EUCTR2014-001706-17-Outside-EU/EEA进行中（未招募）不适用
Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Subjects Aged 2 to 45 Years in Mexico
Sanofi Pasteur SA0 个研究点目标入组 126 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
- 126
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 2 to 45 years on the day of inclusion (Scr.).
- •2) Informed consent form signed by the subject, by two independent witnesses, and by the parent(s) or legal representative(s) for subjects under 18 years old (Scr.).
- •3) For a woman, inability to bear a child or negative serum pregnancy test at screening (Scr.).
- •4) Able to attend all scheduled visits and to comply with all trial procedures (Scr.+V01).
- •5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least four weeks prior to the first vaccination and at least four weeks after each vaccination (Scr.+V01).
- •6) For a woman, inability to bear a child or negative urine pregnancy test on the day of the first injection (V01).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 108
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.).
- •2) Breast-feeding (Scr.).
- •3) Systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine containing the same substances (Scr.).
- •4) Previous vaccination against flavivirus diseases (including Japanese encephalitis and YF) (Scr.).
- •5) Current abuse of alcohol or drug addiction that might interfere with the subjects ability to comply with trial procedures (Scr.).
- •6) Planned participation in another clinical trial during the present trial period (Scr.+V01).
- •7) History of flavivirus infection (confirmed either clinically, serologically or microbiologically) (Scr.+V01).
- •8) 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 (Scr.+V01).
- •9) Chronic illness at a stage that could interfere with trial conduct or completion (Scr.+V01).
- •10) Blood or blood-derived products received in the past three months (Scr.+V01).
- •11) Vaccination planned in the four weeks following any trial vaccination (Scr.+V01).
- •12) Flavivirus vaccination planned during the present trial period (Scr.+V01).
- •13) Planned travel during the present trial period to areas with high dengue infection endemicity (Scr.+V01).
- •14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent (Scr.+V01).
- •15) Participation in another clinical trial in the four weeks preceding the first trial vaccination (V01).
- •16) Any vaccination in the four weeks preceding the first trial vaccination (V01).
- •17) Human Immunodeficiency Virus (HIV), hepatitis B (Ag HBs) or hepatitis C (HC) seropositivity in blood sample taken at Screening (V01).
- •18) Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening (V01).
研究者
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