Novavax has completed enrolment for the first stage of a two-stage clinical study of the company’s 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in Mexico.
The first stage of the study will evaluate the vaccine’s safety, immunogenicity and exploratory efficacy among 1,000 healthy adults, made up of 750 VLP vaccine recipients and 250 placebo recipients.
The results of this phase of the study will then be used to select a dose for evaluation in the second stage, which will test 3,000 subjects (2,000 vaccine and 1,000 placebo recipients).
The results of this final study will then be used to support registration of Novavax’s 2009 H1N1 VLP pandemic influenza vaccine in Mexico and other countries.
Novavax president and chief executive officer Dr Rahul Singhvi said that the company hopes to evaluate results early in 2010.
“If our findings are positive, Novavax and our partners plan to seek immediate approval to market our vaccine in Mexico, which faces a critical shortage of H1N1 influenza vaccine,” Singhvi said.