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            輝瑞Prevenar13里程碑CAPiTA研究達主要和次要目標
            2014-03-16         

             

            輝瑞Prevenar13里程碑CAPiTA研究達主要和次要目標

            2014年3月12日訊 /生物谷BIOON/ --輝瑞(Pfizer)3月12日公布了肺炎球菌結合型疫苗Prevenar 13(沛兒13)里程碑意義的大型CAPiTA研究的詳細數據。該項研究涉及約8.5萬名受試者,研究結果表明,Prevenar 13預防了65歲及以上成人群體中疫苗型社區獲得性肺炎(community-acquired pneumonia,CAP)的首次流行發作(first episode),達到了研究的主要目標。這是首次在成人群體中明確地證明疫苗型肺炎球菌CAP流行發作顯著降低的研究,更重要的是,顯著降低了非菌血癥性/非侵入性疫苗型肺炎球菌CAP的流行發作。該項研究的數據,已提交至2014年3月12日在印度海德拉巴舉行的第九屆肺炎球菌及肺炎球菌病國際研討會(ISPPD-9)。

            CAPiTA(Community-Acquired Pneumonia Immunization Trial in Adults,成人社區獲得性肺炎免疫試驗)研究也達到了2個次要終點:(i)顯著降低了非菌血癥性/非侵入性疫苗型肺炎球菌CAP;(ii)顯著降低了疫苗型侵入性肺炎球菌?。↖PD)。

            研究中,與安慰劑組相比,Prevenar 13免疫組疫苗型CAP首次發作減少45.56%(p=0.0006)。同時,Prevenar 13免疫組非菌血癥性/非侵入性疫苗型肺炎球菌CAP首次發作減少45.00%(p=0.0067),疫苗型IPD首次發作減少75.00%。該項研究中Prevenar 13的安全性與既往研究一致。

            其他數據顯示,接種Prevenar 13的受試者,在免疫之后長達4年的時間內,疫苗型CAP、非菌血癥性/非侵入性疫苗型CAP、疫苗型IPD首次發作均得到降低。

            CAPiTA研究的數據,將作為Prevenar 13用于成人的建議的重要組成部分。其他關鍵因素,也將加以考慮,包括成年群體中當前的肺炎球菌病負擔。

            關于沛兒13(Prevenar 13):

            Prevenar 13是由輝瑞開發的一款13價肺炎鏈球菌結合型疫苗,是目前唯一一種獲FDA和歐盟批準用于全年齡段(從嬰兒期至成年期)的肺炎球菌疫苗,用于預防13株肺炎鏈球菌菌株(1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,23F)導致的肺炎球菌性肺炎和侵入性疾病。Prevenar 13于2011年由FDA通過加速審批程序批準,以解決老年群體中的醫療需求。作為加速審批的要求,輝瑞開展了CAPiTA來驗證Prevenar13的臨床利益。(生物谷Bioon.com)

            英文原文:Pfizer (PFE) Reports Prevenar 13 Met Primary, Secondary Objectives in CAPTA

            Pfizer Inc. (NYSE: PFE) presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

            CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) also met both of its secondary study objectives –significant reduction in (i) non-bacteremic/non-invasive vaccine-type pneumococcal CAP and (ii) vaccine-type invasive pneumococcal disease (IPD).

            Regarding the study’s primary objective, there were 45.56 percent fewer first episodes of vaccine-type CAP among Prevenar 13-vaccinated subjects than in subjects who received placebo (P=0.0006). Regarding the study’s secondary objectives, the Prevenar 13 group experienced 45.00 percent fewer first episodes of non-bacteremic/non-invasive vaccine-type CAP (P=0.0067) and 75.00 percent fewer first episodes of vaccine-type IPD (P=0.0005) compared with the placebo group. The safety profile of Prevenar 13 in this study was consistent with studies previously conducted in adults.

            Additional data showed reductions in vaccine-type CAP, non-bacteremic/non-invasive vaccine-type CAP, and vaccine-type IPD for up to four years after vaccination among subjects who received Prevenar 13.

            “With the aging of the population, hospitalizations due to pneumococcal pneumonia represent a growing burden to public health systems. Evidence from this study is particularly important for a population in which age-related decline of the immune system makes it difficult to prevent disease,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer.

            “This study demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal,” said principal investigator Prof. Marc Bonten, professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences & Primary Care, University Medical Center Utrecht in the Netherlands.

            The CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study data will be an important part of any consideration of potential new or updated recommendations for Prevenar 13 in adults. Other key factors also are expected to be taken into consideration, including the current burden of pneumococcal disease in adults.

            About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)

            In 2011, Prevnar 13 was licensed by the U.S. Food and Drug Administration under an accelerated approval process to address an unmet medical need in older adults. As a requirement of the accelerated approval pathway, Pfizer conducted CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) to verify clinical benefit.

            This was a parallel-group, randomized, placebo-controlled, double-blind, single-center trial in which subjects aged 65 years and older were randomly assigned to receive a single dose of either Prevnar 13 or placebo. A total of 84,496 subjects were enrolled. The trial was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-eight sentinel hospitals were used for the surveillance of CAP and IPD.

            Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine. Non-bacteremic/noninvasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.

             

            關鍵詞:輝瑞,沛兒13,Prevenar 13,肺炎球菌,疫苗

            信息來源:生物谷

             


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