Impact of Rotavirus Vaccination on Acute Gastroenteritis outpatient and emergency department visits using “Real World Data” from the Valencia Region, Spain

Study identification

• EU PAS number:
  EUPAS30772
• Study ID:
  30773
• Official title and acronym:
  Impact of Rotavirus Vaccination on Acute Gastroenteritis outpatient and emergency department visits using “Real World Data” from the Valencia Region, Spain
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Acute 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Study timelines

Date when funding contract was signed

Actual: 28/11/2018

Study start date

Actual: 28/12/2018

Data analysis start date

Planned: 28/07/2019

Date of final study report

Planned: 28/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable