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

Silvia Candela, Sara Pergolizzi, Pietro Ragni, Silvio Cavuto, Lucia Nobilio, Simona Di Mario, Valentina Dragosevic, Nicola Groth, Nicola Magrini

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: 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. Method: 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.

Original languageEnglish
Pages (from-to)1431-1437
Number of pages7
JournalVaccine
Volume31
Issue number10
DOIs
Publication statusPublished - Feb 27 2013

Keywords

  • Active surveillance study
  • H1N1 pandemic vaccine
  • Italy
  • Vaccine safety

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

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