Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children.

•The relative risks of fever were 2 times higher for CSL's TIV compared to the established vaccine in children less than 9 years of age.•No febrile seizures or other vaccine-related SAEs were reported.•CSL's TIV demonstrated immunological non-inferiority to the established vaccine in all pediatric cohorts.