ROCKVILLE, Md. — Novavax Inc. announced March 8 that more than 3,500 volunteers ages 18 to 64 in Mexico have been enrolled in Stage B of its 2009 H1N1 virus-like-particle pandemic influenza vaccine study.
With 1,000 people already enrolled in Stage A of the trial, the enrollment in this trial is complete with more than 4,500 people.
This is the largest clinical trial in the company’s history, according to Rahul Singhvi, Novavax’s president and CEO.
In Stage B, 2,500 of the 3,500 volunteers received a 15-mcg single dose of Novavax’s unadjuvanted 2009 H1N1 VLP pandemic influenza vaccine candidate while 1,000 of the subjects received a placebo. The 15 mcg single dose regimen was recommended by the Data and Safety Monitoring Board after reviewing the results of safety and immunogenicity data from a subset of the 1,000 subjects in Stage A of this trial.
These data were recently presented at a meeting sponsored by the World Health Organization in Geneva.
The purpose of the Stage B portion of the study was to evaluate safety. Favorable data from Stage B of this study will position Novavax for possible registration of the 2009 H1N1 VLP pandemic influenza vaccine candidate in Mexico.
VLP vaccines can be produced using portable recombinant cell-culture technology more rapidly than egg-based vaccines, the company says.