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Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season.

Ron DaganLaura L HammittBeatriz Seoane NuñezManuel Baca CotsMiroslava BoshevaShabir A MadhiWilliam J MullerHeather J ZarYue ChangAlexander CurrieAmy GrenhamManish ShroffTherese TakasVaishali S MankadAmanda LeachTonya Villafana
Published in: Journal of the Pediatric Infectious Diseases Society (2024)
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.
Keyphrases
  • respiratory tract
  • clinical trial
  • respiratory syncytial virus
  • phase iii
  • study protocol
  • phase ii
  • young adults
  • double blind
  • randomized controlled trial
  • contrast enhanced
  • dual energy