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赛诺菲:老年群体高剂量Fluzone疫苗预防流感更有效

来源:生物谷 2013-08-28 11:57

2013年8月28日讯 /生物谷BIOON/ --赛诺菲(Sanofi)8月26日公布了一项大规模、多中心疗效试验的顶级数据。数据显示,高剂量Fluzone疫苗用于65岁及以上老年群体预防流感时,比标准剂量Fluzone疫苗更加有效,达到了该项研究的主要终点。次要终点的进一步数据分析正在进行中,包括基于疫苗株与流行流感毒株匹配性的相对有效性评估。赛诺菲计划于2014年初向FDA提交完全的临床研究报告,并寻求修改Fluzone高剂量疫苗(Fluzone High-Dose vaccine)的标签信息,以体现该疫苗在65岁及以上老年人中的卓越疗效数据。

该项研究中,在用于65岁及以上老年人预防流感时,高剂量Fluzone疫苗有效性比标准剂量Fluzone疫苗高24.4%,结果符合预先指定的研究主要目标,证明了高剂量Fluzone疫苗的统计学显着优越性。此外,该项研究也再次验证了高剂量Fluzone疫苗的安全性。

高剂量Fluzone疫苗于2009年12月获FDA批准,该剂量疫苗的获批,是基于其相对于标准剂量Fluzone疫苗的安全属性及优越的免疫原性。高剂量Fluzone疫苗,每支针剂中每株流感病毒株血凝素抗原含量为60微克(mcg),而标准剂量Fluzone疫苗中每株流感病毒株血凝素抗原含量为15mcg。

高剂量Fluzone疫苗是FDA通过快速审批程序批准,以满足老龄群体的医疗需求。作为加速审批程序的要求,赛诺菲开展了这项大型、双季、疗效验证试验,涉及超过30000名65岁及以上老年受试者,以评估高剂量Fluzone在预防流感方面,相对于标准剂量Fluzone的临床益处。(生物谷Bioon.com)

英文原文:Sanofi Pasteur’s Fluzone High-Dose Vaccine Significantly More Effective Than Standard Dose Fluzone Vaccine in Preventing Influenza in Adults 65 Years of Age and Older

–Efficacy trial in more than 30,000 older adults meets primary endpoint for superior efficacy–

Lyon, France - August 26, 2013 - 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? 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 trialcomplements 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 inadults 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, influenzavirus 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 complications in all age groups; 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 2/3to 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 standarddose Fluzone vaccine. Fluzone High-Dose vaccine was licensed by the FDA under an acceleratedapproval 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.

About Influenza Disease in People 65+ Years of Age

Research has shown that the immune system weakens as people age. Older adults are not only more susceptible to infections, but also less responsive to vaccination. When infected with the influenza virus, they are less able to mount an effective immune response to neutralize the attack. Compared toyounger adults, people 65 years of age and older suffer disproportionately from seasonal influenza disease and its complications, including severe illness leading to hospitalization and death. Although this group comprises only 15 percent of the U.S. population, on average it accounts for 65 percent of the estimated 226,000 hospitalizations and 90 percent of the 3,000 to 49,000 deaths attributed to seasonal influenza and its complications each year. The first baby boomers began to turn 65 in 2011 and, by the year 2030, the number of adults 65 years of age and older is anticipated to double and surpass 70 million people, comprising 20 percent of the U.S. population. Thus, better prevention ofinfluenza in older adults can have a significant impact on public health, quality of life, and healthcare costs.

About Fluzone High-Dose Vaccine

Indication

Fluzone High-Dose vaccine is an inactivated influenza virus vaccine given for active immunization in persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Approval of Fluzone High-Dose vaccine is based on superior immune response relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine have not yet been reviewed by FDA.

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