This Phase I/IIa clinical trial is designed to assess the safety, tolerability, immunogenicity and viral shedding of the intranasal respiratory syncytial virus (RSV) vaccine in infants and young children. It is a randomized, double-blind, placebo-controlled and multi-dose study that will enroll 320 children.
The investigational vaccine, MEDI-559, is being developed through a cooperative R&D agreement with the National Institute of Allergy and Infectious Diseases (NAID), part of the National Institutes of Health, to help address RSV disease in children.
Filip Dubovsky, vice president of clinical development for vaccines at MedImmune, said: “MedImmune is committed to developing therapies that can combat the most common cause of pediatric respiratory illness. Because respiratory illness due to RSV occurs in otherwise healthy children, developing a vaccine is a public health priority.”