Hepatitis B vaccine, adjuvanted has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Hepatitis B vaccine, adjuvanted studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
105757 III A phase III, multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of an investigational vaccination regimen to that of GlaxoSmithKline Biologicals’ adjuvanted hepatitis B vaccine, Fendrix®, administered according to 0, 1, 2, 6 months schedule, in hepatitis B naïve pre-dialysis, peritoneal dialysis and haemodialysis patients (>/ 15 years of age). Fendrix® (HBV): GlaxoSmithKline Biologicals’ adjuvanted hepatitis B vaccine
105758 III A phase III, multicentric, multinational, long-term follow-up study to evaluate the persistence of anti-HBs antibodies at Months 12, 24 and 36 in pre-dialysis / peritoneal dialysis or haemodialysis patients who had previously received a primary vaccination course of either an investigational vaccination regimen or GlaxoSmithKline Biologicals’ Fendrix. FendrixTM (HBV): GlaxoSmithKline (GSK) Biologicals’ inactivated Hepatitis B vaccine.