Status: Ongoing First registered on: 02/08/2019
Last updated on: 02/08/2019
1. Study identification
EU PAS Register NumberEUPAS30772
Official titleImpact of Rotavirus Vaccination on Acute Gastroenteritis outpatient and emergency department visits using “Real World Data” from the Valencia Region, Spain
Study title acronym
Study typeObservational study
Brief description of the studyAcute gastroenteritis is a frequent disease, with rotavirus being the main cause in children under 5 years of age. Every year, RV accounted for 231 deaths, more than 87,000 hospitalisations, and nearly 700,000 outpatient visits in Europe. In addition to the clinical impact, these rotavirus-associated events result in increased medical expenses, lost productivity, and other costs to society and families. In Spain, rotavirus vaccines have been available since 2006 (RV1) and 2007 (RV5). Benefits of rotavirus vaccines have been widely studied. These kind of studies in Spain have separately, and for varied populations and time periods, analysed vaccines impact on RVAGE-hospitalizations (up to 71% reduction in infants), all-cause AGE hospitalizations (up to 39% reduction in infants) (11) and effectiveness (over 85% effective against rotavirus hospitalization among young children). The effects of rotavirus vaccine on ED and outpatients visits are not widely documented. This study aims to provide for the first time a comprehensive evaluation of the impact of rotavirus vaccines on ED and outpatient utilization among children <5 years of age of the Valencia Region, for acute gastroenteritis. This approach will provide estimates of the economic impact of rotavirus vaccines on outpatients and ED visits and the national health system associated costs. The Valencia Region accounts with a network of health care databases linked together, which allow the linkage of ED and outpatients registries with the vaccine status at individual level. Secondary objectives: - To estimate the risk of AGE-O and AGE-ED consultations between vaccinated and nonvaccinated children aged less than 5 years from the Valencia Region. - To estimate the economic impact of rotavirus vaccines on AGE-O and AGE-ED visits and the national health system associated costs among children aged less than 5 years from the Valencia Region.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFISABIO
Centre locationValencia
Details of (Primary) lead investigator
Title Dr
Last name Orrico-Sánchez
First name Alejandro
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/11/2018
Start date of data collection28/12/2018
Start date of data analysis28/07/2019
Date of interim report, if expected
Date of final study report28/07/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMSD100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Orrico-Sánchez
First name Alejandro
Address line 1Avenida Cataluña 21
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain
Phone number (incl. country code)0034961925980 
Alternative phone number 
Fax number (incl. country code) 
Email address orrico_ale@gva.es
Public Enquiries
Title Dr 
Last name Orrico-Sánchez 
First name Alejandro 
Address line 1Avenida Cataluña 21 
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain 
Phone number (incl. country code)0034961925980 
Alternative phone number 
Fax number (incl. country code) 
Email address orrico_ale@gva.es 
Top