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.
Identifieur interne : 000C63 ( PubMed/Corpus ); précédent : 000C62; suivant : 000C64An 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.
Auteurs : Silvia Candela ; Sara Pergolizzi ; Pietro Ragni ; Silvio Cavuto ; Lucia Nobilio ; Simona Di Mario ; Valentina Dragosevic ; Nicola Groth ; Nicola MagriniSource :
- Vaccine [ 1873-2518 ] ; 2013.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Humans, Infant, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Italy, Male, Middle Aged, Polysorbates (administration & dosage), Pregnancy, Prospective Studies, Squalene (administration & dosage), Young Adult.
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , adverse effects : Influenza Vaccines.
- geographic : Italy.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Pregnancy, Prospective Studies, Young Adult.
Abstract
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.
DOI: 10.1016/j.vaccine.2012.06.030
PubMed: 22766247
Links to Exploration step
pubmed:22766247Le document en format XML
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<front><div type="abstract" xml:lang="en">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.</div>
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<Day>12</Day>
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<JournalIssue CitedMedium="Internet"><Volume>31</Volume>
<Issue>10</Issue>
<PubDate><Year>2013</Year>
<Month>Feb</Month>
<Day>27</Day>
</PubDate>
</JournalIssue>
<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
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<ArticleTitle>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.</ArticleTitle>
<Pagination><MedlinePgn>1431-7</MedlinePgn>
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<Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">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.</AbstractText>
<AbstractText Label="METHOD" NlmCategory="METHODS">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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
<CopyrightInformation>Copyright © 2012 Elsevier Ltd. All rights reserved.</CopyrightInformation>
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