Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

Exclusion Criteria

• •1. Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, would substantially increase the risk associated with the maternal or infant participant's participation in and completion of the study
• •2. Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future newborn/infant in the study
• •3. High risk of prematurity as judged by treating clinician
• •4. Multiple pregnancy (i.e. twins, triplets or more)
• •5. Previous participation in the PIPELINE-RSV trial
• •6. Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial
• •7. Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine)
• •8. History of Guillain Barré Syndrome (GBS)