Harmonie RSV Study

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

Status: Closed to recruitment 

Population: Paediatric  

Disease Group: Respiratory Syncytial Virus (RSV) 

Funder: Sanofi Pasteur 

Sponsor: Sanofi Pasteur 

Principal Investigator: Dr Eva Galiza 

Study Aims 

RSV can cause a variety of respiratory tract symptoms and is one of the most frequent causes of hospitalisation in babies and young children. The symptoms of RSV include: runny nose, fever, cough, trouble eating and drinking. In some babies and young children, the illness may move into the lungs and cause wheezing and difficulty breathing. In some instances, severe respiratory disease may require hospitalisation for support, such as oxygen. 

 The HARMONIE Research Study is looking at a new medicine which protects against RSV; an antibody injection called Nirsevimab. This study looks at how strongly babies can be protected from serious illness due to RSV infection by comparing a single antibody dose with no intervention. The study measures this by how many children need to be admitted to hospital with RSV during the course of the study. The study will continue to collect more safety information about this new medicine as well.  

What does participating in the study involve?

This study involves babies who probably haven’t had RSV yet. We will first talk in detail to the family, check the baby is fit and well and appropriate for the study. The baby will then be randomly assigned (like flipping a coin) into one of two groups. One group will receive the antibody dose by having an injection into their thigh, in the same way babies receive their routine vaccination injections, and in the other group no injection will be given.  

 There is just one visit to the study site which is when the antibody dose would be given, if assigned. After this, monthly diaries are filled in for 6 months to collect information about possible RSV infections and other symptoms.  After 12 months, there is one more phone call from the study team and then the follow-up period is complete.  

This study will involve thousands of babies across France, Germany and the UK. We’re proud to be taking part in this exciting study, looking at a new medicine for preventing RSV because there are no widely available treatments at the moment. If you would like to know more about this study please feel free to read the patient information sheet or get in touch on the email below.  

To find out more about the study, contact the study team at: harmoniersv@sgul.ac.uk