Enrollment will begin for a pivotal influenza vaccine clinical trial sponsored by the National Institutes of Health (NIH), CSL Biotherapies has announced. The study will assess the safety and immunogenicity of single-dose and multi-dose formulations of influenza vaccine and has been designed to meet FDA requirements.
Nine sites across the U.S. will enroll approximately 1,350 healthy adults in a Phase III, randomized, double-blind, placebo-controlled study. Overall, 26 clinical studies have already been conducted in other countries with this vaccine.