NCT00984139已完成4 期
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (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
- 306
- 试验地点
- 25
- 主要终点
- Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
研究概览
简要总结
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
- •A male or female of 12 to 13 years of age at the time of enrolment.
- •With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
- •Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
- •Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
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 hepatitis B disease.
- •Hepatitis B vaccination at birth.
- •Adolescents living in institutional care.
- •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 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 (no laboratory testing required).
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- •Acute disease and/or fever at the time of enrolment.
研究组 & 干预措施
Engerix-B Group
Experimental
Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
干预措施: Engerix™-B Kinder (Biological)
结局指标
主要结局
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
时间窗: One month after the challenge dose (Month 1)
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.
时间窗: One month after the challenge dose (Month 1)
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
次要结局
- Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values(Before (Day 0) and one month (Month 1) after the challenge dose)
- Number of Subjects With Serious Adverse Events (SAEs)(After the challenge dose of the vaccine (Day 0) up to the study end (Month 1))
- Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values(Before (Day 0) and one month (Month 1) after the challenge dose)
- Number of Subjects With Solicited Local and General Symptoms(During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination)
- Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.(One month after the challenge dose (Month 1))
- Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.(One month after the challenge dose (Month 1))
研究者
研究点 (25)
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