Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 5
- 主要终点
- Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
研究概览
简要总结
To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.
Subjects were aged 11 to 15 years at the time of the primary vaccination course.
At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects have participated in primary study HBV-280
- •Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
时间窗: At Month 30, Month 42, Month 54 and Month 66
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody Titers Against Hepatitis-B Virus.
时间窗: At Month 30, Month 42, Month 54 and Month 66
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period after each vaccination and overall)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Day 0-3) follow-up period after each vaccination and overall)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).(During the 31-day (Day 0-30) follow-up period after each vaccination and overall)
- Antibody Titers Against Hepatitis-B Virus.(At Months 1, 2, 6 and 7)
- Number of Subjects Seroprotected for Anti-HBs Antibody.(At Months 1, 2 and 6)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Month 0 to Month 66))
- Number of Subjects With Serious Adverse Events (SAEs).(At Month 30, Month 42, Month 54 & Month 66)