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The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
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 | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Experimental |
| |
| Group E | Experimental |
| |
| Group F | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBsAg formulated with different concentrations of MPL and Aluminium Salts | Biological | Intramuscular injection, 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | After two doses and after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and intensity of local and general solicited symptoms | 8 days after vaccination | |
| Anti-HBs antibody concentrations | Screening, M1, 2, 3, 4, 6, 12, 13 | |
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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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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Engerix™-B | Biological | Intramuscular injection, 3 doses |
|
| Occurrence of unsolicited adverse events |
| 30-day after vaccination |
| Occurrence of serious adverse events | During the study period and 30 days after the last vaccination |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |