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    Clinical Trial Results:
    An open multicentre, multicountry study to evaluate long-term antibody persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccinated with Twinrix Adult following a two-dose schedule or Twinrix Junior following a three-dose schedule

    Summary
    EudraCT number
    		 2008-006083-11
    Trial protocol
    		 BE   CZ  
    Global end of trial date
    18 Jul 2014

    Results information
    Results version number
    		 v3(current)
    This version publication date
    06 Apr 2023
    First version publication date
    06 Jun 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    110699 to 110704
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00875485
    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
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    For the long-term follow-up phase: To evaluate anti-HAV and anti-HBs antibody persistence at Years 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose Twinrix Adult or a three-dose Twinrix Junior primary vaccination course. For the Challenge dose phase: To evaluate the immune memory 15 years after primary vaccination with a two-dose Twinrix Adult versus a three-dose Twinrix Junior vaccination course in subjects who became seronegative for anti-HAV antibodies (less than 15 mIU/ml) or whose anti-HBs antibody concentrations decreased below 10 mIU/ml during the long-term follow-up period.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccine.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 72
    Country: Number of subjects enrolled
    Czech Republic: 138
    Worldwide total number of subjects
    210
    EEA total number of subjects
    210
    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)
    210
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this study, a total of 210 subjects were enrolled who participated at Year 11 (Y11) and Y12. There were a total of 8 additional subjects at Y13 and Y14 who came back from the primary study but did not participate in Y11 and Y12 as allowed by the protocol. One subject from the 210 subjects who participated in Y11 and Y12 did not return at Y15.

    Period 1
    Period 1 title
    Year 11
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 1
    		Twinrix Adult Group Twinrix Junior Group
    Started
    99
    111
    Completed
    99
    111
    Period 2
    Period 2 title
    Year 12
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 2
    		Twinrix Adult Group Twinrix Junior Group
    Started
    101
    109
    Completed
    101
    109
    Period 3
    Period 3 title
    Year 13
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 3
    		Twinrix Adult Group Twinrix Junior Group
    Started
    101
    109
    Year 13, Started
    102
    113
    Completed
    102
    113
    Joined
    1
    4
         Additional subjects who joined at Year 13
    1
    4
    Period 4
    Period 4 title
    Year 14
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 4 [1]
    		Twinrix Adult Group Twinrix Junior Group
    Started
    100
    113
    Completed
    100
    113
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In this study, a total of 210 subjects were enrolled who participated at Year 11 (Y11) and Y12. There were a total of 8 additional subjects at Y13 and Y14 who came back from the primary study but did not participate in Y11 and Y12 as allowed by the protocol. One subject from the 210 subjects who participated in Y11 and Y12 did not return at Y15
    Period 5
    Period 5 title
    Year 15
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 5 [2]
    		Twinrix Adult Group Twinrix Junior Group
    Started
    98
    111
    Completed
    98
    111
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In this study, a total of 210 subjects were enrolled who participated at Year 11 (Y11) and Y12. There were a total of 8 additional subjects at Y13 and Y14 who came back from the primary study but did not participate in Y11 and Y12 as allowed by the protocol. One subject from the 210 subjects who participated in Y11 and Y12 did not return at Y15.
    Period 6
    Period 6 title
    Challenge dose epoch
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Twinrix Adult Group
    Arm description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Arm title
    		 Twinrix Junior Group
    Arm description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Investigational medicinal product name
    Havrix 1440
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly into the upper arm (deltoid muscle) region.

    Number of subjects in period 6 [3]
    		Twinrix Adult Group Twinrix Junior Group
    Started
    8
    11
    Completed
    7
    11
    Not completed
    1
    0
         Pregnancy
    1
    -
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 8 subjects in the Twinrix Adult Group and 11 subjects in the Twinrix Junior Group were eligible to receive the challenge dose.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.

    Reporting group values
    		 Twinrix Adult Group Twinrix Junior Group Total
    Number of subjects
    		 99 111 210
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.5 ± 1.06 24.5 ± 1.05 -
    Gender categorical
    Units: Subjects
        Female
    		 49 52 101
        Male
    		 50 59 109
    Subject analysis sets

    Subject analysis set title
    Twinrix Adult Group (Year 12)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 12. The analysis Population includes all subjects that returned for the Year 12 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 12)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 12. The analysis Population includes all subjects that returned for the Year 12 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 13)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 13. The analysis Population includes all subjects that returned for the Year 13 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 13)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 13. The analysis Population includes all subjects that returned for the Year 13 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 14)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 14. The analysis Population includes all subjects that returned for the Year 14 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 14)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 14. The analysis Population includes all subjects that returned for the Year 14 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 15)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 15. The analysis Population includes all subjects that returned for the Year 15 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 15)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 15. The analysis Population includes all subjects that returned for the Year 15 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (challenge dose epoch)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to the challenge dose epoch. The analysis Population includes all subjects that were administrated a challenge dose.

    Subject analysis set title
    Twinrix Junior Group (challenge dose epoch)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to the challenge dose epoch. The analysis Population includes all subjects that were administrated a challenge dose.

