Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent dengue infection.
The primary objectives are:
- To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
- To develop operational infrastructure for potential Phase III dengue efficacy trial sites.
- To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.
研究概览
详细说明
All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.
No vaccine will be provided or administered in this study.
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria :
- Aged 2 to 14 years on the day of inclusion and resident of the site zone
- Subject in good health, based on medical history and physical examination
- Assent form has been signed and dated by the subject (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the subject and/or an independent witness if required by local regulations)
- Subject able to attend all scheduled visits and to comply with all study procedures
- For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to enrollment.
Exclusion Criteria :
- Known pregnancy at the Enrollment Visit
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
- Planned participation in another clinical trial during the present study period
- 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)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with study procedures
- Receipt of blood or blood-derived products in the past 3 months
- Receipt of any vaccine in the 4 weeks preceding the day of enrollment except for pandemic influenza vaccination, which may be received at least 2 weeks before enrollment
- Planned receipt of any vaccine in the 4 weeks following enrollment
- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as 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, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the 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:
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of enrollment.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
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Cohort Population (Case )
Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To provide information on the incidences of febrile episodes and confirmed and probable Dengue fever, and to determine other causes of febrile episodes in the cohort population
大体时间：Up to 12 months after enrollment
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Up to 12 months after enrollment
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合作者和调查者
赞助
调查人员
- 研究主任：Medical Director、Sanofi Pasteur SA.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.