Trial intelligence / Profile preview

Safety and Efficacy of Nirsevimab in Neonates, Infants, and Children Vulnerable to RSV

NCT07109297Phase 4Active, not recruiting

Sponsor
Sanofi
Start
Jul 2025
Primary completion
Jun 2026
Modality
Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
Countries
1
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Overview

Phase 4, open-label, single-arm trial of nirsevimab in respiratory syncytial virus infection (RSV), sponsored by Sanofi. Primary endpoints: Presence of immediate adverse events at 30 minutes, Presence of non-serious adverse events at 1 month and 3 more. Started Jul 2025; status: active, not recruiting.

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Drugs

nirsevimab
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Conditions

respiratory syncytial virus infection (RSV)

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