What was the “placebo injection”? – SM

 

 

The Safety of Inactivated Influenza Vaccine in Adults and Children with Asthma

The American Lung Association Asthma Clinical Research Centers

Table of Contents Full Text of this article PDF of this article Editor's Summary Find Similar Articles in the Journal Weekly Briefings Summary Add to Personal Archive Download to Citation Manager Alert me when this article is cited Asthma Vaccines Viral Diseases

ABSTRACT

Background Influenza causes substantial morbidity in adults and children with asthma, and vaccination can prevent influenza and its complications. However, there is concern that vaccination may cause exacerbations of asthma.

Methods To investigate the safety of the inactivated trivalent split-virus influenza vaccine in adults and children with asthma, we conducted a multicenter, randomized, double-blind, placebo-controlled, crossover trial in 2032 patients with asthma (age range, 3 to 64 years). The order of injection of vaccine and placebo was assigned randomly, with a mean of 22 days between the injections. Each day during the two weeks after each injection, the patients recorded peak expiratory flow rates, symptoms thought to be related to the injection, use of asthma medications, unscheduled health care visits for asthma, and asthma-related absences from school or work. The primary outcome measure was an exacerbation of asthma in the two weeks after the injections.

Results The frequency of exacerbations of asthma was similar in the two weeks after the influenza vaccination and after placebo injection (28.8 percent and 27.7 percent, respectively; absolute difference, 1.1 percent; 95 percent confidence interval, –1.4 percent to 3.6 percent). The exacerbation rates were similar in subgroups defined according to age, severity of asthma, and other factors. Among symptoms thought to be associated with the injection, only body aches were more frequent after the vaccine injection than after placebo injection (25.1 percent vs. 20.8 percent, P<0.001).

Conclusions The inactivated influenza vaccine is safe to administer to adults and children with asthma, including those with severe asthma. Given the morbidity of influenza, all those with asthma should receive the vaccine annually.

Source Information

The Writing Committee (Mario Castro, M.D., M.P.H., Allen Dozor, M.D., James Fish, M.D., Charles Irvin, Ph.D., Steven Scharf, M.D., Ph.D., Mary Ellen Scheipeter, R.N., B.S.N., Janet Holbrook, Ph.D., M.P.H., James Tonascia, Ph.D., and Robert Wise, M.D.) assumes responsibility for the overall content of the manuscript.

Address reprint requests to Dr. Castro at Washington University School of Medicine, Box 8052, 660 S. Euclid Ave., St. Louis, MO 63110-1093, or at mcastro@im.wustl.edu.

Sign in for Full Text

 

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.