Trials / Completed
CompletedNCT01733862
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,394 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 1824 Days
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Data collection | 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. |
Timeline
- Start date
- 2012-11-27
- Primary completion
- 2017-02-08
- Completion
- 2017-02-08
- First posted
- 2012-11-27
- Last updated
- 2019-05-30
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01733862. Inclusion in this directory is not an endorsement.