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The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
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 A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant MPL- adjuvanted hepatitis B vaccine | Biological | Intramuscular injection, 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At months 2, 6, 7 and 12 | |
| Occurrence and intensity of solicited local symptoms | 4-day follow-up after vaccination | |
| Occurrence, intensity and relationship of solicited general symptoms |
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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 | Leuven | 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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| Engerix™-B |
| Biological |
Intramuscular injection, 3 doses |
|
| 4-day follow-up after vaccination |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | Within 30 days after vaccination |
| Incidence of serious AEs | Throughout the entire study up to and including 30 days after the last vaccination |
| Cell mediated immunity | At months 0, 2, 6, 7, 12 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |