EUCTR2005-002175-32-FR进行中（未招募）1 期
Take evaluation and safety of smallpox vaccine (LISTER strain) in naïve healthy adults
Sanofi Pasteur SA0 个研究点目标入组 260 人开始时间: 2005年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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. Patients aged 18 to 25 years on the day of screening
- •2. Informed consent form signed
- •3. Able to attend all scheduled visits and to comply with all trial procedures
- •4. For a woman, inability to bear a child or negative serum pregnancy test performed at screening (checked at V01)
- •5. Subject entitled to national social security
- •6. Subject registered in the French file of healthy volunteers in clinical trials
- •7. For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least three months prior to screening to three months following trial vaccination
- •8. For a woman, inability to bear a child or negative urine pregnancy test
- •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
- •Exclusion criteria 1 to 27 will be checked at screening and on D0:
- •1. Previous smallpox vaccination confirmed by vaccination record or typical scar
- •2. Participation in another clinical trial in the three months preceding the trial vaccination
- •3. Planned participation in another clinical trial during the present trial period
- •4. Chronic illness at a stage that could interfere with trial conduct or completion
- •5. Breast-feeding
- •6. Allergy to any known components of vaccinia immune globulin or previous allergic reaction to immunoglobulins
- •7. Systemic hypersensitivity to eggs or to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine
- •8. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or any treatment including corticosteroids (systemic, topical, ophthalmic)
- •9. Treatment with antiviral drugs (interferon, vidarabine, acyclovir, etc.) within one month before vaccination
- •10. History of organ or bone marrow transplant
- •11. History of skin disorders or atopy (such as progressive eczema, eczema, atopic dermatitis, Darier’s disease, severe acnea, etc.)
- •12. History of autoimmune disease (multiple sclerosis, lupus, etc.) in the subject’s parents, siblings or children
- •13. History or current cardiac disease: ECG abnormalities, pericarditis, myopericarditis, myocardial infarction/heart attack, angina pectoris, congestive heart failure, cardiomyopathy, arrhythmia, stroke or transient ischemic attacks, or chest pain or shortness of breath with activity (such as walking up stairs), or other coronary artery disease and heart conditions under the care of a physician and associated with a heart condition, or family history of sudden death before the age of 50 years
- •14. History or current central nervous system disease: neurodegenerative, infectious, or progressive tumoral disease, or epilepsy
- •15. Subject having three or more major risk factors, including: current tobacco use, hypertension, hypercholesterolemia, hypertriglyceridemia, diabetes mellitus, or family history of heart disease (a heart condition before age 50 in a parent, brother, or sister)
- •16. Ongoing acute infectious disease
- •17. Blood or blood-derived products received in the past six months
- •18. Any vaccination with a live-attenuated vaccine within the 60 days preceding the trial vaccination
- •19. Any vaccination (other than a live-attenuated vaccine) in the four weeks preceding the trial vaccination
- •20. Vaccination planned in the eight weeks following the trial vaccination
- •21. Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •22. Planned or foreseeable close contact after vaccination with infants of less than 12 months of age, or with immunosuppressed persons, pregnant and/or lactating woman, or with persons known to have chronic eczema, or severe skin disorders until the crust separates, leaving a permanent scar at the vaccination site
- •23. Planned practice of contact sports or water sports after vaccination until the crust separates, leaving a permanent scar at the vaccination site
- •24. Cutaneous lesion near the vaccination site
- •25. Apparent lack of personal hygiene
- •26. Lack of understanding of the questionnaire
- •27. Subject deprived of freedom by an administrative or court order, or in an
- •emergency setting, or hospitalized without his/her con
研究者
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