NCT00356564已完成4 期
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B and Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 43
- 主要终点
- Anti-HBs antibody concentration
研究概览
简要总结
Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female aged 7 to 9 years at the time of study entry .
- •Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
- •Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.
排除标准
- 未提供
结局指标
主要结局
Anti-HBs antibody concentration
次要结局
- Sol & unsol symptoms after HBV vaccination, SAEs
- Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
研究者
研究点 (43)
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