下载丁香园App送15丁当
关注今日：6 | 主题：405378
每发1个新帖可以获得0.5个丁当奖励
【drug-news】【资讯翻译】赛诺菲：高剂量的流感疫苗Fluzone对老人更有效
楼层直达：
这个帖子发布于2年零213天前，其中的信息可能已发生改变或有所发展。
【认 领 须 知】
1、认领翻译的战友请跟帖注明“
认领本文翻译，48小时内未完成，请其他战友认领！
2、请根据自己专业背景选择认领，如
使用翻译软件翻译，被发现者扣分1-2分
3、经常认领而不能及时提供优质稿件者将被列入黑名单，取消认领资格，请大家注意！
4、翻译时请参照版规：
5、在首位认领战友未超过规定时间的其他任何认领属违规认领，将不会给予丁当或加分！
6、翻译完成后加分（或丁当）的时限为三日，请耐心等待
，若超过时限未加者可进行申诉：
题目仅供译者参考
，篇幅较长者可申请适当延时
8、翻译前请查一下有无重复帖9、为保证翻译质量，每人每天最多只能认领两篇
原文链接：
Sanofi: Fluzone High-Dose More Effective Than Standard Dose in Seniors
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:
SNY), today announced topline results of a large-scale, multi-center
efficacy trial in people 65 years of age and older showing a superior
clinical benefit of Fluzone(R) High-Dose (Influenza Virus Vaccine)
relative to the standard dose of Fluzone vaccine in preventing influenza.
Today's announcement reflects the positive findings related to the
primary endpoint for the study population. Further data analyses of
secondary endpoints are ongoing, including an evaluation of the relative
efficacy based on the match of the vaccine strains to circulating
influenza virus strains. Sanofi Pasteur anticipates submitting the full
clinical study report to the FDA for review by early 2014 and will seek
a modification to the label for Fluzone High-Dose vaccine reflecting the
superior efficacy data in adults 65 years of age and older.
&We are pleased that this study demonstrates the superior relative
efficacy of Fluzone High-Dose vaccine compared to Fluzone vaccine in
preventing influenza in older adults,& said David P. Greenberg,
M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi
Pasteur. &This efficacy trial complements the previous evidence of
superior immune responses for Fluzone High-Dose vaccine compared to
Fluzone vaccine and reaffirms the Phase III safety data in this
population that were the basis for FDA licensure of Fluzone High-Dose
vaccine in 2009.&
In the study, Fluzone High-Dose vaccine was 24.2 percent more effective
in preventing influenza in adults 65 years of age and older than Fluzone
vaccine. The results met the pre-specified primary objective of the
study, demonstrating statistically superior efficacy for Fluzone
High-Dose vaccine. Additionally, the study results suggested consistent
clinical benefit across the study years, influenza virus types, clinical
illness definitions, and laboratory methods of influenza confirmation.
This large, multi-year trial also reaffirmed the safety of Fluzone
High-Dose vaccine as demonstrated in previous studies.
&Influenza vaccines have been shown to offer public health benefits
in preventing influenza and its complicatio
however, older adults still have the highest rates of influenza-related
hospitalization and death despite having high immunization rates, &
said John Shiver, Senior Vice President, Research and Development,
Sanofi Pasteur. &This led Sanofi Pasteur to develop Fluzone
High-Dose vaccine, which this trial has confirmed provides better
protection against influenza compared to Fluzone vaccine in people 65
years of age and older.&
Fluzone High-Dose vaccine was licensed in the United States by the Food
and Drug Administration (FDA) in December 2009 based on the vaccine's
safety profile and superior immunogenicity compared to Fluzone vaccine.
Immunogenicity (the ability of a vaccine to trigger the body to produce
antibodies against an infectious agent) is commonly used to evaluate
vaccines in clinical trials. Fluzone High-Dose vaccine contains 60 mcg
of hemagglutinin antigen per strain of influenza virus in the vaccine as
compared to 15 mcg of influenza virus hemagglutinin antigen per strain
of influenza virus in standard dose Fluzone vaccine. Fluzone High-Dose
vaccine was licensed by the FDA under an accelerated approval process to
address the medical need in older adults. As a requirement of the
accelerated approval pathway, Sanofi Pasteur embarked on this
large-scale, two-season, confirmatory efficacy trial, involving more
than 30,000 participants 65 years of age and older, to evaluate the
clinical benefit of Fluzone High-Dose vaccine compared to Fluzone
vaccine in the prevention of influenza disease.
