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This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Active Comparator | Non-responders to vaccination after at least 7 previous injections |
|
| Group A2 | Experimental | Non-responders to vaccination after at least 7 previous injections |
|
| Group B1 | Active Comparator | Vaccine-responders requiring a booster dose |
|
| Group B2 | Experimental | Vaccine-responders requiring a booster dose |
|
| Group C1 | Active Comparator | Volunteers participating in the hospital's vaccination program |
|
| Group C2 | Experimental | Volunteers participating in the hospital's vaccination program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV-MPL vaccine 208129 | Biological | IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and intensity of solicited local and general symptoms | 4-day follow-up period after each vaccination | |
| Occurrence of unsolicited adverse events | During the course of the study | |
| Occurrence of serious adverse events | During the course of the study | |
| Anti-HBs antibody concentrations | Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Brussels | Belgium |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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|
| Group D1 | Active Comparator | Unvaccinated haemodialysis patients |
|
| Group D2 | Experimental | Unvaccinated haemodialysis patients |
|
| Engerix™-B | Biological | IM injection |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |