Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
2015年3月6日 更新者：GlaxoSmithKline
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
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.
研究概览
详细说明
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.
研究类型
观察性的
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2个月 至 5年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
描述
Inclusion Criteria:
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.
For Cases:
• 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.
Exclusion Criteria:
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cases
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory.
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Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED.
Stool samples will be tested to determine the presence or absence of rotavirus (RV).
Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
|
|
Controls
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay.
|
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED.
Stool samples will be tested to determine the presence or absence of rotavirus (RV).
Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
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).
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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).
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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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).
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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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).
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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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.
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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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.
大体时间：At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
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At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
|
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Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
大体时间：During hospitalisation and after discharge (approximately 12 months from study initiation).
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During hospitalisation and after discharge (approximately 12 months from study initiation).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年12月1日
初级完成 (预期的)
2015年12月1日
研究完成 (预期的)
2015年12月1日
研究注册日期
首次提交
2013年10月31日
首先提交符合 QC 标准的
2013年10月31日
首次发布 (估计)
2013年11月7日
研究记录更新
最后更新发布 (估计)
2015年3月9日
上次提交的符合 QC 标准的更新
2015年3月6日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.