Hoberman A, Greenberg DP, Paradise JL, et al. Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children. A randomized controlled trial. JAMA 2003; 290:1608–1616.
Harsha P. Jayatilake, MD Kendra Schwartz, MD, MSPH Department of Family Medicine, Wayne State University, Detroit, Mich. E-mail: kensch@med.wayne.edu.
BACKGROUND: Influenza vaccines have been shown to prevent acute otitis media in children aged <2 years; reductions of 30% to 44% have been reported. This study was designed to determine the effectiveness of influenza vaccine in reducing the occurrence of acute otitis media in children aged 6 to 24 months.
POPULATION STUDIED: The investigators recruited 786 healthy children aged 6 to 24 months from Children’s Hospital of Pittsburgh primary care center (52%) and from the community (48%) over 2 consecutive respiratory seasons (December 1–March 31) starting in 1999. The 2 cohorts included 411 children and 375 children, respectively.
STUDY DESIGN AND VALIDITY: Children were randomly assigned to either vaccine or placebo in a 2:1 ratio after stratification by attendance in day care, history of multiple acute otitis media episodes, and a history of pneumococcal conjugate vaccination (second cohort only). Allocation was concealed.
OUTCOMES MEASURED: The investigators measured four primary endpoints: 1) proportion of children who developed acute otitis media; 2) monthly occurrence rate of acute otitis media; 3) estimated proportion of time with middle-ear effusion, and 4) use of selected health care and related resources.
RESULTS: For both cohorts, there was no significant difference in the proportion of vaccinated children who experienced at least 1 episode of acute otitis media (49.2% and 55.8% for first and second cohorts, respectively) compared with placebo groups (52.2% and 48.3%) during the respiratory season.