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Novavax Initiates Global Pivotal Phase 3 Trial of the RSV F Vaccine to Protect Infants via Maternal Immunization

GAITHERSBURG, Md., Dec. 03, 2015 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the enrollment of the first participant in a global pivotal Phase 3 clinical trial, known as Prepare™, of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in healthy pregnant women.

The Prepare trial is a randomized, observer-blinded, placebo-controlled trial that utilizes a group sequential design, offering flexibility in trial size that is responsive to the rate of endpoint events and evolving evidence of efficacy while maintaining the trial’s blinding integrity. Thus, the eventual sample size may vary between 5,000 and 8,255 pregnant women over a period of two to four years. Participants are being vaccinated at a number of global clinical sites in advance of each region’s RSV season. Novavax previously announced it was awarded a grant up to $89 million from the Bill & Melinda Gates Foundation to support development of this RSV F Vaccine Phase 3 clinical trial in pregnant women.

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