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.
The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia in infants through the first 90 days of life. The trial’s objectives, endpoints and statistical approach were finalized following a recent End of Phase 2 meeting with the
“We believe that maternal immunization offers the optimal way of protecting young infants, who are among the most susceptible populations to RSV disease. Initiation of this trial builds on our groundbreaking Phase 2 clinical data in this important population, and incorporates discussions with experts in the field and the FDA,” said
A fact sheet on maternal immunization is available at: http://novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.pdf
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the US, RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age.2,3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4,5 Currently, there is no approved RSV vaccine available.
- Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
- Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
- Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
- Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Statements herein relating to the future of
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