Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
6 maart 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
2 maanden tot 5 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
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).
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
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).
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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).
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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).
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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.
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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.
Tijdsspanne: At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
|
At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
|
|
Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
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.
Tijdsspanne: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2014
Primaire voltooiing (Verwacht)
1 december 2015
Studie voltooiing (Verwacht)
1 december 2015
Studieregistratiedata
Eerst ingediend
31 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
31 oktober 2013
Eerst geplaatst (Schatting)
7 november 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
9 maart 2015
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2015
Laatst geverifieerd
1 maart 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 116494
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .