Results of the first season of a randomized study showed adjuvanted and high-dose influenza vaccines did not differ in effectiveness against PCR-confirmed influenza.

一项随机研究的第一季度结果显示，佐剂和高剂量流感疫苗对PCR确诊的流感的有效性没有差异。

This is the first randomized study to evaluate the relative vaccine effectiveness of adjuvanted influenza vaccines compared to high-dose influenza vaccines for prevention of lab-confirmed influenza.

这是第一项评估佐剂流感疫苗与高剂量流感疫苗相比预防实验室确诊流感的相对疫苗有效性的随机研究。

SUMMIT, N.J., Oct. 18, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced the first season (2023-2024 influenza season) results of the first pragmatic randomized study to evaluate the relative vaccine effectiveness (rVE) of adjuvanted inactivated influenza vaccine (aIIV) compared to high-dose inactivated influenza vaccine (HD-IIV) for prevention of lab-confirmed influenza.

SUMMIT，N.J.，2024年10月18日/PRNewswire/--CSL（ASX:CSL）的企业CSL-Seqirus今天宣布了第一个实用随机研究的第一个季节（2023-2024流感季节）的结果，该研究旨在评估佐剂灭活流感疫苗（aIIV）与高剂量灭活流感疫苗（HD-IIV）相比预防实验室确诊流感的相对疫苗有效性（rVE）。

Results for the first season demonstrated that adjuvanted and high-dose influenza vaccines did not differ in effectiveness against Polymerase Chain Reaction (PCR)-confirmed influenza with a rVE of aIIV vs HD-IIV of 1.5% (95% confidence interval: -8.4 to 10.5) among adults 65 years of age and older. In addition, there was no difference in effectiveness between aIIV and HD-IIV for the prevention hospitalization or emergency department visits for PCR-confirmed influenza, and hospitalization for all-cause community-acquired pneumonia..

第一季的结果表明，佐剂和高剂量流感疫苗对聚合酶链反应（PCR）证实的流感的有效性没有差异，aIIV与HD-IIV的rVE为1.5%（95%置信区间：-8.4至10.5）在65岁及以上的成年人中。此外，aIIV和HD-IIV在预防PCR确诊流感住院或急诊就诊以及全因社区获得性肺炎住院方面的有效性没有差异。。

This study is a collaborative study between CSL Seqirus and a large health system. The data was presented during an oral presentation this week at the IDWeek 2024 conference taking place in Los Angeles, California from October 16-19, 2024.

这项研究是CSL-Seqirus与大型卫生系统之间的合作研究。这些数据是在本周于2024年10月16日至19日在加利福尼亚州洛杉矶举行的IDWeek 2024会议上的口头报告中提供的。

The current findings of this pragmatic study align with previous research based on diagnostic and test confirmed outcomes, systematic reviews and meta-analyses which have generally shown comparable effectiveness between aIIV and HD-IIV influenza vaccines. The findings also support the current U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommendation that preferentially recommends any adjuvanted or higher-dose influenza vaccines for adults 65 years of age and older..

这项实用研究的当前发现与先前基于诊断和测试证实结果，系统评价和荟萃分析的研究一致，这些研究通常显示aIIV和HD-IIV流感疫苗之间具有可比的有效性。这些发现也支持目前美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）的建议，该建议优先推荐65岁及以上成年人使用任何佐剂或更高剂量的流感疫苗。。

The collaborative study is being conducted as a two-season pragmatic randomized study with approximately 480,000 individuals 65 years of age and older anticipated each season throughout facilities within a large health system. The second season and pooled season analyses will be performed following the end of the 2024-2025 season..

这项合作研究是一项为期两个季度的实用随机研究，在大型卫生系统的整个设施中，预计每个季度约有480000名65岁及以上的人。第二季和汇总季分析将在2024-2025季结束后进行。。

'The findings of the first season of this study align with previous research based on diagnostic and test confirmed outcomes and systematic reviews and meta-analyses, which have shown comparable effectiveness between adjuvanted and high-dose influenza vaccines,' says Ian McGovern, Associate Director, Center of Outcomes Research and Epidemiology.

。

'Further, this data showcases the commitment of CSL Seqirus in generating high-quality real-world evidence data (RWE).'.

“此外，这些数据显示了CSL-Seqirus在产生高质量的真实世界证据数据（RWE）方面的承诺。”。

About the StudyThis study was a collaborative effort between CSL Seqirus and a large health maintenance organization within Northern California that both provides insurance and health care to their patient population.

关于这项研究，这项研究是CSL-Seqirus与北加利福尼亚州一家大型健康维护组织之间的合作，该组织为患者群体提供保险和医疗保健。

Individual medical facilities are randomized to administer either aIIV or HD-IIV and in alternating weeks which allowed individuals to be vaccinated as they would in routine clinical practice. Vaccinated individuals are tested for influenza per routine care using PCR for all tests.

个别医疗机构被随机分配给aIIV或HD-IIV，并在交替的几周内进行接种，这使得个人可以像常规临床实践中那样接种疫苗。使用PCR对所有测试进行常规护理，对接种疫苗的个体进行流感检测。

The study is designed to test the hypothesis that aIIV is non-inferior to HD-IIV, with a non-inferiority margin of -20% (i.e., lower bound of 95% CI needs to be above -20%). The primary outcome is PCR confirmed influenza in any setting. Secondary outcomes in each season include prevention of hospitalization or emergency department visits for PCR-confirmed influenza, and hospitalization for all-cause community-acquired pneumonia.

该研究旨在检验aIIV不劣于HD-IIV的假设，非劣效性边缘为-20%（即95%CI的下限需要高于-20%）。。每个季节的次要结果包括预防PCR确诊的流感住院或急诊就诊，以及全因社区获得性肺炎住院治疗。

A pooled analysis of the two seasons additionally includes the outcome of hospitalized PCR-confirmed influenza as well as analysis by age and risk groups..

对这两个季节的汇总分析还包括住院PCR确诊流感的结果以及按年龄和风险组进行的分析。。

A total of 429,600 individuals were enrolled in the study for the first season: 212,877 adjuvanted inactivated influenza vaccine (aIIV); 216,723 high-dose inactivated influenza vaccine (HD-IIV). The randomization combined with broad patient inclusion results in a more representative but still balanced study population compared to a typical clinical study..

第一季共有429600人参加了这项研究：212877佐剂灭活流感疫苗（aIIV）；216723高剂量流感灭活疫苗（HD-IIV）。与典型的临床研究相比，随机化与广泛的患者纳入相结合，可以产生更具代表性但仍然平衡的研究人群。。

The second season of the study is ongoing. Results may differ depending on the match between the vaccine and circulating influenza strains and other factors. This study was funded by CSL Seqirus. CSL Seqirus provided all the adjuvanted influenza vaccine doses to members of a large health system for this study..

该研究的第二季正在进行中。结果可能会有所不同，这取决于疫苗与流行流感病毒株之间的匹配程度以及其他因素。这项研究由CSL-Seqirus资助。CSL-Seqirus为这项研究的大型卫生系统成员提供了所有佐剂流感疫苗剂量。。

About Seasonal InfluenzaInfluenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.1 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.1 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.1 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there were an estimated 390,000-830,000 influenza-related hospitalizations in the U.S.2 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.3 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.3 The CDC recommends that for most people who need only 1 dose of influenza vaccine, vaccination should ideally happen in September or October.3.

关于季节性流感流感是一种常见的传染性季节性呼吸道疾病，可能会在某些人中引起严重疾病和危及生命的并发症。1流感可导致临床症状，从轻度至中度呼吸道疾病到严重并发症，住院治疗，在某些情况下甚至死亡。1由于流感病毒可能在症状出现前一天传播给他人，并且在患病后5至7天内传播给他人，因此该疾病很容易传播给他人。1疾病控制和预防中心（CDC）的初步估计显示，在2023/24流感季节，美国估计有390000-830000例与流感相关的住院治疗。2 CDC建议每年为6个月大的人接种疫苗。年龄较大，没有任何禁忌症。3由于接种疫苗后大约需要两周才能在体内产生抗体，从而有助于防止流感病毒感染，建议人们在流感开始在社区传播之前接种疫苗。3疾病预防控制中心建议，对于大多数只需要1剂流感疫苗的人，最好在9月或10月接种疫苗。

About CSL SeqirusCSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is a transcontinental partner in pandemic preparedness.