不知道邀请谁？试试他们
微信扫一扫
广告宣传推广
政治敏感、违法虚假信息
恶意灌水、重复发帖
违规侵权、站友争执
附件异常、链接失效
认领本文翻译，48小时内未完成，请其他战友认领！
微信扫一扫
广告宣传推广
政治敏感、违法虚假信息
恶意灌水、重复发帖
违规侵权、站友争执
附件异常、链接失效
认领本文翻译，48小时内未完成，请其他战友认领
微信扫一扫
广告宣传推广
政治敏感、违法虚假信息
恶意灌水、重复发帖
违规侵权、站友争执
附件异常、链接失效
Sanofi: Fluzone High-Dose More Effective
Than Standard Dose in Seniors
赛诺菲：高剂量的流感疫苗
对老人更有效
Sanofi Pasteur, the vaccines division of
Sanofi (EURONEXT: SAN and NYSE: SNY), today announced topline results
of a large-scale, multi-center efficacy trial in people 65 years of
age and older showing a superior clinical benefit of Fluzone(R)
High-Dose (Influenza Virus Vaccine) relative to the standard dose of
Fluzone vaccine in preventing influenza.
泛欧证交所代号：
和纽约证交所代号：
的疫苗分公司
赛诺菲巴斯德公司今日宣布，在
岁及以上人群进行的一项大规模、多中心的药效试验的结果摘要显示，高剂量
Fluzone(R) (
流感病毒疫苗
在预防流感方面的临床效益要优于标准剂量
Today's announcement reflects the positive findings related to
the primary endpoint for the study population. Further data analyses
of secondary endpoints are ongoing, including an evaluation of the
relative efficacy based on the match of the vaccine strains to
circulating influenza virus strains. Sanofi Pasteur anticipates
submitting the full clinical study report to the FDA for review by
early 2014 and will seek a modification to the label for Fluzone
High-Dose vaccine reflecting the superior efficacy data in adults 65
years of age and older.
今日的这则
声明显示出了与研究人群主要终点相关的阳性结果。目前正在对次要终点数据进行进一步的分析，包括基于该疫苗株与流行流感病毒株匹配性的相对疗效评估。赛诺菲巴斯德公司预计于
递交完整的临床研究报告以便进行审评，进而将寻求修改标签以便反映高剂量
岁及以上成人具有较好疗效的数据。
&We are pleased that this study demonstrates the superior
relative efficacy of Fluzone High-Dose vaccine compared to Fluzone
vaccine in preventing influenza in older adults,& said David P.
Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs,
Sanofi Pasteur. &This efficacy trial complements the previous
evidence of superior immune responses for Fluzone High-Dose vaccine
compared to Fluzone vaccine and reaffirms the Phase III safety data in
this population that were the basis for FDA licensure of Fluzone
High-Dose vaccine in 2009.&
赛诺菲巴斯德美国科学和医学事务副总裁
David P. Greenberg
医学博士说：
高兴的是，这项研究表明高剂量
疫苗在预防老年流感方面的相对疗效要优于
这项药效试验是对之前证明高剂量
免疫反应方面优于
疫苗的补充，同时再次肯定了该群体内的
期安全性数据，这些数据是
年批准高剂量
疫苗的基础。
”In the study, Fluzone High-Dose
vaccine was 24.2 percent more effective in preventing influenza in
adults 65 years of age and older than Fluzone vaccine. The results met
the pre-specified primary objective of the study, demonstrating
statistically superior efficacy for Fluzone High-Dose vaccine.
Additionally, the study results suggested consistent clinical benefit
across the study years, influenza virus types, clinical illness
definitions, and laboratory methods of influenza confirmation. This
large, multi-year trial also reaffirmed the safety of Fluzone
High-Dose vaccine as demonstrated in previous studies.
