Efficacy of intranasal virosomal influenza vaccine in the prevention of recurrent acute otitis media in children.
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.
Marchisio
Paola
P
Pediatric Department 1, University of Milan, 20122 Milan, Italy.
Cavagna
Roberta
R
Maspes
Barbara
B
Gironi
Stefania
S
Esposito
Susanna
S
Lambertini
Lara
L
Massimini
Alessandra
A
Herzog
Christian
C
Principi
Nicola
N
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
D007252:Influenza Vaccines; D022223:Vaccines, Subunit; D022721:Vaccines, Virosome