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

Highlights ► Safety of a MF59-adjuvanted A/H1N1 pandemic influenza vaccine (Focetria® ) was assessed. ► An active surveillance system enrolling subjects vaccinated with Focetria® was set-up. ► Adverse events occurring within 6 weeks post-vaccination in an Italian province were registered. ► No alarm...

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Bibliographic Details
Published in:Vaccine 2013-02, Vol.31 (10), p.1431-1437
Main Authors: Candela, Silvia, Pergolizzi, Sara, Ragni, Pietro, Cavuto, Silvio, Nobilio, Lucia, Di Mario, Simona, Dragosevic, Valentina, Groth, Nicola, Magrini, Nicola
Format: Article
Language:English
Subjects:
Active surveillance study
Adjuvants, Immunologic - administration & dosage
Adolescent
Adult
Aged
Aged, 80 and over
Allergy and Immunology
Applied microbiology
Biological and medical sciences
Child
Child, Preschool
death
diagnostic techniques
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drug-Related Side Effects and Adverse Reactions - pathology
Female
Fundamental and applied biological sciences. Psychology
H1N1 pandemic vaccine
health services
Hospitals
Humans
Immunization
Infant
infants
influenza
Influenza A Virus, H1N1 Subtype - immunology
Influenza Vaccines - administration & dosage
Influenza Vaccines - adverse effects
Influenza Vaccines - immunology
Italy
Male
Microbiology
Middle Aged
monitoring
myocardial infarction
nervous system diseases
pandemic
Pandemics
physicians
Polysorbates - administration & dosage
Pregnancy
pregnant women
Prospective Studies
seizures
Squalene - administration & dosage
Swine flu
vaccination
Vaccine safety
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Womens health
Young Adult
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Description
Summary:Highlights ► Safety of a MF59-adjuvanted A/H1N1 pandemic influenza vaccine (Focetria® ) was assessed. ► An active surveillance system enrolling subjects vaccinated with Focetria® was set-up. ► Adverse events occurring within 6 weeks post-vaccination in an Italian province were registered. ► No alarming signals were detected in this real time study. ► A larger study was thereafter developed and conducted at the Emilia-Romagna regional level.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2012.06.030