19 (0.11 to 0.32)
    0.2 (0.14 to 0.28)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines

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    End point title
    GMRs calculated to post booster baselines [25]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    48
    51
    105
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.36 (0.21 to 0.6)
    0.22 (0.13 to 0.36)
    0.18 (0.13 to 0.26)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups [26]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 2
    94.29 (80.84 to 99.3)
    100 (90.97 to 100)
    96.3 (89.56 to 99.23)
        ≥ 50 years: Antibody Titers ≥ 2 (N=13;12;25)
    100 (75.29 to 100)
    100 (73.54 to 100)
    100 (86.28 to 100)
        ≥ 60 years: Antibody Titers ≥ 2 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups [27]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 2
    91.43 (76.94 to 98.2)
    100 (90.97 to 100)
    93.83 (86.18 to 97.97)
        ≥ 50 years: Antibody Titers ≥ 2 (N=13;12;25)
    100 (75.29 to 100)
    100 (73.54 to 100)
    100 (86.28 to 100)
        ≥ 60 years: Antibody Titers ≥ 2 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups [28]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 2
    88.57 (73.26 to 96.8)
    97.44 (86.52 to 99.94)
    92.59 (84.57 to 97.23)
        ≥ 50 years: Antibody Titers ≥ 2 (N=13;12;25)
    92.31 (63.97 to 99.81)
    100 (73.54 to 100)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 2 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups [29]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 2
    88.57 (73.26 to 96.8)
    92.31 (79.13 to 98.38)
    91.36 (83 to 96.45)
        ≥ 50 years: Antibody Titers ≥ 2 (N=13;12;25)
    92.31 (63.97 to 99.81)
    100 (73.54 to 100)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 2 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups [30]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 2
    88.57 (73.26 to 96.8)
    94.87 (82.68 to 99.37)
    92.59 (84.57 to 97.23)
        ≥ 50 years: Antibody Titers ≥ 2 (N=13;12;25)
    92.31 (63.97 to 99.81)
    100 (73.54 to 100)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 2 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups [31]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 10
    94.29 (80.84 to 99.3)
    100 (90.97 to 100)
    96.3 (89.56 to 99.23)
        ≥ 50 years: Antibody Titers ≥ 10 (N=13;12;25)
    100 (75.29 to 100)
    100 (73.54 to 100)
    100 (86.28 to 100)
        ≥ 60 years: Antibody Titers ≥ 10 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups [32]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Number of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 10
    91.43 (76.94 to 98.2)
    100 (90.97 to 100)
    93.83 (86.18 to 97.97)
        ≥ 50 years: Antibody Titers ≥ 10 (N=13;12;25)
    100 (75.29 to 100)
    100 (73.54 to 100)
    100 (86.28 to 100)
        ≥ 60 years: Antibody Titers ≥ 10 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups

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    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups [33]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 10
    88.57 (73.26 to 96.8)
    97.44 (86.52 to 99.94)
    91.36 (83 to 96.45)
        ≥ 50 years: Antibody Titers ≥ 10 (N=13;12;25)
    92.31 (63.97 to 99.81)
    100 (73.54 to 100)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 10 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups

    Close Top of page
    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups [34]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 10
    88.57 (73.26 to 96.8)
    92.31 (79.13 to 98.38)
    91.36 (83 to 96.45)
        ≥ 50 years: Antibody Titers ≥ 10 (N=13;12;25)
    92.31 (63.97 to 99.81)
    100 (73.54 to 100)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 10 (N=4;3;7)
    100 (39.76 to 100)
    100 (29.24 to 100)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups

    Close Top of page
    End point title
    Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups [35]
    End point description
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Percentage of subjects
    number (confidence interval 95%)
        15-49 years: Antibody Titers ≥ 10
    88.57 (73.26 to 96.8)
    94.87 (82.68 to 99.37)
    92.59 (84.57 to 97.23)
        ≥ 50 years: Antibody Titers ≥ 10 (N=13;12;25)
    92.31 (63.97 to 99.81)
    91.67 (61.52 to 99.79)
    96 (79.65 to 99.9)
        ≥ 60 years: Antibody Titers ≥ 10 (N=4;3;7)
    100 (39.76 to 100)
    66.67 (9.43 to 99.16)
    100 (59.04 to 100)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of 15-49 years

