文章来源：http://news.bioon.com/article/6667198.html

2015年3月21日訊/生物谷BIOON/--輝瑞公司公布了其肺炎疫苗Prevenar13臨床試驗CAPiTA結果，數據已經在三月份的《新英格蘭醫學》雜志上發表。（相關閱讀：歐盟批準輝瑞肺炎疫苗Prevenar13（沛兒13）用于18歲及以上成人群體）肺炎鏈球菌是細菌性肺炎最常見的感染源，而Prevenar13是輝瑞公司開發的用于預防13種肺炎鏈球菌致病的疫苗。該疾病也是在全球范圍內導致住院和死亡的主要原因。肺炎球菌病也同樣可以導致兒童而不感染和其它多種疾病。CAPiTA研究是近來有輝瑞公司與荷蘭烏特勒支大學醫學中心和JuliusClinical合作開展的，該研究用于評估Prevenar13對于第一階段的肺炎球菌肺炎、侵入性肺炎球菌病和非細菌性獲得性肺炎在65歲以上成年中的預防效果。受試者體質非常虛弱，因為他們脆弱的免疫系統已經無法保護他們免受肺炎和其它危及生命的細菌感染。輝瑞公司宣布該疫苗已經達到了首次和第二次的研究目標，因為其可以保護病人在血液和其它無菌區域免于危險的感染。該實驗共招募84496個受試者，其中一半接受Prevenar13，另一半給予安慰劑。試驗結果表明該疫苗可以降低45.6%肺炎球菌肺炎的發生。Prevenar13已經成為了全球范圍內使用最廣泛的用于預防肺炎鏈球菌感染的疫苗。全球已經有7.5億份Prevenar疫苗售出，在歷史上已成為第二大高利潤的疫苗。該疫苗也同樣是輝瑞第二大產生高收入的產品，在2014年為公司帶來45億美金的銷售。目前在全球已有超過120個國家批準該疫苗上市，歐洲與今年2月批準，美國FDA也已經批準其用于6周到17歲的兒童和49歲以上的成年人。（生物谷Bioon.com）本文系生物谷原創編譯整理。歡迎轉載！轉載請注明來源并附原文鏈接。更多資訊請下載生物谷資訊APP。信源：bidness生物谷推薦英文原文報道：PfizerInc.PublishesPrevenar13DataFromCAPiTAStudyPfizerInc.(NYSE:PFE)announcedthattheresultsfromtheCommunity-AcquiredPneumoniaImmunizationTrialinAdults(CAPiTA),conductedtoevaluateitsblockbustervaccinePrevenar13,havebeenpublishedintheMarchissueoftheNewEnglandJournalofMedicine.Prevenar13isavaccinedevelopedbyPfizerforprotectionagainst13strainsofpneumococcaldisease,whichisknowntobethemostcommoncauseofpneumoniaduetobacteria.Thediseaseisalsoknowntobetheleadingcauseofhospitalizationsanddeathsworldwide.Pneumococcaldiseasecanalsoleadtoearinfectionsandvariousotherdiseasesinchildren.TheCAPiTAstudywasrecentlyconductedbyPfizerincollaborationwiththeUniversityMedicalCentreUtrecht,situatedinNetherlands,andJuliusClinicaltoevaluatetheimmunizationefficacyofPrevenar13againstfirststageofvaccine-typepneumococcalCommunity-AcquiredPneumonia(CAP)andInvasivePneumococcalDisease(IPD),andnon-bacteremic/non-invasiveCAPinadults65andolder.Patientsamongthesaidagegroupareparticularlymorevulnerable,astheirweakeningimmunesystemsarenotabletoprotectthemagainstpneumoniaandotherlife-threateningbacterialinfections.Pfizerannouncedthatthevaccinemetbothprimaryandsecondaryendpointsspecifiedforthestudy,asitprovedtoprotectthepatientsfromthesaidagegroupfromthethreateninginfectionsfoundinthebloodstreamsandothersterileregionsofthebody.Asmanyas84,496peoplewereenrolledintheCAPiTAstudy,halfofwhomweregivenadoseofPrevenar13,whiletheotherhalfweregivenaplaceboshot.Inthestudy,PrevenarprovedtoreducetheCAPinfectionsbyasmuchas45.6%.Pfizerfurthersaidthatmoredangerousbutlesscommonbloodstreamandvariousotherinvasivebacterialinfectionswereshowntooccurin75%fewerpatientswhowerereceivingtheactualvaccineshots,incomparisontothepatientswhoweregiventhedummyshots.PfizerwasrequiredtoconductCAPiTAbyregulatorybodiesofvariouscountriesglobally.Prevenar13iswellknowntobethemostcommonlyandwidelyusedvaccineworldwideforprotectionagainstpneumococcalinfections.Globally,asmanyas750milliondosesofPrevenar13aredistributedanditstandstobethesecond-mostlucrativevaccinedruginrecordedhistory.Thevaccineisalsothesecond-highestrevenue-generatingproductforPfizer,bringing$4.5billioninsalesin2014.Prevenar13isalreadyapprovedinover120countries.ThemostrecentapprovalgrantedtothevaccinecameinFebruary2015astheEuropeanCommissiongaveagreenlightfortheexpandeduseofthedrugtobeadministeredinadultsforprotectionagainstvaccine-typepneumococcalpneumonia.Followingtheapproval,theSummaryofProductCharacteristicsforPrevenar13wasupdatedastheefficacydatawasincludedinit.TheUSFoodandDrugAdministration(FDA)hasapprovedthevaccineforuseinchildrenagedsixweeksto17yearsandinadultsaged49andabove.TherecentlypublishedresultsforPrevenar13havealsobeensubmittedtotheFDA.Theresultshavefurtherbeensubmittedtoregulatorybodiesofothermajormarketsglobally,suchasCanadaandAustralia,fortheadditionoftheindicationtotheapproveduseofthevaccine.TheNewEnglandJournalofMedicinehasrecentlyreceivedalotoflimelightfromthemedia,asthedatapublishedinthejournalhasresultedinsignificantupwardmovementfortherelevantstocks.Thejournalrecentlypublisheddatafortwodrugswhichbelongtothenewgenerationofcholesterol-loweringdrugsknownasPCSK9inhibitors;amongthesedrugs,onewasdevelopedbyAmgen,Inc.(NASDAQ:AMGN),whiletheotherdrugwasdevelopedbySanofiSA(ADR)(NYSE:SNY)andRegeneronPharmaceuticalsInc(NASDAQ:REGN).Stocksofallthreecompaniessoaredonthebackofthepositivedatafromtherecentstudiesthatwerepublishedinthesaidjournal.溫馨提示：87%用戶都在生物谷APP上閱讀，掃描立刻下載!天天精彩！

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