in any of the 9 studies. Symptoms reported by subjects were generally consistent with
those observed following administration of licensed TIVs, and consisted primarily of mild local
reactions that occurred at similar or lower frequencies when compared with subjects who
received TIV. Systemic symptoms such as malaise, headache, or myalgias were also observed,
but were generally mild. Additional pertinent data related to the safety and tolerability of these
formulations are provided in Section 5 of this briefing document