Vaccine and Treatment Evaluation Units (VTEU) 24-0003

BAYLOR COLLEGE OF MEDICINE- ABSTRACT The purpose of this Phase 4 study is to compare strategies for prevention of RSV lower respiratory tract disease infection in infants in a single study. Both maternal vaccination with RSVpreF and passive immunization of infant with monoclonal antibody at birth are recommended. Sequential administration of both products for some infants may be indicated but this has not been studied. This study will evaluate the safety and immunogenicity of 4 prevention strategies using these approved products. It is expected that the results of this study will policy recommendations and clinical decision-making for pregnant women and their infants.