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Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media.
Pediatr Infect Dis J 2009; 28(10):855-9PI

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.

Authors+Show Affiliations

Department of Maternal and Pediatric Sciences, University of Milan, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19564812

Citation

Marchisio, Paola, et al. "Efficacy of Injectable Trivalent Virosomal-adjuvanted Inactivated Influenza Vaccine in Preventing Acute Otitis Media in Children With Recurrent Complicated or Noncomplicated Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 28, no. 10, 2009, pp. 855-9.
Marchisio P, Esposito S, Bianchini S, et al. Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media. Pediatr Infect Dis J. 2009;28(10):855-9.
Marchisio, P., Esposito, S., Bianchini, S., Dusi, E., Fusi, M., Nazzari, E., ... Principi, N. (2009). Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media. The Pediatric Infectious Disease Journal, 28(10), pp. 855-9. doi:10.1097/INF.0b013e3181a487b4.
Marchisio P, et al. Efficacy of Injectable Trivalent Virosomal-adjuvanted Inactivated Influenza Vaccine in Preventing Acute Otitis Media in Children With Recurrent Complicated or Noncomplicated Acute Otitis Media. Pediatr Infect Dis J. 2009;28(10):855-9. PubMed PMID: 19564812.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of injectable trivalent virosomal-adjuvanted inactivated influenza vaccine in preventing acute otitis media in children with recurrent complicated or noncomplicated acute otitis media. AU - Marchisio,Paola, AU - Esposito,Susanna, AU - Bianchini,Sonia, AU - Dusi,Elisa, AU - Fusi,Michela, AU - Nazzari,Erica, AU - Picchi,Raffaella, AU - Galeone,Carlotta, AU - Principi,Nicola, PY - 2009/7/1/entrez PY - 2009/7/1/pubmed PY - 2010/3/31/medline SP - 855 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 28 IS - 10 N2 - 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/19564812/Efficacy_of_injectable_trivalent_virosomal_adjuvanted_inactivated_influenza_vaccine_in_preventing_acute_otitis_media_in_children_with_recurrent_complicated_or_noncomplicated_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=19564812 DB - PRIME DP - Unbound Medicine ER -