EUCTR2014-001708-24-Outside-EU/EEA进行中（未招募）不适用
Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
Sanofi Pasteur SA0 个研究点目标入组 10,278 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
- 10,278
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrolment:
- •1) Aged 2 to 14 years on the day of inclusion and resident of the site zone
- •2) Subject in good health, based on medical history and physical examination
- •3) Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
- •4) Subject able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10278
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrolment:
- •1) Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination).
- •2) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •3) Planned participation in another clinical trial during the present trial period
- •4) Self-reported 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)
- •5) Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
- •6) Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- •7) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •8) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •10) Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •11) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •12) Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator
- •Temporary Contraindications
- •A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:
- •13) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- •14) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
研究者
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