Giuseppe
Emeritus
(1.11): Vaccine. 2008 May 2;26(19):2378-88. Epub 2008 Mar 27.
Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.
R?mke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Dram? M, S?nger R, Ballou WR. - VAXINOSTICS BV, University Vaccine Center Rotterdam Nijmegen, Beursplein 37, PO Box 30142, 3001 DC Rotterdam, The Netherlands. rumke@vaxinostics.com
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.
PMID: 18407382 [PubMed - indexed for MEDLINE]
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Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.
R?mke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Dram? M, S?nger R, Ballou WR. - VAXINOSTICS BV, University Vaccine Center Rotterdam Nijmegen, Beursplein 37, PO Box 30142, 3001 DC Rotterdam, The Netherlands. rumke@vaxinostics.com
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.
PMID: 18407382 [PubMed - indexed for MEDLINE]
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