Q&A

Influenza vaccine does not prevent acute otitis media in young children

Author and Disclosure Information

  • 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.


 

PRACTICE RECOMMENDATIONS

Administration of influenza vaccine to children aged 6 to 24 months to prevent acute otitis media is not recommended.

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