Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
研究概览
简要总结
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.
This protocol posting deals with objectives & outcome measures of the challenge phase. 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
- 17 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study
- •Written informed consent obtained from the subject and/or parent/guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.
排除标准
- •Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
- •Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
- •Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
- •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.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究组 & 干预措施
Engerix 2 Doses + Challenge Dose
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
干预措施: Engerix™-B (Biological)
Engerix 3 Doses + Challenge Dose
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
干预措施: Engerix™-B (Biological)
结局指标
主要结局
Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
时间窗: 30 days post-challenge dose
Immune response defined as: * For initially seronegative subjects (anti-HBs antibody concentration \<3.3 milli-international unit per milliliter \[mIU/mL\] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. * For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.
次要结局
- Number of Participants Reporting Solicited Local Symptoms(During the 4-day follow-up period (Day 0-3) after the challenge dose)
- Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value(30 days post-challenge dose)
- Concentration of Anti-HBs Antibodies(30 days post-challenge dose)
- Number of Participants Reporting Solicited General Symptoms(During the 4-day follow-up period (Day 0-3) after the challenge dose)
- Number of Participants Reporting Serious Adverse Events (SAE)(During the 31-day follow-up period (Day 0-30) after the challenge dose)
- Number of Participants Reporting Unsolicited Adverse Events (AE)(During the 31-day follow-up period (Day 0-30) after the challenge dose)