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

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• 作者：Silvia Candela^a ; ^{silvia.candela@gmail.com} ; Sara Pergolizzi^a ; Pietro Ragni^a ; Silvio Cavuto^b ; Lucia Nobilio^c ; Simona Di Mario^d ; Valentina Dragosevic^e ; Nicola Groth^e ; Nicola Magrini^d ; for the SaFoH1N1 working group ¹
• 关键词：AE ; adverse event ; AESI ; adverse event of special interest ; EMA ; European Medicines Agency ; GBS ; Guillain Barré ; Syndrome ; GP ; general practitioner ; LHA ; local health authority ; PASS ; post-authorisation safety study ; PV ; pharmacovigilance ; SAE ; seri
• 刊名：Vaccine
• 出版年：2013
• 出版时间：27 February, 2013
• 年：2013
• 卷：31
• 期：10
• 页码：1431-1437
• 全文大小：331 K

文摘

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.