Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
研究概览
简要总结
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.
The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.
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
- 16 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)
- •Written informed consent obtained from each subject before each blood sampling visit
排除标准
- 未提供
结局指标
主要结局
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
时间窗: Years 17, 18, 19 and 20.
During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Prevalence of Serological Markers for Hepatitis B Infection
时间窗: Years 17, 18, 19 and 20.
It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg \& anti-HBe
Clinical Review for Hepatitis B Infection Status
时间窗: Over the entire 4 year follow up period (17 - 20 years)
Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
次要结局
未报告次要终点