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 the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
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 | Active Comparator |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPL-Adjuvanted recombinant hepatitis B vaccine | Biological | Intramuscular injection, 2 or 3 doses, 2 different formulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At M3 and M13 | |
| Occurrence of local and general solicited symptoms | 4-day follow-up after vaccination | |
| Occurrence of unsolicited symptoms | 30-day follow-up after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs | Throughout the study up to 30 days after last vaccination | |
| Anti-HBs antibody concentrations | Months 2, 3, 6, 9, 12, 13 |
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 | Vienna | Austria |
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
| Engerix™-B | Biological | Intramuscular injection, 2 or 3 doses |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |