Double-blind, Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 6 Month Schedule in Healthy Adult Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
研究概览
简要总结
The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
详细描述
This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination.
The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).
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
- None
入排标准
- 年龄范围
- 29 Years 至 60 Years（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
- •Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
排除标准
- 未提供
研究组 & 干预措施
Havrix Group
Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up.
干预措施: Havrix™ (Biological)
结局指标
主要结局
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
时间窗: Before the additional dose, 14 days and 30 days after the additional dose
Concentrations given as GMC expressed as mIU/mL.
Number of Seropositive Subjects for Anti-HAV Antibodies.
时间窗: From Year 11 to Year 20
Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points. The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.
次要结局
- Number of Subjects Reporting Serious Adverse Events (SAE)(During the follow-up period after additional vaccination up to Year 20)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)(During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15))
- Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy(Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period after additional vaccination)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period after additional vaccination)