关于CSL-sequirus CSL-sequirus是CSL的一部分（ASX:CSL）。作为保护公共卫生的全球领导者和世界上最大的流感疫苗供应商之一，CSL-Sevirus致力于预防流感和新型冠状病毒等传染病，并且是大流行防范的跨洲合作伙伴。

With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus offers a broad portfolio of innovative, differentiated vaccines in more than 20 countries around the world..

凭借在美国、英国和澳大利亚拥有最先进的生产设施，以及领先的研发能力，CSL-Sevirus在全球20多个国家提供了广泛的创新、差异化疫苗组合。。

For more information about CSL Seqirus, visit www.CSL.com.

有关CSL-Seqirus的更多信息，请访问www.CSL.com。

About CSLCSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

关于CSLCSL（ASX:CSL；USOTC:CSLLY）是一家全球生物技术公司，拥有动态的救生药物组合，包括治疗血友病和免疫缺陷的药物，预防流感的疫苗以及缺铁和肾脏病的疗法。。

Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

如今，CSL（包括我们的三大业务：CSL Behring、CSL Sequirus和CSL Vifor）为100多个国家的患者提供救生产品，拥有32000名员工。我们独特的商业实力、研发重点和卓越运营相结合，使我们能够识别、开发和提供创新，使我们的患者能够过上最充实的生活。

For inspiring stories about the promise of biotechnology, visit csl.com/we-are-csl/vita-original-stories and follow us on x.com/CSL..

。。

For more information about CSL, visit www.CSL.com.

有关CSL的更多信息，请访问www.CSL.com。

Intended AudienceThis press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products..

意向受众本新闻稿由美国新泽西州Summit的CSL Sequirus发布，旨在提供有关我们全球业务的信息。请注意，与批准的CSL-Seqirus产品的批准状态和标签相关的信息可能因国家而异。请咨询当地监管机构关于CSL-Seqirus产品的批准状态。。

Forward-Looking StatementsThis press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements.

前瞻性声明本新闻稿可能包含前瞻性声明，包括有关未来结果、绩效或成就的声明。这些声明涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致我们的实际结果、业绩或成就与前瞻性声明中明示或暗示的任何未来结果、业绩或成就存在重大差异。

These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements..

这些声明反映了我们目前对未来事件的看法，并且基于假设，并且存在风险和不确定性。鉴于这些不确定性，您不应过度依赖这些前瞻性声明。。

MEDIA CONTACTTiffany Cody+1 (908) 370-1863Tiffany.Cody@Seqirus.com

媒体联系人Tiffany Cody+1（908）370-1863Tiffany.Cody@Seqirus.com

1 Centers for Disease Control and Prevention (CDC). Key Facts about Influenza. Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed October 2024.

1疾病控制和预防中心（CDC）。关于流感的关键事实。检索自：https://www.cdc.gov/flu/about/keyfacts.htm.2024年10月访问。

2 CDC. Preliminary Estimated Flu Disease Burden 2023–2024 Flu Season. Retrieved from: https://www.cdc.gov/flu-burden/php/data-vis/2023-2024.html. Accessed October 2024.

2 CDC。初步估计2023-2024年流感季节的流感疾病负担。检索自：https://www.cdc.gov/flu-burden/php/data-vis/2023-2024.html.2024年10月访问。

3 CDC. Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed October 2024.

3 CDC。谁需要流感疫苗以及何时需要。检索自：https://www.cdc.gov/flu/prevent/vaccinations.htm.2024年10月访问。

SOURCE CSL Seqirus

源CSL-Seqirus

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