Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

Summary

Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.

Timeline

Start

2020-08-19

Primary completion

2023-02-17

Completion

2023-02-17

Drugs

Indications