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...

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Bibliographic Details
Published in:Vaccine 1999-04, Vol.17 (15), p.1905-1909
Main Authors: Jackson, Lisa A., Holmes, Sandra J., Mendelman, Paul M., Huggins, Linda, Cho, Iksung, Rhorer, Janelle
Format: Article
Language:English
Subjects:
Administration, Intranasal
Aged
Biological and medical sciences
Body Temperature
Cardiovascular Diseases
Chronic Disease
Diabetes Mellitus
Double-Blind Method
Epidemiology. Vaccinations
Female
Fundamental and applied biological sciences. Psychology
General aspects
Humans
Infectious diseases
Influenza vaccine
Influenza Vaccines - administration & dosage
Influenza Vaccines - adverse effects
Injections
Lung Diseases
Male
Medical sciences
Microbiology
Pharyngitis - etiology
Prospective Studies
Time Factors
Vaccination
Vaccine safety
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies
Vaccines, Attenuated - administration & dosage
Vaccines, Attenuated - adverse effects
Vaccines, Inactivated - administration & dosage
Vaccines, Inactivated - adverse effects
Virology
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Summary: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.
ISSN:0264-410X
1873-2518
DOI:10.1016/S0264-410X(98)00471-X