Observational studyEuropean journal of pediatrics2025
Respiratory syncytial virus-related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study.
Observational study in European journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06180993 (Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization), which is not on this map. Cited by 4 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Who cites it
4 citing papers in PubMed.
- Observational
- Comment on Kura et al. Cost-Effectiveness Analysis of Clesrovimab for Respiratory Syncytial Virus in Infants in the United States.Vaccines · 2026Article
- Cost-Effectiveness of Nirsevimab and Clesrovimab in Preventing Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants in the United States: A Modeling Study.Infectious diseases and therapy · 2026Article
- Prophylactic monoclonal antibodies against respiratory syncytial virus in early life: An in-depth review of mechanisms of action, failure factors, and future perspectives.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025Review
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22 authors.
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Abstract
As part of the NIRSEGAL study ( https://www.nirsegal.es/en ), we present the clinical characteristics and course of respiratory syncytial virus (RSV)-related low respiratory tract infection (LRTI) hospitalizations in infants eligible for nirsevimab administration during the 2023-2024 season. Infants eligible for nirsevimab immunization (born between 1 April, 2023, and 30 March, 2024) who were hospitalized due to RSV-related LRTI between September 25, 2023, and April 15, 2024, in a hospital from the Galician Public Health system were included. Clinical and demographic characteristics of RSV-related LRTI hospitalizations were analyzed, with comparisons made between breakthrough cases (those immunized with nirsevimab) and non-breakthrough cases. During the study period, 69 RSV-related LRTI hospitalizations were recorded, with a median hospital stay of 4 (interquartile range (IQR) 3-6) days; 65.2% (N = 45) were breakthrough cases. The median age was 2.7 (IQR 1.5-5.2) months, and more than half of them (N = 39, 56.5%) were male. The incidence of cases was parallel to the RSV epidemic curve, suggesting no waning of nirsevimab efficacy. Of the total hospitalizations, 16 infants (23.2%) had a high-risk condition, 44 (63.8%) needed oxygen support, 15 (21.7%) were admitted to the intensive care unit (ICU), and 11 (15.9%) received non-invasive mechanical ventilation (NIMV). No statistically significant differences were observed in these characteristics when comparing breakthrough and non-breakthrough cases.
conclusionIn the nirsevimab era, a substantial proportion of children who were hospitalized for RSV-related LRTI needed oxygen support, NIMV, and ICU admission. Clinical characteristics, timing, and outcomes were comparable between breakthrough and non-breakthrough cases.
trial registrationThe NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993). WHAT IS KNOWN: • Nirsevimab, a long-acting monoclonal antibody, has shown high effectiveness in preventing RSV-related hospitalizations and has been included in some European countries' immunization programs. WHAT IS NEW: • During the first RSV season after the universal implementation of nirsevimab in Galicia (Spain), a large proportion of hospitalized infants had high-risk conditions, yet disease severity markers (oxygen need, ICU admission, NIVM) were comparable between breakthrough and non-breakthrough cases. • No signal of waning protection over time was observed among breakthrough cases, reinforcing the potential value of early, season-wide immunization.
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