Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
研究概览
简要总结
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.
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 to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
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 participated in the primary study.
- •Written informed consent obtained from the subject.
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
时间窗: At Years 16, 17, 18, 19 and 20 after primary vaccination
Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
时间窗: At Years 16, 17, 18,19 and 20 after primary vaccination
Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).
Number of Subjects With Chronic and With Clinical HBV Infection
时间窗: From year 16 through to year 20
* Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points. * Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.
次要结局
未报告次要终点