跳至主要内容
临床试验/NCT01236066
NCT01236066已完成不适用

A Study on the Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia

GlaxoSmithKline0 个研究点目标入组 1 人开始时间: 2010年10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
1
主要终点
Occurrence of all cause gastroenteritis (GE) in children < 5 years by age group, state and year

研究概览

简要总结

This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in children < 5 years of age after the introduction of Rotarix in 2006 by year, both inside and outside rotavirus season in Australia. It further aims to compare the two dose regimen of Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.

研究设计

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

入排标准

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

入选标准

  • Children <5 years of age;
  • Children with a diagnosis of all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis in the Australian Institute of Health and Welfare (AIHW) database in New South Wales, Australian Capital Territory, Tasmania and Northern Territory, from 1998 to 2009;
  • Children who were vaccinated with Rotarix or RotaTeq in New South Wales and Queensland, registered in the Australian Childhood Immunisation Register (ACIR) database in Queensland and New South Wales, from 2007 to 2009.

排除标准

  • No exclusion criteria will be applied.

结局指标

主要结局

Occurrence of all cause gastroenteritis (GE) in children < 5 years by age group, state and year

时间窗: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Occurrence of rotavirus gastroenteritis (RV GE) in children < 5 years by age group, state and year

时间窗: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Mean age of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland

时间窗: From 2007 to 2009

Occurrence of bronchiolitis in children < 5 years by age group, state and year

时间窗: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Percentage of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland according to age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

Percentage of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

Percentage of children immunised with the last dose of Rotarix outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

Percentage of children immunised with the last dose of RotaTeq outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

Percentage of children immunised with the last dose of Rotarix according to age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

Percentage of children immunised with the last dose of RotaTeq according to age-specific recommendations for rotavirus (RV) immunisation in Australia

时间窗: From 2007 to 2009

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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