NCT00697853已完成2 期
Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
详细描述
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between 15 and 50 years of age at the time of the first vaccination.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
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.
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- •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.
- •History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
- •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.
- •Acute disease at the time of enrollment.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Oral temperature of ≥37.5°C (99.5°F).
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- •Pregnant or lactating female.
- •History of chronic alcohol consumption and/or intravenous drug abuse
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At month 7
次要结局
- Occurrence and intensity of solicited local and general symptoms(4-day follow-up period after each vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(30-day follow-up period after each vaccination)
- Anti-HBs antibody concentrations(At months 1, 2 and 6)
- Occurrence, intensity and relationship to vaccination of SAEs(Throughout the entire study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)Bacterial Infections Virus DiseasesNCT00551629Merck Sharp & Dohme LLC708
已完成
3 期
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and OlderInfluenzaNCT00979602GlaxoSmithKline4,048
已完成
4 期
Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B VaccineHepatitis AHepatitis BNCT02445703Sinovac Biotech Co., Ltd301
进行中（未招募）
早期 1 期
The Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB002COVID-19NCT05928468Guangzhou Patronus Biotech Co., Ltd.210
已完成
2 期
Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating AdjuvantHay FeverNCT01506375BioTech Tools S.A.24