Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media.
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.
Marchisio
Paola
P
Department of Maternal and Pediatric Sciences, University of Milan, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy.
Esposito
Susanna
S
Bianchini
Sonia
S
Dusi
Elisa
E
Fusi
Michela
M
Nazzari
Erica
E
Picchi
Raffaella
R
Galeone
Carlotta
C
Principi
Nicola
N
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
D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated; D022701:Virosomes