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www.fdanews.com/articles/70466-id-biomedical-enrolls-1-000-subjects-for-fluviral-trial-in-the-u-s

ID Biomedical Enrolls 1,000 Subjects for Fluviral Trial in the U.S.

March 30, 2005

ID Biomedical has completed the enrollment of 1,000 subjects for its Fluviral clinical trial intended to support accelerated approval in the U.S.

The company expanded this trial from 300 subjects to 1,000 healthy adults from age 18 to 64. This randomized, double-blind, comparator-controlled study is designed to evaluate the safety and immunogenicity of Fluviral in healthy adults.

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. The Canadian trial is being conducted in adults in two age groups, 50 to 64 years old and over 64 years of age; these data will also be filed in support of U.S. licensure.