VRS Cover - Immunization coverage rate study on the prophylactic strategies of infants against Respiratory Syncytial Virus (RSV) in France

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Respiratory syncytial virus (RSV) is the leading infectious cause of acute lower respiratory tract infection (LRTI). During epidemic seasons, this translates into substantial and recurrent pressure on pediatric units, neonatal intensive care units and emergency departments, with requirements for oxygen therapy and mechanical ventilation1. In France, RSV is a widely circulating virus, and bronchiolitis affects nearly 30% of infants under 2 years of age every winter, representing approximately 480,000 cases per year2. Each year, 2 to 3% of infants under 1 year of age are hospitalized for more severe bronchiolitis, accounting for almost one third of all hospitalizations in this age group3.
The burden of severe RSV disease is not uniformly distributed across the population; while all newborns and infants are at risk of RSV-associated LRTI in their first years of life, the majority of hospitalizations occur in infants who are previously healthy4. The high-risk infants include premature infants (<35 weeks of gestational age), infants <2 years old with bronchopulmonary dysplasia or with hemodynamically significant congenital heart disease, who are associated with a substantially elevated risk of severe infection and hospitalization. Deaths attributable to acute bronchiolitis are very rare (less than 1%). These high-risk populations have historically constituted the primary target population for RSV prophylaxis.

The study will be submitted to the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé (CESREES) for ethical and scientific review prior to submission to the Commission Nationale de l’Informatique et des Libertés (CNIL) and the Plateforme des Données de Santé (PDS).

As this study is purely observational and retrospective, involves no intervention, and uses only pseudonymized administrative data, it is exempt from the requirement for individual informed consent under French law (Article L.1121-1 and Article 44 of the Loi Informatique et Libertés). The rights of individuals are preserved in accordance with GDPR provisions.

The study does not involve any direct contact with patients or healthcare providers.