Novavax, a Maryland-based clinical-stage biotechnology company, has completed the enrollment of over 3,500 subjects in Mexico in Stage B of its 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study, bringing the total number of subjects involved to over 4,500 subjects.
The company said that in Stage B of the study of H1N1 influenza vaccine candidate, a group of 3,500 healthy volunteers aged 18 to 64 years old were enrolled, and of these, 2,500 were given a 15mcg single dose of the company’s unadjuvanted 2009 H1N1 VLP pandemic influenza vaccine candidate while 1,000 of the subjects received placebo.
The 15mcg single dose regimen was recommended by the Data and Safety Monitoring Board (DSMB) after reviewing the results of safety and immunogenicity data from a subset of the 1,000 subjects in Stage A of this trial.
The aim of the Stage B portion of the study was to assess safety. Favorable data from Stage B of this study will position the company for possible registration of the 2009 H1N1 VLP pandemic influenza vaccine candidate in Mexico.
Rahul Singhvi, president and CEO of Novavax, said: “Novavax has now completed enrollment of the largest clinical trial in the Company’s history. This was an ambitious program from the start and we now have realized a remarkable milestone in less than five months. To conduct a clinical trial of this magnitude is a significant undertaking in any circumstance.
“For a company of our size to achieve this goal under such time pressure is testament to the dedication of our employees and collaborators in Mexico. 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.”