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In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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 | Active Comparator |
| |
| Group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢-B | Biological | Intramuscular injection, 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis B surface antigen (HBs) antibody concentrations | At M2 and M7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-pre-S1 antibody concentrations | Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation | |
| Anti-HBs antibody concentrations | Screening, Months 1, 2, 3, 6, 7, 8 and 12 | |
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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 | ||||
| GSK Clinical Trials Call Center |
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| Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Biological |
Intramuscular injection, 3 doses |
|
| Occurrence and intensity of local and general solicited symptoms |
| 4-day after vaccination |
| Cell mediated immunity | Month 0, Month 2 and month 7 |
| Occurrence of unsolicited adverse events | 30 days after vaccination |
| Occurrence of serious adverse events | During the study period and 30 days after last vaccine dose |
| Ghent |
| Belgium |
| GSK Clinical Trials Call Center | Hvidovre | Denmark |
| GSK Clinical Trials Call Center | Reykjavik | Iceland |
| 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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