To evaluate the efficacy of an intranasal, inactivated, virosomal subunit influenza vaccine for prevention of new episodes of acute otitis media (AOM) in children with recurrent AOM, 133 children aged 1-5 years were randomized to receive the vaccine (n=67) or no vaccination (n=66). During a 6-month period, 24 (35.8%) vaccine recipients had 32 episodes of AOM; 42 (63.6%) control subjects had 64 episodes. The overall efficacy of vaccination in preventing AOM was 43.7% (95% confidence interval, 18.6-61.1; P=.002). Children vaccinated before influenza season had a significantly better outcome than did those vaccinated after the onset of influenza season. The cumulative duration of middle ear effusion was significantly less in vaccinated children than in control subjects. Data suggest that the intranasal virosomal influenza vaccine might be considered among the options for the prevention of AOM in children <5 years old with recurrent AOM

Efficacy of intranasal virosomal influenza vaccine in the prevention of recurrent acute otitis media in children / P. Marchisio, R. Cavagna, B. Maspes, S. Gironi, S. Esposito, L. Lambertini, A. Massimini, C. Herzog, N. Principi. - In: CLINICAL INFECTIOUS DISEASES. - ISSN 1058-4838. - 35:2(2002 Jul 15), pp. 168-174.

Efficacy of intranasal virosomal influenza vaccine in the prevention of recurrent acute otitis media in children

P. Marchisio
Primo
;
S. Esposito;N. Principi
Ultimo
2002

Abstract

To evaluate the efficacy of an intranasal, inactivated, virosomal subunit influenza vaccine for prevention of new episodes of acute otitis media (AOM) in children with recurrent AOM, 133 children aged 1-5 years were randomized to receive the vaccine (n=67) or no vaccination (n=66). During a 6-month period, 24 (35.8%) vaccine recipients had 32 episodes of AOM; 42 (63.6%) control subjects had 64 episodes. The overall efficacy of vaccination in preventing AOM was 43.7% (95% confidence interval, 18.6-61.1; P=.002). Children vaccinated before influenza season had a significantly better outcome than did those vaccinated after the onset of influenza season. The cumulative duration of middle ear effusion was significantly less in vaccinated children than in control subjects. Data suggest that the intranasal virosomal influenza vaccine might be considered among the options for the prevention of AOM in children <5 years old with recurrent AOM
Acute disease ; otitis media with effusion ; humans ; vaccines, subunit ; otitis media ; vaccines, virosome ; immunization schedule ; recurrence ; child, preschool ; infant ; prospective studies ; single-blind method ; respiratory tract diseases ; administration, intranasal ; influenza A virus ; treatment outcome ; influenza, human ; follow-up studies ; female ; influenza vaccines ; male
Settore MED/38 - Pediatria Generale e Specialistica
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/183349
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