A phase III multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBVAXPRO®, administered according to a 0, 1 months schedule, in pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age), who did not respond to previous hepatitis B vaccination. NOTE: Age at enrolment will be above or equal to 18 years for subjects in Poland. - HN017/HBV-003

Henogen0 个研究点目标入组 300 人开始时间: 2007年9月26日最近更新: 2022年8月8日

试验速览

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•A male or female subject above or equal to 18 years of age at the time of the first vaccination.
•Seronegative for anti-HBc antibodies and HBsAg at screening.
•Pre-dialysis, peritoneal dialysis or haemodialysis patients. Pre-dialysis patient is defined as a patient with a documented creatinine clearance of less than or equal to 30 ml/min as estimated by the Cockroft-Gault formula.
•Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine. The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
•Documented evidence of non-response to previous hepatitis B vaccination (non-response defined as anti-HBs antibody < 10mIU/ml) after at least one to maximum three months after the full course of licensed vaccine / or the last booster dose
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects who have been included in the HN014/HBV-001 study.
•Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Use of any registered vaccine within 7 days preceding the first dose of study vaccine.
•History of hepatitis B infection or known exposure to hepatitis B virus within 6 months at the exception of the dialysis procedure.
•Use of immunoglobulins within six months preceding the first dose of study vaccine.
•Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
•Any confirmed or suspected human immunodeficiency virus (HIV) infection.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•Pregnant or lactating female

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