EUCTR2006-003649-18-SE进行中（未招募）不适用
A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - Older Adult Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- •Generally healthy male and female adults =50 years of age.
- •Prior to vaccination a full medical history.
- •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
- •Prior history of hepatitis B infection or vaccination with any hepatitis B vaccine
- •Recent febrile illness
- •Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminium, yeast).
- •Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product.
- •Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •Known or suspected impairment of immunologic function or recent (within past 14 days) use of immunomodulatory medications (e.g., systemic corticosteroids
- •Receipt of investigational drugs or other investigational vaccines within 14 days prior to first injection with the study vaccine.
研究者
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