Flulaval Quadrivalent (Influenza Vaccine) filed with FDA for expanded indication- GlaxoSmithKline

GlaxoSmithKline has announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for Flulaval Quadrivalent (Influenza Vaccine). This vaccine is currently approved for active immunisation against influenza A subtype viruses and type B viruses, in persons three years of age and older. The submission seeks an expanded indication for children six months through 35 months of age. With this approval, providers would be able to use the same dose of Flulaval Quadrivalent (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from six months and up.

The sBLA application is based on one Phase III pivotal study and three supportive clinical studies conducted in children six months through 35 months of age. GSK has submitted for presentation the results of the pivotal study to the Pediatric Academic Societies for their annual meeting.