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
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EudraCT number |
2009-014853-33 |
Trial protocol |
BE |
Global end of trial date |
28 Feb 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
16 Sep 2018
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First version publication date |
23 May 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
112266
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01037114 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, B-1330, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Jan 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
49
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
At Y16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix vaccine. None of the subjects received a challenge dose at Y17 and Y19. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Year 16 (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Twinrix Group_Y16 | ||||||||||||||||||||||||||||||
Arm description |
Subjects who received 3 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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Havrix 1440
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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Twinrix Group_Y17 | ||||||||||||||||||||||||||||||
Arm description |
Subjects who received 3 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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Havrix 1440
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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Twinrix Group_Y18 | ||||||||||||||||||||||||||||||
Arm description |
Subjects who received 3 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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Havrix 1440
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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Twinrix Group_Y19 | ||||||||||||||||||||||||||||||
Arm description |
Subjects who received 3 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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Engerix-B
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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Twinrix Group_Y20 | ||||||||||||||||||||||||||||||
Arm description |
Subjects who received 3 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. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Havrix 1440
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Engerix-B
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
Twinrix Group_Y16
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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_Y20
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Reporting group description |
Subjects who received 3 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Twinrix Group_Y16
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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
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Reporting group description |
Subjects who received 3 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_Y20
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Reporting group description |
Subjects who received 3 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. |
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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.
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End point type |
Primary
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End point timeframe |
At Years 16, 17, 18 and 19 and 20.
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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. |
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No statistical analyses for this end point |
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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.
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End point type |
Primary
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End point timeframe |
At Years 16, 17, 18, 19 and 20.
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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. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
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. This outcome measure therefore is applicable only to Twinrix Group_Y16. |
|||||||||||||||
|
|||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-HAV Concentrations After the Challenge Dose of Havrix [4] | |||||||||||||||||||||
End point description |
Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these 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: 2 subjects were eligible for the challenge dose of Havrix at the Years 18 & 20 time points. This outcome measure therefore is applicable only to Twinrix Group_Y18 & Twinrix Group_Y20. |
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|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
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. This outcome measure therefore is applicable only to Twinrix Group_Y16. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix [6] | ||||||||||||
End point description |
2 subjects received a challenge dose of Havrix at Year 18 & Year 20.
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: 2 subjects received a challenge dose of Havrix at Year 18 and Year 20. This outcome measure therefore is applicable only to Twinrix Group_Y18 and Twinrix Group_Y20. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of Subjects Reporting Unsolicited Adverse Events (AEs) [7] | ||||||||||||||||
End point description |
At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. 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: At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. This outcome measure therefore is applicable to Twinrix Group_Y16, Twinrix Group_Y18 and Twinrix Group_Y20. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
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 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. This outcome measure therefore is applicable only to Twinrix Group_Y18 and Twinrix Group_Y20. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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 20.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs) [9] | ||||||||||||
End point description |
One subject received a challenge dose of Havrix at Year 18 and another at Year 20. 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 16 of Engerix-B. This outcome measure therefore is applicable only to Twinrix Group_Y16. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
SAEs: During the 31-day (Days 0 to 30) follow-up period after the challenge dose and from the beginning of the long term follow-up to Year 20; Unsolicited symptoms: During the 31-day (Days 0 to 30) follow-up period after the challenge dose.
|
||||||||||||||||||||||||||||
Adverse event reporting additional description |
As no challenge dose was administered during Y 17 & 19, SAEs & other AEs were not assessed. At Y16, 1 subject was administered challenge dose of Engerix-B & at Y 18 & 20, 2 subjects were administered challenge dose of Havrix, for whom the SAEs and other AEs were assessed during 31 day period post challenge dose.
|
||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
18.0
|
||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||
Reporting group title |
Twinrix Group_Y16
|
||||||||||||||||||||||||||||
Reporting group description |
Subjects who received 3 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. | ||||||||||||||||||||||||||||
Reporting group title |
Twinrix Group_Y18
|
||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Twinrix Group_Y20
|
||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||
|
|
|||
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 |