tetano
Editor, Senior Moderator
Vaccine. 2012 Jul 2. [Epub ahead of print]
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 S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; for the SaFoH1N1 working group.
Source
Servizio di Epidemiologia, Dipartimento di Sanit? Pubblica, Azienda USL di Reggio Emilia, Via Amendola 2, 42122 Reggio Emilia, Italy.
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.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22766247
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22766247
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 S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; for the SaFoH1N1 working group.
Source
Servizio di Epidemiologia, Dipartimento di Sanit? Pubblica, Azienda USL di Reggio Emilia, Via Amendola 2, 42122 Reggio Emilia, Italy.
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.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22766247
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22766247