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QUESTION: In children and adults with stable asthma, is the inactivated trivalent split virus influenza vaccine safe?
Design
Randomised (allocation concealed), blinded (clinicians and patients), placebo controlled crossover trial with follow up to 14 days after each injection.
Setting
19 centres in the US.
Patients
2032 patients who were 3–64 years of age, had stable asthma, and had been taking prescribed treatment for asthma within the preceding 12 months. Exclusion criteria included hypersensitivity to egg products or thimerosal, inability to use the peak flow meter properly, lack of a telephone, history of Guillain-Barré syndrome, influenza vaccine in the previous 6 months, and a temperature ≥38.0oC within 24 hours before enrolment. 1952 patients (96%) (mean age 30 y, …
Footnotes
Sources of funding: American Lung Associations; Baylor College of Medicine; Thalheim Family; Duke University; Ernest N Morial Asthma, Allergy, and Respiratory Disease Center; Merck Foundation; and Glaxo-SmithKline.
For correspondence: Dr M Castro, Washington University School of Medicine, St. Louis, MO, USA. mcastro{at}im.wustl.edu
A modified version of this abstract appears in ACP Journal club.