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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

Healthy Volunteer Clinical Trial

Official title:
A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)

Clinical Trial Summary

The purpose of this study is 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 are not eligible to receive palivizumab. The visit frequency will be 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 will also include a 12-month (Day 366) follow-up telephone call. The D366 follow-up telephone call will be the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study will include an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.

Clinical Trial Description

12 months post-dosing/randomization for France, Germany and UK non-reconsented participants, 24 months post-dosing/randomization for UK reconsented participants. D01 will be the day of randomization (both study groups) and immunization (nirsevimab group). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05437510
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 8, 2022
Completion date March 14, 2025
View Details
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