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临床试验/NCT00740935
NCT00740935已完成4 期

Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 7,204 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
7,204
试验地点
2
主要终点
Hospitalization for gastroenteritis

研究概览

简要总结

Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.

Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus.

Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination.

The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Weeks 至 12 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • infants aged 6 to 12 weeks
  • born in Brest District, France
  • born between Feb 01, 2007 and Nov 19, 2009

排除标准

  • contraindication to rotavirus vaccine

结局指标

主要结局

Hospitalization for gastroenteritis

时间窗: 2 years

次要结局

  • Emergency department consultation for gastroenteritis(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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