Published ahead of print on December 4, 2003, doi:10.1164/rccm.200309-1251OC
Am. J. Respir. Crit. Care Med., Volume 169, Number 4, February 2004, 488-493
A more recent version of this article appeared on February 15, 2004
Submitted on September 9, 2003
Accepted on November 27, 2003
Influenza vaccination in asthmatic children: randomised double-blind placebo-controlled trial
Herman J Bueving1, Roos M.D Bernsen1, Johan C de Jongste2, Lisette W.A van Suijlekom-Smit3, Guus F Rimmelzwaan4, Albert D.M.E Osterhaus4, Maureen P.M.H Rutten-van Molken5, Siep Thomas1, and Johannes C van der Wouden1*
1 General Practice, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands,
2 Pediatrics, Subdivision of Pediatric Respiratory Medicine, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands,
3 Pediatrics, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands,
4 Virology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands,
5 Institute for Medical Technology Assessment, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands
* To whom correspondence should be addressed. E-mail: j.vanderwouden{at}erasmusmc.nl.
There is little evidence that influenza vaccination reduces asthma exacerbations. We determined whether influenza vaccination is more effective than placebo in asthmatic children 6-18 years of age.
We performed a randomised double-blind placebo-controlled trial. Parenteral vaccination with inactivated influenza vaccine or placebo took place around November 1st and children were followed until April 1st of the next year. Airway symptoms were reported in a diary. When symptom scores reached a predefined level, a pharyngeal swab was taken. Primary outcome was the number of asthma exacerbations associated with virologically proven influenza infection.
349 children were assigned placebo and 347 were assigned vaccine. Pharyngeal swabs positive for influenza were related to 42 asthma exacerbations, 24 in the vaccine group, 18 in the placebo group, a difference of 33% favouring placebo (31% after adjustment for confounders, 95%CI -34% to 161%). Influenza-related asthma exacerbations were of similar severity in both groups, they lasted 3.1 days shorter in the vaccine group (95%CI -6.2 to 0.002 days, p=0.06).
We conclude that influenza vaccination did not result in a significant reduction of the number, severity or duration of asthma exacerbations caused by influenza. Additional studies are warranted to justify routine influenza vaccination of asthmatic children.
Key words: influenza vaccination, asthma, children
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