- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01978223
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
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).
Délai: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
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).
Délai: 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).
Délai: 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).
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 116494
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infections, rotavirus
-
Radboud University Medical CenterSint MaartenskliniekActif, ne recrute pasInfection du site opératoire | Infection articulaire | Infection, site chirurgical | Prothèse Infection Hanche et Genou | Infection liée aux prothèses | InfectionProPays-Bas
-
West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
-
Taipei Medical University WanFang HospitalInconnue
-
Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
-
Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
-
Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
-
Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis
-
Hospices Civils de LyonRecrutement
Essais cliniques sur Stool sample collection
-
Hillel Yaffe Medical CenterInconnue