Safety and Immunogenicity Following Administration of a Live, Attenuated Monovalent 2009 H1N1 Influenza Vaccine to Children and Adults in Two Randomized Controlled Trials 英文参考文献.docVIP

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Safety and Immunogenicity Following Administration of a Live, Attenuated Monovalent 2009 H1N1 Influenza Vaccine to Children and Adults in Two Randomized Controlled Trials 英文参考文献.doc

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Safety and Immunogenicity Following Administration of a Live, Attenuated Monovalent 2009 H1N1 Influenza Vaccine to Children and Adults in Two Randomized Controlled Trials 英文参考文献

SafetyandImmunogenicityFollowingAdministrationof aLive,AttenuatedMonovalent2009H1N1Influenza VaccinetoChildrenandAdultsinTwoRandomized ControlledTrials RaburnM.Mallory*,ElissaMalkin,ChristopherS.Ambrose,TerramikaBellamy,LiShi,TingtingYi,Taff Jones,GeorgeKemble,FilipDubovsky MedImmune,LLC,Gaithersburg,Maryland,UnitedStatesofAmerica Abstract Background:Thesafety,tolerability,andimmunogenicityofamonovalentintranasal2009A/H1N1liveattenuatedinfluenza vaccine(LAIV)wereevaluatedinchildrenandadults. Methods/PrincipalFindings:Tworandomized,double-blind,placebo-controlledstudieswerecompletedinchildren(2–17 y)andadults(18–49y).Subjectswereassigned4:1toreceive2dosesofH1N1LAIVorplacebo28daysapart.Theprimary safety endpoint was fever $38.3uC during days 1–8 after the first dose; the primary immunogenicity endpoint was the proportionofsubjectsexperiencingapostdoseseroresponse.Solicitedsymptomsandadverseeventswererecordedfor14 daysaftereachdoseandsafetydatawerecollectedfor180dayspost-finaldose.Intotal,326children(H1N1LAIV,n=261; placebo,n=65)and300adults(H1N1LAIV,n=240;placebo,n=60)wereenrolled.Afterdose1,fever$38.3uCoccurredin 4(1.5%)pediatricvaccine recipientsand1 (1.5%)placeborecipient(ratedifference,0%;95% CI:–6.4%,3.1%). Noadults experiencedfeverfollowingdose1.Seroresponseratesinchildren(H1N1LAIVvs.placebo)were11.1%vs.6.3%afterdose1 (ratedifference,4.8%;95%CI:–9.6%,13.8%)and32.0%vs.14.5%afterdose2(ratedifference,17.5%;95%CI:5.5%,27.1%). Seroresponse rates in adults were 6.1% vs. 0% (rate difference, 6.1%; 95% CI: –5.6%, 12.6%) and 14.9% vs. 5.6% (rate difference,9.3%;95%CI:–0.8%,16.3%)afterdose1anddose2,respectively.Solicitedsymptomsafterdose1(H1N1LAIVvs. placebo)occurredin37.5%vs.32.3%ofchildrenand41.7%vs.31.7%ofadults.Solicitedsymptomsoccurredlessfrequently afterdose2inadultsandchildren.Novaccine-relatedseriousadverseeventsoccurred. Conclusions/Significance:Insubjectsaged2to49years,twodosesofH1N1LAIVhaveasafetyandimmunogenicityprofile similartootherpreviouslystudiedand