Novavax has announced positive results from the 1,000-subject Stage A of its two-stage pivotal study to evaluate the safety and immunogenicity of its 2009 A/H1N1 VLP pandemic influenza vaccine.
The Independent Data Safety Monitoring Board (DSMB) concluded that Novavax's vaccine was well tolerated and that it induced a robust immune responses with a single injection at all dose levels tested.
Novavax is jointly conducting the study with Avimex Laboratories in Mexico and other countries.
Stage A of the study consisted of a double-blind, placebo-controlled, randomised trial in 1,000 healthy subjects aged between 18 and 64 years old.
The study indicated that the vaccine at all three dose levels of 5mcg, 15mcg or 45mcg induced protective immune responses, was well tolerated, and exhibited no systemic side effects and mostly mild local site reactions similar to the placebo.
Novavax said the data confirmed that a single dose of 15mcg is optimal to induce immune responses in broader age populations with a satisfactory safety profile.
Novavax has filed for regulatory approval for its vaccine candidate in Mexico following the positive results.
Earlier in March, Novavax completed enrolment of over 3,500 subjects in Stage B of the pivotal study, of which over 2,500 received a single 15mcg injection of the vaccine while 1,000 received a placebo.