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

被引：7

作者：

Candela, Silvia ^{[1
]}

Pergolizzi, Sara ^{[1
]}

Ragni, Pietro ^{[1
]}

Cavuto, Silvio ^{[2
]}

Nobilio, Lucia ^{[3
]}

Di Mario, Simona ^{[4
]}

Dragosevic, Valentina ^{[5
]}

Groth, Nicola ^{[5
]}

Magrini, Nicola ^{[4
]}

机构：

[1] Azienda USL Reggio Emilia, Dipartimento Sanita Pubbl, Serv Epidemiol, I-42122 Reggio Emilia, Italy

[2] IRCCS, Azienda Osped Arcispedale Santa Maria Nuova, Direz Sci, I-42123 Reggio Emilia, Italy

[3] Area Programma Rischio Infett, Agenzia Sanit & Sociale Reg Emilia Romagna, I-40127 Bologna, Italy

[4] World Hlth Org Collaborating Ctr Evidence Based R, Azienda USL Modena, CeVEAS, I-4100 Modena, Italy

[5] Novartis Vaccines & Diagnost, Siena, Italy

来源：

VACCINE | 2013年 / 31卷 / 10期

关键词：

H1N1 pandemic vaccine; Vaccine safety; Active surveillance study; Italy; ADVERSE EVENTS; PREGNANT-WOMEN; HOSPITALIZATIONS; SEASON;

D O I：

10.1016/j.vaccine.2012.06.030

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (c) 2012 Elsevier Ltd. All rights reserved.

引用

页码：1431 / 1437

页数：7