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    Clinical Trial Results:
    An open single centre study to evaluate the long-term antibody persistence and immune memory between 16 and 20 years after the primary study HAB-032 (208127/022) in which healthy adults were vaccinated with Twinrix™ Adult following a three-dose schedule.

    Summary
    EudraCT number
    		 2009-014853-33
    Trial protocol
    		 BE  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    01 Apr 2016
    First version publication date
    23 May 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    112266
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01037114
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, B-1330, 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
    Interim
    Date of interim/final analysis
    27 Feb 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To evaluate anti-HAV and anti-HBs antibody persistence at Years 16, 17, 18, 19 and 20 after a three-dose primary vaccination course with Twinrix Adult.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of the vaccine.Vaccines/products were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2010
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At Year 16 and Year 18, 1 subject was administered a challenge dose of Engerix™-B vaccine and 1 subject was administered a challenge dose of Havrix™ vaccine, respectively. None of the subjects received a challenge dose at Year 17 and Year 19.

    Period 1
    Period 1 title
    Year 16 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Twinrix Group_Y16
    Arm description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.
    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    Arm title
    		 Twinrix Group_Y17
    Arm description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.
    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    Arm title
    		 Twinrix Group_Y18
    Arm description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.
    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    Arm title
    		 Twinrix Group_Y19
    Arm description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.
    Arm type
    		 Experimental

    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    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
    If a subject became seronegative for antibodies against hepatitis A virus (anti-HAV), i.e. anti-HAV antibody concentrations < 15 mIU/mL or had anti-hepatitis B surface antigen (anti-HBs) antibody concentrations < 10 mIU/mL during the LTFU period, the immune memory to the antigens was evaluated by administering a challenge dose of the Havrix™ or Engerix™-B vaccines at the next planned visit.

    Number of subjects in period 1
    		Twinrix Group_Y16 Twinrix Group_Y17 Twinrix Group_Y18 Twinrix Group_Y19
    Started
    49
    48
    44
    45
    Completed
    49
    48
    44
    45

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Twinrix Group_Y16
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y17
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y18
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y19
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: At Year 16 and Year 18, 1 subject was administered a challenge dose of Engerix™-B vaccine and 1 subject was administered a challenge dose of Havrix™ vaccine, respectively. None of the subjects received a challenge dose at Year 17 and Year 19.
    Reporting group values
    		 Twinrix Group_Y16 Twinrix Group_Y17 Twinrix Group_Y18 Twinrix Group_Y19 Total
    Number of subjects
    		 49 48 44 45
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 5.66 ) 38.6 ( 5.73 ) 39.7 ( 5.89 ) 40.7 ( 5.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 38 35 36 149
        Male
    		 9 10 9 9 37

    End points

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    End points reporting groups
    Reporting group title
    Twinrix Group_Y16
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y17
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y18
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Reporting group title
    Twinrix Group_Y19
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Primary: Number of subjects seropositive for anti-hepatitis A virus antibodies (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies and with anti-HBs antibody concentrations >= 10 milliinternational units per milliliter (mIU/mL)

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    End point title
    		 Number of subjects seropositive for anti-hepatitis A virus antibodies (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies and with anti-HBs antibody concentrations >= 10 milliinternational units per milliliter (mIU/mL) [1]
    End point description
    Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 16, 17, 18 and 19
    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
    		 Twinrix Group_Y16 Twinrix Group_Y17 Twinrix Group_Y18 Twinrix Group_Y19
    Number of subjects analysed
    28
    27
    25
    25
    Units: Subjects
        anti-HAV >= 15 mIU/mL
    28
    26
    25
    24
        anti-HBs >= 6.2 mIU/mL
    27
    25
    23
    23
        anti-HBs >= 10 mIU/mL
    26
    25
    23
    23
    No statistical analyses for this end point

    Primary: Anti-HAV and anti-HBs Geometric Mean Concentrations (GMCs)

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    End point title
    		 Anti-HAV and anti-HBs Geometric Mean Concentrations (GMCs) [2]
    End point description
    Concentrations were expressed as GMCs in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 16, 17, 18 and 19
    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
    		 Twinrix Group_Y16 Twinrix Group_Y17 Twinrix Group_Y18 Twinrix Group_Y19
    Number of subjects analysed
    28
    27
    25
    25
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        anti-HAV
    262.5 (189.9 to 362.9)
    369.4 (257.9 to 529.1)
    237.7 (163.7 to 345.4)
    234.3 (159 to 345.5)
        anti-HBs
    79.9 (45.2 to 141)
    71.7 (39.6 to 129.8)
    61.3 (36.8 to 102.3)
    59.7 (35.1 to 101.4)
    No statistical analyses for this end point

    Secondary: Anti-HBs Concentrations After the Challenge Dose of Engerix-B

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    End point title
    		 Anti-HBs Concentrations After the Challenge Dose of Engerix-B [3]
    End point description
    Concentration was given in mIU/mL.Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion.
    End point type
    Secondary
    End point timeframe
    Before, 14 days and one month (30 days) after the challenge dose of Engerix-B at Year 16
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point.
    End point values
    		 Twinrix Group_Y16
    Number of subjects analysed
    1
    Units: mIU/mL
    number (not applicable)
        before challenge dose at Year 16
    7.7
        14 days after challenge dose at Year 16
    48761.4
        1 month (Day 30) after challenge dose at Year 16
    30178
    No statistical analyses for this end point

    Secondary: Anti-HAV Concentrations After the Challenge Dose of Havrix

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    End point title
    		 Anti-HAV Concentrations After the Challenge Dose of Havrix [4]
    End point description
    Concentration was given in mIU/mL. Only 1 subject was eligible for the challenge dose of Havrix at the Year 18 time point. Therefore the values for this subject are given without a measure of dispersion.
    End point type
    Secondary
    End point timeframe
    Before, 14 days and one month (30 days) after the challenge dose of Havrix at Year 18
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only 1 subject was eligible for the challenge dose of Havrix at the Year 18 time point.
    End point values
    		 Twinrix Group_Y16
    Number of subjects analysed
    1
    Units: mIU/mL
    number (not applicable)
        Anti-HAV concentrations before challenge dose
    25
        Anti-HAV concentration 14-days post-challenge dose
    3421
        Anti-HAV concentration 1-month post-challenge dose
    3389
    No statistical analyses for this end point

    Secondary: Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B

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    End point title
    		 Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B [5]
    End point description
    At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B. Anti-HBs anamnestic response to the challenge dose was defined as: Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point. 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 point.
    End point type
    Secondary
    End point timeframe
    30 days after the challenge dose of Engerix-B at Year 16
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.
    End point values
    		 Twinrix Group_Y16
    Number of subjects analysed
    1
    Units: Subjects
        Number of Subjects With Anamnestic Response
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix

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    End point title
    		 Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix [6]
    End point description
    Only 1 subject received a challenge dose at Year 18 of Havrix™. Anti-HAV anamnestic response to the challenge dose was defined as: Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point. At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point. Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point.
    End point type
    Secondary
    End point timeframe
    30 days after the challenge dose of Havrix.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only 1 subject received a challenge dose at Year 18 of Havrix™.
    End point values
    		 Twinrix Group_Y18
    Number of subjects analysed
    1
    Units: Subjects
        Number of Subjects With Anamnestic Response
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events (AEs) [7]
    End point description
    1 subject received a challenge dose of Engerix-B at Year 16 and 1 subject received a challenge dose of Havrix at Year 18. An AE is 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.
    End point type
    Secondary
    End point timeframe
    31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: 1 subject received a challenge dose of Engerix-B at Year 16 and 1 subject received a challenge dose of Havrix at Year 18.
    End point values
    		 Twinrix Group_Y16 Twinrix Group_Y18
    Number of subjects analysed
    1
    1
    Units: Subjects
        Number of Subjects Reporting Unsolicited AEs
    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) [8]
    End point description
    Only 1 subject received a challenge dose at Year 16 of Engerix-B. An 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
    During the 31-day (Days 0-30) follow-up period after the Engerix™-B challenge dose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only 1 subject received a challenge dose at Year 16 of Engerix-B.
    End point values
    		 Twinrix Group_Y16
    Number of subjects analysed
    1
    Units: Subjects
        Number of Subjects With SAEs
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication

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    End point title
    		 Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication
    End point description
    An 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
    Up to Year 19
    End point values
    		 Twinrix Group_Y16 Twinrix Group_Y17 Twinrix Group_Y18 Twinrix Group_Y19
    Number of subjects analysed
    49
    48
    44
    45
    Units: Subjects
        Number of Subjects Reporting SAEs
    0
    0
    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) [9]
    End point description
    Only 1 subject received a challenge dose at Year 18 of Havrix™. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) follow-up period after the Havrix™ challenge dose
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only 1 subject received a challenge dose at Year 18 of Havrix™.
    End point values
    		 Twinrix Group_Y18
    Number of subjects analysed
    1
    Units: Subjects
        Number of Subjects With SAEs
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs: During the 31-day (Days 0-30) follow-up period after the challenge doses at Years 16 and 18, and up to Year 19. Unsolicited AEs: During the 31-day (Days 0-30) after the Engerix-B™ challenge dose at Year 16 and Havrix™ challenge dose at Year 18.
    Adverse event reporting additional description
    Unsolicited AEs were collected/assessed for the subjects who received the challenge doses, but no unsolicited AEs were reported. Among all the subjects who entered this LTFU study, no SAEs related to study participation or a concurrent GSK medication were reported until Year 19 time point.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Twinrix Group_Y16
    Reporting group description
    		 Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point.

    Serious adverse events
    		 Twinrix Group_Y16
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Twinrix Group_Y16
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    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: Unsolicited AEs were collected/assessed for the subjects who received the challenge doses, but no unsolicited AEs were reported.

    More information

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

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

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