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 journalArticle

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

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Influenza Vaccines
Pandemics
pandemic
influenza
Italy
Vaccines
vaccines
Safety
Vaccination
monitoring
vaccination
Anniversaries and Special Events
Psychotropic Drugs
International Classification of Diseases
Marketing
Nervous System Diseases
nervous system diseases
Telephone
myocardial infarction
Human Influenza

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

Cite this

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

In: Vaccine, Vol. 31, No. 10, 27.02.2013, p. 1431-1437.

Research output: Contribution to journalArticle

Candela, Silvia ; Pergolizzi, Sara ; Ragni, Pietro ; Cavuto, Silvio ; Nobilio, Lucia ; Di Mario, Simona ; Dragosevic, Valentina ; Groth, Nicola ; Magrini, Nicola. / 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. In: Vaccine. 2013 ; Vol. 31, No. 10. pp. 1431-1437.
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AU - Ragni, Pietro

AU - Cavuto, Silvio

AU - Nobilio, Lucia

AU - Di Mario, Simona

AU - Dragosevic, Valentina

AU - Groth, Nicola

AU - Magrini, Nicola

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