Novavax, Inc. (NVAX) Announces Positive Top-Line Data From Dose-Confirmatory Phase 2 Clinical Trial Of Its RSV Vaccine Candidate In Women Of Childbearing Age
4/28/2014 5:15:45 PM
GAITHERSBURG, Md., April 28, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response (measured by levels of serum IgG antibody specific for the F protein). The study enrolled 720 healthy women between the ages of 18 and 35 years, who received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant. These top-line data relate to the safety and immunogenicity over the 91-day period following first immunization and support Novavax' maternal immunization strategy.
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