Safety and Pharmacokinetics of Nirsevimab in Japanese Infants: Primary Analysis of the Open Label JUBILUS Trial

Key Points

• To assess the safety and pharmacokinetics of nirsevimab in Japanese infants at risk for severe RSV infections.
• Conducted open label trial in infants aged ≤12 months.
• Administered two doses of nirsevimab 5-6 months apart.
• Monitored for safety concerns and anti-drug antibodies.
• No safety concerns were observed in the participating infants.
• No anti-drug antibodies occurred among participants.
• Serum concentrations aligned with those previously shown to be effective.