NCT00519649已完成4 期
An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 36
- 主要终点
- Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
研究概览
简要总结
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. 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
- 7 Years 至 8 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 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
- •With documented evidence of previous vaccination with three consecutive doses of Engerix™-B 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 third dose of Engerix™-B vaccine.
- •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 HBV vaccine challenge and ending 30 days after.
- •Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge 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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
研究组 & 干预措施
Group Engerix
Experimental
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
干预措施: Engerix™-B Kinder (Biological)
结局指标
主要结局
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
时间窗: One month after the challenge dose of HBV vaccine
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
次要结局
- Number of Participants Reporting Solicited General Symptoms(During the 4-day follow-up period after the challenge dose of HBV vaccine.)
- Number of Participants Reporting Serious Adverse Events (SAE)(After the challenge dose of HBV vaccine.)
- Number of Participants Reporting Unsolicited Adverse Events(During the 31-day follow-up period after the challenge dose of HBV vaccine.)
- Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value(Before challenge dose of HBV vaccine)
- Number of Participants Reporting Solicited Local Symptoms(During the 4-day follow-up period after the challenge dose of HBV vaccine.)
研究者
研究点 (36)
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