Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 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 and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- •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
研究组 & 干预措施
Twinrix Group
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)
干预措施: TWINRIX™ ADULT (Biological)
Engerix-B Additional Dose (Adult)
Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).
干预措施: Engerix TM (Biological)
Engerix-B Additional Dose (Pediatric)
Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).
干预措施: Engerix TM (Biological)
结局指标
主要结局
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
时间窗: Years 6, 7, 8, 9, and 10.
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
时间窗: One month after the additional dose administration
Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
时间窗: Before and 1 month after the additional dose administration
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
时间窗: At Year 6, 7, 8, 9 and 10
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Solicited Local and General Symptoms
时间窗: During the 4-day follow-up period after additional dose
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Number of Subjects Reporting Unsolicited Adverse Events
时间窗: During the 30-day follow-up period after additional dose
Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs)
时间窗: During the 30-day follow-up period after additional dose
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
次要结局
未报告次要终点