HARMONIE

• Research type

  Research Study

• Full title

  A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)

• IRAS ID

  1005180

• Contact name

  NA NA

• Contact email

  uk-medicalinformation@sanofi.com

• Sponsor organisation

  Sanofi Pasteur

• Eudract number

  2022-000099-20

• Clinicaltrials.gov Identifier

  NCT05437510

• Research 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 hospitalisations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalisations) in all infants under 12 months of age who are not eligible to receive Palivizumab.

  The visit frequency will be one (1) in-person dosing/randomisation visit, with monthly safety follow-up electronic contacts through the first 6 months’ post dosing/randomisation.

  The study will also include a 12-month (Day 366) final follow-up telephone call.

  The study duration will be 12 months post- dosing/randomisation

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  22/SC/0132

• Date of REC Opinion

  23 May 2022

• REC opinion

  Further Information Favourable Opinion