title: Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip.
abstract: Safety data on the inactivated split influenza vaccine, Vaxigrip, were compiled and analysed from 28 clinical trials (total: 4599 subjects aged 6 months to 99 years) to provide a robust estimate of the reactogenicity profile. The most frequent solicited reactions were non-severe injection site pain and erythema in children, adults, and elderly. Mild or moderate fever was the most frequent reaction in 6-36 months olds; few systemic reactions were reported in older groups. Reactogenicity was comparable in healthy and high-risk children. The long-term experience with the world's most widely used influenza vaccine, Vaxigrip, confirms its excellent tolerability, and supports its continued use in clinical practice worldwide.
authors.affiliation: Medical Affairs, Sanofi Pasteur, 2 avenue Pont Pasteur, 69367 Lyon, France. Valentine.delore@sanofipasteur.com
authors.forename: Valentine
authors.initials: V
authors.lastname: Delore
authors.forename: Camille
authors.initials: C
authors.lastname: Salamand
authors.forename: Grenville
authors.initials: G
authors.lastname: Marsh
authors.forename: Sabine
authors.initials: S
authors.lastname: Arnoux
authors.forename: Stephanie
authors.initials: S
authors.lastname: Pepin
authors.forename: Pierre
authors.initials: P
authors.lastname: Saliou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology; D008875:Middle Aged; D012449:Safety; D015164:Vaccines, Inactivated / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated