EUCTR2014-003474-16-FI进行中（未招募）1 期
Immunity elicited by concomitant administration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines
Helsinki University Hospital0 个研究点目标入组 60 人开始时间: 2015年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •1. Male or female subjects aged =18 to =65 years.
- •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.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Vaccination against typhoid fever or cholera within 5 years before dosing.
- •2. History of clinical typhoid fever or cholera.
- •3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
- •4. Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration.
- •5. Chronic (longer than 14 days) 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 allowed.
- •6. Acute or chronic clinically significant gastrointestinal disease.
- •7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •8. Pregnancy or lactation.
- •9. Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of =38 °C).
- •10. Alcohol or drug abuse.
- •11. Suspected non-compliance.
- •12. Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •13. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
- •14. Employee at the investigational site or relative or spouse of the investigator.
- •15. Any other criteria which, in the investigator’s opinion, would compromise the ability of a subject to participate in the study, a subject’s well-being, or the outcome of the study.
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