The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
The main questions it aims to answer are:
* How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine?
* How strong is the immune response after vaccination, and how many people show a noticeable boost in immune response?

开始日期2025-10-01

申办/合作机构

Emory University

[+1]

NCT05873751

/ CompletedN/A

Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study

Brief Summary:
The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.
This study looks at data records from a database in the United States.
This study includes patient's data from the database who:
* Are 15-30 years old.
* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.
This data has already been collected in the past and is being studied between April and June of 2023.

开始日期2023-04-24

申办/合作机构

Pfizer Inc.

NCT04893811

/ Completed临床4期

A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

开始日期2021-08-18

申办/合作机构

Pfizer Inc.

100 项与 B群脑膜炎球菌疫苗（辉瑞）相关的临床结果

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项与 B群脑膜炎球菌疫苗（辉瑞）相关的文献（医药）

2025-05-01·VACCINE

Molecular and WGS-based characterization of invasive Neisseria meningitidis isolates collected in Belgium (2016–2022) and MenB-FHbp vaccine coverage estimation of serogroup B

Article

作者: Bogaerts, Bert ; Goeders, Nathalie ; Mattheus, Wesley ; Roosens, Nancy H C ; Vanneste, Kevin

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis can result in life-threatening meningitis and septicaemia. There are twelve serogroups of N. meningitidis, but most cases of IMD are caused by serogroups A, B, C, W, X and Y. In Europe, serogroup B (MenB) accounts for 51 % of documented cases as recently reported by the European Centre for Disease Prevention and Control (ECDC). As a major cause of IMD, genomic surveillance of circulating MenB strains and assessment of the potential impact of vaccination programs could help inform public health policy. In this study, a collection of 493 strains was analysed, collected in Belgium by the National Reference Centre between 2016 and 2022. Slide agglutination was used for serogroup determination and whole genome sequencing (WGS) was used to further characterize these strains. The observed serogroups were: MenB (n = 281), MenY (n = 95), MenW (n = 83), MenC (n = 30), non-groupable isolates (n = 2), MenE (n = 1) and MenX (n = 1). A higher prevalence of MenY and MenW was observed in older adults. MenB isolates were grouped into 110 sequence types (STs), 89 of which belonged to 16 clonal complexes (CCs). Coverage of the MenB-FHbp vaccine (Trumenba, bivalent rLP2086; Pfizer Inc., New York, NY, USA ipv Philadelphia) was predicted using the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) index. Of the 281 MenB strains collected between 2016 and 2022, 89.1 % (lower limit - upper limit: 78.6-100.0 %) were predicted by MenDeVAR to be covered by the vaccine. This study highlights the benefits of a pathogen surveillance program and the need for experimental characterization of continuously evolving antigenic variants.

2024-09-01·LANCET INFECTIOUS DISEASES

Use of a meningococcal group B vaccine (4CMenB) in populations at high risk of gonorrhoea in the UK

Review

作者: White, Peter J ; Folkard, Kate ; Fifer, Helen ; Andrews, Nick ; Mandal, Sema ; Campbell, Helen ; Ramsay, Mary E ; Drisdale-Gordon, Lana ; Saunders, John ; Callan, Emma ; Mohammed, Hamish ; Borrow, Ray ; Ladhani, Shamez N ; Sinka, Katy ; Bhopal, Sunil

The meningococcal group B vaccine, 4CMenB, is a broad-spectrum, recombinant protein vaccine that is licensed for protection against meningococcal group B disease in children and adults. Over the past decade, several observational studies supported by laboratory studies have reported protection by 4CMenB against gonorrhoea, a sexually transmitted infection caused by Neisseria gonorrhoeae. Gonorrhoea is a major global public health problem, with rising numbers of diagnoses and increasing resistance to multiple antibiotics. In England, more than 82 000 cases of gonorrhoea were diagnosed in 2022, with nearly half of the cases diagnosed among gay, bisexual, and other men who have sex with men. There are currently no licensed vaccines against gonorrhoea but 4CMenB is estimated to provide 33-47% protection against gonorrhoea. On Nov 10, 2023, the UK Joint Scientific Committee on Vaccination and Immunisation agreed that a targeted programme should be initiated using 4CMenB to prevent gonorrhoea among individuals at higher risk of infection attending sexual health services in the UK. This decision was made after reviewing evidence from retrospective and prospective observational studies, laboratory and clinical data, national surveillance reports, and health economic analyses. In this Review, we summarise the epidemiology of invasive meningococcal disease and gonorrhoea in England, the evidence supporting the use of 4CMenB for protection against gonorrhoea, and the data needed to inform long-term programme planning and extension to the wider population.

