Novavax Initiates Pivotal Phase 3 Trial of the RSV F Vaccine in Older Adults
The Resolve trial is a randomized, observer-blinded, placebo-controlled trial designed to enroll up to 11,850 older adults at 60 sites in
The primary efficacy objective of the Resolve trial is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. The trial’s objectives, endpoints and statistical approach were finalized based on the FDA’s recommendations during the recent End of Phase 2 meeting. The results of a Phase 2 trial in older adults, reported by
“We have taken advice and recommendations from the
Respiratory syncytial virus, commonly referred to as RSV, is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with an incidence rate of 2.5 million infections per year in
- Falsey, A.R. et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med, 2005; 352:1749–59; extrapolated to 2015 census population.
- Falsey, A.R. et al. Respiratory Syncytial Virus and Influenza A Infections In The Hospital Elderly. J. Infect Dis,1995;172:389-94
- CDC: http://www.cdc.gov/rsv/research/us-surveillance.html
- Widmer, K. et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus and Influenza Virus in Older Adults. J Infect Dis, 2012; 206: 56-62.
- Widmer, K. et al.
Respiratory Syncytial Virus & Human Metapneumovirus-Associated Emergency Departmentand Hospital Burden in Adults. Influenza Other Respir Viruses, 2014; 8(3): 347-352.
Statements herein relating to the future of
Novavax, Inc. Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Andrea N. Flynn, Ph.D. Senior Manager, Investor Relations firstname.lastname@example.org 240-268-2000 Russo Partners, LLC David Schull Todd Davenport, Ph.D. email@example.com firstname.lastname@example.org 212-845-4271