EUCTR2005-000100-14-AT进行中（未招募）不适用
Safety and tolerability of the Japanese encephalitis vaccine IC51 (JE-PIV). Double blind, randomized, placebo controlled phase 3 study - IC51- 302
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 3,475
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
- •At least 18 years of age
- •In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in protocol section 6.4
- •Written informed consent obtained prior to study entry. (subjects should give their consent themselves. Consent by legal representatives is allowed.)
- •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
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •Administration of yellow fever vaccine 30 days before and 30 days after study treatment
- •Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •A family history of congenital or hereditary immunodeficiency
- •History of autoimmune disease
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Topical and inhaled steroids, are allowed.)
- •Any acute infections within 2 weeks prior to enrollment
- •History of severe hypersensitivity reactions (in particular to a component of the IC%! vaccine; e:g: protamine sulphate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
- •Known or suspected HIV Infection
- •Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approx. 60 g alcohol per day, or conditions which might interfere with the study conduct)
- •Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- •Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to protocol section 6.4)
- •Inability or unwillingness to provide informed consent and to abide by the requirements of the study
研究者
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