ArticlePathogens (Basel, Switzerland)2024
Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials.
Article in Pathogens (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
Who cites it
25 citing papers in PubMed.
- A phase I, randomized, placebo-controlled trial to evaluate the pharmacokinetics, safety, and tolerability of nirsevimab in healthy Chinese adults.Clinical and translational science · 2025Trial
- Post-licensure safety of nirsevimab from the Canadian National Vaccine Safety (CANVAS) network.Human vaccines & immunotherapeutics · 2026Article
- Target-Based Antiviral Drug Development Against Human Respiratory Viruses.Pathogens (Basel, Switzerland) · 2026Review
- Two-season effectiveness of a single nirsevimab dose against RSV hospitalisation in healthy term-born infants: a population-based case-control study, Spain, October 2023 to March 2025.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- Real-world effectiveness of nirsevimab against respiratory syncytial virus in pediatric practice: the Piemonitorab study.Italian journal of pediatrics · 2026Observational
- Insights Into monoclonal antibodies and vaccines targeting respiratory viruses.Frontiers in pediatrics · 2026Review
- CXCL13 and IL-33 as Immunomodulatory Adjuvants Combined with Respiratory Syncytial Virus Fusion (RSV F) Protein to Enhance Mucosal RSV Vaccination.Infection and drug resistance · 2026Review
- Impact of nirsevimab universal prophylaxis on RSV bronchiolitis hospitalizations. A tertiary level children's hospital perspective.Frontiers in pediatrics · 2026Article
- Innovations in pediatric lung health amid global health shifts.World journal of pediatrics : WJP · 2025Article
- 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
- Real-world impact of nirsevimab immunisation against respiratory disease on emergency department attendances and admissions among infants: a multinational retrospective analysis.The Lancet regional health. Europe · 2025Article
- The Number Needed to Immunize (NNI) to Assess the Benefit of a Prophylaxis Intervention with Monoclonal Antibodies Against RSV.Vaccines · 2025Review
- A review of synergistic strategies in cancer therapy: resveratrol-loaded hydrogels for targeted and multimodal treatment.Discover oncology · 2025Review
- Challenges and Limitations of Current RSV Prevention Strategies in Infants and Young Children: A Narrative Review.Vaccines · 2025Review
- Post-Marketing Surveillance of Nirsevimab: Safety Profile and Adverse Event Analysis from Spain's 2023-2024 RSV Immunisation Campaign.Vaccines · 2025Article
- Expert consensus on the burden of respiratory syncytial virus disease and the utility of nirsevimab for disease prevention and protection of infants.World journal of pediatrics : WJP · 2025Review
- RSV Prevention Strategies in Korean Children: A Review of Current Approaches and Emerging Options.Infection & chemotherapy · 2025Review
- Global Pediatric Pulmonology Alliance recommendations to protect all infants against respiratory syncytial virus with prophylactic monoclonal antibodies.Pediatric investigation · 2025Article
- Acceptance and impact of Nirsevimab and the RSVpreF vaccine following implementation in Austria.Frontiers in public health · 2025Article
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundNirsevimab is approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season and in children aged ≤24 months who remain vulnerable to severe RSV disease through their second RSV season. We summarize a pre-specified analysis of nirsevimab safety data from three randomized controlled trials: Phase 2b (NCT02878330; healthy infants born ≥29 to <35 weeks' gestational age [wGA]); Phase 3 MELODY (NCT03979313; healthy infants born ≥35 wGA); and Phase 2/3 MEDLEY (NCT03959488; infants with congenital heart disease [CHD] and/or chronic lung disease of prematurity [CLD] or born ≤35 wGA).
methodsParticipants (randomized 2:1) received a single intramuscular dose of nirsevimab or comparator (placebo, Phase 2b/MELODY; 5× once-monthly palivizumab, MEDLEY) before their first RSV season (recipients < 5 kg, nirsevimab 50 mg; ≥5 kg, nirsevimab 100 mg). In MEDLEY, children with CHD/CLD continued to a second RSV season: first-season nirsevimab recipients received nirsevimab 200 mg; first-season palivizumab recipients were re-randomized 1:1 to receive nirsevimab 200 mg or 5× once-monthly palivizumab.
resultsThe incidence, severity, and nature of AEs were similar across treatments (nirsevimab,
conclusionsA single dose per season of nirsevimab for the prevention of RSV disease had a favorable safety profile, irrespective of wGA or comorbidities.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.