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A Randomized, Placebo-Controlled Trial

Karen L. Margolis, MD; Kristin L. Nichol, MD, MPH; Gregory A. Poland, MD; Robert E. Pluhar, PharmD

JAMA. 1990;264(9):1139-1141.

Abstract
Concern about side effects constitutes a major deterrent to patient compliance with influenza vaccination, yet there is a paucity of data about the occurrence of adverse reactions in the population targeted for immunization. We conducted a randomized, double-blind, crossover trial to compare the frequency of adverse reactions following administration of 1988-1989 trivalent split-antigen influenza vaccine and saline placebo. Outpatient veterans 65 years of age or over (n = 336) were recruited by mail and were randomly assigned to receive vaccine followed 2 weeks later by placebo injection or placebo followed 2 weeks later by vaccine. There was no significant difference between influenza vaccine and placebo with respect to the proportion of subjects reporting disability or systemic symptoms.

(JAMA. 1990;264:1139-1141)

Author Affiliations
From the Hennepin County Medical Center, Minneapolis, Minn (Dr Margolis); Department of Veterans Affairs Medical Center, Minneapolis, Minn (Drs Nichol and Pluhar); and Mayo Clinic and Foundation, Rochester, Minn (Dr Poland).

Footnotes
Presented in part at the 12th Annual Meeting of the Society of General Internal Medicine, Arlington, Va, April 27, 1989.

Reprint requests to Department of Medicine, Hennepin County Medical Center, 701 Park Ave S, Minneapolis, MN 55415 (Dr Margolis).

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