Early data from trials of Novavax's H1N1 influenza vaccine in Mexico have shown the vaccine produces a robust immune response and is well tolerated.
Data showed that the virus-like-particle (VLP) vaccine has met the seroconversion and seroprotection criteria recommended by the US and European regulatory authorities, clearing the way for enrolment in Stage B of the study to begin immediately.
In Stage A of this pivotal Phase II study, 1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of the vaccine or placebo. The vaccine was found to be well tolerated at all three dose levels and exhibited no systemic side effects in this review period.
Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico.
Novavax president and CEO Rahul Singhvi said that the data suggests that the company's vaccine is competitive with other marketed H1N1 influenza vaccines administered at the same dose.
"The DSMB's decision will enable us to begin enrollment in the second stage of this trial and begin final preparations for possible registration and commercialisation of this promising vaccine in Mexico and potentially other countries," Singhvi said.
Trials will now be taken to Stage B of testing, where vaccine safety will be evaluated in 3,000 subjects with a 15mcg single-dose regimen, results of which will be available in January 2010.