The study is designed to evaluate the safety and immunogenicity of Fluviral in healthy adults and has been expanded from 300 to 1,000 subjects. It is intended to support accelerated approval of Fluviral in the US.
“We are extremely pleased with the quick enrollment of the 1,000 subjects in this clinical trial. The completion of the enrollment arrives six weeks earlier than we had originally expected,” said Dr Anthony Holler, ID Biomedical’s CEO.
“This achievement represents another very positive step towards a biologics license application (BLA) filing later in the year with a view, pending necessary regulatory approvals, to manufacture and ship influenza vaccine to the US for the 2006-2007 season,” he added.
ID Biomedical is also conducting a similar clinical trial of Fluviral in Canada. The Canadian clinical trial enrolled 658 people and is also designed to evaluate the safety and immunogenicity of Fluviral. Data from this trial will also be filed in support of US licensure.