Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. 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 15 papers, 2 of them syntheses 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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2025) and Update on Immunization for Children Aged 0 Through 18 Years.Indian pediatrics · 2026Guideline
- 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
- Nirsevimab for respiratory syncytial virus prevention: A comprehensive product review.Human vaccines & immunotherapeutics · 2026Review
- Acute Respiratory Infections in Children: A Narrative Perspective on Integrated Primary-Hospital Care in Italy.Children (Basel, Switzerland) · 2026Article
- National real-life impact of prevention with nirsevimab on infants' RSV hospitalizations in Belgium.BMC infectious diseases · 2026Article
- Respiratory Viral Co-Infections in Pediatric Patients: Clinical Impact and Implications for Healthcare Practice-A Narrative Review.Healthcare (Basel, Switzerland) · 2026Review
- Article
- 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
- Article
- Determinants of success and failure of antibody-based strategies against respiratory viruses: insights from RSV and SARS-CoV-2.Frontiers in immunology · 2026Review
- Cost-effectiveness analysis of nirsevimab for prevention of respiratory syncytial virus disease among infants in Shanghai, China: A modeling study.Human vaccines & immunotherapeutics · 2025Article
- Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Using COVID-19 pandemic perturbation to model RSV-hMPV interactions and potential implications under RSV interventions.Nature communications · 2025Article
- Systematic Review and Expert Consensus on the Use of Long-acting Monoclonal Antibodies for Prevention of Respiratory Syncytial Virus Disease: ARMADA (Advancing RSV Management And Disease Awareness) Taskforce.Open forum infectious diseases · 2025Review
- Navigating parental hesitancy in public health: the case for RSV immunization in newborns.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
backgroundNirsevimab is an extended half-life, highly potent, anti-respiratory syncytial virus (RSV) fusion protein neutralizing monoclonal antibody with efficacy against RSV-associated medically attended (MA) lower respiratory tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during MELODY: a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab in healthy term and late preterm (ie, gestational age ≥35 weeks) infants entering their first RSV season.
methodsA total of 3012 participants were randomized to nirsevimab (n = 2009) or placebo (n = 1003). Nasopharyngeal swabs were collected from infants who presented with an LRTI and tested for 22 different respiratory pathogens using the BioFire® Respiratory 2.1 Panel. Incidence of RSV and non-RSV MA-LRTIs through day 511 and LRTI severity were assessed.
resultsA total of 852 nasopharyngeal swabs were collected from 561 participants through day 511: 519 swabs from 337 nirsevimab participants and 333 swabs from 224 placebo participants. RSV and non-RSV infections were detected in 193 of 852 (22.7%) and 55 of 852 (64.7%) swabs, respectively. RSV infection rates were lower with nirsevimab compared with placebo, including RSV-rhinovirus/enterovirus coinfections. Rates of other viral infections were similar between study arms. Approximately 70% of single RSV infections and RSV coinfections were adjudicated as mild, and 26.2% of single RSV infections and 24.5% of RSV coinfections required hospitalization.
conclusionsNirsevimab protected against RSV single and coinfections, with no evidence of replacement of RSV with other respiratory viruses. Clinical Trials Registration. NCT03979313.
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What Socratic 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 Socratic graph.