Immune response to intradermally administrated Ixiaro in healthy adults: a randomized study

Helsinki University Centrel Hospital0 个研究点目标入组 240 人开始时间: 2015年10月21日最近更新: 2016年4月18日

适应症

试验速览

暂无简介。

•1. Male or female subjects aged 18-64
•2. General good health as established by medical history and physical examination
•3. Written informed consent
•4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
•5. Available for all visits scheduled in this study.
•6. No previous Japanese encephalitis vaccination
•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 240
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Previous Japanese encephalitis vaccination
•2. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
•3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
•4. Pregnancy or lactation
•5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C).
•6. Alcohol or drug abuse
•7. Suspected non-compliance
•8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period
•9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
•10. Employee at the investigational site, relative or spouse of the investigator
•11. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study

发起方

Helsinki University Centrel Hospital