RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Barcelona, Spain.

新泽西州拉赫韦（商业新闻短讯）--默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，今天在西班牙巴塞罗那举行的第34届欧洲临床微生物学和传染病学会（ESCMID Global）上宣布了STRIDE-10的结果，STRIDE-10是一项评估V116（该公司的研究性成人特异性21价肺炎球菌结合疫苗）的3期试验。

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine..

该试验评估了V116与PPSV23（肺炎球菌疫苗，多价[23价]）相比在50岁及以上未接种肺炎球菌疫苗的成年人中的免疫原性，耐受性和安全性。。

Key results from the study include:

该研究的主要结果包括：

V116 elicited immune responses that were noninferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30.

在第30天通过血清型特异性调理吞噬活性（OPA）几何平均滴度（GMT）测量，V116引发的免疫应答与两种疫苗共有的12种血清型（或菌株）的PPSV23相比并不劣于PPSV23。

Immune responses elicited by V116 were superior for the nine serotypes included in V116 but not PPSV23, as measured by OPA GMT ratios at Day 30, and superior for eight of nine serotypes unique to V116 compared to PPSV23, as measured by the proportions of participants with ≥4-fold rise in immune responses..

通过第30天的OPA-GMT比率测量，V116引发的免疫反应优于V116中包含的9种血清型，而不是PPSV23，并且与PPSV23相比，V116特有的9种血清型中的8种优于PPSV23，这是通过免疫反应增加≥4倍的参与者的比例来衡量的。。

V116 had a safety profile comparable to PPSV23.

V116的安全性与PPSV23相当。

These data build upon Phase 3 trial results that were presented at this year’s Meeting of the International Society of Pneumonia and Pneumococcal Diseases and the 2023 World Vaccine Congress West Coast.

这些数据建立在今年国际肺炎和肺炎球菌病学会会议和西海岸2023年世界疫苗大会上提交的第三阶段试验结果的基础上。

“Invasive pneumococcal disease and pneumococcal pneumonia represent significant public health challenges, particularly among older adult populations and those with risk conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee.

埃默里大学医学、流行病学、全球健康和儿科荣誉退休教授兼默克公司科学咨询委员会成员沃尔特·奥伦斯坦博士说：“侵袭性肺炎球菌病和肺炎球菌肺炎代表着重大的公共卫生挑战，尤其是在老年人群和有风险的人群中。”。

“These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.”.

“这些阳性结果表明，V116有可能帮助预防成年人群中的侵袭性肺炎球菌疾病。”。

“Even with the availability of current pneumococcal conjugate vaccines for adults, gaps in serotype coverage for invasive pneumococcal disease persist,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These data add to the evidence supporting the potential for V116 to become an important new preventative option for adults, with results showing V116 elicited immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.”.

默克研究实验室高级副总裁、全球临床开发负责人兼首席医疗官Eliav Barr博士说：“即使目前成人可以使用肺炎球菌结合疫苗，侵袭性肺炎球菌疾病的血清型覆盖率仍然存在差距。”。“这些数据增加了支持V116成为成人重要的新预防选择的可能性的证据，结果显示V116引发了对大多数成人侵袭性肺炎球菌疾病负责的血清型的免疫反应。”。

In addition to the clinical data on V116, Merck also presented findings that suggest V116 may help to reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in France, Sweden, Spain, and the Netherlands.

除了V116的临床数据外，默克公司还提出了一些发现，表明V116可能有助于减轻法国、瑞典、西班牙和荷兰成年人与侵袭性肺炎球菌疾病和非细菌性肺炎球菌肺炎相关的健康和经济负担。

V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S.

V116目前正在接受美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）的审查。FDA批准V116优先审查，并于2024年6月17日颁布《处方药使用费法案》（PDUFA）或目标行动日期。V116专门用于帮助保护成年人免受侵袭性肺炎球菌疾病的侵害；据美国统计，V116血清型约占65岁及以上成人侵袭性肺炎球菌疾病的83%。

Centers for Disease Control and Prevention data from 2018-2021. An overview of the V116 late-stage development program is available here..

疾病控制和预防中心2018-2021年的数据。此处提供了V116后期开发计划的概述。。

Summary of Findings from Select Studies Presented at ESCMID

ESCMID上提交的部分研究结果摘要

Data from STRIDE-10 (Abstract #353)

STRIDE-10的数据（摘要#353）

STRIDE-10 (NCT05569954) is a Phase 3, randomized, double-blind, active comparator-controlled study evaluating the immunogenicity, tolerability and safety of V116 compared to PPSV23 in adults 50 years of age and older who had not previously received pneumococcal vaccine (n=1,484). Participants were randomized to receive a single dose of either V116 or PPSV23..

