Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
2015년 3월 6일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2개월 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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).
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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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).
기간: 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).
기간: 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).
기간: 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.
기간: 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 SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.
기간: 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 hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.
기간: 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.
기간: 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.
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 12월 1일
기본 완료 (예상)
2015년 12월 1일
연구 완료 (예상)
2015년 12월 1일
연구 등록 날짜
최초 제출
2013년 10월 31일
QC 기준을 충족하는 최초 제출
2013년 10월 31일
처음 게시됨 (추정)
2013년 11월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 3월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 3월 6일
마지막으로 확인됨
2015년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 116494
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