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

Summary

The 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.

Timeline

Start

2022-08-08

Primary completion

2024-03-27

Completion

2025-04-09

Publications

• Munro APS, Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Vassilouthis NC, Carreno M, Moreau C, Bourron P, Marcelon L, Mari K, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025 Jun;9(6):404-412. doi: 10.1016/S2352-4642(25)00102-6.
• Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J, Bangert M, Mari K, Nteene R, Wague S, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023 Dec 28;389(26):2425-2435. doi: 10.1056/NEJMoa2309189.

Drugs

Indications