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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00383227 |
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Biological: Hepatitis B adjuvanted vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Clinical Trial Comparing the Immunogenicity and Safety of SmithKline Beecham Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age) |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic, Králové | |
GSK Clinical Trials Call Center | |
Hradec, Králové, Czech Republic | |
Malaysia | |
GSK Clinical Trials Call Center | |
Kuala Lumpur, Malaysia | |
Spain | |
GSK Clinical Trials Call Center | |
Malaga, Spain |
Study Director: | Clinical Trials | GlaxoSmithKline |
Study ID Numbers: | 208129/032 |
Study First Received: | October 2, 2006 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00383227 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Hepadnaviridae Infections |