- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
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).
Időkeret: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
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).
Időkeret: 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).
Időkeret: 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).
Időkeret: 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.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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.
Időkeret: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 116494
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