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1.
Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season.
Dagan, Ron; Hammitt, Laura L; Seoane Nuñez, Beatriz; Baca Cots, Manuel; Bosheva, Miroslava; Madhi, Shabir A; Muller, William J; Zar, Heather J; Chang, Yue; Currie, Alexander; Grenham, Amy; Shroff, Manish; Takas, Therese; Mankad, Vaishali S; Leach, Amanda; Villafana, Tonya.
J Pediatric Infect Dis Soc ; 13(2): 144-147, 2024 Feb 26.
Article in English | MEDLINE | ID: mdl-38219024

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.


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Respiratory Tract Infections , Child , Humans , Infant , Antibodies, Monoclonal, Humanized/therapeutic use , Respiratory Syncytial Virus Infections/drug therapy , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/prevention & control , Seasons
2.
Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants.
Muller, William J; Madhi, Shabir A; Seoane Nuñez, Beatriz; Baca Cots, Manuel; Bosheva, Miroslava; Dagan, Ron; Hammitt, Laura L; Llapur, Conrado J; Novoa, Jose M; Saez Llorens, Xavier; Grenham, Amy; Kelly, Elizabeth J; Mankad, Vaishali S; Shroff, Manish; Takas, Therese; Leach, Amanda; Villafana, Tonya.
N Engl J Med ; 388(16): 1533-1534, 2023 04 20.
Article in English | MEDLINE | ID: mdl-37018470

Subject(s)
Antibodies, Monoclonal, Humanized , Antiviral Agents , Infant, Newborn, Diseases , Infant, Premature , Respiratory Syncytial Virus Infections , Humans , Infant , Infant, Newborn , Antibodies, Monoclonal, Humanized/therapeutic use , Antiviral Agents/therapeutic use , Hospitalization , Palivizumab , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus Infections/drug therapy , Term Birth , Infant, Newborn, Diseases/drug therapy , Infant, Newborn, Diseases/prevention & control
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