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    End point title
    Evaluation of GMTs in the age group of 15-49 years [36]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;39;79)
    76 (27 to 215)
    253 (153 to 417)
    263 (185 to 375)
        Baseline GMT post booster (N=35;39;80)
    638 (413 to 984)
    1299 (861 to 1959)
    1008 (757 to 1343)
        GMT Year 6
    332 (186 to 593)
    341 (197 to 590)
    235 (160 to 344)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of 15-49 years

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    End point title
    Evaluation of GMTs in the age group of 15-49 years [37]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;39;79)
    76 (27 to 215)
    253 (153 to 417)
    263 (185 to 375)
        Baseline GMT post booster (N=35;39;80)
    638 (413 to 984)
    1299 (861 to 1959)
    1008 (757 to 1343)
        GMT Year 7
    304 (164 to 564)
    384 (214 to 691)
    250 (166 to 375)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of 15-49 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of 15-49 years [38]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;39;79)
    76 (27 to 215)
    253 (153 to 417)
    263 (185 to 375)
        Baseline GMT post booster (N=35;39;80)
    638 (413 to 984)
    1299 (861 to 1959)
    1008 (757 to 1343)
        GMT Year 8
    151 (80 to 287)
    219 (119 to 402)
    160 (105 to 243)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of 15-49 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of 15-49 years [39]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;39;79)
    76 (27 to 215)
    253 (153 to 417)
    263 (185 to 375)
        Baseline GMT post booster (N=35;39;80)
    638 (413 to 984)
    1299 (861 to 1959)
    1008 (757 to 1343)
        GMT Year 9
    218 (107 to 443)
    211 (108 to 413)
    191 (120 to 305)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of 15-49 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of 15-49 years [40]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=9;39;79)
    76 (27 to 215)
    253 (153 to 417)
    263 (185 to 375)
        Baseline GMT post booster (N=35;39;80)
    638 (413 to 984)
    1299 (861 to 1959)
    1008 (757 to 1343)
        GMT Year 10
    188 (92 to 382)
    266 (136 to 520)
    200 (126 to 319)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 50 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 50 years [41]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;12;25)
    0 (0 to 0)
    163 (77 to 348)
    145 (86 to 244)
        Baseline GMT post booster
    201 (111 to 364)
    733 (395 to 1361)
    914 (595 to 1403)
        GMT Year 6
    207 (107 to 401)
    178 (89 to 355)
    183 (114 to 295)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 50 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 50 years [42]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;12;25)
    0 (0 to 0)
    163 (77 to 348)
    145 (86 to 244)
        Baseline GMT post booster
    201 (111 to 364)
    733 (395 to 1361)
    914 (595 to 1403)
        GMT Year 7
    272 (126 to 588)
    237 (107 to 528)
    270 (155 to 470)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 50 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 50 years [43]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;12;25)
    0 (0 to 0)
    163 (77 to 348)
    145 (86 to 244)
        Baseline GMT post booster
    201 (111 to 364)
    733 (395 to 1361)
    914 (595 to 1403)
        GMT Year 8
    98 (39 to 245)
    189 (73 to 492)
    142 (73 to 275)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 50 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 50 years [44]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;12;25)
    0 (0 to 0)
    163 (77 to 348)
    145 (86 to 244)
        Baseline GMT post booster
    201 (111 to 364)
    733 (395 to 1361)
    914 (595 to 1403)
        GMT Year 9
    193 (74 to 505)
    224 (82 to 609)
    202 (101 to 403)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 50 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 50 years [45]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;12;25)
    0 (0 to 0)
    163 (77 to 348)
    145 (86 to 244)
        Baseline GMT post booster
    201 (111 to 364)
    733 (395 to 1361)
    914 (595 to 1403)
        GMT Year 10
    119 (47 to 302)
    189 (72 to 496)
    129 (66 to 251)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 60 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 60 years [46]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;3;7)
    0 (0 to 0)
    64 (13 to 316)
    69 (24 to 197)
        Baseline GMT post booster
    173 (71 to 425)
    573 (203 to 1616)
    498 (253 to 982)
        GMT Year 6
    189 (52 to 688)
    96 (22 to 427)
    76 (29 to 202)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 60 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 60 years [47]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;3;7)
    0 (0 to 0)
    64 (31 to 316)
    69 (24 to 197)
        Baseline GMT post booster
    173 (71 to 425)
    573 (203 to 1616)
    498 (253 to 982)
        GMT Year 7
    133 (26 to 677)
    120 (18 to 789)
    105 (31 to 360)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 60 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 60 years [48]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;3;7)
    0 (0 to 0)
    64 (13 to 316)
    69 (24 to 197)
        Baseline GMT post booster
    173 (71 to 425)
    573 (203 to 1616)
    498 (253 to 982)
        GMT Year 8
    128 (26 to 620)
    81 (13 to 504)
    71 (21 to 234)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 60 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 60 years [49]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;3;7)
    0 (0 to 0)
    64 (13 to 316)
    69 (24 to 197)
        Baseline GMT post booster
    173 (71 to 425)
    573 (203 to 1616)
    498 (253 to 982)
        GMT Year 9
    224 (52 to 965)
    67 (12 to 362)
    128 (42 to 385)
    No statistical analyses for this end point