    Subject analysis sets values
    		 Twinrix Adult Group (Year 12) Twinrix Junior Group (Year 12) Twinrix Adult Group (Year 13) Twinrix Junior Group (Year 13) Twinrix Adult Group (Year 14) Twinrix Junior Group (Year 14) Twinrix Adult Group (Year 15) Twinrix Junior Group (Year 15) Twinrix Adult Group (challenge dose epoch) Twinrix Junior Group (challenge dose epoch)
    Number of subjects
    101
    109
    102
    113
    100
    113
    98
    111
    8
    11
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    25.4 ± 1.06
    25.4 ± 1.04
    26.40 ± 1.07
    26.40 ± 1.06
    27.40 ± 1.11
    27.40 ± 1.05
    28.4 ± 1.15
    28.3 ± 1.09
    29.4 ± 1.2
    29.4 ± 1.3
    Gender categorical
    Units: Subjects
        Female
    50
    50
    50
    53
    49
    53
    47
    52
    4
    7
        Male
    51
    59
    52
    60
    51
    60
    51
    59
    4
    4

    End points

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    End points reporting groups
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.

    Subject analysis set title
    Twinrix Adult Group (Year 12)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 12. The analysis Population includes all subjects that returned for the Year 12 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 12)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 12. The analysis Population includes all subjects that returned for the Year 12 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 13)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 13. The analysis Population includes all subjects that returned for the Year 13 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 13)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 13. The analysis Population includes all subjects that returned for the Year 13 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 14)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 14. The analysis Population includes all subjects that returned for the Year 14 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 14)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 14. The analysis Population includes all subjects that returned for the Year 14 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (Year 15)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 15. The analysis Population includes all subjects that returned for the Year 15 follow up time point.

    Subject analysis set title
    Twinrix Junior Group (Year 15)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to Year 15. The analysis Population includes all subjects that returned for the Year 15 follow up time point.

    Subject analysis set title
    Twinrix Adult Group (challenge dose epoch)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to the challenge dose epoch. The analysis Population includes all subjects that were administrated a challenge dose.

    Subject analysis set title
    Twinrix Junior Group (challenge dose epoch)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The baseline measure data here corresponds to the challenge dose epoch. The analysis Population includes all subjects that were administrated a challenge dose.

    Primary: Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value

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    End point title
    		 Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value [1]
    End point description
    Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    78
    92
    Units: Subjects
        Year 11
    78
    92
        Year 12
    75
    90
        Year 13
    76
    92
        Year 14
    75
    91
        Year 15
    74
    88
    No statistical analyses for this end point

    Primary: Anti-HAV antibody concentrations

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    End point title
    		 Anti-HAV antibody concentrations [2]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    78
    92
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Year 11 (N= 78; 92)
    360.5 (292 to 445.1)
    257.2 (215.1 to 307.5)
        Year 12 (N= 75; 90)
    450.8 (359.6 to 565.1)
    335.6 (279 to 403.6)
        Year 13 (N= 77; 92)
    401.5 (328.2 to 491.1)
    293.6 (244.2 to 352.9)
        Year 14 (N= 75; 91)
    388 (309.2 to 487)
    291.4 (240.6 to 352.9)
        Year 15 (N= 74; 88)
    387.5 (306.6 to 489.8)
    299.4 (247.6 to 362)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values

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    End point title
    		 Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values [3]
    End point description
    Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).
    End point type
    Primary
    End point timeframe
    At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    78
    92
    Units: Subjects
        Year 11 [6.2 mIU/mL] (N = 78;91)
    68
    79
        Year 12 [6.2 mIU/mL] (N = 75;90)
    64
    80
        Year 13 [6.2 mIU/mL] (N = 77;92)
    65
    83
        Year 14 [6.2 mIU/mL] (N= 75;91)
    66
    80
        Year 15 [6.2 mIU/mL] (N= 74;88)
    62
    79
        Year 11 [10 mIU/mL] (N = 78;91)
    64
    75
        Year 12 [10 mIU/mL] (N = 75;90)
    62
    76
        Year 13 [10 mIU/mL] (N = 77;92)
    62
    77
        Year 14 [10 mIU/mL] (N= 75;91)
    62
    73
        Year 15 [10 mIU/mL] (N= 74;88)
    60
    72
    No statistical analyses for this end point

    Primary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations [4]
    End point description
    Antibodies concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA.
    End point type
    Primary
    End point timeframe
    At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    78
    92
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Year 11 (N = 78;91)
    88 (63.2 to 122.5)
    75.2 (55.6 to 101.8)
        Year 12 (N = 75;90)
    93.3 (66.2 to 131.6)
    77 (56.1 to 105.7)
        Year 13 (N = 77;92)
    92.4 (65.9 to 129.5)
    70.1 (51.2 to 96)
        Year 14 (N= 75;91)
    81.8 (57.5 to 116.4)
    70.2 (51 to 96.8)
        Year 15 (N= 74;88)
    87.2 (61 to 124.5)
    69.6 (50 to 96.9)
    No statistical analyses for this end point

