EUCTR2009-016721-33-SE进行中（未招募）不适用
A Study to Estimate the Immune Response Following a Challenge Dose in Adults (= 50 years old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
Sanofi Pasteur MSD S.N.C0 个研究点目标入组 296 人开始时间: 2010年8月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 296
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. In general good health based on a medical history taken on Day 1 prior to receiving the study vaccine injection.
- •2. Received 3 doses of either modified process RECOMBIVAX HB™ or ENGERIX-BTM as per protocol for study V232-059 at least 2 years prior to enrollment in this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known history of previous hepatitis B infection.
- •2.History of vaccination with any hepatitis B vaccine beyond what was administered in study V232-059.
- •3.History of febrile illness (oral temperature =37.8ºC or =100.0ºF) within 72 hours prior to study vaccine injection.
- •4.Known or suspected hypersensitivity to any component of modified process RECOMBIVAX HB™ (e.g., aluminum, yeast).
- •5.Receipt of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product within 3 months prior to study vaccine injection and until Visit 2
- •6.Receipt of any licensed inactivated or recombinant vaccine within 14 days prior to study vaccine injection and until Visit 2
- •7.Receipt of any licensed live-virus vaccine within 30 days prior to study vaccine injection and until Visit 2.
- •8.Receipt of any investigational drug or other investigational vaccine within 3 months prior to study vaccine injection and until Visit 2.
- •9.Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids or chemotherapeutic agents). Subjects on systemic corticosteroids should be excluded if they received within 4 weeks prior to study entry, are receiving, or are expected to receive prior to Visit 2 systemic corticosteroid doses >5 mg prednisone (or equivalent) daily for >2 weeks. The exclusion does not apply to topical and inhaled steroids.
- •10.Known or suspected immune dysfunction that is caused by a medical condition, or other cause. Examples of such conditions include: congenital immune deficiency, human immunodeficiency virus infection, transplantations, leukemia, lymphoma, Hodgkin’s’ disease, multiple myeloma/MGUS, or generalize malignancy. Subjects with a history of cancer who have been cancer free since their participation in the original V232-059 study will be eligible for enrollment.
- •11. Pregnant women and nursing mothers. A urine pregnancy test will be administered to women of childbearing potential prior to vaccination. For the purposes of this protocol, women of non-childbearing potential are defined as having no menses for one year, post-hysterectomy, post-bilateral tubal ligation, or post-bilateral oophorectomy.
- •12.Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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