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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Veröffentlicht in:Vaccine 1999-04, Vol.17 (15), p.1905-1909
Hauptverfasser: Jackson, Lisa A., Holmes, Sandra J., Mendelman, Paul M., Huggins, Linda, Cho, Iksung, Rhorer, Janelle
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container_end_page 1909
container_issue 15
container_start_page 1905
container_title Vaccine
container_volume 17
creator Jackson, Lisa A.
Holmes, Sandra J.
Mendelman, Paul M.
Huggins, Linda
Cho, Iksung
Rhorer, Janelle
description 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.
doi_str_mv 10.1016/S0264-410X(98)00471-X
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Psychology</subject><subject>General aspects</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Influenza vaccine</subject><subject>Influenza Vaccines - administration &amp; dosage</subject><subject>Influenza Vaccines - adverse effects</subject><subject>Injections</subject><subject>Lung Diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Pharyngitis - etiology</subject><subject>Prospective Studies</subject><subject>Time Factors</subject><subject>Vaccination</subject><subject>Vaccine safety</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</subject><subject>Vaccines, Attenuated - administration &amp; dosage</subject><subject>Vaccines, Attenuated - adverse effects</subject><subject>Vaccines, Inactivated - administration &amp; dosage</subject><subject>Vaccines, Inactivated - adverse effects</subject><subject>Virology</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUcFu1DAQtRCIbgufAPIBIZAa8CRx4pwQqiggFXEoSHuzvPZENco6i-0sKud-CX_Db_AlzG5WFHHhYs9I772ZeY-xRyBegIDm5aUom7qoQSyfdeq5EHULxfIOW4Bqq6KUoO6yxR_IETtO6YsQQlbQ3WdHIEpopVIL9vPS9Jiv-dhzw3P0WzNgyHzwW-QmZwyTyei4DzmaYJIZqOyHCcN3w7fGWh_wlJ8P0wef8q-bH6fcuLUP1GDc06h3Pvsx8DzyjYkkjpFUbkf5YGymZh7zj_aOlTD4MSb-zecrbq_iGLzla3Teko4dw6yfHrB7vRkSPjz8J-zz-ZtPZ--Ki49v35-9vihs1YlcwMrKyilV1X2rhGuwq2pFb-lUD40kh1aqVitJZVnL2nVKWiDHXQlgQLTVCXs6627i-HXClPXaJ4vDYAKOU9JN1wLIRhBQzkAbx5Qi9noT_drEaw1C7zLU-wz1LiDdKb3PUC-J9_gwYFrRmX-x5tAI8OQAMIk86CkZ69MtrlVKlLtFX80wJDe2HqNO1mOw5FxEm7Ub_X82-Q3KE762</recordid><startdate>19990409</startdate><enddate>19990409</enddate><creator>Jackson, Lisa A.</creator><creator>Holmes, Sandra J.</creator><creator>Mendelman, Paul M.</creator><creator>Huggins, Linda</creator><creator>Cho, Iksung</creator><creator>Rhorer, Janelle</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19990409</creationdate><title>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</title><author>Jackson, Lisa A. ; Holmes, Sandra J. ; Mendelman, Paul M. ; Huggins, Linda ; Cho, Iksung ; Rhorer, Janelle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-1bc53d8834f780d6e93486e92d8f165053b848b56502454d985c1101d211a1073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Administration, Intranasal</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Body Temperature</topic><topic>Cardiovascular Diseases</topic><topic>Chronic Disease</topic><topic>Diabetes Mellitus</topic><topic>Double-Blind Method</topic><topic>Epidemiology. 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source MEDLINE; Elsevier ScienceDirect Journals
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
title 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
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