在这项研究中，高剂量
疫苗在预防
岁及以上成人流感方面的疗效要比
结果符合该研究预先确定的主要目标，证明了
疫苗的较好疗效具有统计学意义。此外，该研究结果表明，无论研究持续时间、流感病毒类型、临床疾病定义还是流感确认的实验室方法，都具有一致的临床效益。这项大型、多年试验还再次肯定了之前研究所证明的高剂量
疫苗的安全性。
&Influenza vaccines have been shown to offer public health
benefits in preventing influenza and its complications in all age
however, older adults still have the highest rates of
influenza-related hospitalization and death despite having high
immunization rates, & said John Shiver, Senior Vice President,
Research and Development, Sanofi Pasteur. &This led Sanofi
Pasteur to develop Fluzone High-Dose vaccine, which this trial has
confirmed provides better protection against influenza compared to
Fluzone vaccine in people 65 years of age and older.&
赛诺菲巴斯德研发高级副总裁
John Shiver
已证明流感疫苗在预防各个年龄群体流感及其并发症方面提供了
公共健康效益；然而，老年人尽管具有高免疫率，但其与流感相关的住院率和死亡率却是最高的。这就导致赛诺菲巴斯德开发高剂量
疫苗，这项试验已证实，在预防
岁及以上人群流感方面，高剂量
疫苗提供的保护作用要优于
”Fluzone High-Dose vaccine was
licensed in the United States by the Food and Drug Administration
(FDA) in December 2009 based on the vaccine's safety profile and
superior immunogenicity compared to Fluzone vaccine. Immunogenicity
(the ability of a vaccine to trigger the body to produce antibodies
against an infectious agent) is commonly used to evaluate vaccines in
clinical trials. Fluzone High-Dose vaccine contains 60 mcg of
hemagglutinin antigen per strain of influenza virus in the vaccine as
compared to 15 mcg of influenza virus hemagglutinin antigen per strain
of influenza virus in standard dose Fluzone vaccine. Fluzone High-Dose
vaccine was licensed by the FDA under an accelerated approval process
to address the medical need in older adults. As a requirement of the
accelerated approval pathway, Sanofi Pasteur embarked on this
large-scale, two-season, confirmatory efficacy trial, involving more
than 30,000 participants 65 years of age and older, to evaluate the
clinical benefit of Fluzone High-Dose vaccine compared to Fluzone
vaccine in the prevention of influenza disease.
基于该疫苗相对于
疫苗的安全性和较好的免疫原性，美国食品药品管理局
疫苗。免疫原性
能够刺激机体形成抵抗传染性病原体抗体的能力
普遍用于临床试验中来评估疫苗。
血凝素抗原每株流感病毒株疫苗，而标准剂量
流感病毒血凝素抗原每株流感病毒。为解决老年人的医疗需求，
根据加速审评程序批准了高剂量
疫苗。作为加速审批途径的要求，赛诺菲巴斯德着手进行了这项大规模、双季、药效验证性试验，涉及超过
岁及以上参与者，旨在评价高剂量
疫苗相对于
疫苗在预防流感疾病方面的临床效益。
微信扫一扫
广告宣传推广
政治敏感、违法虚假信息
恶意灌水、重复发帖
