title: The safety and effectiveness of self-administration of intranasal live attenuated influenza vaccine in adults.
abstract: Intranasal live attenuated influenza vaccine (LAIV) has potential for self-administration (SA) by adults and adolescents, which could save time and cost in mass vaccination settings. Participants in a study of LAIV in adults (n=4561) selected either SA or health care provider (HCP) administration and were followed for febrile illness during the influenza season. More LAIV recipients chose SA-LAIV (72%) than HCP-LAIV (28%). Overall, 97% of SA-LAIV and 98% of HCP-LAIV recipients had no problems with vaccine administration. Four of 13 study sites enrolled more than 50 subjects in both cohorts. Overall and for these 4 sites, illness incidence was similar with SA-LAIV and HCP-LAIV. Solicited reactogenicity events and adverse events through 7 days post vaccination were comparable for SA-LAIV and HCP-LAIV recipients; both groups exhibited increased runny nose, sore throat, and cough relative to placebo recipients. SA-LAIV and HCP-LAIV appeared similarly effective against influenza-like illness and had comparable safety profiles.
authors.affiliation: MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA. ambrosec@medimmune.com
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Ambrose
authors.forename: Xionghua
authors.initials: X
authors.lastname: Wu
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D012646:Self Administration / Q000009:adverse effects* / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D010919:Placebos; D014613:Vaccines, Attenuated