EUCTR2014-001707-53-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Sanofi Pasteur SA0 个研究点目标入组 600 人开始时间: 2014年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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) Aged 9 to 16 years on the day of inclusion
- •2) Subject in good health, based on medical history and physical examination
- •3) Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
- •4) Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
- •5) For a female subject of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first injection until at least 4 weeks after the last injection
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •F.1.2 Adults (18-64 years) no
- •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) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
- •2) For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
- •3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial injection
- •4) Breast-feeding woman
- •5) Planned participation in another clinical trial during the present trial period
- •6) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •7) Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
- •8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •10) Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
- •11) Receipt of any vaccine in the 4 weeks preceding the first trial injection
- •12) Planned receipt of any vaccine in the 4 weeks following the first trial injection
- •13) Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •14) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection on the day of injection, according to Investigator’s judgment
研究者
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