2023-12-31·Expert review of vaccines

Invasive meningococcal disease epidemiology and vaccination strategies in four Southern European countries: a review of the available data

Review

作者: Iantomasi, Raffaella ; Montuori, Eva Agostina ; Detsis, Marios ; Zografaki, Irini ; Maia, Ana ; Mendez, Cristina ; Del Amo, Maria

INTRODUCTION:

Invasive meningococcal disease (IMD) is a major health concern which can be prevented through vaccination. Conjugate vaccines against serogroups A, C, W, and Y and two protein-based vaccines against serogroup B are currently available in the European Union.

AREAS COVERED:

We present epidemiologic data for Italy, Portugal, Greece, and Spain using publicly available reports from national reference laboratories and national or regional immunization programs (1999-2019), aiming to confirm risk groups, and describe time trends in overall incidence and serogroup distribution, as well as impact of immunization. Analysis of circulating MenB isolates in terms of the surface factor H binding protein (fHbp) using PubMLST is discussed as fHbp represents an important MenB vaccine antigen. Predictions of potential reactivity of the two available MenB vaccines (MenB-fHbp and 4CMenB) with circulating MenB isolates are also provided as assessed using the recently developed MenDeVAR tool.

EXPERT OPINION:

Understanding dynamics of IMD and continued genomic surveillance are essential for evaluating vaccine effectiveness, but also prompting proactive immunization programs to prevent future outbreaks. Importantly, the successful design of further effective meningococcal vaccines to fight IMD relies on considering the unpredictable epidemiology of the disease and combining lessons learnt from capsule polysaccharide vaccines and protein-based vaccines.

