Epidemiological, Observational, Post Marketing Study of the Genetic Stability of GSK Biologicals' Rotavirus Vaccine (Rotarix™) in Children <5 Years of Age Diagnosed With Severe Gastroenteritis, in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
研究概览
简要总结
The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium population after the introduction of Rotarix™. The study will also detect if there is any alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine strain is still efficacious in preventing rotavirus gastroenteritis.
详细描述
This study is conducted in two phases: Phase I and Phase II. Phase I will be retrospective and consist of re-using the data collected in RotaBel (EPI-ROTA-111426) study. Phase II will be prospective and consist of maintaining the active surveillance system to identify rotavirus cases in several hospitals in Belgium.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 14 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaccinated and unvaccinated confirmed G1 and/or P[8] rotavirus gastroenteritis cases from the RotaBel study.
- •A male or a female, born after 1 October 2006 and aged between 14 weeks and < 5 years at the time of hospital admission.
- •Child admitted at the study hospital for severe gastroenteritis during the study period.
- •Onset of severe gastroenteritis ≤14 days prior to admission.
- •Child whose stool sample was tested positive for rotavirus by a hospital routine test.
- •Written informed consent obtained from the parent or guardian of the child.
排除标准
- •Child in care.
结局指标
主要结局
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
时间窗: Over a three-year period
Occurrence of co-infections due to other common viral intestinal pathogens (norovirus, astrovirus, adenovirus) among hospitalized children with rotavirus gastroenteritis
时间窗: Over a three-year period
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
时间窗: Over a three-year period
Occurrence of mutated vaccine strains and re-assortments among hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments
时间窗: Over a three-year period
Occurrence of vaccine-derived G1 and/or P[8] encoding gene segments among children hospitalized with rotavirus gastroenteritis due to G1 and/or P[8] strains
时间窗: Over a three-year period
Clinical characteristics of hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
时间窗: Over a three-year period
Clinical characteristics include symptoms of current gastroenteritis (GE) episode, severity of GE episode by Vesikari score, date of onset of GE episode, diagnosis at admission, diagnosis at discharge, treatment, medical history and co-infections.
Epidemiological characteristics of hospitalized children with vaccine-derived G1 and/or P(8) encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
时间窗: Over a three-year period
Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.
次要结局
未报告次要终点