A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)
Open to recruitment: Open to recruitment
Aim of the study: The HARMONIE Research Study is looking at how strongly babies can be protected from serious illness due to RSV infection (respiratory syncytial virus) by giving them a single antibody dose.
- Age: Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age) who are entering their first RSV season on the day of inclusion
- Informed Consent Informed consent form has been signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations)
- Participant and parent/LAR are able to attend the scheduled visit and to comply with all study procedures
What participating in the study involves:
If the study is appropriate for your baby, they will be randomly assigned into one of two groups. One group will receive the antibody dose by having an injection into their thigh, in the same way your baby will receive their routine vaccination injections, and in the other group no injection will be given. For the babies not receiving the antibody dose, the information you will provide will be extremely useful and vital to the success of the study. This preventative solution is the result of many years of research by Sanofi and AstraZeneca and has already been given to more than 3000 babies.
The study will last about 12 months for you and your baby, and participation involves the following:
- 1 visit to the study site – This is called the study visit and is when the antibody dose would be given.
- Monthly diary for 6 months – You will be asked to answer a short selection of yes/no questions once a month for a 6-month period. This can be done from the comfort of your home.
- 1 telephone call with the study team 12 months after the study visit
Want to know more and apply?
Visit the study website at rsvharmoniestudy.com/en-gb
Contact the study team at: firstname.lastname@example.org