Baxter International Inc. has voluntarily suspended enrolment in the phase II/III clinical study currently underway in Europe of its PreFluCel influenza vaccine, due to a higher than expected rate of mild fever and associated symptoms in the clinical trial participants, the company announced here.
"In developing a vaccine, we aim to achieve a high level of efficacy while minimizing potential side effects," Norbert G. Riedel, Baxter's chief scientific officer said adding, "Based on the preliminary data we've seen, the rate of fever and associated symptoms observed with the current formulation of PreFluCel is higher compared to other vaccines available on the market."
Baxter has put further clinical studies planned for 2005 on hold while the company continues to analyze the data from this clinical trial.
Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with the treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology.