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

6. März 2015 aktualisiert von: 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.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Monate bis 5 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Verfahren: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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).
Zeitfenster: During hospitalisation and after discharge (approximately 12 months from study initiation).
During hospitalisation and after discharge (approximately 12 months from study initiation).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: During hospitalisation and after discharge (approximately 12 months from study initiation).
During hospitalisation and after discharge (approximately 12 months from study initiation).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2014

Primärer Abschluss (Voraussichtlich)

1. Dezember 2015

Studienabschluss (Voraussichtlich)

1. Dezember 2015

Studienanmeldedaten

Zuerst eingereicht

31. Oktober 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Oktober 2013

Zuerst gepostet (Schätzen)

7. November 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 116494

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