EUCTR2006-002076-18-DE进行中（未招募）不适用
COMPARISON OF THREE BATCHES OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (JE-PIV). DOUBLE BLIND, RANDOMIZED, CONTROLLED PHASE 3 STUDY.
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
- 624
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 entire study period 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.)
- •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
- •-History of clinical manifestation of any flavivirus infection
- •-History of vaccination against Japanese encephalitis (incl. study participation in any
- •IC51 clinical study), Yellow fever and Dengue fever
- •-Use of any other investigational or non-registered drug or vaccine in addition to the
- •study vaccine during the study period or within 30 days preceding the first dose of
- •study vaccine
- •-Administration of another vaccine within 4 weeks before randomization and during
- •the study period
- •-Immunodeficiency including post-organ-transplantation or immunosuppressive
- •-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, = 0.05 mg/kg/day. Topical and inhaled steroids are allowed.)
- •-Any acute infections within 4 weeks prior to randomization
- •-History of severe hypersensitivity reactions in particular to a component of the IC51
- •vaccine (e.g. protamine sulphate), anaphylaxis or severe cases of atopy requiring
- •emergency treatment or hospital admission
- •-Infection with HIV (a negative test result within 30 days before screening is
- •acceptable), Hepatitis B (HBsAg) or Hepatitis C
- •History of urticaria after hymenoptera envenomation, drugs, physical or other
- •provocations, or of idiopathic cause
- •-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)
- •-Inability or unwillingness to avoid more than the usual intake of alcohol during the
- •48 hours after vaccination
- •-Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary
- •disorders, history of malignancy in the past 5 years
- •-Pregnancy (positive pregnancy test during screening or at baseline), lactation or
- •unreliable contraception in female subjects with child-bearing potential (for details
- •please refer to section 6.4)
- •-Subjects with any condition which in the opinion of the investigator makes the
- •subject unsuitable for inclusion
- •-Inability or unwillingness to provide informed consent and to abide by the
- •requirements of the study.
研究者
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