    Primary: Anti-HBs anamnestic response

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    End point title
    		 Anti-HBs anamnestic response [5]
    End point description
    Anamnestic response was defined as: Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points. At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points.
    End point type
    Primary
    End point timeframe
    One month after the challenge dose
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        ANTI-HBS ANAMNESTIC RESPONSE
    8
    10
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection
    End point description
    SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Since the last long-term follow-up visit up to Year 11
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    99
    111
    Units: Subjects
        SAE (s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection
    End point description
    SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Since the last long-term follow-up visit up to Year 12
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    101
    109
    Units: Subjects
        SAE (s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection
    End point description
    SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Since the last long-term follow-up visit up to Year 13
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    102
    113
    Units: Subjects
        SAE (s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection
    End point description
    SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Since the last long-term follow-up visit up to Year 14
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    100
    113
    Units: Subjects
        SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection

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    End point title
    		 Number of subjects reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection
    End point description
    SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Since the last long-term follow-up visit up to Year 15
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    98
    111
    Units: Subjects
        SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis A (HAV) antibody concentrations equal to or above the cut-off value

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    End point title
    		 Number of subjects with anti-hepatitis A (HAV) antibody concentrations equal to or above the cut-off value
    End point description
    Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL). Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose.
    End point type
    Secondary
    End point timeframe
    Before (PRE) the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        PRE (N = 8;11)
    8
    11
    No statistical analyses for this end point

    Secondary: Anti-HAV antibody concentrations

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    End point title
    		 Anti-HAV antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        PRE (N =8;11)
    270.9 (173.8 to 422.3)
    201.3 (123.1 to 329)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations equal to or above the cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations equal to or above the cut-off values
    End point description
    Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        PRE [6.2 MIU/ML] (N = 8;11)
    0
    2
        POST [6.2 MIU/ML] (N = 8;11)
    8
    11
        PRE [10 MIU/ML] (N = 8;11)
    0
    1
        POST [10 MIU/ML] (N = 8;11)
    8
    10
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        PRE (N= 8;11)
    3.1 (3.1 to 3.1)
    4.1 (2.5 to 6.9)
        POST (N= 8;11)
    3022.8 (407.8 to 22405.5)
    1433.1 (324.5 to 6328.9)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local adverse events

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local adverse events
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        ANY PAIN
    5
    4
        GRADE 3 PAIN
    0
    0
        ANY REDNESS
    1
    2
        GRADE 3 REDNESS
    0
    0
        ANY SWELLING
    0
    0
        GRADE 3 SWELLING
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        ANY FATIGUE
    3
    3
        GRADE 3 FATIGUE
    0
    0
        RELATED FATIGUE
    3
    3
        ANY GASTROINTESTINAL SYMPTOMS
    1
    1
        GRADE 3 GASTROINTESTINAL SYMPTOMS
    0
    0
        RELATED GASTROINTESTINAL SYMPTOMS
    1
    1
        ANY HEADACHE
    1
    2
        GRADE 3 HEADACHE
    0
    0
        RELATED HEADACHE
    1
    2
        ANY TEMPERATURE
    0
    0
        GRADE 3 TEMPERATURE
    0
    0
        RELATED TEMPERATURE
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited symptoms
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0 to 30) follow-up period after the challenge dose
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        ANY AE(S)
    4
    0
        GRADE 3 AE(S)
    0
    0
        RELATED AE(S)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with Serious Adverse Events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the challenge dose (Month 0 to Month 1)
    End point values
    		 Twinrix Adult Group Twinrix Junior Group
    Number of subjects analysed
    8
    11
    Units: Subjects
        SAE(S)
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Year 15 of the long-term follow-up. SAEs: one month post challenge dose, solicited symptoms: during the 4-day (Days 0-3) post challenge dose and unsolicited AEs: within the 31-day (Days 0-30) post challenge dose.
    Adverse event reporting additional description
    No Serious Adverse Events (SAEs) related to primary vaccination or to lack of vaccine efficacy were reported during this long-term follow-up study up to Year 15. Other (non-serious) adverse events were not assessed for the long-term follow-up phase (up to Year 15) as per protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Twinrix Adult Group
    Reporting group description
    		 Subjects received 2 doses of Twinrix Adult intramuscularly according to a 0, 6 month schedule in the primary study.

    Reporting group title
    Twinrix Junior Group
    Reporting group description
    		 Subjects received 3 doses of Twinrix Junior (= half dose Twinrix Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study.

    Serious adverse events
    		 Twinrix Adult Group Twinrix Junior Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    ABORTION SPONTANEOUS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Twinrix Adult Group Twinrix Junior Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    7 / 11 (63.64%)
    Nervous system disorders
    HEADACHE (solicited)
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    HEADACHE (unsolicited)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    PAIN
         subjects affected / exposed
    5 / 8 (62.50%)
    4 / 11 (36.36%)
         occurrences all number
    5
    4
    REDNESS
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    FATIGUE
         subjects affected / exposed
    3 / 8 (37.50%)
    3 / 11 (27.27%)
         occurrences all number
    3
    3
    Gastrointestinal disorders
    GASTROINTESTINAL SYMPTOMS
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1

    More information

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

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

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