Novavax announces presentation of data from Phase 3 Prepare trial of ResVax
Novavax announced the presentation of new data from the company's Prepare trial, a global Phase 3 clinical trial of ResVaxan aluminum adjuvanted respiratory syncytial virus fusion protein recombinant nanoparticle vaccine. Geeta K. Swamy, M.D., Associate Professor of Obstetrics and Gynecology and Vice Dean and Associate Vice Provost for Scientific Integrity at Duke University, made the presentation at the 2019 IDSOG Annual Meeting held in Big Sky, Montana. Dr. Swamy's presentation included new observations based on the recently completed analyses of the 1-year safety data, including a 59.6% reduction in the incidence of serious adverse events diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life. A similar efficacy of approximately 50% was found for all SAEs with a clinical diagnosis of pneumonia, also extending over a year. When x-ray-confirmed pneumonia SAEs associated with detection of RSV were considered, efficacy was 72.9% through 180 days of life, the last time point at which active detection of RSV was carried out.