title: Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.
abstract: A multicentre, randomized, phase III clinical trial in 5071 healthy adults was conducted to evaluate the safety and reactogenicity of a 15 microg HA dose of a candidate oil-in-water emulsion-based adjuvant system (AS)-adjuvanted split-virion H5N1 (AS-H5N1) vaccine compared to a licensed seasonal influenza vaccine, Fluarix.(1) Stringent criteria were used to evaluate adverse events and reactogenicity profile. Overall, 96.7% of the 5071 vaccinated subjects completed the study. Significantly more participants in the AS-H5N1 vaccine group reported general or local adverse events. Pain was the most common symptom in both treatment groups. Less than 1% of subjects withdrew from the study due to adverse events and no withdrawals were due to serious adverse events related to vaccination. The safety and reactogenicity profile of the AS-H5N1 candidate vaccine can be considered clinically acceptable in the context of its use against pandemic influenza.
authors.affiliation: VAXINOSTICS BV, University Vaccine Center Rotterdam Nijmegen, Beursplein 37, PO Box 30142, 3001 DC Rotterdam, The Netherlands. rumke@vaxinostics.com
authors.forename: Hans C
authors.initials: HC
authors.lastname: Rümke
authors.forename: José-María
authors.initials: JM
authors.lastname: Bayas
authors.forename: José-Ramón
authors.initials: JR
authors.lastname: de Juanes
authors.forename: Covadonga
authors.initials: C
authors.lastname: Caso
authors.forename: Jan Hendrik
authors.initials: JH
authors.lastname: Richardus
authors.forename: Magda
authors.initials: M
authors.lastname: Campins
authors.forename: Lars
authors.initials: L
authors.lastname: Rombo
authors.forename: Xavier
authors.initials: X
authors.lastname: Duval
authors.forename: Viktor
authors.initials: V
authors.lastname: Romanenko
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Rustem
authors.initials: R
authors.lastname: Fassakhov
authors.forename: Francisco
authors.initials: F
authors.lastname: Abad-Santos
authors.forename: Frank
authors.initials: F
authors.lastname: von Sonnenburg
authors.forename: Mamadou
authors.initials: M
authors.lastname: Dramé
authors.forename: Roland
authors.initials: R
authors.lastname: Sänger
authors.forename: W Ripley
authors.initials: WR
authors.lastname: Ballou
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004196:Disease Outbreaks / Q000517:prevention & control; D004655:Emulsions / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control / Q000821:virology; D008297:Male; D008875:Middle Aged
chemical_list: D000276:Adjuvants, Immunologic; D004655:Emulsions; D007252:Influenza Vaccines