NCT00411697已完成4 期
Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With 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
- 301
- 试验地点
- 37
- 主要终点
- Anti-hepatitis B surface antigen (HBs) antibody concentrations
研究概览
简要总结
The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- •A male or female of 4 to 5 years of age at the time of enrolment.
- •With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.
- •Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
- •Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
- •History of or intercurrent hepatitis B disease.
- •Hepatitis B vaccination at birth.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
- •Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.
结局指标
主要结局
Anti-hepatitis B surface antigen (HBs) antibody concentrations
时间窗: One month after the challenge dose of HBV vaccine
次要结局
- Anti-HBs antibody concentrations(Before and after challenge dose of HBV vaccine)
- Occurrence of serious adverse events(During the entire study period.)
研究者
研究点 (37)
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