Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial.
- Carbonell-Estrany X, Sim\uf5es EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA
- Faldella G
- Motavizumab Study Group [
- Lanari M
- ]
DOIAbstract
OBJECTIVE: Palivizumab reduces respiratory syncytial virus (RSV) hospitalization in children at high risk by approximately 50% compared with placebo. We compared the efficacy and safety of motavizumab, an investigational monoclonal antibody with enhanced anti-RSV activity in preclinical studies, with palivizumab. METHODS: This randomized, double-blind, multinational, phase 3, noninferiority trial assessed safety and RSV hospitalization in 6635 preterm infants aged <or=6 months at enrollment or children aged <or=24 months with chronic lung disease of prematurity who received 15 mg/kg palivizumab or motavizumab monthly. Secondary end points included outpatient medically attended lower respiratory tract infections (MALRIs), RSV-specific LRIs, ...
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