NCT00430534已完成2 期
To Evaluate the Safety, Immunogenicity and Efficacy of GSK Biologicals' EBV Vaccine (268664) in Healthy Seronegative Adolescents/Adults When Injected Intramuscularly According to a 0-1-5 Month Schedule in Belgium.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Henogen
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Attack rates of infectious mononucleosis over 18 months after Dose 2
研究概览
简要总结
To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period.
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
- Double
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening.
- •Written informed consent obtained from the subject prior to enrolment.
- •Seronegative for EBV antibody.
排除标准
- •Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •History of intravenous drug abuse within the past 2 years.
- •Known or suspected allergy to any vaccine component.
结局指标
主要结局
Attack rates of infectious mononucleosis over 18 months after Dose 2
次要结局
- Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)
研究者
研究点 (1)
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