Safety of cold-adapted live attenuated influenza vaccine in a large cohort of children and adolescents

作者：Randy Bergen, Steve B. Black, Henry R. Shinefield, Edwin M. Lewis, Paula Ray, John R. Hansen, ROBERT E. WALKER, Colin Hessel, Julie M. Cordova, Paul M. Mendelman · 发表于：The Pediatric Infectious Disease Journal · 年份：2004 · DOI：10.1097/01.inf.0000109392.96411.4f · 被引用次数：167 · 研究领域：Influenza Virus Research Studies、Respiratory viral infections research、Pneumonia and Respiratory Infections

OBJECTIVE: To determine the safety of cold-adapted trivalent intranasal influenza virus vaccine (CAIV) in children and adolescents. STUDY DESIGN: A randomized, double blind, placebo-controlled safety trial in healthy children age 12 months to 17 years given CAIV (FluMist; MedImmune Vaccines, Inc.) or placebo (randomization, 2:1). Children <9 years of age received a second dose of CAIV or placebo 28 to 42 days after the first dose. Enrolled children were then followed for 42 days after each vaccination for all medically attended events. Prespecified outcomes included 4 prespecified diagnostic groups and 170 observed individual diagnostic categories. The relative risk and the 2-sided 90% confidence interval were calculated for each diagnostic group and individual category by clinical setting, dose and age. More than 1500 relative risk analyses were performed. RESULTS: A total of 9689 evaluable children were enrolled in the study. Of the 4 prespecified diagnostic categories (acute respiratory tract events, systemic bacterial infection, acute gastrointestinal tract events and rare events potentially associated with wild-type influenza), none was associated with vaccine. Of the biologically plausible individual diagnostic categories, 3, acute gastrointestinal events, acute respiratory events and abdominal pain, had different analyses that demonstrated increased and decreased relative risks, making their association with the vaccine unlikely. For reactive airway disease a significa...