    Primary: Evaluation of GMTs in the age group of ≥ 60 years

    Close Top of page
    End point title
    Evaluation of GMTs in the age group of ≥ 60 years [50]
    End point description
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline GMT pre booster (N=0;3;7)
    0 (0 to 0)
    64 (13 to 316)
    69 (24 to 197)
        Baseline GMT post booster
    173 (71 to 425)
    573 (203 to 1616)
    498 (253 to 982)
        GMT Year 10
    181 (35 to 928)
    57 (9 to 377)
    72 (21 to 248)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of 15-49 years [51]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    39
    79
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    6.73 (3.02 to 15.01)
    1.35 (0.92 to 1.98)
    0.92 (0.7 to 1.2)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of 15-49 years [52]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    39
    79
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    3.85 (1.34 to 11.04)
    1.52 (0.92 to 2.52)
    0.96 (0.68 to 1.38)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of 15-49 years [53]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    39
    79
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.67 (0.22 to 2.08)
    0.87 (0.5 to 1.49)
    0.62 (0.42 to 0.91)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of 15-49 years [54]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    39
    79
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.08 (0.3 to 3.88)
    0.84 (0.45 to 1.54)
    0.73 (0.47 to 1.12)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of 15-49 years [55]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    9
    39
    79
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.76 (0.24 to 2.48)
    1.05 (0.6 to 1.85)
    0.78 (0.52 to 1.16)
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 50 years

