Novavax has completed enrolment of over 3,500 subjects for Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study in Mexico.
In this stage of the influenza vaccine study, 2,500 of the 3,500 healthy volunteers aged 18 to 64 years old received a 15mcg single dose of Novavax's unadjuvanted 2009 H1N1 VLP pandemic influenza vaccine candidate while 1,000 of the subjects received placebo.
The purpose of this Stage B portion of the study is to evaluate safety, adding the final piece of the puzzle to the safety and immunogenicity data from 1,000 subjects in Stage A of the trial.
Favourable data from Stage B of this study will position Novavax for possible registration of the 2009 H1N1 VLP pandemic influenza vaccine candidate in Mexico.
Novavax president and chief executive officer Dr Rahul Singhvi said that Novavax has now completed enrolment of the largest clinical trial in the company's history.
"I am confident that the quality of the data from this part of the study together with the encouraging results to date from Stage A of the trial will enable Novavax to move closer to ultimate product registration," Singhvi said.
VLPs mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection.