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The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.
Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.
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 | HBV-MPL Lot A |
|
| Group B | Experimental | HBV-MPL Lot B |
|
| Group C | Experimental | HBV-MPL Lot C |
|
| Group D | Active Comparator | Engerix™-B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV-MPL vaccine 208129 | Biological | 3 consecutive lots; 3-dose intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | At M1, M2, M3 | |
| Anti-RF1 antibody titres in a subset of 50 subjects per group | At months 0 and 3 | |
| Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 208129/037 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 | 3-dose intramuscular injection |
|
|
| During a 4-day follow-up after vaccination |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | Within 30 days after each vaccination |
| Occurrence, intensity and relationship to vaccination of serious adverse events | During the study period |
For additional information about this study please refer to the GSK Clinical Study Register |
| 208129/037 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208129/037 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208129/037 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208129/037 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208129/037 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |