Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 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 persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
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. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), 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 extend the follow up until Year 20.
The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
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: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). \*\* = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
Number of Seropositive Subjects Against Hepatitis A Virus
时间窗: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (\>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). \*\* = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
次要结局
- Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after additional vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy(At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246)
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration(Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination)
- Number of Subjects Reporting Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after additional vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 30-day follow-up period after additional vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination(During the 30-day follow-up period after additional vaccination)
- Number of Subjects Reporting Pregnancies After Additional Vaccination(At Months 186 and 198)