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This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
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 | Active Comparator | Three doses according to 0, 1, 6-month schedule |
|
| Group B | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
|
| Group C | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
|
| Group D | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV-MPL vaccine 208129 | Biological | 2-dose intramuscular injection 3 different vaccine lots |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms | Full course of vaccination | |
| Incidence of serious adverse events | Study period | |
| Anti-HBs antibody concentrations | At Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and intensity of solicited local signs and symptoms | 4-day after vaccination | |
| Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms | 4-day after vaccination |
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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 | Parkville | Victoria | 3052 | Australia | ||
| GSK Clinical Trials Call Center |
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| Engerix™-B | Biological | 3-dose intramuscular injection |
|
| Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms | 30 days after vaccination |
| Occurrence and relationship to vaccination of SAEs | During the study period |
| Anti-HBs antibody concentrations | At Months 1, 2, 6 and 7 |
| Hradec Kralové |
| Czechia |
| GSK Clinical Trials Call Center | München | Germany |
| GSK Clinical Trials Call Center | Bari | Italy |
| GSK Clinical Trials Call Center | Utrecht | Netherlands |
| GSK Clinical Trials Call Center | Lausanne | Switzerland |
| GSK Clinical Trials Call Center | London | United Kingdom |
| 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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