QALY 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) (QALYs lost due to RSV)

Study identification

• EU PAS number:
  EUPAS27465
• Study ID:
  30698
• Official title and acronym:
  QALY 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) (QALYs lost due to RSV)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Respiratory 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

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

Spain

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

Study timelines

Date when funding contract was signed

Planned: 01/07/2018

Actual: 01/07/2018

Study start date

Planned: 01/12/2018

Actual: 01/12/2018

Date of final study report

Planned: 30/11/2019

Sources of funding

Other

More details on funding

Regional Grant

Regulatory

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