项与 B群脑膜炎球菌疫苗（辉瑞）相关的新闻（医药）

2025-11-22

·生物制品圈

从实验室到全球接种：4CMenB 疫苗的十年逆袭之路

摘要：4CMenB 疫苗作为首款获批的广谱蛋白基B 群脑膜炎球菌（MenB）疫苗，上市已整整十年。如今它已在全球 50 多个国家注册使用，累计接种超 1 亿剂。真实世界数据证实，这款疫苗对侵袭性 MenB 疾病的保护效力达71%-95%，还能交叉防护 W 群等非 B 群脑膜炎球菌，甚至对淋病展现出中度保护效果。本文将拆解 4CMenB 疫苗的十年历程、保护效果、安全性，以及未来的接种普及方向，让你看懂这款 “全能疫苗” 的价值。一、什么是 4CMenB？一款 “打破僵局” 的脑膜炎疫苗说起脑膜炎，很多人只知道它凶险，却不知道背后的 “元凶” 之一是脑膜炎球菌。这类细菌分 A、B、C、W、Y、X 等多个血清群，其中 B 群（MenB）曾是防控难点 —— 因为它的多糖荚膜免疫原性差，还可能诱发自身免疫反应，传统多糖疫苗根本没用。直到 2013 年，4CMenB 疫苗（商品名 Bexsero）获批上市，才打破了这个僵局。它是首款广谱蛋白基 MenB 疫苗，核心成分包含三种重组蛋白抗原（NadA、NHBA、fHbp），再加上从新西兰流行株中提取的外膜囊泡（OMV），能针对不同 MenB 菌株产生保护，不像早期疫苗只对特定菌株有效。上市第二年，另一款二价 MenB 疫苗（MenB-FHbp）也获批，但 4CMenB 凭借更广的保护范围，成为全球多数国家的首选。截至目前，它已在 50 多个国家注册，其中 16 个国家将其纳入婴儿国家免疫规划，部分国家还覆盖青少年群体（图 1）。二、十年真实数据：4CMenB 的保护力有多强？一款疫苗的价值，终究要靠真实世界数据说话。过去十年，多个国家的接种数据，给 4CMenB 的保护力交出了亮眼答卷。1.对 MenB 疾病：保护效力最高达 95% 英国是最早将 4CMenB 纳入婴儿免疫规划的国家（2015 年）。数据显示，接种后 3 年内，符合接种条件的人群中 MenB 发病率下降 75%，相当于每 4 天就避免 1 例病例；意大利托斯卡纳地区的接种数据更惊人，4CMenB 对 MenB 疾病的保护效力达 93.6%；西班牙、葡萄牙的病例对照研究也证实，完成接种的儿童保护效力分别达 71%、79%。就连应对疫情暴发，4CMenB 也表现出色。加拿大魁北克曾出现 MenB 疫情，2014 年开展大规模接种后，目标人群发病率下降 96%，2014-2016 年甚至无新增病例；美国多所大学暴发 MenB 疫情时，接种 4CMenB 后也未再出现新病例。2.意外收获：交叉防护非 B 群脑膜炎球菌更惊喜的是，4CMenB 不仅防 B 群，还能对抗其他血清群。英国数据显示，接种 4CMenB 的婴儿群体中，W 群脑膜炎球菌病例减少 69%；西班牙研究证实，两剂 4CMenB 对所有血清群脑膜炎球菌病的保护效力达 76%，对非 B 群的保护力甚至达 92%。这是因为 4CMenB 的抗原成分，在非 B 群菌株中也有表达，能触发交叉免疫。3.隐藏技能：对淋病的中度保护脑膜炎球菌和淋球菌同属奈瑟菌属，而 4CMenB 中的 NHBA 抗原与淋球菌的同源蛋白高度相似。真实世界数据显示，这款疫苗对淋病有中度保护效果：加拿大魁北克接种后，淋球菌感染风险下降 59%；美国纽约、费城的研究证实，两剂 4CMenB 对淋病的保护效力达 40%；澳大利亚南澳的青少年群体中，保护效力也达 33.2%。虽然目前相关随机对照试验结果尚未完全达标，但考虑到淋病耐药问题日益严重，4CMenB 的这一潜力已被多国关注，纽约、英国等甚至已建议高风险人群接种（图 3c）。三、安全吗？十年接种的 “安心答卷” 疫苗的安全性，是家长和公众最关心的问题。4CMenB 的十年接种数据，给出了明确答案：其安全性与上市前的临床试验一致，无新增安全风险。上市前的临床试验覆盖超 6000 人，婴儿接种后最常见的反应是注射部位红肿、发热、烦躁，青少年和成人则多为乏力、头痛，这些反应与常规儿童疫苗类似。需要注意的是，4CMenB 与其他常规疫苗同时接种时，发热风险会略升高（约 51%-61%），但提前用对乙酰氨基酚预防，能大幅降低发热概率，且不影响疫苗效果。大规模接种后的监测数据更有说服力：英国接种超 129 万婴儿、300 万剂次，未发现严重安全问题；澳大利亚为 3 万多名青少年接种后，不良反应报告率仅 0.33%，且均为轻微反应；法国、德国、意大利等国的上市后监测，也未发现与疫苗相关的严重不良反应。少数研究提到接种后癫痫、热性惊厥风险略有上升，但因 4CMenB 常与其他疫苗同接种，无法确定具体诱因，且整体风险极低（图 3b）。四、谁该接种？这些人群别错过目前 4CMenB 的接种推荐，主要围绕 MenB 疾病高发人群：婴儿：是核心接种人群，全球 16 个国家将其纳入婴儿免疫规划，因为婴儿是 MenB 疾病最高发的群体，且重症风险最高；青少年/年轻成人：这是 MenB 疾病的第二个高发高峰，捷克、瑞士、法国等已将其纳入接种范围，美国推荐 16-23 岁人群基于临床决策接种；高风险人群：包括补体缺陷、脾切除/脾功能异常、HIV 感染者等，这类人群患脑膜炎球菌病的风险是普通人的数倍，但目前接种率极低（美国补体缺陷人群接种率仅 4.6%）；老年人群：老年人患脑膜炎球菌病的病死率最高，且发病率呈上升趋势，未来也应纳入接种考量。不过目前各国接种政策差异较大，部分国家虽有流行病学证据支持，但因经费等问题未普及接种，导致不同人群、不同地区的接种可及性不均等 —— 这也是未来需要解决的核心问题。五、未来：让更多人享受到疫苗保护 4CMenB 的十年，是从 “实验室突破” 到 “全球应用” 的十年，但仍有不少挑战：提升接种可及性：需推动更多国家将 4CMenB 纳入免疫规划，尤其是低收入国家，同时缩小不同人群（如高风险人群、老年人）的接种差距；优化评估方法：传统的 hSBA 检测只能评估少数菌株，而新的 enc-hSBA 检测能利用接种者自身补体，评估 110 种全球代表性 MenB 菌株的保护效果，更贴近真实世界（图 7）；探索联合接种：4CMenB 与 MenACWY 疫苗同时接种，可覆盖 5 种主要脑膜炎球菌血清群，且无免疫干扰，未来可推广这种 “一站式” 接种方式；深入研究淋病保护效果：需开展更多临床试验，明确 4CMenB 对淋病的保护效力，为防控耐药淋病提供新方向。结语从2013年获批到 2024 年，4CMenB 用十年时间证明了自己的价值：不仅成为防控 MenB 疾病的 “主力军”，还展现出跨血清群、抗淋病的潜力。疫苗的终极目标是 “人人可及”，希望未来能有更多国家、更多人群，享受到这款疫苗带来的保护，让脑膜炎、淋病这类疾病的危害降到最低。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

