Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media

Paola Marchisio, Susanna Esposito, Sonia Bianchini, Elisa Dusi, Michela Fusi, Erica Nazzari, Raffaella Picchi, Carlotta Galeone, Nicola Principi

Research output: Contribution to journalArticle

Abstract

Background: Most cases of acute otitis media (AOM) follow an upper respiratory infection due to viruses, including influenza viruses. As effective and safe influenza vaccines are available, their use has been considered among the possible measures of AOM prophylaxis. Objectives: To evaluate the efficacy of an inactivated virosomal-adjuvanted influenza vaccine in preventing AOM in children with a history of noncomplicated recurrent AOM (rAOM) or rAOM complicated by spontaneous perforation. Methods: In this prospective, randomized, single-blinded, placebo-controlled study, 180 children aged 1 to 5 years with a history of rAOM and previously unvaccinated against influenza were randomized to receive the inactivated virosomal-adjuvanted subunit influenza vaccine (n = 90) or no treatment (n = 90), and AOM-related morbidity was monitored every 4 to 6 weeks for 6 months. Results: The number of children experiencing at least 1 AOM episode was significantly smaller in the vaccinated group (P <0.001), as was the mean number of AOM episodes (P = 0.03), the mean number of AOM episodes without perforation (P <0.001), and the mean number of antibiotic courses (P <0.001); the mean duration of bilateral OME was significantly shorter (P = 0.03). The only factor that seemed to be associated with the significantly greater efficacy of influenza vaccine in preventing AOM was the absence of a history of recurrent perforation (crude odds ratio, P = 0.01; adjusted odds ratio, P = 0.006). Conclusions: The intramuscular administration of injectable trivalent inactivated virosomal-adjuvanted influenza vaccine in children with a history of rAOM significantly reduces AOM-related morbidity. However, the efficacy of this preventive measure seems to be reduced in children with rAOM associated with repeated tympanic membrane perforation.

Original languageEnglish
Pages (from-to)855-859
Number of pages5
JournalPediatric Infectious Disease Journal
Volume28
Issue number10
DOIs
Publication statusPublished - Oct 2009

Keywords

  • Acute otitis media
  • Children
  • Influenza
  • Influenza vaccination
  • Recurrent acute otitis media
  • Vaccine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases
  • Microbiology (medical)

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