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临床试验/NCT03465254
NCT03465254进行中(未招募)不适用

Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines

University of the Philippines0 个研究点目标入组 2,996 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,996
主要终点
virologically-confirmed dengue (VCD)

研究概览

简要总结

This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.

详细描述

This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with <5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

virologically-confirmed dengue (VCD)

时间窗: 5 years

The primary outcome measure is virologically confirmed dengue by RT-PCR

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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