A prospective observational safety study on MF59® adjuvanted cell culture-derived vaccine, Celtura® during the A/H1N1 (2009) influenza pandemic

Article ID	Journal	Published Year	Pages	File Type
10969265	Vaccine	2012	8 Pages	PDF

Abstract

âº Prospective observational study conducted to meet post marketing commitments for Celtura. âº 3989 subjects followed for occurrence of adverse events following vaccination with Celtura. âº No concern was raised regarding the occurrence of adverse events of special interest. âº Supports good safety profile of MF59 adjuvanted cell culture-derived influenza H1N1 vaccine.

Keywords

EMA SAE AESI CHMP HLT European Medicines agency Immunization Preferred term World Health Organization SOC adverse event Serious adverse event System organ class Committee for Medicinal Products for Human Use WHO

Related Topics

Life Sciences Immunology and Microbiology Immunology

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A prospective observational safety study on MF59® adjuvanted cell culture-derived vaccine, Celtura® during the A/H1N1 (2009) influenza pandemic

Authors

Humberto Reynales, Pedro Astudillo, Serge de ValliÃ¨re, Christoph Hatz, Patricia Schlagenhauf, Barbara Rath, Priscilla Velentgas, Ariel Fariña, Victor Sales-Carmona, Nicola Groth,