Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine 英文参考文献.docVIP

ShortandLong-TermSafetyofthe2009AS03- AdjuvantedPandemicVaccine GastonDeSerres1,2*,Marie-ClaudeGarie′py1,BrendaColeman3,IsabelleRouleau1,ShellyMcNeil4, Me′lanieBeno??t1,AllisonMcGeer3,ArdithAmbrose4,JudyNeedham5,ChantalBergeron6, CynthiaGrenier7,KennaSleigh8,ArleneKallos5,ManaleOuakki2,NajwaOuhoummane2,GrantStiver8, LouisValiquette7,AnneMcCarthy6,JulieBettinger5 onbehalfofthePHAC-CIHRinfluenzaResearch Network(PCIRN) 1CentrederechercheduCHUQ-CHUL,LavalUniversity,QuebecCity,Quebec,Canada,2Institutnationaldesante′ publiqueduQue′bec (INSPQ),QuebecCity,Quebec, Canada,3MountSinaiHospitalandUniversityofToronto,Toronto,Ontario,Canada,4CanadianCenterforVaccinology,Halifax,NovaScotia,Canada,5VaccineEvaluation Center, BC Children’s Hospital and the University of British Columbia, Vancouver, British Columbia, Canada, 6The Ottawa General Hospital, Ottawa, Ontario, Canada, 7Universite′ deSherbrooke,Sherbrooke,Quebec,Canada,8UniversityofBritishColumbia,Vancouver,BritishColumbia,Canada Abstract Background:Thisstudyassessedtheshortandthelongtermsafetyofthe2009AS03adjuvantedmonovalentpandemic vaccinethroughanactiveweb-basedelectronicsurveillance.Wecompareditssafetyprofiletothatoftheseasonaltrivalent inactivatedinfluenzavaccine(TIV)for2010–2011. Methodology/PrincipalFindings:Healthcareworkers(HCW)vaccinatedin2009withthepandemicvaccine(ArepanrixH fromGSK)orHCWvaccinatedin2010withthe2010–2011TIVwereinvitedtoparticipateinaweb-basedactivesurveillance ofvaccinesafety.Theycompletedtwosurveystheday-8surveycoveredthefirst7dayspost-vaccinationandtheday-29 surveycoveredeventsoccurring8to28daysaftervaccination.Thosewhoreportedaproblemwerecalledbyanurseto obtain details. The main outcome was the occurrence of a new health problem or the worsening of an existing health conditionthatresultedinamedicalconsultationorworkabsenteeism.Forthepandemicvaccine,asix-monthfollow-upfor theoccurrenceofseriousadverseevents(SAE)wasconducted.Amongthe6242HCWwhoreceivedthepandemicvaccine, 440(7%)reporte