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    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 50 years [56]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [57]
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.09 (0.75 to 1.59)
    1.27 (0.98 to 1.64)
    Notes
    [57] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 50 years [58]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [59]
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.45 (1.01 to 2.1)
    1.87 (1.45 to 2.41)
    Notes
    [59] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 50 years [60]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [61]
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.16 (0.62 to 2.17)
    0.98 (0.63 to 1.52)
    Notes
    [61] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 50 years [62]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [63]
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.37 (0.71 to 2.65)
    1.39 (0.88 to 2.21)
    Notes
    [63] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 50 years [64]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [65]
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.16 (0.63 to 2.12)
    0.89 (0.58 to 1.35)
    Notes
    [65] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 60 years [66]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [67]
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.5 (0.76 to 2.97)
    1.1 (0.7 to 1.72)
    Notes
    [67] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 60 years [68]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [69]
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.88 (0.97 to 3.64)
    1.52 (0.99 to 2.35)
    Notes
    [69] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 60 years [70]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [71]
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.27 (0.44 to 3.66)
    1.03 (0.51 to 2.05)
    Notes
    [71] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 60 years [72]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [73]
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    1.05 (0.37 to 2.94)
    1.85 (0.94 to 3.64)
    Notes
    [73] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to pre booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to pre booster baselines in the age group of ≥ 60 years [74]
    End point description
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [74] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    0 [75]
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    ( to )
    0.89 (0.39 to 2.06)
    1.04 (0.6 to 1.81)
    Notes
    [75] - There were no subjects in the TBE_R group with baselines calculated using pre booster values
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of 15-49 years [76]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    80
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.52 (0.35 to 0.78)
    0.26 (0.18 to 0.38)
    0.23 (0.18 to 0.3)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of 15-49 years [77]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    80
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.48 (0.28 to 0.81)
    0.3 (0.18 to 0.49)
    0.24 (0.17 to 0.35)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of 15-49 years [78]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [78] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    80
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.24 (0.13 to 0.43)
    0.17 (0.1 to 0.3)
    0.16 (0.11 to 0.23)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of 15-49 years [79]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    80
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.34 (0.18 to 0.66)
    0.16 (0.09 to 0.3)
    0.19 (0.12 to 0.3)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of 15-49 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of 15-49 years [80]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [80] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    35
    39
    80
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.29 (0.15 to 0.56)
    0.2 (0.11 to 0.38)
    0.2 (0.13 to 0.3)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 50 years [81]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.03 (0.7 to 1.52)
    0.24 (0.16 to 0.37)
    0.2 (0.15 to 0.27)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 50 years [82]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [82] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.36 (0.79 to 2.33)
    0.32 (0.18 to 0.57)
    0.3 (0.2 to 0.44)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 50 years [83]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.49 (0.23 to 1.04)
    0.26 (0.12 to 0.57)
    0.16 (0.09 to 0.27)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 50 years [84]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [84] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.96 (0.44 to 2.08)
    0.31 (0.14 to 0.68)
    0.22 (0.13 to 0.39)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 50 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 50 years [85]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    13
    12
    25
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.59 (0.28 to 1.24)
    0.26 (0.12 to 0.55)
    0.14 (0.08 to 0.24)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 60 years [86]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 6
    Notes
    [86] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.09 (0.47 to 2.55)
    0.17 (0.06 to 0.45)
    0.15 (0.08 to 0.29)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 60 years [87]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 7
    Notes
    [87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.77 (0.21 to 2.86)
    0.21 (0.05 to 0.96)
    0.21 (0.08 to 0.57)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 60 years [88]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 8
    Notes
    [88] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    0.74 (0.2 to 2.72)
    0.14 (0.03 to 0.64)
    0.14 (0.05 to 0.38)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 60 years

    Close Top of page
    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 60 years [89]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 9
    Notes
    [89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.29 (0.43 to 3.84)
    0.12 (0.03 to 0.41)
    0.26 (0.11 to 0.58)
    No statistical analyses for this end point

    Primary: GMRs calculated to post booster baselines in the age group of ≥ 60 years

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    End point title
    GMRs calculated to post booster baselines in the age group of ≥ 60 years [90]
    End point description
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
    End point type
    Primary
    End point timeframe
    At Year 10
    Notes
    [90] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    TBE_R Group TBE_C Group TBE_AC Group
    Number of subjects analysed
    4
    3
    7
    Units: Ratios
    geometric mean (confidence interval 95%)
        Ratios
    1.05 (0.31 to 3.49)
    0.1 (0.02 to 0.4)
    0.14 (0.06 to 0.36)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Not applicable (NA)
    Adverse event reporting additional description
    The study was intended to evaluate the persistence of antibody response up to 10 years after booster vaccine administration. Safety profile of the vaccine was not evaluated as per study protocol. Hence, there are no safety results as per planned analysis.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NA
    Dictionary version
    NA
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The study was intended to evaluate the persistence of antibody response up to 10 years after booster vaccine administration. Safety profile of the vaccine was not evaluated as per study protocol. Hence, there are no safety results as per planned analysis.

    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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