title: Long-lasting immunogenicity and safety of a 2009 pandemic influenza A(H1N1) MF59-adjuvanted vaccine when co-administered with a 2009-2010 seasonal influenza vaccine in young patients with type 1 diabetes mellitus.
abstract: OBJECTIVE
  To evaluate the long-lasting immunogenicity and safety of a pandemic vaccine co-administered with a seasonal influenza vaccine in young subjects with Type 1 diabetes.
  
  
  METHODS
  Eighty patients (mean age: 16.7 ± 5.5 years, disease duration: 10.2 ± 4.7 years) were randomly assigned to receive a single or a double dose (1 month apart) of MF59-adjuvanted influenza A(H1N1) vaccine, simultaneously with a single dose of a virosome-adjuvanted trivalent influenza vaccine for the 2009-2010 season.
  
  
  RESULTS
  One month after immunization, the rate of seroconversion to 2009 pandemic A(H1N1) was 92.5% with an overall 100% proportion of vaccinees with protective antibody titres (≥ 1:40). No significant differences were observed between vaccinees who received the one-dose or the two-dose schedule. Seasonal vaccine induced a significant increase of both seroprotection rates and antibody levels. Local adverse events at the injection site of pandemic and seasonal vaccines were reported by 66.3% and 50% of subjects, respectively. Solicited systemic adverse events, mainly mild in intensity, were reported by 26.7% of vaccinees. No subjects had an influenza-like illness during the 6-month follow-up.
  
  
  CONCLUSIONS
  One injection of 2009 pandemic influenza A(H1N1) MF59-adjuvanted vaccine is immunogenic and safe in young patients with Type 1 diabetes who are at increased risk of influenza morbidities. Pandemic vaccine can be safely co-administered with seasonal influenza vaccine.
authors.affiliation: Department of Paediatrics, Università degli Studi di Milano, Ospedale Luigi Sacco, Milan, Italy.
authors.forename: G V
authors.initials: GV
authors.lastname: Zuccotti
authors.forename: E
authors.initials: E
authors.lastname: Pariani
authors.forename: A
authors.initials: A
authors.lastname: Scaramuzza
authors.forename: L
authors.initials: L
authors.lastname: Santoro
authors.forename: E
authors.initials: E
authors.lastname: Giani
authors.forename: M
authors.initials: M
authors.lastname: Macedoni
authors.forename: A
authors.initials: A
authors.lastname: Gazzarri
authors.forename: G
authors.initials: G
authors.lastname: Anselmi
authors.forename: A
authors.initials: A
authors.lastname: Amendola
authors.forename: A
authors.initials: A
authors.lastname: Zanetti
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology / Q000276:immunology*; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D007558:Italy / Q000453:epidemiology; D008297:Male; D058873:Pandemics; D018579:Patient Selection; D011136:Polysorbates / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D013185:Squalene / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene