On Dec. 14, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved GlaxoSmithKline’s quadrivalent formulation of Fluarix (inactivated influenza vaccine for use in persons 3 years of age and older.

A PREA postmarketing requirement was included in the approval letter for conducting a study to evaluate the safety and immunogenicity of D-QIV in children 6 to 35 months of age.