The company intends to ship product to the US and initiate enrollment of subjects before the end of January 2005. The Fluviral vaccine to be tested was produced using a terminal sterile filtration step, a minor modification to the production process required by the FDA for flu vaccines entering the US market.
ID Biomedical also announced that it has completed enrollment of a similar clinical trial of Fluviral in Canada.
The US clinical trial will involve approximately 300 people from age 18 to 64 and is designed to evaluate the safety and immunogenicity of Fluviral in healthy adults. The Canadian clinical trial enrolled 658 people and is also designed to compare the safety and immunogenicity of Fluviral utilizing the new production process versus a comparator flu vaccine.
The Canadian trial is being conducted in adults in two age groups, 50 to 64 years old and over 64 years of age, thereby addressing a key vaccine target population in both the US and Canada.
Between the Canadian and US studies, ID Biomedical will test Fluviral in 958 people, with 528 subjects receiving Fluviral and 430 receiving a comparator influenza vaccine.
Over the last several years, over 40 million doses of Fluviral have been distributed throughout Canada. ID Biomedical is the market leader for influenza vaccines in Canada, and is one of only two flu vaccine manufacturers located in North America.
“We are very excited to initiate clinical testing of Fluviral in the US. We believe this trial data, along with that being obtained from our ongoing Canadian study, will be necessary to support licensure of Fluviral for the US market,” commented Dr Louis Fries, vice president of clinical affairs.
ID Biomedical produces Fluviral from its two flu vaccine production facilities located in Laval and Quebec City, Quebec. The company’s Quebec City facility is being expanded to increase total manufacturing capacity to approximately 50 million doses by 2007, and will house what is believed to be the newest egg-based vaccine production facility in the world.
Upon FDA approval, Fluviral will be distributed in the US by ID Biomedical’s distribution partners: Henry Schein Inc, AmerisourceBergen Corporation’s Specialty Group and McKesson Corporation.