Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.
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.
Rümke
Hans C
HC
VAXINOSTICS BV, University Vaccine Center Rotterdam Nijmegen, Beursplein 37, PO Box 30142, 3001 DC Rotterdam, The Netherlands. rumke@vaxinostics.com
Bayas
José-María
JM
de Juanes
José-Ramón
JR
Caso
Covadonga
C
Richardus
Jan Hendrik
JH
Campins
Magda
M
Rombo
Lars
L
Duval
Xavier
X
Romanenko
Viktor
V
Schwarz
Tino F
TF
Fassakhov
Rustem
R
Abad-Santos
Francisco
F
von Sonnenburg
Frank
F
Dramé
Mamadou
M
Sänger
Roland
R
Ballou
W Ripley
WR
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
D000276:Adjuvants, Immunologic; D004655:Emulsions; D007252:Influenza Vaccines