2025-10-13

·Business Wire

Pfizer to Highlight Advancements in Respiratory Health and Infectious Disease Research at IDWeek 2025

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025. Data in 46 abstracts from company- and collaborator-led studies will showcase significant advancements in preventing and treating infectious diseases. “IDWeek 2025 offers a critical opportunity to highlight our cutting-edge scientific progress and collaborate with global health experts in our ongoing battle against infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “At Pfizer, we continue to prioritize innovation and rigorous data generation through clinical studies and real-world analysis supporting the vaccines and therapeutics for our infectious disease pipeline.” Presentations will include research from Pfizer’s diverse infectious disease portfolio, including COVID-19, respiratory syncytial virus (RSV), pneumococcal disease, Lyme disease, meningococcal disease, and other serious bacterial and viral infections. Details for the oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (ET) Location ORAL & LATE-BREAKING PRESENTATIONS Attitudes about COVID and Community Engagement with Patients (ACCEPt): Global Survey Reveals the Ongoing Impact of Long COVID-19 on Medically Vulnerable Populations, Five Years On R Paredes Oct 22 4:15 – 4:30PM B211-B212 Effectiveness of the JN.1-adapted BNT162b2 COVID-19 Vaccine in High-Risk Groups against Hospitalization in Europe: A Test-Negative Case-Control using the id.DRIVE Platform H Volkman Oct 21 1:45 – 3:00PM B401-B402 Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related Lower Respiratory Tract Disease (LRTD) Hospitalizations and Emergency Department Admissions over Two RSV Seasons—Kaiser Permanente of Southern California (KPSC), October 2023–April 2025 S Tartof Oct 20 3:15 – 4:30PM B401-B402 Immunosuppression and RSV Prefusion F Protein Vaccine Effectiveness in Older Adults: A Prespecified sub analysis from the DAN-RSV Trial A Jensen Oct 20 3:15 – 4:30PM B401-B402 POSTER PRESENTATIONS COVID-19 COVID-19 vaccine uptake in children aged 1 - 4 years from state vaccine registry data through March 2024 T Ahi Oct 22 12:15 PM Poster Hall B4-5 Public Health and Economic Impact of Increased Uptake of an Additional Dose of Pfizer-BioNTech KP.2-Adapted COVID-19 Vaccine, 2024-2025 Formula, Among US Adults ≥ 65 Years of Age A Yehoshua 12:15 PM Poster Hall B4-5 Physician Perceptions and Decision-Making Factors in Prescribing COVID-19 Antivirals: Qualitative Research Findings M Fernandez 12:15 PM Poster Hall B4-5 Ibuzatrelvir Potently Reduced Viral RNA Levels Despite the High Rate of Anti-S Seropositivity: a Post Hoc Analysis of Serology in the Phase 2b Study in Adults Without Risk Factors for Severe COVID-19 JH Kim 12:15 PM Poster Hall B4-5 Inpatient Burden of Respiratory Syncytial Virus, COVID-19, or Influenza in the United States Among Children < 5 Years of Age K Andersen 12:15 PM Poster Hall B4-5 Severity of Omicron COVID-19 variants: a global systematic literature review D Malhotra 12:15 PM Poster Hall B4-5 COVID-19 Case Attack Rate Differences by Vaccination Status and Vaccine Effectiveness among US Nursing Home Residents, October 5, 2024 to January 5, 2025 F Khan 12:15 PM Poster Hall B4-5 Invasive Group B Streptococcus (GBS) Invasive Group B Streptococcus among hospitalized pregnant and postpartum women, 2016-2024: a Unites States database study S Willis 12:15 PM Poster Hall B4-5 Long-Term Healthcare Utilization and Expenditures for Infants with Invasive Bacterial Infections During Birth Hospitalizations K Schley 12:15 PM Poster Hall B4-5 Lyme Disease Risk Perception and Communication about Lyme Disease Prevention by Healthcare providers: A Mixed-Methods Study N Patel 12:15 PM Poster Hall B4-5 Gestational Lyme disease incidence and pregnancy-related outcomes among women in the United States, 2015-2024 S Willis 12:15 PM Poster Hall B4-5 Healthcare Costs Associated With Lyme Disease Among Medicare Fee-for-Service Beneficiaries in the United States: A Retrospective Claims-Based Study H Yu 12:15 PM Poster Hall B4-5 Meningococcal Disease Need for Broad Protection Against Invasive Meningococcal Disease Among US College Students J Presa 12:15 PM Poster Hall B4-5 Characterization of Factor H Binding Protein Expression for Neisseria meningitidis Serogroup B Isolates, 2015–2022 K Weiss 12:15 PM Poster Hall B4-5 Clinical Development of MenABCWY (PenbrayaTM), a Broadly Protective Pentavalent Meningococcal Vaccine L Zoloras 12:15 PM Poster Hall B4-5 Utility of the Pentavalent MenABCWY Meningococcal Vaccine (PenbrayaTM) Within Alternative US Meningococcal Vaccination Schedules J Presa 12:15 PM Poster Hall B4-5 Ten-year retrospective review of medical records at five hospitals in the United States highlights the potential for under-detection of invasive meningococcal disease F Angulo 12:15 PM Poster Hall B4-5 Awareness, Attitudes and Perceptions of Meningococcal Vaccines among Caregivers of Adolescents in the United States J Presa 12:15 PM Poster Hall B4-5 Pneumococcal Disease Re-evaluating economic & health impact of PCV20 in adults using real-world effectiveness data J Vietri 12:15 PM Poster Hall B4-5 Invasive pneumococcal pneumonia: is bacteremia the appropriate indication of severity? P Peyrani 12:15 PM Poster Hall B4-5 Variability in Case-Ascertainment Methodology and Rates of Adult Invasive Pneumococcal Disease using a US Healthcare Claims Database A Miles 12:15 PM Poster Hall B4-5 Temporal Trends in Rates of Hospitalized Pneumonia among US Adults and Residual Disparities by Race and Socioeconomic Status A Miles 12:15 PM Poster Hall B4-5 Demographic and Clinical Characteristics, by Pneumococcal Serotype, of Adults Hospitalized with Community Acquired Pneumonia in the US L Grant 12:15 PM Poster Hall B4-5 Differences in invasive pneumococcal disease clinical presentations and serotype distribution among children with and without underlying risk factors K Hulten 12:15 PM Poster Hall B4-5 Nasopharyngeal Colonization in South Texas Children Less Than 6 Years of Age With or Without Lower Respiratory Tract Infections K Hulten 12:15 PM Poster Hall B4-5 Real-world effectiveness of 20-valent pneumococcal conjugate vaccine among adults 65-74, 75-84, and ≥85 years of age in the United States A Miles 12:15 PM Poster Hall B4-5 Uptake and Series Completion with Pneumococcal Conjugate Vaccine by Social Determinants of Health among Children in the United States A Miles 12:15 PM Poster Hall B4-5 Influenza Symptom Burden During the First Week of Acute Influenza Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study during the 2024/25 Season T Hu 12:15 PM Poster Hall B4-5 The Burden of Influenza on Health-Related Quality of Life and Work Productivity During the First Week of infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study T Hu 12:15 PM Poster Hall B4-5 The Socioeconomic Value of Adult Respiratory Vaccination in the United States: A Benefit-Cost Analysis T Hu 12:15 PM Poster Hall B4-5 Respiratory Syncytial Virus (RSV) How do recent population-level RSVpreF vaccine impact results from the United Kingdom relate to previously reported vaccine effectiveness results? N Aliabadi 12:15 PM Poster Hall B4-5 Bivalent RSV Prefusion F-Based Subunit Vaccine Recipients with Chronic Kidney Disease Achieved High Neutralizing Titers One Month After Vaccination F Rahman 12:15 PM Poster Hall B4-5 Immunogenicity and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Non-Pregnant HIV Infected Older Adults T Mikati 12:15 PM Poster Hall B4-5 Estimating Risk of Guillain-Barré Syndrome in US Medicare-Enrolled Older Adults Following Medically Attended Respiratory Syncytial Virus Disease: A Self-Controlled Case Series Analysis C Liang 12:15 PM Poster Hall B4-5 Time to Testing, Diagnosis, and Hospitalization Among Pediatric and Adult Patients with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Time-Series Model Estimation of RSV-Attributable Respiratory Hospitalizations and Mortality in Adults in Finland C Liang 12:15 PM Poster Hall B4-5 Burden of Hospitalizations Due to Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age and Those with Congestive Heart Failure or Chronic Obstructive Pulmonary Disease Exacerbations A Tippett 12:15 PM Poster Hall B4-5 What if Adult RSV Vaccine Uptake in the US was High Like in Scotland? Missed Opportunities to Reduce Public Health and Economic Burden of RSV R Sato 12:15 PM Poster Hall B4-5 Strategies to promote adult vaccination against respiratory pathogens: a narrative literature review E Williams 12:15 PM Poster Hall B4-5 Attributes of Point-of-Care Nucleic Acid Amplification Tests for Respiratory Syncytial Virus (RSV): Results of a Systematic Literature Review K Date 12:15 PM Poster Hall B4-5 RSV Signs and Symptoms at Time of Hospitalization among Pediatric and Adult Population with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Tick-Borne Encephalitis (TBE) Tick-borne encephalitis (TBE) in international travelers and TBE vaccine recommendations for travelers to Europe F Angulo 12:15 PM Poster Hall B4-5 Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com. Please see full Prescribing Information for COMIRNATY® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com. Please see full Prescribing Information including BOXED WARNING for PAXLOVIDTM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com. Please see full Prescribing Information for PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com. Please see full Prescribing Information for PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) or visit https://penbraya.pfizerpro.com. Please see full Prescribing Information for TRUMENBA® (Meningococcal Group B Vaccine) or visit https://trumenba.pfizerpro.com. Please see full Prescribing Information for TICOVAC™. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of October 13, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations, including uncertainties related to the potential impact of narrowing recommended patient populations; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

