Trial reportJournal of the Pediatric Infectious Diseases Society2024
Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03979313 (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), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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 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, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Efficacy and safety of a single dose of nirsevimab against respiratory syncytial virus infection in infants: a meta-analysis and time-to-event analysis.Italian journal of pediatrics · 2025Pooled it
- Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Observational
- Live-attenuated vaccines of human respiratory syncytial virus for infants and young children: Progress and prospects of an old yet promising platform.Biosafety and health · 2026Review
- Catching our breath: development of interventions and therapies for respiratory syncytial virus.Microbiology and molecular biology reviews : MMBR · 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
- 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
- Respiratory syncytial virus immunization with nirsevimab: Acceptance and satisfaction assessment in infants and risk groups in the region of Murcia (Spain).Human vaccines & immunotherapeutics · 2025Article
- Risk factors associated with severe RSV disease among hospitalized children in the second year of life: a multicenter study.European journal of pediatrics · 2025Article
- Recommendation for use of a long-acting monoclonal antibody to prevent respiratory syncytial virus infection in infants and young children.Clinical and experimental pediatrics · 2025Article
- Review
- Respiratory Syncytial Virus Strain Evolution and Mutations in Western Australia in the Context of Nirsevimab Prophylaxis.Open forum infectious diseases · 2025Article
- Pediatric respiratory syncytial virus rehospitalization rate - a retrospective observational study from Switzerland.BMC pediatrics · 2025Observational
- Respiratory syncytial virus preventives for children in Australia: current landscape and future directions.The Medical journal of Australia · 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
- Review
- Impact of routine prophylaxis with monoclonal antibodies and maternal immunisation to prevent respiratory syncytial virus hospitalisations, Lombardy region, Italy, 2024/25 season.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2025Article
- The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.The Lancet. Infectious diseases · 2024Review
- Postpandemic fluctuations of regional respiratory syncytial virus hospitalization epidemiology: potential impact on an immunization program in Switzerland.European journal of pediatrics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 10 institutions in 6 countries.
Funding
Abstract
To characterize nirsevimab in the prevention of RSV, children from the Phase 3 MELODY trial were followed through their second RSV season. No increase in medically attended RSV lower respiratory tract infections or evidence of antibody-dependent enhancement of infection or disease severity was found for nirsevimab vs placebo recipients. Clinical Trial Registration: Clinicaltrials.gov, NCT03979313, https://clinicaltrials.gov/ct2/show/NCT03979313.
Indexed as
Identifiers
What OpenQuestion holds
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.