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This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerixâ„¢-B as the control vaccine
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.
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 | Active Comparator |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Experimental |
| |
| Group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢-B | Biological | 3-dose intramuscular injection |
| |
| HBV-MPL vaccine 208129 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At months 1, 2 and 6 | |
| Occurrence and intensity of solicited local and general symptoms | 4-day follow-up period after each vaccination | |
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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 Trial 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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| Biological |
2-dose intramuscular injection |
|
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms |
| 30-day follow-up period after each vaccination |
| Occurrence, intensity and relationship to vaccination of SAEs | Throughout the entire study |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |