ACTRN12605000576628尚未招募不适用
A MULTICENTRE, RANDOMISED, DOUBLE BLIND, PHASE III STUDY OF THE COMPARATIVE IMMUNOGENICITY, SAFETY AND TOLERABILITY OF TWO JAPANESE ENCEPHALITIS VACCINES (ChimeriVaxTM-JE AND JE-VAX®)
PPD Development (Australia)0 个研究点目标入组 816 人开始时间: 2005年10月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 816
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Written informed consent 2. In good general health 3. Available for the study duration 4. For female subjects: Negative pregnancy tests at Screening and Day 0, Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30.
排除标准
- •1. A history of vaccination or infection with JE or Yellow fever or other flaviviruses2. Previous or current military service3. History of residence in or travel to flavivirus endemic areas in the tropics for periods of 4 weeks or more4. Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs during the study5. History of thymoma, thymic surgery (removal) or myasthenia gravis6. Clin significant abnormalities on lab assessment7. Anaphylaxis or other serious adverse reactions to foods, Hymenoptera (bee family) stings, or drugs (including vaccines)8. Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 609. Administration of another vaccine or antiviral within 30 days preceding the Screening Visit or up to Day 6010. Physical exam indicating any clin significant med condition11. Oral temperature >38 degrees C or acute illness within 3 days prior to vaccination12. Seropositive to HCV or HIV or positive for Hepatitis B Surface Antigen13. Lactation or intended pregnancy in female subjects14. Excessive alcohol consumption, drug abuse, significant psychiatric illness15. A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier16. A known hypersensitivity to constituents of JE-VAX including thimerosal, proteins of Rodent origin, neural tissue or gelatine17. Participation in another clinical study within 30 days of the screening visit for this study18. Employee of the study site, Sponsor or CRO involved with the management of the study19. Any other reasons, which in the investigators opinion, makes the subject unsuitable to participate in the study.
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