NCT01177657已完成不适用
Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,944
- 试验地点
- 1
- 主要终点
- Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
研究概览
简要总结
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
详细描述
The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female child born after 6 March 2006 and at least 12 weeks of age.
- •Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
- •Onset of severe gastroenteritis ≤ 14 days prior to admission.
- •Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
- •Written informed consent obtained from the parent or guardian of the subject.
- •For controls:
- •Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
- •Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
- •Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
- •Written informed consent obtained from the parent or guardian of the child.
排除标准
- •Subject has previously participated as case or control in this study.
- •Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections).
- •For controls:
- •For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.
- •Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
- •Child has participated in the past as a case or control in this study.
- •Child living in the same house as the case
结局指标
主要结局
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
时间窗: Average time frame: 12-24 months
次要结局
- Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children(Average time frame: 12-24 months)
- Occurrence of rotavirus serotypes among children(Average time frame: 36 months)
- Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis(Average time frame: 12-24 months)
研究者
研究点 (1)
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