Abstract

To review human data on the efficacy, safety, and clinical use of trivalent intranasal influenza vaccine, live (TIIVL). A MEDLINE search (1966-3rd week of January 2004) using the terms influenza vaccine, intranasal administration, and FluMist was conducted. References from pertinent articles were also reviewed. Studies conducted in humans and published in English were selected. Double-blind, controlled trials evaluating the efficacy and safety of TIIVL were evaluated. Administration of TIIVL results in mucosal and humoral immunity to influenza. Results of clinical trials in children and adults have demonstrated that TIIVL reduces the incidence of influenza. In children, TIIVL was also associated with a decrease in febrile illness and febrile otitis media. In adults, reductions in workday absences and medical visits due to febrile upper respiratory tract illness were also documented. TIIVL is well tolerated, with rhinorrhea or nasal congestion and sore throat occurring more frequently than with placebo. TIIVL is an alternative to intramuscular inactivated influenza vaccine in healthy individuals between 5 and 49 years of age. However, the vaccine is contraindicated in the majority of patient populations for whom annual influenza vaccination is recommended.

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