title: An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.
abstract: BACKGROUND
  An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic.
  
  
  METHODS
  This study assessed the short-term (six-week) safety profile of the investigational vaccine in real time. After vaccination (N=7943), adverse events (AE) were assessed using both active (telephone) and passive (healthcare database) follow-up in enrolled vaccinated subjects, including infants (6-23 months), pregnant women, and the immunosuppressed. The treating physicians of all subjects experiencing AEs post-vaccination were consulted for clinical information on the conditions reported. All AEs were coded according to ICD-10.
  
  
  RESULTS
  A total of 1583 AEs occurred during the study, 67 (4.2%) of which were serious adverse events (SAEs). One SAE was considered to be possibly related to vaccination (transitory and ill-defined neurologic disorder experienced by a 16-year-old asthmatic male). Three adverse events of special interest (AESI) were identified (convulsions experienced by two epileptic subjects), none of which were considered to be vaccine-related. Six individuals died during the study period, in each case the cause of death was not related to vaccination (four cases of severe underlying co-morbidity, one case of psychoactive drug misuse, and one case of acute myocardial infarction).
  
  
  CONCLUSIONS
  No cases of clinically relevant AEs, SAEs, or AESI were observed within a six-week period of vaccine administration. In accordance with existing clinical and post-marketing safety data, the results of this active surveillance study demonstrate a good safety profile for the MF59-adjuvanted A/H1N1 vaccine, Focetria, within the general population.
authors: Servizio di Epidemiologia, Dipartimento di Sanità Pubblica, Azienda USL di Reggio Emilia, Via Amendola 2, 42122 Reggio Emilia, Italy. silvia.candela@gmail.com
authors: Silvia
authors: S
authors: Candela
authors: Sara
authors: S
authors: Pergolizzi
authors: Pietro
authors: P
authors: Ragni
authors: Silvio
authors: S
authors: Cavuto
authors: Lucia
authors: L
authors: Nobilio
authors: Simona
authors: S
authors: Di Mario
authors: Valentina
authors: V
authors: Dragosevic
authors: Nicola
authors: N
authors: Groth
authors: Nicola
authors: N
authors: Magrini
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D007558:Italy; D008297:Male; D008875:Middle Aged; D011136:Polysorbates / Q000008:administration & dosage*; D011247:Pregnancy; D011446:Prospective Studies; D013185:Squalene / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; C558220:focetria; D013185:Squalene