EUCTR2004-005262-20-BE进行中（未招募）1 期
A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix-B in multidose presentation to that elicited by Engerix-B in monodose presentation when administered according to 0, 1, 6 months schedule in healthy adults aged equal to or above 18 years. - HBV-308
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •Male or female adult aged greater than or equal to 18 years, who is free from obvious health problems and from whom written informed consent is obtained. If the subject is a female then 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 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.
- •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
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
- •Previous vaccination against hepatitis B
- •History of hepatitis B infection
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
研究者
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