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Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

6 mars 2015 uppdaterad av: 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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 månader till 5 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Procedur: Stool sample collection
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.
Procedur: Stool sample collection
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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).
Tidsram: During hospitalisation and after discharge (approximately 12 months from study initiation).
During hospitalisation and after discharge (approximately 12 months from study initiation).

Sekundära resultatmått

Resultatmått
Tidsram
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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: During hospitalisation and after discharge (approximately 12 months from study initiation).
During hospitalisation and after discharge (approximately 12 months from study initiation).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2014

Primärt slutförande (Förväntat)

1 december 2015

Avslutad studie (Förväntat)

1 december 2015

Studieregistreringsdatum

Först inskickad

31 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

31 oktober 2013

Första postat (Uppskatta)

7 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 116494

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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