STRIDE-10（NCT05569954）是一项3期，随机，双盲，主动比较对照研究，评估V116与PPSV23相比在50岁及以上未接受过肺炎球菌疫苗的成年人中的免疫原性，耐受性和安全性（n=1484）。参与者被随机分配接受单剂量的V116或PPSV23。。

The primary objectives included serotype-specific OPA GMTs 30 days post-vaccination and percentage of participants with greater than or equal to four-fold rise from baseline in serotype-specific OPAs. Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs).

主要目标包括疫苗接种后30天血清型特异性OPA GMT，以及血清型特异性OPA从基线上升大于或等于四倍的参与者百分比。在基线和接种后30天测量血清型特异性OPA反应。安全性评估为不良事件（AE）参与者的比例。

Results demonstrated that:.

结果表明：。

V116 elicited noninferior immune responses for the 12 serotypes (or strains) shared with PPSV23 (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F), as measured by serotype-specific OPA GMTs 30 days post-vaccination;

V116对与PPSV23（3,7F，8,9N，10A，11A，12F，17F，19A，20A，22F，33F）共享的12种血清型（或菌株）引发非劣效免疫应答，如通过血清型特异性OPA GMT所测量的接种后30天；

V116 elicited superior immune responses for the nine serotypes only covered by V116 and not PPSV23 (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMT ratios 30 days post-vaccination;

通过疫苗接种后30天的血清型特异性OPA-GMT比率评估，V116对仅由V116而非PPSV23（6A，15A，15C，16F，23A，23B，24F，3135B）覆盖的9种血清型引发了优异的免疫应答；

The proportion of patients with ≥4-fold rise in OPA GMT ratios from Day 1 to Day 30 for serotype-specific OPA for V116 was superior to PPSV23 for eight out of nine serotypes unique to V116 compared to PPSV23;

与PPSV23相比，V116血清型特异性OPA从第1天到第30天OPA-GMT比值升高≥4倍的患者比例优于PPSV23，V116特有的9种血清型中有8种优于PPSV23；

V116 had a comparable safety profile to PPSV23.

V116的安全性与PPSV23相当。

Data from Health and Economic Burden of Disease Studies (Abstract #7201, Abstract #2784, Abstract #2738, and Abstract #2843)

来自疾病健康和经济负担研究的数据（摘要#7201、摘要#2784、摘要#2738和摘要#2843）

Four studies were conducted to quantify the health and economic burden of invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia attributable to V116 and PCV20 (pneumococcal 20-valent conjugate vaccine) serotypes among adults in France, Sweden, Spain, and the Netherlands. Across the studies, results showed that when compared with PCV20, V116 serotypes were associated with considerably higher health and economic burden in France, Sweden, Spain, and the Netherlands––the difference is driven largely by the eight unique V116 serotypes not in any currently approved pneumococcal vaccine, suggesting V116 may help reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in these countries..

进行了四项研究，以量化法国，瑞典，西班牙和荷兰成年人中V116和PCV20（肺炎球菌20价结合疫苗）血清型引起的侵袭性肺炎球菌疾病和非细菌性肺炎球菌肺炎的健康和经济负担。在整个研究中，结果表明，与PCV20相比，V116血清型在法国、瑞典、西班牙和荷兰的健康和经济负担要高得多-这种差异主要是由目前任何批准的肺炎球菌疫苗中都没有的八种独特的V116血清型所驱动的，这表明V116可能有助于减轻这些国家成年人与侵袭性肺炎球菌病和非菌血症性肺炎球菌肺炎相关的健康和经济负担。。

About V116

关于V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes not in any currently approved pneumococcal vaccine (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) which account for approximately 30% of adult invasive pneumococcal disease, according to CDC data from 2018-2021.

V116是一种研究性的21价肺炎球菌结合疫苗，处于3期开发阶段，用于预防成年人群的侵袭性肺炎球菌疾病和肺炎球菌肺炎。根据CDC 2018-2021年的数据，V116专门用于解决主要导致成人肺炎球菌疾病的肺炎链球菌血清型，包括目前任何批准的肺炎球菌疫苗（15A，15C，16F，23A，23B，24F，31和35B）中没有的八种独特血清型，约占成人侵袭性肺炎球菌疾病的30%。

The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data. V116 is designed to be administered as a single dose to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults..

