Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
6 marca 2015 zaktualizowane przez: 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.
Przegląd badań
Status
Wycofane
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
2 miesiące do 5 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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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).
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 grudnia 2014
Zakończenie podstawowe (Oczekiwany)
1 grudnia 2015
Ukończenie studiów (Oczekiwany)
1 grudnia 2015
Daty rejestracji na studia
Pierwszy przesłany
31 października 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 października 2013
Pierwszy wysłany (Oszacować)
7 listopada 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
9 marca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 marca 2015
Ostatnia weryfikacja
1 marca 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 116494
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