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Investigators from multiple institutions and the manufacturer of the test drug conducted a double-blind, placebo-controlled randomized trial at multiple centers to test the safety and efficacy of a new recombinant human monoclonal antibody (nirsevimab) against respiratory syncytial virus (RSV) in healthy preterm infants. Infants born between 29 and 34 weeks’ gestation at 1 of 164 study sites in 23 countries were eligible. Infants were excluded if they were eligible or had received RSV prophylaxis (eg, palivizumab) or had previously had an RSV infection. Demographics of participants were collected at enrollment.
Participants were randomly assigned in a 2:1 ratio to receive either a single intramuscular injection of 50 mg of nirsevimab or placebo during a 2-month period before the RSV season. Participants were monitored …
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