根据CDC的相同数据，V116所涵盖的血清型约占65岁及以上人群侵袭性肺炎球菌疾病的83%。V116被设计为单剂量给药，以帮助预防成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。。

The V116 Phase 3 program includes multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).

V116第三阶段计划包括多项研究，包括STRIDE-3（NCT05425732），STRIDE-4（NCT05464420），STRIDE-5（NCT05526716），STRIDE-6（NCT05420961），STRIDE-7（NCT05393037），STRIDE-8（NCT05696080），STRIDE-9（NCT05633992）和STRIDE-10（NCT05569954）。

Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)

肺炎球菌23（肺炎球菌疫苗多价）的适应症

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).

PNEUMOVAX 23是一种用于主动免疫的疫苗，用于预防由疫苗中包含的23种血清型（1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19F、19A、20、22F、23F和33F）引起的肺炎球菌疾病。

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23被批准用于50岁或以上的人和年龄≥2岁的肺炎球菌疾病风险增加的人。

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

PNEUMOVAX 23不能预防由疫苗中包含的肺炎球菌以外的荚膜型肺炎球菌引起的疾病。

Select Safety Information for PNEUMOVAX 23

选择PNEUMOVAX 23的安全信息

PNEUMOVAX 23 is contraindicated in individuals with a history of a hypersensitivity reaction to any component of PNEUMOVAX 23.

PNEUMOVAX 23禁用于对PNEUMOVAX 23的任何成分有超敏反应史的个体。

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

不要向对疫苗的任何成分有超敏反应史的个体施用PNEUMOVAX 23。

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

中度或重度急性疾病患者推迟接种肺炎球菌23。

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

对于心血管和/或肺功能严重受损且全身反应会带来重大风险的个体，在使用PNEUMOVAX 23时要谨慎和适当小心。

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

妊娠期肺炎23型临床试验的可用人体数据尚未确定是否存在与疫苗相关的风险。

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

由于老年人可能无法像年轻人一样忍受医疗干预，因此不能排除某些老年人的反应频率更高和/或更严重。

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

免疫功能低下的人，包括接受免疫抑制治疗的人，可能对肺炎球菌23的免疫反应减弱。

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.

对于先天性病变，颅骨骨折或神经外科手术导致慢性脑脊液（CSF）渗漏的患者，PNEUMOVAX 23可能无法有效预防肺炎球菌性脑膜炎。

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

在临床试验中首次接种PNEUMOVAX 23疫苗的受试者中，最常见的不良反应是：注射部位疼痛/酸痛/压痛，注射部位肿胀/硬结，头痛，注射部位红斑，虚弱和疲劳，以及肌痛。

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

对于临床研究中年龄在65岁或以上的受试者，研究者确定与疫苗相关的全身不良反应在再次接种后比初次接种后更高。

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

接种肺炎球菌23可能无法提供100%的肺炎球菌感染保护。

About Pneumococcal Disease

关于肺炎球菌疾病

Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs)..

肺炎球菌病是由称为肺炎链球菌的细菌引起的感染。肺炎球菌有100多种不同类型（称为血清型），对成年人的影响与儿童不同。某些血清型可能会使更多人面临侵袭性肺炎球菌疾病的风险，例如菌血症（血液感染）；菌血症性肺炎（肺炎伴菌血症）；脑膜炎（脑部和脊髓覆盖物的感染），以及非侵入性肺炎（肺炎球菌疾病局限于肺部）。。

While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions (including diabetes, HIV, or heart, lung and liver diseases). Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older..

虽然健康成年人可能患有肺炎球菌疾病，但特别容易感染的患者人群包括老年人和某些慢性或免疫功能低下的健康状况（包括糖尿病，艾滋病毒或心脏，肺病和肝病）。侵袭性肺炎球菌病的死亡率在50岁及以上的成年人中最高。。

Merck’s Commitment to Pneumococcal Disease Protection

默克公司对肺炎球菌疾病保护的承诺

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups.

40多年来，默克一直站在通过疫苗接种预防肺炎球菌疾病的最前沿，并致力于帮助保护所有年龄段的人免受这种疾病的影响。默克正在进行的肺炎球菌疫苗开发计划旨在提供解决不同人群（包括婴儿和儿童，健康成年人和高危人群）特定需求的选择。

This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck’s pipeline, visit www.merck.com..

这种方法认识到，儿科和成人人群的疾病负担通常由不同的细菌菌株或血清型驱动，旨在通过提供针对对每个人群构成最大全球风险的血清型的疫苗选择来解决未满足的需求。欲了解有关默克公司管道的更多信息，请访问www.Merck.com。。

About Merck

默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司，今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。