疫苗临床结果临床2期

2025-06-16

·PRNewswire

Solu Therapeutics Appoints Enda Moran, PhD, MBA as Chief Operating Officer

BOSTON, June 16, 2025 /PRNewswire/ -- Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced the appointment of Enda Moran, PhD, MBA as Chief Operating Officer (COO). "As we advance our Phase 1 clinical trial of STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies, Enda brings outstanding experience in large-scale biomanufacturing and company operations to our leadership team," said Philip J. Vickers, President and CEO of Solu Therapeutics. "His expertise in scaling biologic therapeutics and guiding early-stage programs through development will be instrumental as we grow and work to deliver transformative therapies for patients living with cancer, immunological diseases and other serious illnesses." As COO, Dr. Moran will lead core operational functions at Solu including chemistry manufacturing and controls (CMC), quality, program management, IT, and facilities management. He will also play a key role in building the infrastructure needed to support Solu's CyTAC™ (Cytotoxicity Targeting Chimera) and TicTAC™ (Therapeutic Index Control Targeting Chimera) platforms as the company progresses toward multiple clinical and regulatory milestones. "I am very excited to join the Solu Therapeutics team at this pivotal moment as the company moves into a new phase of growth," said Dr. Moran. "The CyTAC and TicTAC platforms are rooted in strong science and have the potential to change the landscape for patients who are desperately in need of new treatment options. I look forward to applying my experience to maximize the potential of these platforms and bring a new generation of innovative therapies to the patients who need them most." Dr. Moran has over three decades of experience leading biomanufacturing and technical development across pharma and biotech. He previously held senior scientific roles at GSK and Wyeth before joining Pfizer as Senior Director of Biomanufacturing, where he led global teams supporting the development and production of successful commercial therapies including Enbrel®, Trumenba®, Xyntha®, and the Prevnar®13 vaccine. He later joined Northern Biologics as Vice President and Head of CMC and Manufacturing, where he was instrumental in advancing multiple development programs and enabling the strategic acquisition of assets by AstraZeneca and Boehringer Ingelheim. Most recently, he served as CEO of Matrivax, leading a successful corporate restructuring and completion of a Phase 1 clinical trial. About Solu Therapeutics Solu Therapeutics is a biotechnology company cofounded by Longwood Fund and committed to developing an innovative class of therapeutic agents that uniquely pair small molecules with monoclonal antibodies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas. By leveraging its proprietary CyTAC (Cytotoxicity Targeting Chimera) and TicTAC (Therapeutic Index Control Targeting Chimera) platforms, Solu is advancing therapies that combine the target-binding capability of small molecules with the therapeutic power of biologics. Our lead product candidate, STX-0712, is currently in Phase 1 clinical development for the treatment of advanced hematologic malignancies including CMML. For more information, visit . Media Contact Holly Stevens [email protected] CG Life SOURCE Solu Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期高管变更疫苗

100 项与 B群脑膜炎球菌疫苗（辉瑞）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH09	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
流行性脑脊髓膜炎	澳大利亚	Pfizer Australia Pty Ltd.	2017-09-14
Invasive meningococcal disease	欧盟	Pfizer Europe MA EEIG	2017-05-24
Invasive meningococcal disease	冰岛	Pfizer Europe MA EEIG	2017-05-24
Invasive meningococcal disease	列支敦士登	Pfizer Europe MA EEIG	2017-05-24
Invasive meningococcal disease	挪威	Pfizer Europe MA EEIG	2017-05-24
脑膜炎球菌感染	美国	Wyeth Pharmaceuticals LLC	2014-10-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
脑膜炎	临床2期	澳大利亚	Pfizer Inc.	2006-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02531698 (CTgov)	临床2期	脑膜炎球菌感染	400	rLP2086 (Group 1 Bivalent rLP2086 (>=24 Months to <4 Years))	製齋製膚齋觸顧觸壓醖 = 膚簾齋窪淵鹹簾製鹹範顧築窪廠鹹鹹餘淵網醖 (廠鹹顧選壓糧壓選鑰鹹, 夢製鏇遞膚壓繭齋糧壓 ~ 衊夢襯獵積獵顧齋遞願) 更多	-	2018-03-27
				rLP2086 (Group 1 Bivalent rLP2086 (>=4 Years to <10 Years))	製齋製膚齋觸顧觸壓醖 = 鹽鏇壓製鏇積窪網簾壓顧築窪廠鹹鹹餘淵網醖 (廠鹹顧選壓糧壓選鑰鹹, 夢膚糧艱願築憲觸鏇鏇 ~ 憲範繭餘夢觸願餘選顧) 更多
NCT01461980 (CTgov)	临床2期	脑膜炎球菌感染	2,648	pertussis (Tdap) vaccine+Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine (MCV4+Tdap+rLP2086)	廠範鬱範構壓鑰餘鬱鹽(餘鹹積膚憲鬱糧艱鹹蓋) = 壓積糧壓網艱觸範襯鏇積鏇網醖膚淵範壓願夢 (範廠廠構顧簾襯網遞襯, 膚夢構製壓獵夢窪網鹹 ~ 夢壓膚築夢淵構艱襯顧) 更多	-	2015-05-25
				Tdap+MCV4 (MCV4+Tdap+Saline)	廠範鬱範構壓鑰餘鬱鹽(餘鹹積膚憲鬱糧艱鹹蓋) = 齋壓壓壓醖鬱廠簾衊觸積鏇網醖膚淵範壓願夢 (範廠廠構顧簾襯網遞襯, 膚齋蓋膚餘夢蓋淵構艱 ~ 鹽衊餘醖築鬱鏇鹽鹹憲) 更多
NCT01352793 (CTgov)	临床3期	流行性脑脊髓膜炎	5,715	Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine (Group 1: rLP2086)	鹽齋餘夢膚夢構觸壓鹹 = 繭衊獵築糧壓鑰糧膚獵網鹽選衊製衊憲鏇顧襯 (壓蓋襯餘衊鑰壓艱窪廠, 廠獵選襯獵選襯廠艱鬱 ~ 鹽選積繭獵夢壓獵範壓) 更多	-	2015-03-11
