Novavax Reaches Significant Enrollment Milestone in the Prepare(TM) Phase 3 Trial of its RSV F Vaccine
- Prepare trial is assessing the efficacy of Novavax’ RSV F Vaccine for infants via maternal immunization
- Enrollment of ~4,600 participants enables initiation of interim efficacy analysis
- Topline efficacy data from analysis expected in the first quarter of 2019
Prepare is a global, pivotal Phase 3 clinical trial of the RSV F Vaccine, in healthy, third trimester pregnant women, which initiated in
“Reaching this enrollment target for the Prepare trial is a significant milestone in the advancement of our RSV F Vaccine franchise,” said
The Prepare trial is supported by a grant of up to
RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.2 In the U.S., RSV is the leading cause of hospitalization of infants.3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4 Currently, there is no approved RSV vaccine available.
About the FDA’s Fast Track Drug Development Program
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A Fast Track designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a BLA on a rolling basis as data become available, which permits the
Statements herein relating to the future of
Senior Manager, Investor & Public Relations
1 Assumes 2:1 randomization
3 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
4 PLOS. “How immunity to respiratory syncytial virus develops in childhood, deteriorates in adults.” ScienceDaily. 21 April 2016. https://www.sciencedaily.com/releases/2016/04/160421145747.htm
Source: Novavax, Inc.