Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years. | From Nov 2007 to Oct 2016 |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
The study population will include 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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 457-8510 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29248263 | Background | Yoshikawa T, Matsuki T, Sato K, Mizuno M, Shibata M, Hasegawa S, Morita M, Iwasa M, Gopala K, Holl K. Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 2018 Jan 25;36(4):527-534. doi: 10.1016/j.vaccine.2017.12.006. Epub 2017 Dec 13. |
| Label | URL |
|---|---|
| Results Summary, Full Protocol and Analysis Plan for study 116929 can be found on the GSK Clinical Study Register | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Aichi |
| 457-8511 |
| Japan |
| GSK Investigational Site | Aichi | 457-85 | Japan |
| GSK Investigational Site | Aichi | 466-8650 | Japan |
| GSK Investigational Site | Aichi | 466-86 | Japan |
| GSK Investigational Site | Aichi | 468-8520 | Japan |
| GSK Investigational Site | Aichi | 468-85 | Japan |
| D014076 |
| Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |