Background. Three important studies have supported licensure of live, attenuated, cold-adapted influenza vaccine (CAIV-T [FluMist; MedImmune Vaccines]): (1) a pediatric efficacy trial involving children 15-71 months of age, (2) a large safety study of medically attended events occurring among children 1-17 years of age, and (3) an effectiveness trial involving healthy working adults 18-64 years of age. Methods. During the United States Food and Drug Administration (FDA) review for the approval of CAIV-T for use in healthy persons, additional subgroup analyses were conducted to evaluate the safety, efficacy, and effectiveness of the vaccine, by use of various age subsets not prespecified by the original protocols. CAIV-T is currently approved by the FDA for use in healthy persons 5-49 years of age. In this article, we present data from some of the aforementioned subanalyses. Results. The efficacy of CAIV-T in children ≥5 years of age (age range of the children in year 1 of the study, 60-71 months; age range of the children in year 2 of the study, 60-83 months) was similar to that reported for the entire cohort in year 1 (90.6%; 95% confidence interval [CI], 70.3%-97.1%). In year 2 of the study, efficacy was 86.9% (95% CI, 70.8%-94.1%), despite the presence of antigenically drifted influenza type A/Sydney/5/97 (H3N2), which caused most illnesses that occurred in year 2. Safety outcomes for children 5-17 years of age revealed no significant difference between vaccine recipients and placebo recipients, with regard to acute respiratory events, acute gastrointestinal events, systemic bacterial infection, or rare events possibly related to influenza. Effectiveness among adults 18-49 years of age was similar to that reported for the entire cohort-for example, for occurrence of severe febrile illness, there was a 19.5% reduction (P = .02) in adults. Conclusions. The present reanalysis summarizes data on the indicated uses for CAIV-T in the indicated population aged 5-49 years.
|Original language||English (US)|
|Number of pages||8|
|Journal||Clinical Infectious Diseases|
|State||Published - Oct 1 2004|
Bibliographical noteFunding Information:
Conflict of interest. R.B.B. is a consultant to MedImmune Vaccines and a member of the Speakers’ Bureau for Wyeth. K.L.N. has received research funding from MedImmune Vaccines and Aventis. S.B.B. and H.S. have received research funding from MedImmune Vaccines. All other authors are employees of MedImmune Vaccines.
Extensive research sponsored by the National Institute of Allergy and Infectious Diseases led to the development of the live attenuated intranasal influenza vaccine . Subsequent collaborative development with Med-Immune Vaccines (formerly Aviron) resulted in the development of live, attenuated, cold-adapted, trivalent intranasal influenza vaccine (CAIV-T [FluMist; Med-