Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Experimental |
| |
| Group E | Experimental |
| |
| Group F | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV-MPL vaccine | Biological | 5 different formulations, 2-dose intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Month 1, 2, 6 and 12 | |
| Cell mediated immunity | Month 1, 2, 6, 7 and 12 | |
| Occurrence and intensity and relationship to vaccination of solicited local and general symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Ghent | Belgium |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Engerix™-B | Biological | 3-dose intramuscular injection |
|
| 4-day follow-up after vaccination |
| Occurrence and intensity and relationship to vaccination of unsolicited symptoms | 31-day follow-up after vaccination |
| Incidence of SAE | Throughout the study period |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |