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A Randomized Trial

James A. Wilde, MD; Julia A. McMillan, MD; Janet Serwint, MD; Jeanne Butta, RN; Mary Ann O'Riordan, MS; Mark C. Steinhoff, MD

JAMA. 1999;281:908-913.

Context  Data are limited and conflicting regarding the effectiveness of influenza vaccine in health care professionals.

Objective  To determine the effectiveness of trivalent influenza vaccine in reducing infection, illness, and absence from work in young, healthy health care professionals.

Design  Randomized, prospective, double-blind, controlled trial over 3 consecutive years, from 1992-1993 to 1994-1995.

Setting  Two large teaching hospitals in Baltimore, Md.

Participants  Two hundred sixty-four hospital-based health care professionals without chronic medical problems were recruited; 49 participated for 2 seasons; 24 participated for 3 seasons. The mean age was 28.4 years, 75% were resident physicians, and 57% were women.

Intervention  Participants were randomly assigned to receive either an influenza vaccine or a control (meningococcal vaccine, pneumococcal vaccine, or placebo). Serum samples for antibody assays were collected at the time of vaccination, 1 month after vaccination, and at the end of the influenza season. Active weekly surveillance for illness was conducted during each influenza epidemic period.

Main Outcome Measures  Serologically defined influenza infection (4-fold increase in hemagglutination-inhibiting antibodies), days of febrile respiratory illness, and days absent from work.

Results  We conducted 359 person-winters of serologic surveillance (99.4% follow-up) and 4746 person-weeks of illness surveillance (100% follow-up). Twenty-four (13.4%) of 179 control subjects and 3 (1.7%) of 180 influenza vaccine recipients had serologic evidence of influenza type A or B infection during the study period. Vaccine efficacy against serologically defined infection was 88% for influenza A (95% confidence interval [CI], 47%-97%; P=.001) and 89% for influenza B (95% CI, 14%-99%; P=.03). Among influenza vaccinees, cumulative days of reported febrile respiratory illness were 28.7 per 100 subjects compared with 40.6 per 100 subjects in controls (P=.57) and days of absence were 9.9 per 100 subjects vs 21.1 per 100 subjects in controls (P=.41).

Conclusions  Influenza vaccine is effective in preventing infection by influenza A and B in health care professionals and may reduce reported days of work absence and febrile respiratory illness. These data support a policy of annual influenza vaccination of health care professionals.

Author Affiliations: Department of Pediatrics (Dr Wilde) and Division of Clinical Epidemiology (Ms O'Riordan), Case Western Reserve University School of Medicine, Rainbow Babies and Childrens Hospital, Cleveland, Ohio; and the Department of Pediatrics, School of Medicine (Drs McMillan, Serwint, and Steinhoff and Ms Butta) and School of Hygiene and Public Health (Ms Butta and Dr Steinhoff), Johns Hopkins University, Baltimore, Md. Dr Wilde is now with the Departments of Emergency Medicine and Pediatrics at the Medical College of Georgia, Augusta.

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