Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase IV, open-label, single-center study to evaluate long term immunogenicity up to 15 years after the first booster immunization with Encepur Adults (Polygeline-free Tick-borne Encephalitis vaccine for adults) in adults who received 1 of 3 different primary vaccination schedules

    Summary
    EudraCT number
    		 2017-001356-59
    Trial protocol
    		 CZ  
    Global end of trial date
    08 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2022
    First version publication date
    06 Nov 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    205847
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03294135
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Clinical Trials Call Centre, GlaxoSmithKline Biologicals, +44 20 8990 4466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Clinical Trials Call Centre, GlaxoSmithKline Biologicals, +44 20 8990 4466, 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
    03 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to investigate the persistence of antibody response in adults up to 15 years after one Encepur Adults booster dose.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccine, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 2017
    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
    Czechia: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    159
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 194 subjects, who participated in study V48P7E2(NCT01562444), received in a parent V48P7 study one of the following primary schedules: rapid(R), conventional(C), or accelerated conventional(AC), who received a booster dose in study V48P7E1(NCT00387634) or before study V48P7E1(only R-schedule), and agreed to participate in this study, were enrolled.

    Pre-assignment
    Screening details
    		 No participant received vaccination in study V48P7E2 (NCT01562444).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Conventional Group
    Arm description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encepur Adults
    Investigational medicinal product code
    Other name
    Polygeline-free Tick-borne Encephalitis vaccine for adults
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of study vaccine (0.5 mL) will be administered intramuscularly (IM) in the deltoid of the non-dominant arm.

    Arm title
    		 Accelerated/Rapid Group
    Arm description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encepur Adults
    Investigational medicinal product code
    Other name
    Polygeline-free Tick-borne Encephalitis vaccine for adults
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of study vaccine (0.5 mL) will be administered intramuscularly (IM) in the deltoid of the non-dominant arm.

    Arm title
    		 Accelerated Conventional Group
    Arm description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encepur Adults
    Investigational medicinal product code
    Other name
    Polygeline-free Tick-borne Encephalitis vaccine for adults
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of study vaccine (0.5 mL) will be administered intramuscularly (IM) in the deltoid of the non-dominant arm.

    Number of subjects in period 1
    		Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Started
    50
    43
    101
    Completed
    46
    43
    99
    Not completed
    4
    0
    2
         Consent withdrawn by subject
    -
    -
    1
         Not specified
    2
    -
    -
         Lost to follow-up
    1
    -
    1
         Serious Adverse Event
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Conventional Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.

    Reporting group title
    Accelerated/Rapid Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

    Reporting group title
    Accelerated Conventional Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

    Reporting group values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group Total
    Number of subjects
    		 50 43 101 194
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 42 34 83 159
        From 65-84 years
    		 8 9 18 35
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 47.0 ± 14.1 48.8 ± 15.3 48.1 ± 14.5 -
    Sex: Female, Male
    Units: Participants
        Female
    		 31 22 52 105
        Male
    		 19 21 49 89
    Race/Ethnicity, Customized
    Units: Subjects
        WHITE
    		 50 43 101 194

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Conventional Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.

    Reporting group title
    Accelerated/Rapid Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

    Reporting group title
    Accelerated Conventional Group
    Reporting group description
    		 Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

    Primary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 11

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 11 [1]
    End point description
    Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. The analysis was performed on the Per Protocol set-1 (PPS-1) which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 11
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    48
    43
    101
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (92.6 to 100)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Primary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 12

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 12 [2]
    End point description
    Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 12
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Percentage of participants
        number (confidence interval 95%)
    98.0 (89.4 to 99.9)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Primary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 13

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 13 [3]
    End point description
    Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 13
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    49
    43
    101
    Units: Percentage of participants
        number (confidence interval 95%)
    95.9 (86.0 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Primary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 14

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 14 [4]
    End point description
    Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 14
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    49
    43
    101
    Units: Percentage of participants
        number (confidence interval 95%)
    95.9 (86.0 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Primary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 15

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 15 [5]
    End point description
    Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 15
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    48
    43
    100
    Units: Percentage of participants
        number (confidence interval 95%)
    95.8 (85.7 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titers (GMTs) by age categories at Year 11

