The trial's Stage B of testing, which will enroll approximately 3,000 subjects, is currently ongoing and more than fifty percent of the subjects have now been enrolled in this expanded safety phase. Subjects enrolled in this stage of the study receive a single dose of 15 mcg of Novavax's 2009 H1N1 VLP pandemic vaccine. Currently, an independent Data and Safety Monitoring Board (DSMB) is reviewing the safety and immunogenicity data from all 1,000 subjects of Stage A of the study and will provide an update in the near future.
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "The data presented today suggest that our H1N1 VLP vaccine is well tolerated and has a robust immune response even at a low dose of 5 mcg. This is remarkable given that our vaccine does not contain any adjuvant. Stage B enrollment of 3,000 subjects, which is more than fifty percent complete, coupled with subjects previously enrolled in Stage A of this trial and other clinical trials should provide us with a sizeable database of safety information that is key to progressing our vaccine to ultimate regulatory approval and commercialization worldwide."
SOURCE Novavax, Inc.