NCT01978223撤回不适用
Case-control Study to Evaluate the Vaccine Effectiveness of RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
研究概览
简要总结
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.
详细描述
The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.
No vaccine will be administered during this study.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For SGE subjects:
- •A male or female child aged 12 weeks to < 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
- •Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
- •Onset of SGE ≤ 14 days prior to admission/ ED stay.
- •Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.
- •Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
- •For Controls:
- •Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
- •Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
- •Subjects born within ± 2 weeks from the date of birth of the case.
排除标准
- •For SGE subjects:
- •Child in care.
- •Hospitalisation is unrelated to GE.
- •Onset of SGE > 48 hours after admission to (or ED stay at) the hospital.
- •Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
- •Subject with immunodeficiency.
- •Subjects who live out of the federative entity where hospital(s) are located.
- •For Controls:
- •Subject has previously participated as case in this study.
结局指标
主要结局
Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
时间窗: During hospitalisation and after discharge (approximately 12 months from study initiation).
次要结局
- Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.(At hospital admission/ ED stay or during the first 48 hours of hospitalisation.)
- Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.(During hospitalisation and after discharge (approximately 12 months from study initiation).)
- Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.(During hospitalisation and after discharge (approximately 12 months from study initiation).)
研究者
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