title: Efficacy of intranasal virosomal influenza vaccine in the prevention of recurrent acute otitis media in children.
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.
authors.affiliation: Pediatric Department 1, University of Milan, 20122 Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Marchisio
authors.forename: Roberta
authors.initials: R
authors.lastname: Cavagna
authors.forename: Barbara
authors.initials: B
authors.lastname: Maspes
authors.forename: Stefania
authors.initials: S
authors.lastname: Gironi
authors.forename: Susanna
authors.initials: S
authors.lastname: Esposito
authors.forename: Lara
authors.initials: L
authors.lastname: Lambertini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Massimini
authors.forename: Christian
authors.initials: C
authors.lastname: Herzog
authors.forename: Nicola
authors.initials: N
authors.lastname: Principi
mesh_terms: D000208:Acute Disease; D000281:Administration, Intranasal; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D010033:Otitis Media / Q000453:epidemiology / Q000517:prevention & control*; D010034:Otitis Media with Effusion / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D012008:Recurrence; D012140:Respiratory Tract Diseases / Q000453:epidemiology / Q000517:prevention & control; D016037:Single-Blind Method; D016896:Treatment Outcome; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D022721:Vaccines, Virosome / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007252:Influenza Vaccines; D022223:Vaccines, Subunit; D022721:Vaccines, Virosome