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Novavax Reaches Significant Enrollment Milestone in the Prepare Phase 3 Trial of its RSV F Vaccine
May. 07, 2018 08:41AM PST
Biotech InvestingNovavax (Nasdaq:NVAX) announced it has reached a significant milestone in the Prepare Phase 3 clinical trial of its respiratory syncytial virus F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization. Enrollment has reached approximately 4,600 participants, of whom, at least 3,000 have received the RSV F Vaccine. As quoted in the …
Novavax (Nasdaq:NVAX) announced it has reached a significant milestone in the Prepare Phase 3 clinical trial of its respiratory syncytial virus F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization. Enrollment has reached approximately 4,600 participants, of whom, at least 3,000 have received the RSV F Vaccine.
As quoted in the press release:
Prepare is a global, pivotal Phase 3 clinical trial of the RSV F Vaccine, in healthy, third trimester pregnant women, which initiated in December 2015. The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against medically significant RSV-positive lower respiratory tract infection (LRTI) in infants through a minimum of the first 90 days of life and up through the first six months of life.
“Reaching this enrollment target for the Prepare trial is a significant milestone in the advancement of our RSV F Vaccine franchise,” said Stanley C. Erck, President and CEO of Novavax, Inc. “RSV remains an urgent global unmet medical need due to the mortality and morbidity associated with RSV disease in infants and the absence of a vaccine to prevent such disease. We look forward to completing the interim analysis of the Prepare trial as this is the next step on the path to filing marketing applications in the U.S. and Europe for the first-ever RSV vaccine.”