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; Nicola Principi

doi:10.1086/341028

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

Clin Infect Dis. 2002 Jul 15;35(2):168-74. doi: 10.1086/341028. Epub 2002 Jun 19.

Authors

Paola Marchisio¹, Roberta Cavagna, Barbara Maspes, Stefania Gironi, Susanna Esposito, Lara Lambertini, Alessandra Massimini, Christian Herzog, Nicola Principi

Affiliation

¹ Pediatric Department 1, University of Milan, 20122 Milan, Italy.

PMID: 12087523
DOI: 10.1086/341028

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.

Publication types

Clinical Trial
Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Acute Disease
Administration, Intranasal
Child, Preschool
Female
Follow-Up Studies
Humans
Immunization Schedule
Infant
Influenza A virus / immunology*
Influenza Vaccines / administration & dosage
Influenza Vaccines / adverse effects
Influenza Vaccines / therapeutic use*
Influenza, Human / epidemiology
Influenza, Human / prevention & control
Male
Otitis Media / epidemiology
Otitis Media / prevention & control*
Otitis Media with Effusion / epidemiology
Otitis Media with Effusion / prevention & control
Prospective Studies
Recurrence
Respiratory Tract Diseases / epidemiology
Respiratory Tract Diseases / prevention & control
Single-Blind Method
Treatment Outcome
Vaccines, Subunit / administration & dosage
Vaccines, Subunit / adverse effects
Vaccines, Subunit / therapeutic use
Vaccines, Virosome / administration & dosage
Vaccines, Virosome / adverse effects
Vaccines, Virosome / therapeutic use

Substances

Influenza Vaccines
Vaccines, Subunit
Vaccines, Virosome