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news.Novavax has started patient enrollment in Phase II trial of quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate.
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The comparator-controlled study, conducted in Australia under its contract with the US Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority, will enroll up to 500 patients.
The randomized, observer-blind study will evaluate immunogenicity and safety of three dose levels of quadrivalent seasonal recombinant VLP influenza vaccine in healthy adults.
The company expects to evaluate the top-line data from the Phase II trial in the third quarter of 2012.
Novavax president and chief executive officer Stanley Erck said most seasonal vaccines in the future will contain a second B strain and thus consist of a quadrivalent, or four-strain, composition.
"This trial allows us to transition from a trivalent to a quadrivalent seasonal vaccine candidate," Erck added.