Status: Ongoing First registered on: 21/02/2019
Last updated on: 29/07/2019
1. Study identification
EU PAS Register NumberEUPAS27465
Official titleQALY loss due to respiratory syncytial virus (RSV) infection in children younger than 2 years and their relatives in the Valencian Community and Catalonia (AIV-Fisabio)
Study title acronymQALYs lost due to RSV
Study typeObservational study
Brief description of the studyRespiratory syncytial virus (RSV) is the most important cause of respiratory infection in children younger than 2 years and the cause of the highest number of hospitalizations. Different vaccine development programs for infant or pregnant women are in advanced stages (Phase II / III), so it is estimated that this vaccine could be a reality soon. Pharmaeconomic studies allowing the estimation of the potential impact of these vaccines are required in advance. The reference analysis for the economic-sanitary evaluation of a new health intervention is cost-utility. Their results are expressed in quality-adjusted life-year (QALY), where the utility evaluates the condition of the disease to the health-related quality of life (HRQOL). The few existing studies show that child vaccination against RSV could be cost-effective in other countries. However, they obtained useful data using other countries’ QALYs literature. So far there are no available studies estimating QALYs or utilities loss due to RSV infection in children less than 2 years of age (the range of age where the incidence is higher), nor CUA of RSV vaccines candidates available in Spain. As a previous step, it is a priority to establish an estimate of the loss of HRQOL due to RSV in children younger than 2 years and their relatives, measured through utility (QALY) at the national level. This project includes a prospective, multicenter and observational study among Spanish children less than 24 months of age, recruited in different primary care centers and hospitals of Valencian Community and Catalonia, where QALYs of RSV-infected children and their parents will be evaluated through novel health utilities questionnaire and method. The study will be contribute to generate valid data for the future pharmacoeconomic analysis of the vaccine, which will be necessary for decision making and the establishment of recommendations on the use of the vaccine against RSV in Spain.
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
Multiple centres

In total how many centres are involved in this Study?10
Hospital Lluís Alcanys, Xativa
Centro Atención Primaria de Burriana II, Castellón
Centro Atención Primaria de L'Eliana, Valencia
Centro Atención Primaria de Just Ramirez, Valencia
Centro Atención Primaria de Ausias March, Xativa
Centro pediátrico Medinfant, Barcelona
Centro Atención Primaria de Drassanes, Barcelona
Centro Atención Primaria Valldoreix, Barcelona
Centro de Atención Primaria Sant Cugat del Vallés, Barcelona
Centro Atención Primaria Terrasa Sud, Barcelona
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 signed01/07/201801/07/2018
Start date of data collection01/12/201801/12/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherRegional Grant100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Orrico
First name Alejandro
Address line 1Av. Cataluña, 21
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain
Phone number (incl. country code)961925950 
Alternative phone number 
Fax number (incl. country code) 
Email address orrico_ale@gva.es
Public Enquiries
Title Dr 
Last name Orrico 
First name Alejandro 
Address line 1Av. Cataluña, 21 
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain 
Phone number (incl. country code)961925950 
Alternative phone number 
Fax number (incl. country code) 
Email address orrico_ale@gva.es 
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