title: Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media.
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.
  
  
  OBJECTIVE
  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.
authors: Department of Maternal and Pediatric Sciences, University of Milan, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy.
authors: Paola
authors: P
authors: Marchisio
authors: Susanna
authors: S
authors: Esposito
authors: Sonia
authors: S
authors: Bianchini
authors: Elisa
authors: E
authors: Dusi
authors: Michela
authors: M
authors: Fusi
authors: Erica
authors: E
authors: Nazzari
authors: Raffaella
authors: R
authors: Picchi
authors: Carlotta
authors: C
authors: Galeone
authors: Nicola
authors: N
authors: Principi
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D002675:Child, Preschool; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008297:Male; D010033:Otitis Media / Q000517:prevention & control*; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D055502:Secondary Prevention; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology; D022701:Virosomes / Q000008:administration & dosage
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated; D022701:Virosomes