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This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twinrix | Biological | |||
| Engerix-B | Biological | |||
| Havrix | Biological | |||
| HBVAXPRO | Biological | |||
| Vaqta | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HAV immune response to the challenge dose | ||
| Anti-HBs antibody response to the challenge dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects | Two weeks and one month after the challenge dose | |
| Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilrijk | 2610 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21366801 | Derived | Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111149 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C433226 | twinrix |
| C075654 | Engerix-B |
| D022362 | Hepatitis A Vaccines |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Two weeks and one month after the challenge dose |
| Occurrence and intensity of solicited local symptoms | In the 4-day follow-up period after the challenge dose |
| Occurrence, intensity and relationship of solicited general symptoms | In the 4-day follow-up period after the challenge dose |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported | During the 31-day follow-up period after the challenge dose |
| Occurrence of all serious adverse events (SAEs) reported | Following the administration of the challenge dose |
| Finsterwalde |
| Brandenburg |
| 03238 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Geringswalde | Saxony | 09326 | Germany |
| GSK Investigational Site | Pirna | Saxony | 01796 | Germany |
| GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| GSK Investigational Site | Elmshorn | Schleswig-Holstein | 25335 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111149 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111149 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111149 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111149 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D045424 |
| Complex Mixtures |