违规侵权、站友争执
附件异常、链接失效
编译：字数1004
赛诺菲：高剂量的流感疫苗
对老人更有效
泛欧证交所代号：
和纽约证交所代号：
的疫苗分公司
赛诺菲巴斯德公司今日宣布，在
岁及以上人群进行的一项大规模、多中心的药效试验的结果摘要显示，高剂量
Fluzone(R) (
流感病毒疫苗
在预防流感方面的临床效益要优于标准剂量
今日的这则
声明显示出了与研究人群主要终点相关的阳性结果。目前正在对次要终点数据进行进一步的分析，包括基于该疫苗株与流行流感病毒株匹配性的相对疗效评估。赛诺菲巴斯德公司预计于
递交完整的临床研究报告以便进行审评，进而将寻求修改标签以便反映高剂量
岁及以上成人具有较好疗效的数据。
赛诺菲巴斯德美国科学和医学事务副总裁
David P. Greenberg
医学博士说：
高兴的是，这项研究表明高剂量
疫苗在预防老年流感方面的相对疗效要优于
这项药效试验是对之前证明高剂量
免疫反应方面优于
疫苗的补充，同时再次肯定了该群体内的
期安全性数据，这些数据是
年批准高剂量
疫苗的基础。
在这项研究中，高剂量
疫苗在预防
岁及以上成人流感方面的疗效要比
结果符合该研究预先确定的主要目标，证明了
疫苗的较好疗效具有统计学意义。此外，该研究结果表明，无论研究持续时间、流感病毒类型、临床疾病定义还是流感确认的实验室方法，都具有一致的临床效益。这项大型、多年试验还再次肯定了之前研究所证明的高剂量
疫苗的安全性。
赛诺菲巴斯德研发高级副总裁
John Shiver
已证明流感疫苗在预防各个年龄群体流感及其并发症方面提供了
公共健康效益；然而，老年人尽管具有高免疫率，但其与流感相关的住院率和死亡率却是最高的。这就导致赛诺菲巴斯德开发高剂量
疫苗，这项试验已证实，在预防
岁及以上人群流感方面，高剂量
疫苗提供的保护作用要优于
基于该疫苗相对于
疫苗的安全性和较好的免疫原性，美国食品药品管理局
疫苗。免疫原性
能够刺激机体形成抵抗传染性病原体抗体的能力
普遍用于临床试验中来评估疫苗。
血凝素抗原每株流感病毒株疫苗，而标准剂量
流感病毒血凝素抗原每株流感病毒。为解决老年人的医疗需求，
根据加速审评程序批准了高剂量
疫苗。作为加速审批途径的要求，赛诺菲巴斯德着手进行了这项大规模、双季、药效验证性试验，涉及超过
岁及以上参与者，旨在评价高剂量
疫苗相对于
疫苗在预防流感疾病方面的临床效益。
微信扫一扫
广告宣传推广
政治敏感、违法虚假信息
恶意灌水、重复发帖
违规侵权、站友争执
附件异常、链接失效
关于丁香园spanish flu是什么意思_百度知道
spanish flu是什么意思
提问者采纳
Spanish flu英 [ˈspænɪʃ flu:] 美 [ˈspænɪʃ flu] n.西班牙流; (<img class="word-replace" src="/api/getdecpic?picenc=0a007a18~1919曾经造全世界约10亿染<img class="word-replace" src="/api/getdecpic?picenc=0ad千5百万4千万死亡) [网络]西班牙型流行性冒; 西班牙流行性冒; 西班牙流病毒; [例句]He contracted Spanish flu, which almost killed him. 西班牙流险些丧命
来自团队：
其他类似问题
为您推荐：
spanish的相关知识
等待您来回答
下载知道APP
随时随地咨询
出门在外也不愁灭活流感疫苗Fluzone High-Dose可用于老年人
近日，美国食品药品管理局（FDA）批准赛诺菲巴斯德公司灭活流感疫苗Fluzone&High-Dose用于65岁以上的老年人，这种疫苗可预防由亚型流感病毒A/B引起的疾病。
Fluzone&High-Dose使用3种流感病毒毒株制备，每0.5毫升药剂中共含有180微克流感病毒血凝素。
不久前，该疫苗进入了FDA的快批通道并最终获得批准。FDA的快批通道有利于在安全性及疗效方面已经过证实的药物或可治疗致命性疾病的药物快速进入流通领域。临床试验结果显示，与Fluzone&相比，65岁以上老年人使用Fluzone&High-Dose疫苗之后，身体的免疫应答更强。
但作为疫苗获得快速批准的条件之一，FDA还要求赛诺菲巴斯德对Fluzone&High-Dose的预防效果进行进一步研究，以证实这类人士接种疫苗之后可降低季节性流感发病率。
免责声明：
1、本文系本网编辑转载，转载目的在于传递更多信息，并不代表本网赞同其观点和对其真实性负责。
2、如涉及作品内容、版权和其它问题，请在30日内与本网联系，我们将在第一时间删除内容或提供稿费！
※ 有关作品版权事宜请联系：020- 企鹅:
@ 权威保健品招商网 版权所有 广州市公安局备案编号：3 本站法律顾问：郭彬律师 电话咨询：020-(本站不接受买药咨询) 传真： QQ咨询：2344097 招商QQ群：4545915声明：权威保健品招商网( )为保健品招商网信息平台，不为双方交易承担任何责任及风险，请双方谨慎交易，在交易前请先查看对方三证，以确保您的利益。【权威保健品招商网，专业免费提供保健品招商保健品代理保健品排行榜等保健品招商网及保健品代理网信息，是保健品招商网中保健品排行榜最好的中国保健品招商代理网站】
