- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01733862
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The electronic admission database or any other applicable database of the hospital will be reviewed to identify hospitalized children/children with outpatient visits/emergency room visits, less than five years of age who had been diagnosed with acute gastroenteritis (AGE) or RV GE either by the International Classification of Diseases and Related Health Problems 10th Revision (ICD 10) diagnostic code (AA00-AA09 for intestinal infectious diseases and A08.0 for RV specific GE) or by RV positive rapid diagnosis kit results.
Note: The outcomes for the outpatient and emergency room visits will be assessed only in case the data for outpatient and emergency room visits can be obtained from at least one of the study centers.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Aichi, Japan, 466-8650
- GSK Investigational Site
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Aichi, Japan, 457-8511
- GSK Investigational Site
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Aichi, Japan, 457-8510
- GSK Investigational Site
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Aichi, Japan, 457-85
- GSK Investigational Site
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Aichi, Japan, 466-86
- GSK Investigational Site
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Aichi, Japan, 468-8520
- GSK Investigational Site
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Aichi, Japan, 468-85
- GSK Investigational Site
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.
Exclusion Criteria:
- Not applicable.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group Japan
Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2007 and October 2016 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.
|
Data sheet. Data will be collected and is planned to be analysed at the following time points: Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of RV GE hospitalizations by age group in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
|
Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.
Tidsram: From Nov 2007 to Oct 2016
|
From Nov 2007 to Oct 2016
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 116929
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