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) by age categories at Year 11 [6]
    End point description
    Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (>=) 50 years and >= 60 years. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 11
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        25 to 49 Years of Age (N=24,23,55)
    368.8 (208.9 to 651.1)
    301.5 (168.7 to 538.7)
    235.2 (161.6 to 342.3)
        >=50 Years of Age (N=24,20,46)
    129.6 (76.7 to 218.8)
    177.4 (100.0 to 314.9)
    128.1 (87.7 to 187.0)
        >=60 Years of Age (N=12,13,26)
    127.5 (61.3 to 265.4)
    160.2 (79.2 to 324.0)
    103.0 (62.6 to 169.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titers (GMTs) by age categories at Year 12

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) by age categories at Year 12 [7]
    End point description
    Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 12
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        25 to 49 Years of Age (N=26,23,55)
    323.7 (185.0 to 566.3)
    334.6 (184.6 to 606.4)
    264.3 (179.9 to 388.3)
        >=50 Years of Age (N=24,20,46)
    154.5 (87.6 to 272.4)
    205.8 (110.6 to 383.0)
    158.2 (105.0 to 238.3)
        >=60 Years of Age (N=12,13,26)
    133.6 (62.5 to 285.6)
    190.8 (92.0 to 395.9)
    141.0 (84.2 to 236.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titers (GMTs) by age categories at Year 13

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) by age categories at Year 13 [8]
    End point description
    Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 13
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        25 to 49 Years of Age (N=26,23,55)
    196.9 (112.2 to 345.6)
    238.4 (131.1 to 433.6)
    172.8 (117.3 to 254.3)
        >=50 Years of Age (N=23,20,46)
    98.3 (56.6 to 170.9)
    132.1 (73.0 to 238.9)
    110.9 (75.0 to 164.0)
        >=60 Years of Age (N=12,13,26)
    93.5 (44.7 to 195.6)
    114.8 (56.5 to 233.4)
    96.9 (58.7 to 160.0)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titers (GMTs) by age categories at Year 14

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) by age categories at Year 14 [9]
    End point description
    Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 14
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        25 to 49 Years of Age (N=26,23,55)
    299.7 (164.2 to 547.0)
    299.1 (157.8 to 567.1)
    248.2 (164.1 to 375.4)
        >=50 Years of Age (N=23,20,46)
    147.5 (81.2 to 268.0)
    169.7 (89.5 to 321.8)
    131.1 (86.0 to 200.0)
        >=60 Years of Age (N=12,13,26)
    139.4 (67.2 to 289.3)
    149.9 (74.3 to 302.4)
    117.9 (71.8 to 193.7)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titers (GMTs) by age categories at Year 15

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) by age categories at Year 15 [10]
    End point description
    Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
    End point type
    Primary
    End point timeframe
    At Year 15
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        25 to 49 Years of Age (N=26,23,55)
    217.6 (125.2 to 378.2)
    281.6 (156.5 to 506.9)
    183.9 (125.7 to 268.9)
        >=50 Years of Age (N=22,20,45)
    98.9 (54.4 to 180.0)
    157.0 (83.8 to 294.1)
    103.3 (67.9 to 156.9)
        >=60 Years of Age (N=11,13,25)
    114.1 (52.5 to 247.8)
    158.1 (77.5 to 322.7)
    90.7 (54.2 to 151.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 2 and equal to or above 10 as measured by GSK Biologicals' NT, overall and by study group

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 2 and equal to or above 10 as measured by GSK Biologicals' NT, overall and by study group
    End point description
    Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 2 and >= 10 at 21 days after the booster vaccination. The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
    End point type
    Secondary
    End point timeframe
    At 21 days after the booster vaccination
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Percentage of participants
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [11] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [12] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [13] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Titers (GMTs) as measured by GSK Biologicals' NT, overall and by study group

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Titers (GMTs) as measured by GSK Biologicals' NT, overall and by study group
    End point description
    Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
    End point type
    Secondary
    End point timeframe
    At 21 days after the booster vaccination
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    Units: Titers
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [14] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [15] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [16] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    No statistical analyses for this end point

    Secondary: Geometric Mean Ratios (GMRs) blood draw after/before booster as measured by GSK Biologicals' NT, overall and by study group

    		 Close Top of page
    End point title
    		 Geometric Mean Ratios (GMRs) blood draw after/before booster as measured by GSK Biologicals' NT, overall and by study group
    End point description
    Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
    End point type
    Secondary
    End point timeframe
    At 21 days after the booster vaccination
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    0 [17]
    0 [18]
    0 [19]
    Units: Titers
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [17] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [18] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    [19] - As there was only 1 subject in this category, lower and upper limits were not calculated.
    No statistical analyses for this end point

    Secondary: Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to and above 10 as measured by GSK Biologicals' NT, overall and by study group

    		 Close Top of page
    End point title
    		 Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to and above 10 as measured by GSK Biologicals' NT, overall and by study group
    End point description
    Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 10 from Year 1 to Year 15. The analysis was performed on the set of subjects who completed the entire 15-year follow-up with no protocol deviations related to the persistence analysis.
    End point type
    Secondary
    End point timeframe
    From Year 1 up to Year 15
    End point values
    		 Conventional Group Accelerated/Rapid Group Accelerated Conventional Group
    Number of subjects analysed
    50
    43
    101
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1 (N=47,42,100)
    100 (92.5 to 100)
    100 (91.6 to 100)
    100 (96.4 to 100)
        Year 2 (N=48,42,100)
    100 (92.6 to 100)
    100 (91.6 to 100)
    100 (96.3 to 100)
        Year 3 (N=48,42,100)
    100 (92.6 to 100)
    100 (91.6 to 100)
    100 (96.4 to 100)
        Year 4 (N=46,41,100)
    100 (92.3 to 100)
    97.6 (87.1 to 99.9)
    100 (96.4 to 100)
        Year 5 (N=48,43,100)
    100 (92.6 to 100)
    100 (91.8 to 100)
    100 (96.4 to 100)
        Year 6 (N=48,43,100)
    100 (92.6 to 100)
    100 (91.8 to 100)
    100 (96.4 to 100)
        Year 7(N=48,43,98)
    100 (92.6 to 100)
    100 (91.8 to 100)
    100 (96.3 to 100)
        Year 8 (N=47,42,97)
    100 (92.5 to 100)
    100 (91.6 to 100)
    100 (96.3 to 100)
        Year 9 (N=45,42,97)
    100 (92.1 to 100)
    100 (91.6 to 100)
    100 (96.3 to 100)
        Year 10 (N=46,42,98)
    100 (92.3 to 100)
    100 (91.6 to 100)
    100 (96.3 to 100)
        Year 11 (N=46,43,100)
    100 (92.3 to 100)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
        Year 12 (N=48,43,100)
    97.9 (88.9 to 99.9)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
        Year 13 (N=48,43,100)
    95.8 (85.7 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
        Year 14 (N=48,43,100)
    95.8 (85.7 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
        Year 15 (N=48,43,100)
    95.8 (85.7 to 99.5)
    100 (91.8 to 100)
    99.0 (94.6 to 100)
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of participants with serious adverse events (SAEs) [20]
    End point description
    SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. The analysis was performed on the Safety population which included all subjects who received a booster vaccination in this study. Only one participant (from the Accelerated/Rapid Group) received a booster dose.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 21 after booster vaccination
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only one participant (from the Conventional Group) received a booster dose during this study.
    End point values
    		 Conventional Group
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other SAEs were collected only after the booster vaccination administration (Day 0-Day 21).
    Adverse event reporting additional description
    Other adverse events were not collected as per protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Conventional Group
    Reporting group description
    		 Participants received a second booster vaccination six months after the blood draw only in case their results were with an NT titer below 10 and who belonged to the following vaccination schedule in the primary studies: primary vaccination of 66 participants in study V48P7 on Days 0, 28 (+10) and 300 (+21), booster vaccination of 55 participants in study V48P7E1 (NCT00387634).

    Reporting group title
    Accelerated Conventional Group
    Reporting group description
    		 Participants received a second booster vaccination six months after the blood draw only in case their results were with an NT titer below 10 and who belonged to the following vaccination schedule in the primary studies: primary vaccination of 133 participants in study V48P7 on Days 0, 14 (+3) and 300 (+21), booster vaccination of 109 participants in study V48P7E1 (NCT00387634).

    Reporting group title
    Accelerated/Rapid Group
    Reporting group description
    		 Participants received a second booster vaccination six months after the blood draw only in case their results were with an NT titer below 10 and who belonged to the following vaccination schedule in the primary studies: primary vaccination of 66 participants in study V48P7 on Days 0, 7 (+3) and 21 (+7), booster vaccination of 9 participants in study V48P7E1 (NCT00387634) 40 participants received their booster vaccination before enrolment in study V48P7E1 (NCT00387634).

    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: Non-serious adverse events were not collected as per protocol.
    Serious adverse events
    		 Conventional Group Accelerated Conventional Group Accelerated/Rapid Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 101 (0.99%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    1
    1
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death due to glioblastoma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 101 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Death due to primary COVID-19 pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Conventional Group Accelerated Conventional Group Accelerated/Rapid Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    0 / 43 (0.00%)

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 15:36:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA