Search reports, ask a question, or jump to a page.
The problem
Intervention: Single intramuscular injection of nirsevimab (50 mg if <5 kg, 100 mg if ≥5 kg in first season; 200 mg in second season)
Who it was tested with: 100 immunocompromised children aged ≤24 months with conditions including primary immunodeficiency, previous transplantation, HIV infection, high-dose systemic corticosteroid treatment, immunosuppressive chemotherapy, or other immunosuppressive therapies.
Experience from people who deliver programmes: stories, case studies and lessons learned. Valuable for understanding how and why, and for spotting what to test next, but not a measure of effect.
"The open-label phase II MUSIC trial evaluated the safety and pharmacokinetics of nirsevimab...in immunocompromised children aged ≤24 months." This is a safety and pharmacokinetic study without a control arm, providing preliminary evidence on tolerability and drug exposure but insufficient to establish efficacy for preventing RSV infection.
Open-label design with no control group prevents efficacy determination. A subset of children with increased drug clearance associated with protein loss may have reduced protection, but impact on actual infection prevention is unknown. No comparison to untreated immunocompromised children.
Across countries and designs
1 study · 6 countries
