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Nirsevimab

Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life

Ensayo de Sanofi en RSV Immunization · Healthy Volunteer (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

8.057

previstos

Centros

240

Fin del objetivo primario

mar 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2022.

Qué mide

Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season (From dosing/randomization (Day 1) up to approximately 7 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who were not eligible to receive palivizumab. The visit frequency was 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization for all participants. The study also included a 12-month (Day 366) follow-up telephone call. The D366 follow-up telephone call was the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study included an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.

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Ficha completa en ClinicalTrials.gov (NCT05437510), actualizada en sep 2025.