Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 8
- 主要终点
- Anti-hepatitis B (HBs) Antibody Concentrations
研究概览
简要总结
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 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
Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.
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
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in primary study
- •Written informed consent obtained before each long term follow up visit.
排除标准
- 未提供
研究组 & 干预措施
Twinrix Junior
Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
干预措施: Twinrix™ Junior (Biological)
Twinrix Adult
Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
干预措施: Twinrix™ Adult (Biological)
结局指标
主要结局
Anti-hepatitis B (HBs) Antibody Concentrations
时间窗: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
时间窗: Before and one month after additional vaccination
Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres \< 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.
Anti-hepatitis A (HAV) Antibody Concentrations
时间窗: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
时间窗: Before and One month after additional vaccination
Subjects losing seroprotective anti-HBs antibody titres (i.e. titres \< 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).
次要结局
- Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms(during the 4-day follow-up period after additional vaccination)
- Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.(During the 4-day follow-up period after additional vaccination)
- Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events(At least one month after additional vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.(From last study visit of the primary study up to Year 5 long term follow-up)
- Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).(During the 30-day follow-up period after additional vaccination.)