Actively Recruiting
Led by Federico Martinón Torres · Updated on 2023-12-26
42000
Participants Needed
1
Research Sites
30 weeks
Total Duration
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.
CONDITIONS
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration at birth or start of RSV season
Participants receive a single dose of nirsevimab as part of the routine immunization program in Galicia, administered at birth or at the start of the RSV season depending on cohort.
1 visit (in-person) for dose administration
Duration - 8 months (RSV season from October to May)
Participants are observed through routine RSV testing and data collection via the Galician Regional Surveillance Information System to monitor RSV cases and related hospitalizations.
Total: 1 location
1
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15707
Actively Recruiting
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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