NCT00697554已完成3 期
Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 21-day Schedule) to a Double Dose of Engerix™ -B (0, 7, 21-day Schedule), in Pre-liver Transplant Patients ≥ 18 y, Boosted at Month 6-12
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine
详细描述
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female ≥ 18 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Seronegative for anti-HBs-antibodies, anti-HBc-antibodies & HBsAg.
- •If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate 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.
- •Documented case of liver failure, such that the patient will require an eventual liver transplant
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- •Previous vaccination against hepatitis B (whether or not a non-responder to vaccination).
- •Previous vaccination with an adjuvant system containing MPL®.
- •History of hepatitis B infection.
- •Known exposure to hepatitis B virus within 6 weeks.
- •Previously confirmed human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- •Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute, intercurrent disease at the time of enrollment.
- •Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F).
- •Administration of immunoglobulins and/or any blood products within one month preceding the first dose of study vaccine or planned administration/ administration during the study period.
- •Pregnant or lactating female
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At Day 28
次要结局
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(During a 30 day follow-up period after vaccination)
- Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)(During the study period)
- Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms(During a 4 day follow-up period after vaccination)
- Anti-HBs antibody concentrations(At d21, d28, d56, M6-12, 1M after booster dose)
研究者
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