EUCTR2014-001694-14-Outside-EU/EEA进行中（未招募）不适用
A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Sanofi Pasteur SA0 个研究点目标入组 210 人开始时间: 2014年5月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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) Toddler in good health based on medical history and medical examination (Scr.+V_MV)
- •2) Toddler aged 12 to 15 months on the day of inclusion (Scr.)
- •3) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (Scr.)
- •4) Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) (Scr.)
- •5) Subject and parent/delegate able to attend all scheduled visits and comply with all trial procedures (Scr.)
- •6) Completion of previous vaccination program according to the national immunization schedule, except for measles (Scr.)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •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) Family members from the Investigator or from the staff involved in the trial (Scr.)
- •2) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion (Scr.)
- •3) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) (Scr.)
- •4) History of central nervous system disorder or disease, including seizures (Scr.)
- •5) History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically (Scr.)
- •6) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion (Scr.)
- •7) Previous vaccination against MMR, hepatitis A or varicella (Scr.)
- •8) Previous vaccination against FV diseases (Scr.)
- •9) Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances (Scr.)
- •10) Planned participation in another clinical trial during the present trial period (Scr.)
- •11) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination (Scr.+V_MV)
- •12) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response (Scr.+V_MV)
- •13) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination (V_MV)
- •14) Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening visit (V_MV)
- •15) Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening visit (V_MV)
- •Should one of the conditions listed below occur, the Investigator was to postpone vaccination until the condition was resolved:
- •16) Febrile illness (temperature = 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator’s judgment (Scr.+V_MV)
- •17) Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination (Scr.+V_MV)
- •18) Any vaccination received in the 4 weeks preceding vaccination (Scr.+V_MV)
研究者
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