Journal Article

Efficacy of Intranasal Virosomal Influenza Vaccine in the Prevention of Recurrent Acute Otitis Media in Children

Paola Marchisio, Roberta Cavagna, Barbara Maspes, Stefania Gironi, Susanna Esposito, Lara Lambertini, Alessandra Massimini, Christian Herzog and Nicola Principi

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 35, issue 2, pages 168-174
Published in print July 2002 | ISSN: 1058-4838
Published online July 2002 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/341028
Efficacy of Intranasal Virosomal Influenza Vaccine in the Prevention of Recurrent Acute Otitis Media in Children

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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.

Journal Article.  4337 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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