The Resolve trial is a randomized, observer-blinded, placebo-controlled trial of 11,850 older adults at 60 sites in the United States.
All participants have been enrolled and vaccinated in advance of the 2015-16 RSV season, and top-line results are expected in the second half of 2016. 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.
Novavax president and CEO Stanley Erck said: "Complete enrollment of this 11,850 participant trial in only five weeks is a significant achievement and underscores the strength of our clinical operations and management teams, as well as the support of our numerous clinical trial sites and our dedicated key opinion leaders.
"Our two Phase 3 trials of the RSV F Vaccine, Resolve and Prepare, signal Novavax’ commitment to bring this groundbreaking vaccine to market for the populations most affected by RSV. We look forward to releasing top-line data from the Resolve trial in the third quarter of 2016."
About RSV
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 the United States, RSV is increasingly being recognized as a significant cause of morbidity and mortality in the population of 64 million older adults.
The U.S. Centers for Disease Control and Prevention (CDC) reports that each year the disease causes 177,000 hospitalizations and 14,000 deaths among adults older than 65.3 Annually, there are approximately 900,000 medical interventions directly caused by RSV disease. Currently, there is no approved RSV vaccine available.