EUCTR2005-005939-10-FI进行中（未招募）不适用
A study in healthy, young adults and healthy infants of the safety, tolerability, and immunogenicity of an investigational manufacturing process for the recombinant hepatitis B vaccine - Assessment of GSH/2X Phosphate Hepatitis B Vaccine.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •a. Twenty to 35 years of age.
- •b. In general good health based on a medical history taken on Day 1 prior to receiving the first injection of vaccine. Any underlying chronic illness must be documented to be in stable condition.
- •c. For women, a negative urine pregnancy test just prior to vaccination on Day 1.
- •d. Women of childbearing potential must demonstrate a method of effective contraception. Effective contraception includes the birth control pill or abstinence during the entire study period.
- •a. Healthy infants.
- •b. Two to 4 months old.
- •c. Available for the study period.
- •Are the trial subjects under 18? yes
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Medical History of previous hepatitis B infection. This includes the mothers of subjects in Stage 2.
- •b. Medical History of vaccination with any other hepatitis B vaccine. This includes the mothers of subjects in Stage 2.
- •c. Medical History of injection drug use.
- •d. Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF; rectal temperature =38.1ºC/=100.5ºF ).
- •e. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast).
- •f. Recent administration (within 3 months prior to first injection with the study vaccine) of any of the following or if any of the following are scheduled to be given during the study: hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product (excluding autologous products).
- •g. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or if scheduled to be given during the study.
- •h. Known or suspected impairment of immunologic function or recent use (defined as 3 months prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
- •i. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
- •j. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •k. Inability to comply with the study schedule and attend all required study visits as outlined in the Study Flow Chart.
研究者
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