Safety of a trivalent live attenuated intranasal influenza vaccine, FluMist (TM), administered in addition to parenteral trivalent inactivated influenza vaccine to seniors with chronic medical conditions

We conducted a randomized, double-blind trial to evaluate the safety and to lerability of a live attenuated cold adapted trivalent intranasal influenza vaccine, FluMist(TM), compared with intranasal placebo when given in addit ion to a licensed trivalent injected inactivated influenza vaccine (TIV), T he study population consisted of persons 65 years of age and older with chr onic cardiovascular or pulmonary conditions or diabetes mellitus. During th e 7 days post-vaccination, sore throat was reported on at least one day by 15% (15/100) of FluMist(TM), recipients compared with 2% (2/100) of intrana sal placebo recipients (p = 0.001), No other reactogenicity symptom was sta tistically associated with receipt of FluMist(TM). Among this group, FluMis t(TM) was safe and well tolerated when administered with TIV. (C) 1999 Else vier Science Ltd, All rights reserved.