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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00383591 |
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.
Condition | Intervention | Phase |
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Hepatitis B |
Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, 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 | |
GSK Investigational Site | |
Hradec Kralove, Czech Republic, 500 01 | |
Malaysia | |
GSK Investigational Site | |
Bandar Tun Razak, Cheras, Malaysia, 56000 | |
Spain | |
GSK Investigational Site | |
Madrid, Spain, 28046 | |
GSK Investigational Site | |
Malaga, Spain, 29010 | |
GSK Investigational Site | |
Barcelona, Spain, 08036 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 208129/047 |
Study First Received: | October 2, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00383591 |
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 |
Hepadnaviridae Infections |