EUCTR2005-004059-37-HU进行中（未招募）不适用
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 as a booster dose in pre-dialysis, peritoneal dialysis and haemodialysis subjects (above or equal to 15 years of age) who previously responded to hepatitis B primary vaccination but have lost antibody. - HN018/HBV-004
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Henogen
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects whom the investigator believes that they can and will comply with the
- •requirements of the protocol (e.g., completion of the diary cards, return for follow-up
- •visits) should be enrolled in the study.
- •A male or female subject = 15 years of age at the time of the study entry.
- •Written informed consent obtained from the subject/ subject’s parents or guardians.
- •Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Predialysis
- •patients is defined as a subject with a documented creatinine clearance of
- •= 30 ml/min. (as estimated by the Cockroft-Gault formula).
- •Seronegative for anti-HBc antibodies and for HBsAg at screening.
- •Documented previous hepatitis B vaccination with one full primary course of four
- •injections of licensed vaccine, without any administration of subsequent booster. The
- •last dose should have been administered at least two months before the planned dose
- •of study vaccine in this study.
- •Documented response to previous hepatitis B vaccination (anti-HBs = 10 mIU/ml
- •after one full course of four injections of licensed vaccine, without subsequent
- •boosters) but for whom there is a documented loss of anti-HBs antibody
- •concentrations below 10 mIU/ml.
- •If the subject is female, she must be of non-childbearing potential, i.e., either
- •surgically sterilized or one year post-menopausal; or, if of childbearing potential, she
- •must be abstinent or have used medically-approved contraceptive precautions for 30
- •days prior to vaccination, have a negative pregnancy test and must agree to continue
- •such precautions for two months after completion of the vaccination series.
- •Are the trial subjects under 18? yes
- •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
排除标准
- •who have participated in the HN014/HBV-001 study.
- •Use of any investigational or non-registered drug or vaccine within 30 days
- •preceding the study vaccine administration, or planned use during the study period.
- •Use of any registered vaccine within 7 days preceding the study vaccine
- •administration.
- •History of hepatitis B infection.
- •Known exposure to hepatitis B virus within six months.
- •Use of immunoglobulins within six months preceding the first study vaccination.
- •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.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a
- •moderate or severe illness with or without fever. All vaccines can be administered to
- •persons with a minor illness such as diarrhoea, mild upper respiratory infection with
- •or without low-grade febrile illness, i.e., oral/ axillary temperature < 37.5°C (or 37
- •°C in Czech Republic).
- •Oral/axillary temperature = 37.5 °C (or 37 °C in Czech Republic).
- •Pregnant or lactating female
研究者
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