Study of Nirsevimab to Prevent RSV Infection in Children Up to 24 Months in Galicia

What this Trial Is About

This research aims to evaluate the impact of nirsevimab in preventing respiratory syncytial virus RSV infections in healthy infants and high-risk children under 24 months old at the start of the RSV season in Galicia. The study will analyze longitudinal data collected from public health registries, including hospital and healthcare use related to RSV infections. Historical data will also be used for comparison to better understand the effectiveness of nirsevimab as part of routine immunization. Nirsevimab will be given as a single dose at birth for newborns and at the beginning of each RSV season for other eligible cohorts. The target population includes approximately 14,000 children per RSV season, encompassing healthy newborns, infants under 6 months, and children under 24 months with comorbidities. The administration will follow the usual immunization program in hospitals and primary care centers across Galicia, aiming for high coverage above 80%. Participants data will be collected through the Galician Regional Surveillance Information System, which will integrate information from various electronic databases about RSV cases, hospitalizations, primary care visits, drug administration, and immunizations. RSV cases will be confirmed and classified by clinical experts using established definitions. The study will monitor the incidence of RSV lower respiratory tract infection hospitalizations over an 8-month RSV season from October to May. The total study duration includes three RSV seasons from 2023 to 2026, with ongoing data collection and follow-up.

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization