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The problem
Intervention: Single intramuscular dose of nirsevimab (50 mg for children <5 kg or 100 mg for children ≥5 kg)
Who it was tested with: Infants aged 12 months or younger, born at gestational age of at least 29 weeks, across France, Germany, and UK.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"Infants aged 12 months or younger, born at a gestational age of at least 29 weeks, were randomly assigned (1:1) to receive either a single intramuscular dose of nirsevimab... or standard care... The primary efficacy endpoint for this analysis was the incidence of hospitalisations due to RSV-associated lower respiratory tract infection up to 180 days after nirsevimab administration or randomisation in all randomised participants." This is a randomised controlled design with comparison between treatment and control groups on a pre-specified clinical outcome.
Open-label design without blinding. Interim analysis from ongoing trial. Limited to infants born at ≥29 weeks gestation.
Across countries and designs
6 studies · 17 countries
