NCT01435967已完成不适用
Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
研究概览
简要总结
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.
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
- 否
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
- •Hospitalised at one of the participating centres in Belgium;
- •A stool sample has been provided for a rotavirus detection test during the study period;
- •Laboratory test result of rotavirus is available.
排除标准
- 未提供
结局指标
主要结局
Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
时间窗: up to 2 years post-introduction of liquid formulation of Rotarix™.
次要结局
- Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).(up to 2 years post-introduction of liquid formulation of Rotarix™.)
- Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).(up to 2 years post-introduction of liquid formulation of Rotarix™.)
- Occurrence of rotavirus detected by various types of rotavirus laboratory tests.(up to 2 years post-introduction of liquid formulation of Rotarix™.)
- Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.(up to 2 years post-introduction of liquid formulation of Rotarix™.)
研究者
研究点 (1)
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