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临床试验/NCT01477671
NCT01477671已完成不适用

Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India

Sanofi Pasteur, a Sanofi Company0 个研究点目标入组 667 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
667
主要终点
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4

研究概览

简要总结

This is a descriptive prospective community-based seroprevalence study.

Primary objective:

  • To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India.

Secondary objectives:

  • To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
  • To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 5 and 10 year-old on the day of inclusion
  • Healthy child as reported by the parent or legally qualified guardian
  • Being registered in selected study site
  • Provision of the informed consent form signed by at least one parent or legally qualified guardian
  • For children between 8 and 10 years old, provision of the assent form signed.

排除标准

  • 未提供

结局指标

主要结局

Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4

时间窗: Baseline

次要结局

  • Prevalence of positive serum samples with JEV specific IgG antibodies(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

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