NCT00197158已完成4 期
Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered According to 0,1,6 Mths Schedule in Healthy Adults Aged ≥ 18 Yrs
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Measurement of antibody concentrations to hepatitis B antigen at Month 7.
研究概览
简要总结
GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).
详细描述
Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female >= 18 years of age
- •Written informed consent obtained from the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •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 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.
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, greater than or equal to 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
- •Known exposure to hepatitis B within the previous 6 weeks
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including 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 vaccine(s).
- •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 temperature < 37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F).
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
结局指标
主要结局
Measurement of antibody concentrations to hepatitis B antigen at Month 7.
次要结局
- Measurement of antibody concentrations to hepatitis antigen at Months 1,2and6. Occurrence of solicited local symptoms and solicited general symptoms during the 4-day f/u period after vaccination. Occurrence, intensity and relationship to vaccination
研究者
研究点 (1)
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