				HAV (Group 2: HAV/Saline/HAV)	鹽齋餘夢膚夢構觸壓鹹 = 糧鹹憲構遞築醖遞觸獵網鹽選衊製衊憲鏇顧襯 (壓蓋襯餘衊鑰壓艱窪廠, 壓觸範鬱遞齋遞願製繭 ~ 鏇憲壓顧淵鏇鑰窪鹽艱) 更多
NCT01768117 (B1971042, CTgov)	临床2期	流行性脑脊髓膜炎	13	rLP2086	遞選糧淵築蓋醖構襯衊 = 蓋繭憲壓顧鏇淵積遞顧蓋願淵簾淵範選齋觸範 (餘製選糧獵壓鬱淵願鹽, 願繭顧願艱夢網選襯網 ~ 鹹窪窪淵膚蓋範製鹽選) 更多	-	2015-03-09
NCT00798304 (CTgov)	临床2期	流行性脑脊髓膜炎	46	InfanrixHexa+Rotarix+Prevenar+Meningitec (Control)	蓋繭觸壓範廠遞繭範齋 = 襯醖製鬱範製廠糧醖艱淵鏇範糧醖糧獵網膚衊 (夢顧鹹鑰鹽選醖願餘淵, 醖膚願積製壓構構鏇膚 ~ 鑰製膚餘蓋鏇齋觸網醖) 更多	-	2014-11-26
				Recombinant lipoprotein 2086 (rLP2086) (rLP2086 20 mcg)	蓋繭觸壓範廠遞繭範齋 = 觸憲積築膚鹽簾願鏇構淵鏇範糧醖糧獵網膚衊 (夢顧鹹鑰鹽選醖願餘淵, 蓋顧積餘夢鏇觸憲繭醖 ~ 鏇遞鏇齋鹹選繭遞遞膚) 更多
NCT01323270 (CTgov)	临床2期	流行性脑脊髓膜炎	753	Repevax (Group 1: rLP2086 + Repevax)	膚淵範鏇膚選憲範齋選 = 餘範範襯襯選獵積選獵網鏇構築齋顧遞鏇鑰鬱 (願襯蓋夢艱鹹膚廠網蓋, 製選壓憲獵願觸鏇鏇獵 ~ 鹽糧鏇鬱願觸製蓋襯襯) 更多	-	2014-11-26
				Saline+Repevax (Group 2: Saline+Repevax)	膚淵範鏇膚選憲範齋選 = 範鹹鏇簾齋簾鏇鏇鑰網網鏇構築齋顧遞鏇鑰鬱 (願襯蓋夢艱鹹膚廠網蓋, 鹹製獵餘齋顧鹽糧壓繭 ~ 鑰選築廠觸製蓋構齋積) 更多
NCT01461993 (CTgov)	临床2期	脑膜炎球菌感染	2,499	Gardasil (Group 1: rLP2086 + Gardasil)	願鏇衊選鹹夢積繭顧襯(衊鑰齋淵蓋遞壓襯鹽餘) = 範鬱簾餘積鏇淵顧鏇願構廠願簾餘齋廠鏇餘遞 (顧蓋鹹鏇鏇艱鏇遞餘糧, 壓製壓選淵鏇鹽範顧願 ~ 淵艱鬱觸壓獵顧淵鹹鏇) 更多	-	2014-11-26
				Saline+Gardasil (Group 3: Saline + Gardasil)	願鏇衊選鹹夢積繭顧襯(衊鑰齋淵蓋遞壓襯鹽餘) = 選構鏇窪蓋膚窪選顧選構廠願簾餘齋廠鏇餘遞 (顧蓋鹹鏇鏇艱鏇遞餘糧, 觸夢遞壓餘淵鹽夢糧獵 ~ 憲衊範簾廠網憲襯艱築) 更多
NCT00798304 (Pubmed \| Vaccine)	临床1/2期	-	46	rLP2086 vaccine at 20-μg dose	窪範夢壓襯窪窪衊構選(糧餘醖膚襯遞衊醖積構) = 壓積壓鹹鹹遞顧鑰築夢構壓艱繭積鑰簾衊構壓 (餘鏇膚鑰壓遞鹹窪淵淵 )	-	2014-09-08
				rLP2086 vaccine at 60-μg dose	窪範夢壓襯窪窪衊構選(糧餘醖膚襯遞衊醖積構) = 醖繭醖艱鬱膚廠膚糧夢構壓艱繭積鑰簾衊構壓 (餘鏇膚鑰壓遞鹹窪淵淵 )