EUCTR2014-001717-11-Outside-EU/EEA进行中（未招募）不适用
Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Sanofi Pasteur SA0 个研究点目标入组 250 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
- 250
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 11 years on the day of inclusion
- •2) Assent form has been signed and dated by the subject (for subjects = 7 years) and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative, and by an independent witness if the two parents or legally acceptable representative are illiterate)
- •3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •4) Subject in good health, based on medical history and physical examination
- •5) For a female subject of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 250
- •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) Known pregnancy, or a positive urine pregnancy test (for female subject of childbearing potential only)
- •2) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- •3) Planned participation in another clinical trial during the present trial period
- •4) Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
- •5) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •6) 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •7) Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
- •8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •9) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •10) Subjects who plan to move to another country/region within the 18 coming months
- •11) Identified as a child (adopted or natural) of the Investigator or of site employees 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
- •Temporary Exclusion Criteria:
- •A prospective subject was not to be included in the study until the following conditions and/or symptoms were resolved:
- •12) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least 2 weeks before study vaccines
- •13) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to Investigator’s judgment) on the day of vaccination
研究者
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