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The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerixâ„¢-B and hepatitis B vaccine new formulation when administered at 0, 6 months
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 |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢-B | Biological | Intramuscular injection, 2 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At month 7 | |
| Occurrence and intensity of solicited local and general symptoms | 4-day follow-up after vaccination | |
| Occurrence of unsolicited adverse events | 30-days after vaccination | |
| Incidence of serious adverse events | Throughout the study period | |
| Anti-Hbs antibody concentrations | Months 1, 6 and 24 |
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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 | Vienna | Austria |
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| HBV-MPL 208129 |
| Biological |
Intramuscular injection, 2 doses |
|
| Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation | Biological | Intramuscular injection, 2 doses; experimental formulation |
|
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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