Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
perjantai 6. maaliskuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
2 kuukautta - 5 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
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).
Aikaikkuna: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
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).
Aikaikkuna: 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).
Aikaikkuna: 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).
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. joulukuuta 2014
Ensisijainen valmistuminen (Odotettu)
Tiistai 1. joulukuuta 2015
Opintojen valmistuminen (Odotettu)
Tiistai 1. joulukuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 31. lokakuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 31. lokakuuta 2013
Ensimmäinen Lähetetty (Arvio)
Torstai 7. marraskuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Maanantai 9. maaliskuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 6. maaliskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. maaliskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 116494
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .