Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

Study Overview
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Brief Summary
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This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by Nagoya city, Japan have been implemented from October 2012.

Detailed Description
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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.

Official Title
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A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan

Conditions
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Infections, Rotavirus, Rotavirus Vaccines

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1824 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Japan<br>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. | Other: Data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years. |  | From Nov 2007 to Oct 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age. |  | From Nov 2007 to Oct 2016 | 
| Occurrence of RV GE hospitalizations by age group in children less than five years of age. |  | From Nov 2007 to Oct 2016 | 
| Occurrence of AGE hospitalizations among all hospitalized children aged less than five years. |  | From Nov 2007 to Oct 2016 | 
| Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age. |  | 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. |  | 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. |  | 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. |  | 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. |  | From Nov 2007 to Oct 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impact, Vaccination, Hospitalizations, Rotavirus gastroenteritis, Japan