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
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 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 | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
|
| Group B | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
|
| Group C | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
|
| Group D | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
|
| Group E | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B | Biological | Intramuscular injection, 1 or 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis B surface antigen (HBs) antibody concentrations | One month after the full primary vaccination course and one month after the booster vaccination at 70 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Months 1, 2, 3, 6, 12, 13, 42 | |
| Serious adverse experiences (SAE). | Throughout the study period | |
| Occurrence and intensity of solicited local 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 | Wilrijk | 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
| Group F | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
|
| Group G | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
|
| Group H | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
|
| HBV-MPL vaccine | Biological | Intramuscular injection, 1 or 3 doses |
|
| 8-day follow-up after vaccination |
| Occurrence, intensity and relationship of solicited general symptoms | 8-day follow-up after vaccination |
| Incidence of unsolicited symptoms | During the 30-day follow-up after vaccination |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |