EUCTR2009-012949-33-FI进行中（未招募）不适用
Cross-reactive immunity elicited by oral and parenteral typhoid vaccines against non-typhoid Salmonellae
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •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 within 5 years before dosing.
- •2.History of clinical typhoid fever, clinical paratyphoid A or B fever.
- •3.Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
- •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 are 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 enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C).
- •10.Alcohol or drug abuse
- •11.Suspected non-compliance
- •12.Use of any investigational drug or any investigational 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, relative or spouse of the investigator
- •15.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
研究者
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