Novavax, Inc. (NASDAQ:NVAX) recently announced enrolling participants for its new study that will help in determining safety and efficacy of the RSV F Vaccine. This vaccine is meant for protecting infants through maternal immunization. The study has reached Phase 3 and is meant to understand the potential of vaccination against symptoms, such as RSV lower respiratory tract infection (LRTI). The symptomatic LRTI accompanied with hypoxemia is observed among the infants’ life in first 90 days. Most commonly, the condition is known as Respiratory Syncytial Virus Infections.
Study reaches Phase 3
During the phase 3 of this Group-Sequential, Placebo-Controlled, Observer-Blind, randomized study, the company will determine whether Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine is safe and efficient for healthy third-trimester pregnant women.
While the patients for Phase 3 of this study were enrolled in October 2016, the completion of this study will take place by June 2020. During the study, Novavax, Inc. aims to enrol as many as 8255 patients. The final data collection for the purpose of primary outcome measure shall be done in May 2020.
About the study
The participants of this study are pregnant women aged between 18 and 40 years. During the study, the participants shall be given a single intramuscular (IM) injection along with the test article assigned by specialists, placebo or RSV F vaccine. The study will span over a period of 9 months (approximately) from the time when first dose is given to them. After delivery, the dose shall continue up to a period of 6 months.
The company may also include infants, if they are consented. For these infants, the tenure of study will range approximately 1 year (after delivery of a woman).
The health authorities involve in the study include the U.S. Food and Drug Administration, U.S. Institutional Review Board, along with other bodies from South Africa, the U.K., New Zealand, Spain, Chile as well as Argentina.