An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria (R) in a province of Emilia-Romagna region, Italy - Part One

作者：Candela Silvia^*; Pergolizzi Sara; Ragni Pietro; Cavuto Silvio; Nobilio Lucia; Di Mario Simona; Dragosevic Valentina; Groth Nicola; Magrini Nicola

来源：Vaccine, 2013, 31(10): 1431-1437.

DOI：10.1016/j.vaccine.2012.06.030

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

Introduction: An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria (R), (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.

• 出版日期2013-2-27