EUCTR2015-001516-35-Outside-EU/EEA进行中（未招募）不适用
An open study to evaluate the immunogenicity, safety, and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years. - HAB-148 EXT 076 Y6, HAB-149 EXT 076 Y7, HAB-150 EXT 076 Y8, HAB-151 EXT 076 Y9, HAB-152 EXT 076 Y10
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Persistance phase:
- •Subjects who had received at least one dose of the study vaccine in the primary study HAB-076.
- •Written informed consent was obtained from the subject and/ or parents or guardians of the subject before the blood-sampling visit of each follow-up visit.
- •Challenge dose:
- •Subjects who became seronegative for anti-HAV antibod-ies or had anti-HBs antibody concentrations < 10 mIU/mL at long-term blood sampling time-points up to Year 10 were eligible to receive a challenge dose of the appropriate vaccine 6 to 12 months after the Year 10 visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 178
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-History of previous vaccination against hepatitis A or B.
- •-History of hepatitis.
- •-History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- •-Any acute disease at the moment of entry.
- •-Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •- Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
- •- History of allergic disease likely to be stimulated by any component of the vaccine.
- •- Administration of immunoglobulins within six months of the first vaccination or planned during the study period.
- •-Receipt of any other vaccine within 1 week of a dose of the study vaccine (period extending from 1 week before to 1 week after a dose of vaccine).
- •Simultaneous participation in any other clinical trial, the only exception being involvement in long-term follow-up in another vaccine trial.
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