Pivotal pediatric clinical study comparing Q/LAIV to FluMist meets primary endpoint

The pivotal pediatric clinical study compared Q/LAIV to two trivalent formulations of MedImmune's licensed seasonal influenza vaccine, FluMist® (Influenza Vaccine Live, Intranasal) and met its primary endpoint.

Currently licensed seasonal influenza vaccines are trivalent, containing three strains (two strains of type A influenza,A/H1N1 and A/H3N2, and one B lineage strain).  However, as influenza B strains from 2 different lineages have circulated in recent years (B/Yamagata and B/Victoria), the quadrivalent vaccine contains four strains: A/H1N1, A/H3N2, and B strains from both of the B lineages.  The quadrivalent vaccine is designed to offer protection against a broader range of B strains, and its development demonstrates MedImmune's commitment to innovation within the infectious disease area.

Data from the pediatric Phase 3 study were included in the supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist® (Influenza Vaccine Live, Intranasal). The company submitted the sBLA early in the second quarter of this year.

This abstract will be available for viewing in the exhibit hall in the exhibit Hall B-1 from 12:15 until 2:15 on Friday, October 21, 2011 at the Boston Convention and Exhibition Center.