Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,303
- 试验地点
- 7
- 主要终点
- Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
研究概览
简要总结
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
- •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 parent or guardian of the subject.
- •If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment 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.
- •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 non-response to previous hepatitis B vaccination.
- •Known exposure to hepatitis B within the past 6 weeks.
- •History of hepatitis B infection.
- •Confirmed 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.
- •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
研究组 & 干预措施
Group A
Three doses according to 0, 1, 6-month schedule
干预措施: Engerix™-B (Biological)
Group B
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
干预措施: HBV-MPL vaccine 208129 (Biological)
Group C
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
干预措施: HBV-MPL vaccine 208129 (Biological)
Group D
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
干预措施: HBV-MPL vaccine 208129 (Biological)
结局指标
主要结局
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
时间窗: Full course of vaccination
Incidence of serious adverse events
时间窗: Study period
Anti-HBs antibody concentrations
时间窗: At Month 7
次要结局
- Occurrence and intensity of solicited local signs and symptoms(4-day after vaccination)
- Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms(4-day after vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms(30 days after vaccination)
- Occurrence and relationship to vaccination of SAEs(During the study period)
- Anti-HBs antibody concentrations(At Months 1, 2, 6 and 7)