Safety of a trivalent live attenuated intranasal influenza vaccine, FluMist, 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 tolerability of a live attenuated cold adapted trivalent intranasal influenza vaccine, FluMist, compared with intranasal placebo when given in addition to a licensed trivalent injected inactivated influenza vaccine (TIV). The study population consisted of persons 65 years of age and older with chronic cardiovascular or pulmonary conditions or diabetes mellitus. During the 7 days post-vaccination, sore throat was reported on at least one day by 15% (15/100) of FluMist recipients compared with 2% (2/100) of intranasal placebo recipients (p = 0.001). No other reactogenicity symptom was statistically associated with receipt of FluMist. Among this group, FluMist was safe and well tolerated when administered with TIV.
Jackson
L A
LA
Immunization Studies Program, Center for Health Studies, Group Health Cooperative of Puget Sound, WA, USA. lajack@u.washington.edu
Holmes
S J
SJ
Mendelman
P M
PM
Huggins
L
L
Cho
I
I
Rhorer
J
J
D000281:Administration, Intranasal; D000368:Aged; D001831:Body Temperature; D002318:Cardiovascular Diseases; D002908:Chronic Disease; D003920:Diabetes Mellitus; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007267:Injections; D008171:Lung Diseases; D008297:Male; D010612:Pharyngitis / Q000209:etiology; D011446:Prospective Studies; D013997:Time Factors; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects
D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated