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在患有心脏或肺部疾病的儿童中,在 RSV 季节 2 之前重新给予 Nirsevimab 的安全性。

Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease.

机构信息

Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York, USA.

Vaccines & Immune Therapies, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.

出版信息

J Pediatric Infect Dis Soc. 2023 Aug 31;12(8):477-480. doi: 10.1093/jpids/piad052.

Abstract

In children with congenital heart disease and/or chronic lung disease entering their second respiratory syncytial virus (RSV) season, 200 mg nirsevimab had a similar safety profile to that of palivizumab and resulted in nirsevimab serum exposures associated with efficacy in healthy infants, supporting efficacy in this population at risk of severe RSV disease.

摘要

对于进入第二个呼吸道合胞病毒(RSV)流行季的患有先天性心脏病和/或慢性肺部疾病的儿童,200 毫克尼塞利珠单抗的安全性与帕利珠单抗相似,并且产生了与健康婴儿疗效相关的尼塞利珠单抗血清暴露,支持该高危 RSV 疾病人群的疗效。

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Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants.
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Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity.
N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186.
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Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.
N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
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Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.
N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
8
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
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