Study identification

PURI

https://redirect.ema.europa.eu/resource/30773

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 institution and networks

Institutions

Contact details

Alejandro Orrico-Sánchez

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

MSD
Study protocol
Initial protocol
English (950.26 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable