Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population - IIV-407

开始日期2024-05-13

申办/合作机构-

NCT05873751 / RecruitingN/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.
Have enough months of data in the database.
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.

NCT04819113 / Completed临床3期

A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

开始日期2021-04-09

申办/合作机构

Pfizer Inc.

100 项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Impact of the COVID-19 pandemic on social media utilization, influences related to parental vaccine decision making, and opinions on trustworthy social media vaccination campaigns: A qualitative analysis

Article

作者: Fontenot, Holly B ; Glauberman, Gary ; Zimet, Gregory ; Michel, Alexandra ; Quist, Kevin M

There is a continued need for research to better understand the influence social media has on parental vaccination attitudes and behaviors, especially research capturing the effects of the COVID-19 pandemic. The goal of this study was to explore parents' perspectives related to the impact the pandemic had on 1) social media engagement, 2) vaccine messaging on social media, and 3) factors to guide future intervention development. Between February and March 2022, 6 online, synchronous, text-based focus groups were conducted with parents of adolescents aged 11 to 17 years. Participants who all utilized social media were recruited from across the United States. Qualitative data were analyzed using content analysis. A total of 64 parents participated. Average age was 47 years, and participants were predominantly White (71.9%), female (84.3%), and engaged with social media multiple times per day (51.6%). Participants (95.3%) viewed obtaining all recommended vaccines as important or very important; however, overall vaccination rates for their adolescents were varied (50% ≥1 dose HPV; 59.4% MenACWY; 78.1% Tdap; 65.6% Flu; 81.3% COVID-19). Three themes emerged highlighting the pandemic's impact on parent's (1) general patterns of social media use, (2) engagement about vaccines on social media and off-line behaviors related to vaccination, and (3) perspectives for developing a credible and trustworthy social media intervention about vaccination. Participants reported fatigue from contentious vaccine-related content on social media and desired future messaging to be from recognizable health institutions/associations with links to reputable resources. Plus, providers should continue to provide strong vaccine recommendations in clinic.

2024-05-03·BMC medicine

Driving delivery and uptake of catch-up vaccination among adolescent and adult migrants in UK general practice: a mixed methods pilot study.

Article

作者: Ciftci, Yusuf ; Crawshaw, Alison F ; Hargreaves, Sally ; Majeed, Azeem ; Goldsmith, Lucy P ; Wurie, Fatima ; Aspray, Nathaniel ; Fyle, Desiree ; Yong, Joanna ; Hayward, Sally E ; Lau, Karen ; Forster, Alice S ; Iwami, Michiyo ; Knights, Felicity ; Carter, Jessica ; Seedat, Farah ; Deal, Anna

BACKGROUNDMigrants in the UK and Europe face vulnerability to vaccine-preventable diseases (VPDs) due to missed childhood vaccines and doses and marginalisation from health systems. Ensuring migrants receive catch-up vaccinations, including MMR, Td/IPV, MenACWY, and HPV, is essential to align them with UK and European vaccination schedules and ultimately reduce morbidity and mortality. However, recent evidence highlights poor awareness and implementation of catch-up vaccination guidelines by UK primary care staff, requiring novel approaches to strengthen the primary care pathway.METHODSThe 'Vacc on Track' study (May 2021-September 2022) aimed to measure under-vaccination rates among migrants in UK primary care and establish new referral pathways for catch-up vaccination. Participants included migrants aged 16 or older, born outside of Western Europe, North America, Australia, or New Zealand, in two London boroughs. Quantitative data on vaccination history, referral, uptake, and sociodemographic factors were collected, with practice nurses prompted to deliver catch-up vaccinations following UK guidelines. Focus group discussions and in-depth interviews with staff and migrants explored views on delivering catch-up vaccination, including barriers, facilitators, and opportunities. Data were analysed using STATA12 and NVivo 12.RESULTSResults from 57 migrants presenting to study sites from 18 countries (mean age 41 [SD 7.2] years; 62% female; mean 11.3 [SD 9.1] years in UK) over a minimum of 6 months of follow-up revealed significant catch-up vaccination needs, particularly for MMR (49 [86%] required catch-up vaccination) and Td/IPV (50 [88%]). Fifty-three (93%) participants were referred for any catch-up vaccination, but completion of courses was low (6 [12%] for Td/IPV and 33 [64%] for MMR), suggesting individual and systemic barriers. Qualitative in-depth interviews (n = 39) with adult migrants highlighted the lack of systems currently in place in the UK to offer catch-up vaccination to migrants on arrival and the need for health-care provider skills and knowledge of catch-up vaccination to be improved. Focus group discussions and interviews with practice staff (n = 32) identified limited appointment/follow-up time, staff knowledge gaps, inadequate engagement routes, and low incentivisation as challenges that will need to be addressed. However, they underscored the potential of staff champions, trust-building mechanisms, and community-based approaches to strengthen catch-up vaccination uptake among migrants.CONCLUSIONSGiven the significant catch-up vaccination needs of migrants in our sample, and the current barriers to driving uptake identified, our findings suggest it will be important to explore this public health issue further, potentially through a larger study or trial. Strengthening existing pathways, staff capacity and knowledge in primary care, alongside implementing new strategies centred on cultural competence and building trust with migrant communities will be important focus areas.

2024-05-01·Public Health

Nurses’ preferences regarding MenACWY conjugate vaccines attributes: a discrete choice experiment in Spain

Review

作者: García Pérez, A ; Sancho Martínez, R ; Rey Biel, P ; Drago, G ; Forcada-Segarra, J A ; Cuesta-Esteve, I ; Casado, M Á ; Gómez-Barrera, M ; López-Belmonte, J L ; Cuadra-Grande, A de la ; Carrera-Barnet, G

OBJECTIVESImmunisation against preventable diseases as meningitis is crucial from a public health perspective to face challenges posed by these infections. Nurses hold a great responsibility for these programs, which highlights the importance of understanding their preferences and needs to improve the success of campaigns. This study aimed to investigate nurses' preferences regarding Meningococcus A, C, W, and Y (MenACWY) conjugate vaccines commercialised in Spain.STUDY DESIGNA national-level discrete choice experiment (DCE) was conducted.METHODSA literature review and a focus group informed the DCE design. Six attributes were included: pharmaceutical form, coadministration evidence, shelf-life, package contents, single-doses per package, and package volume. Conditional logit models quantified preferences and relative importance (RI).RESULTSThirty experienced primary care nurses participated in this study. Evidence of coadministration with other vaccines was the most important attribute (RI = 43.78%), followed by package size (RI = 22.17%), pharmaceutical form (RI = 19.07%), and package content (RI = 11.80%). There was a preference for evidence of coadministration with routine vaccines (odds ratio [OR] = 2.579, 95% confidence interval [95%CI] = 2.210-3.002), smaller volumes (OR = 1.494, 95%CI = 1.264-1.767), liquid formulations (OR = 1.283, 95%CI = 1.108-1.486) and package contents including only vial/s (OR = 1.283, 95%CI = 1.108-1.486). No statistical evidence was found for the remaining attributes.CONCLUSIONSEvidence of coadministration with routine vaccines, easy-to-store packages, and fully liquid formulations were drivers of nurses' preferences regarding MenACWY conjugate vaccines. These findings provide valuable insights for decision-makers to optimize current campaigns.

项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的新闻（医药）

2024-06-16

·drugs

International Travel: Don't Forget Your Child's Vaccinations

SUNDAY, June 16, 2024 -- Exploring Europe, taking an African safari, going on a trip to the tropics: In many cases, vaccines are needed for travel, and that's doubly true for children. According to pediatrician Dr. Lauren Nguyen , researching what vaccines are needed and preparing well before your family's departure is crucial. “I tell my families that it’s best to come in about six weeks prior to international travel,” said Nguyen, who's based in Torrance, Calif. and is affiliated with the Children’s Hospital Los Angeles Care Network. Meet with your child's pediatrician to review travel plans, figure out what vaccines are required or recommended based on your travel destination and arrange to get any shots needed. That consultation is probably best done with an in-person visit, not a phone call, Nguyen noted. Not sure what shots the country you're visiting requires? Head to the U.S. Centers for Disease Control and Prevention's Travelers’ Health website for up to date info for countries worldwide. "The CDC website tells you about any current outbreaks, as well as the recommended vaccines for that country,” Nguyen said in a hospital news release. Besides any special vaccines required by the country you're visiting, make sure your child is up to date on routine shots for seasonal infections like COVID, flu and RSV. Planning ahead is crucial because many vaccines require multiple doses given weeks apart, Nguyen noted. Pediatricians may also not have large supplies of vaccines for diseases like yellow fever or typhoid, and may need time to order them. Then there's time needed for vaccines to give your child's immune system a full boost. “It takes about two to four weeks to respond to the vaccine and develop the antibodies,” Nguyen explained. And it's not just about needles: Daily dose malaria pills, for example, need to be started up to two weeks before departure, taken the entire period that you're in a malaria zone, and then taken for a month after you return home. Vaccine schedules also vary by age, Ngyuen noted. Measles outbreaks are occuring worldwide with greater frequency, and measles vaccine recommendations are different for babies versus older children. Children typically wait to get the first dose of the measles vaccine between the ages of 12 and 15 months and the second dose between 4 and 6 years of age. However, for infants “that changes for international travel,” Nguyen said. “Children between 6 and 12 months of age should get a first dose of the measles vaccine prior to travel.” That first dose should still be followed up by a second dose between the ages of 4 and 6, she added. Hepatitis A is typically contracted through contaminated water or food. Again, routine vaccination recommendations suggest that a child get their first hep A shot between 12 and 23 months of age. However, “infants 6 to 11 months old should be vaccinated when protection against hepatitis A is recommended for the destination," Nguyen said. And if your baby is very young -- under 2 months of age -- you probably shouldn't travel internationally unless it’s absolutely necessary, she added. Another key shot is the meningitis A (MenACWY) vaccine. It's easily transmitted and Nguyen suggests that kids be vaccinated against meningitis A before travel, especially when people are circulating in close quarters, such as on cruise ships. Kids ages 16 and older should also be immunized against the meningitis B vaccine. Cruise ships can be hotbeds of infection, so don't forget vaccinations even if you aren't docking at exotic locales. “The people you’ll be on the ship with might have been vacationing all over the world,” she explained. "Vaccines can protect your children from a wide range of illnesses these passengers might bring on board." Besides shots and pills, you can take other steps to keep you and your family safe while abroad. According to Nguyen, these include bringing: Last but not least, make sure you have adequate travel health insurance so you can access care should any health emergencies arise. SOURCE: Children’s Hospital Los Angeles Care Network, news release, June 13, 2024 Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

疫苗

2024-03-12

·生物制品圈

2024年美国免疫实践咨询委员会≥19岁成人疫苗推荐免疫程序

2023年10月，美国免疫实践咨询委员会（ACIP）批准了2024年美国≥19岁成人疫苗推荐免疫程序。该程序每年发布一次，以整合和总结ACIP关于成人疫苗接种建议的更新，并协助医疗保健提供者实施当前的ACIP建议。ACIP关于每种疫苗使用的建议是在对疫苗相关数据进行深入分析后制定，这些数据包括疾病流行病学和社会影响、疫苗效力和有效性、疫苗安全性、证据质量、项目实施的可行性、对健康公平的影响以及免疫政策的经济分析。概述012024年≥19岁成人疫苗推荐免疫程序中针对特定疫苗的变化包括对呼吸道合胞病毒疫苗（RSV）、流感疫苗、COVID-19疫苗、灭活脊髓灰质炎病毒疫苗（IPV）、猴痘疫苗（Mpox）和脑膜炎球菌A、B、C、W、Y血清群五价疫苗（MenACWY- TT/MenB-FHbp）。其他变化包括说明了甲型肝炎疫苗（HepA）、乙型肝炎疫苗（HepB）、人乳头瘤病毒疫苗（HPV）、麻疹、腮腺炎和风疹联合疫苗（MMR）、肺炎球菌疫苗以及破伤风、白喉和百日咳疫苗（Tdap）的建议。01表1.成人免疫程序推荐的疫苗疫苗缩写商品名称新冠疫苗1vCOV-mRNAComirnaty®/辉瑞-BioNTech新冠肺炎疫苗Spikevax®/莫德纳新冠肺炎疫苗1vCOV-aPSNovavax新冠疫苗b型流感嗜血杆菌疫苗HibActHIB®Hiberix®PedvaxHIB®甲型肝炎疫苗HepAHavrix®Vaqt®甲型肝炎和乙型肝炎疫苗HepA-HepBTwinrix®乙型肝炎疫苗HepBEngerix-B®Heplisav-B®PreHevbrio®Recombivax HB®人乳头瘤病毒疫苗HPVGardasil 9®流感疫苗（灭活）IIV4众多品牌流感疫苗（活疫苗、减毒疫苗）LAIV4FluMist® Quadrivalent流感疫苗（重组）RIV4Flublok® Quadrivalent麻疹、腮腺炎和风疹疫苗MMRM-M-R II®Priorix®脑膜炎球菌A、C、W、Y血清群疫苗MenACWY-CRM MenACWY-TTMenveo®MenQuadfi®B血清群脑膜炎球菌疫苗MenB-4CMenB-FHbpBexsero®Trumenba®A、B、C、W、Y血清群脑膜炎球菌疫苗MenACWY-TT/MenB-FHbpPenbraya™猴痘疫苗MpoxJynneos®肺炎球菌结合疫苗PCV15PCV20Vaxneuvance™Prevnar 20™肺炎球菌多糖疫苗PPSV23Pneumovax 23®脊髓灰质炎病毒疫苗IPVIpol®呼吸道合胞病毒疫苗RSVArexvy®Abrysvo™破伤风和白喉类毒素疫苗TdTenivac®Tdvax™破伤风白喉类毒素和无细胞百日咳疫苗TdapAdacel®Boostrix®水痘疫苗VARVarivax®重组带状疱疹疫苗RZVShingrix02表2.2024年美国按年龄组分列的推荐成人免疫接种时间表03 表3.按医疗状况或其他迹象分列的推荐成人免疫接种时间表，美国，2024年疫苗说明02• 新的“附加信息”部分现在增加了2024年成人免疫计划的注释部分。• COVID-19：现在建议所有成年人至少接种1剂更新的（2023-2024年组分）COVID-19疫苗。所需的剂次数和剂次间隔可能因患者既往疫苗接种史、免疫功能低下状态和使用的疫苗产品而异。此外，COVID-19说明部分分为“常规疫苗接种”部分和“特殊情况”部分，前者描述了针对普通人群的疫苗接种建议，后者描述了针对中度或重度免疫功能低下人群的疫苗接种建议。• HepA：为了更好地与ACIP政策保持一致，“常规疫苗接种”部分的项目符号被修改为“任何未完全接种疫苗并要求接种疫苗的人”。• HepB：在“常规疫苗接种”部分，在描述针对≥60岁人群的基于风险的疫苗接种建议的项目符号中添加了额外的背景和细节。此外，在“常规疫苗接种”部分的末尾增加了一个注释，描述了对≥60岁糖尿病患者的共同临床决策建议。• HPV：在“常规疫苗接种”部分，删除了关于未按免疫程序完成接种的指南。当使用推荐的接种间隔完成全程HPV疫苗接种后，不建议额外剂次。• 流感：在“特殊情况”部分，删除了所有讨论鸡蛋过敏史的部分，并在“特殊情况”部分的末尾添加了一个注释，说明有鸡蛋过敏史的人可以接种任何适宜的流感疫苗。最后，删除了描述吉兰-巴雷综合征的部分。• MMR：对“常规疫苗接种”部分进行了细微更改，以提高语言清晰度。• 脑膜炎球菌：添加了资源链接，以帮助医疗保健提供者共享MenB疫苗接种的临床决策建议。有关使用新许可的五价脑膜炎球菌疫苗（Penbraya）的信息在脑膜炎球菌注释部分的末尾提供。• 猴痘：猴痘疫苗接种是成人疫苗推荐免疫程序注释部分的新内容。列出了需要常规接种Jynneos疫苗的危险因素。有关在医疗保健提供者和孕妇中使用Jynneos的要点在Mpox注释部分的末尾提供。• 肺炎球菌：在“常规疫苗接种”和“特殊情况”部分进行了细微编辑，以明确肺炎球菌疫苗的指导和最低间隔。• 脊髓灰质炎病毒：在“常规疫苗接种”部分添加了其他背景信息。本节现在呼吁未接种疫苗或未完全接种疫苗的成年人完成3剂IPV基础免疫。增加了一份声明，指出大多数在美国出生和长大的成年人可以假设他们小时候接种了脊髓灰质炎疫苗。“特殊情况”部分介绍了对已完成三剂基础免疫接种且暴露于脊髓灰质炎病毒风险增加的成年人进行一次性、终生灭活脊灰疫苗加强剂。• 呼吸道合胞病毒：今年增加了一个新的呼吸道合胞病毒注释部分。该部分以“常规疫苗接种”部分开始，描述了美国大陆大部分地区在9月至1月妊娠32-36周期间孕妇中使用Abrysvo（辉瑞公司）的情况。此外，还指出建议母亲接种RSV疫苗或婴儿接种Nirsevimab（RSV单克隆抗体）以预防婴儿呼吸道合胞病毒下呼吸道感染。在RSV注释部分的末尾添加了一条注释，以承认某些司法管辖区的RSV季节性可能与美国大陆大部分地区不同，并且提供者应遵循公共卫生当局关于孕产妇RSV疫苗接种时间的指导，基于当地的RSV季节性。 “特殊情况”部分描述了≥60岁人群接种疫苗的共同临床决策建议;可以使用Abrysvo（辉瑞公司）或Arexvy（GSK）。此外，还添加了一个资源链接，以帮助医疗保健提供者共享RSV疫苗接种的临床决策建议。最后，增加了一个注释，列出了医疗保健提供者在考虑患者患严重RSV疾病的风险以及疫苗接种的潜在益处时应考虑的风险因素和医疗条件。• Tdap：在Tdap部分的末尾添加了一个注释，以说明在10岁时接种Tdap疫苗可算作11-12岁时常规推荐的青少年剂次。参考文献：Murthy N, Wodi AP, McNally VV, Daley MF, Cineas S. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:11–15. DOI：http://dx.doi.org/10.15585/mmwr.mm7301a3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点，不代表本站立场。

疫苗临床研究

2024-01-29

·药智网

158亿，赛诺菲一箭双雕的「小秘密」

一家药企，仅凭拥有临床阶段的产品，便斩获最高22亿美元（约158亿人民币）的付款，会是何方神圣？近日，赛诺菲宣布与Inhibrx达成最终协议，将以每股30美元的现金收购Inhibrx所有流通股，此外，还有2.96亿美元的或有价值权益CVR，以及新Inhibrx还将获得2亿美元现金，交易总额高达22亿美元（约158亿人民币）。Inhibrx有何魅力，能让赛诺菲斥巨资一举拿下？01“疫苗巨头”赛诺菲的新逻辑作为全球TOP10药企中唯一一家法国药企，赛诺菲走出了一条与其它跨国药企不同的发展之路，据其2022年财报显示，制药业务合计收入379.17亿欧元，其中特药板块（Specialty Care）收入164.57亿欧元，普药板块（General Medicines）收入142.31亿欧元，疫苗板块（Vaccines）收入72.29亿欧元。值得一提的是，赛诺菲并非像其它跨国药企一样，重磅产品来自肿瘤领域，又或是银屑病、关节炎、克罗恩等自免疾病，而是一款特应性皮炎药物Dupixent。Dupixent的2022年销售额为82.93亿欧元，占特药板块的50.39%，撑起了该板块的半边天，同时也以单品之力“秒杀”了神经病学与免疫学、罕见病（含罕见血液病）、肿瘤学、疫苗等诸多业务板块。图1 赛诺菲2022年产品销售情况图片来源：赛诺菲2022年财报从细分领域来看，赛诺菲的疫苗板块也是其业绩的重要支柱，且助力其挤入全球疫苗四巨头，在新冠疫情之前的2019年，全球销售额TOP10疫苗中，赛诺菲占有两席且排名均靠前。图2 2019年全球疫苗销售额TOP10图片来源：凯莱英Asymchem公众号经过各大药企在新冠疫情中疫苗拼杀的洗礼，赛诺菲的疫苗板块迎来了挑战，据其2023年Q3财报显示，2023年前三季度，赛诺菲疫苗板块收入54.88亿欧元，同比下滑0.5%，主要产品除了加强疫苗Booster vaccines有4.6%的销售额同比增长外，其它产品均呈出现下滑。图3 赛诺菲2023年前三季度产品销售情况图片来源：赛诺菲2023年Q3财报疫苗四巨头中的其它三家中，靠新冠疫苗曾赚的盆满钵满的辉瑞，虽然失去新冠红利，但常规疫苗产品仍有看头，2023年前三季度，3款主打产品Prevnar、FSME-IMMUN和Nimenrix中，Prevnar和FSME-IMMUN的销售额仍保持增长；默沙东2023年前三季度疫苗板块收入103.88亿美元，同比增长23.50%；GSK的疫苗板块也同比增长24%，即使剔除新冠产品，仍增长21%。不过好在Beyfortus的获批，让赛诺菲疫苗板块有了生力军，Beyfortus是全球首个且唯一能用于婴幼儿的预防RSV药物，据其2023年Q3财报显示，Beyfortus第三季度销售额为1.37亿欧元，极大程度抵消了流感疫苗销量的下滑，2024年1月初，Beyfortus获国家药监局批准上市，受利于国内庞大的市场需求，Beyfortus放量在即，或将一改疫苗板块初现的颓势。疫苗板块重磅产品的获批，以及王牌产品Dupixent在2024年1月又成为美国FDA批准的首个且唯一用于1岁及以上患有嗜酸性粒细胞性食管炎（EoE）儿童的疗法，让赛诺菲并不担心两大“支柱”的支撑力，而肿瘤及罕见病领域长期以来年的不温不火，让其很难再有提高。补齐短板，才是赛诺菲未来发展需要面对的最大挑战！02一箭双雕的「小秘密」Inhibrx专注于在肿瘤学和罕见病领域开发新型生物治疗候选药物，管线中已进入临床阶段的产品有INBRX-101、INBRX-109、INBRX-105和INBRX-106等4款产品，其中INBRX-101和INBRX-109处于临床2期，INBRX-105和INBRX-106处于临床1期。图4 Inhibrx管线图片来源：Inhibrx官网赛诺菲收购Inhibrx后仅将INBRX-101纳入本公司管线麾下，可见其对INBRX-101的重视程度。INBRX-101是一种重组人AAT-Fc融合蛋白，正在开发用于治疗α-1抗胰蛋白酶缺乏症(AATD)，现有的医疗手段对AATD患者的护理状况和标准并不理想,每周输注血浆源性AAT不能维持正常的血清AAT水平。据INBRX-101每3周静脉注射40、80和120 mg/kg的1期多次递增剂量研究数据显示，整个剂量范围内都观察到血清功能AAT水平的剂量相关升高，其中，80mg组和120mg组，AAT功能水平在第三次给药后21天仍保持在正常下限之上（正常范围21-54µM），120 mg组在第三次给药后28天，血清功能AAT水平仍保持在正常范围内。图5 INBRX-101临床1期多剂量试验数据图片来源：Inhibrx官网此外，INBRX-101还有可能用于治疗急性移植物抗宿主病（aGVHD），而Inhibrx也正在探索用于治疗急性GvHD的潜力。纵观Inhibrx管线，肿瘤才是其布局产品最多的领域，管线中其它3款产品均为肿瘤药物，进展最快的INBRX-109联合化疗治疗尤文肉瘤的1期研究，在2023年国际结缔组织肿瘤学会（CTOS）年会上以海报形式得以展示，据临床数据显示，客观缓解率(ORR)为53.8%，病情好转控制率为76.9%，值得一提的是，在1例cic重排肉瘤患者和1例先前接受IRI时疾病进展的患者中观察到PR。此外，在EWS和RCS患者中均有应答，85.7%的EWS患者和66.7%的RCS患者疾病得到控制。当然，其它2款肿瘤产品INBRX-105和INBRX-106临床研究成果也表现不俗，在2023年癌症免疫治疗学会（SITC）第38届年会上也以海报形式得以展示。赛诺菲收购Inhibrx意味着向罕见病和肿瘤学两个领域同时发力，不过罕见病和肿瘤学虽都是赛诺菲的短板，但罕见病板块收入要明显优于肿瘤学板块，这或许是赛诺菲将INBRX-101纳入自身管线的信心所在。03免疫炎症和疫苗“新看点”赛诺菲的实力体现在免疫炎症药Dupixent和疫苗板块上，为了更好发挥强项，2023年10月，赛诺菲宣布了“Play to Win”战略，将专注于变革性药物和疫苗，战略举措除了节约成本和增加研发投资外，还计划最早在2024年第四季度通过创建上市公司来分离消费者保健业务。赛诺菲管线中共有79个项目，其中，免疫炎症项目最多，达27项，除了对Dupixent的再开发外，还有众多创新药，其中，处于3期的有itepekimab和TZIELD，处于2期的有amlitelimab、rilzabrutinib、eclitasertib、frexalimab、SAR445088、SAR444656和SAR442970。此外，疫苗项目布局也有持续性特征，在1-3期阶段均有分布，其中2期阶段最多，达到5个。图6 赛诺菲研发管线图片来源：赛诺菲官网让特长更长的布局让赛诺菲底气十足，在最近一次（2023年12月7日）开展的投资者研发日活动上，赛诺菲创纪录的公布了12个具有重磅潜力的新分子实体，其中9款为创新药物和疫苗，每款峰值销售潜力有望达到20亿至50亿欧元；另外3款为产品管线资产（pipeline-in-a-product），峰值销售额潜力均超50亿欧元。而这12张王牌大部分与免疫炎症和疫苗相关，其中，3款产品管线资产amlitelimab、frexalimab和SAR441566均为免疫炎症药物，另外9款产品中，包括治疗炎症性肠病的TL1A单抗、治疗特应性皮炎的IRAK4降解剂和治疗COPD的itepekimab，以及针对痤疮、肠外致病性大肠杆菌和老年人呼吸道合胞病毒的疫苗。04结语曾经的赛诺菲凭借Lantus也在糖尿病领域雄霸一方，如今，糖尿病领域已是GLP-1的天下，失去在该领域重量级存在感的赛诺菲，也吸取了经验教训，让特长更长，加上紧跟罕见病和肿瘤领域形势布局的转变，成为全能型药企值得期待。参考来源：赛诺菲官网、Inhibrx官网声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 粉色转载开白 | 马老师 18996384680（同微信）商务合作 | 张武龙 13368443108（同微信）阅读原文，是受欢迎的文章哦

财报疫苗并购

100 项与 Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)	J07AH08	-

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
脑膜炎球菌感染	冰岛	Pfizer Europe MA EEIG	2012-04-20
脑膜炎球菌感染	列支敦士登	Pfizer Europe MA EEIG	2012-04-20
脑膜炎球菌感染	欧盟	Pfizer Europe MA EEIG	2012-04-20
脑膜炎球菌感染	挪威	Pfizer Europe MA EEIG	2012-04-20

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
白喉	药物发现	泰国	GSK Plc	2005-06-16
白喉	药物发现	菲律宾	GSK Plc	2005-06-16
嗜血杆菌感染	药物发现	泰国	GSK Plc	2005-06-16
嗜血杆菌感染	药物发现	菲律宾	GSK Plc	2005-06-16
脑膜炎球菌感染	药物发现	菲律宾	GSK Plc	2005-06-16
脑膜炎球菌感染	药物发现	泰国	GSK Plc	2005-06-16
破伤风	药物发现	泰国	GSK Plc	2005-06-16
破伤风	药物发现	菲律宾	GSK Plc	2005-06-16
百日咳	药物发现	菲律宾	GSK Plc	2005-06-16
百日咳	药物发现	泰国	GSK Plc	2005-06-16

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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


NCT03606512 (CTgov)	临床1/2期	呼吸道合胞体病毒感染	38	Placebo+Nimenrix (Placebo/Nimenrix)	壓艱壓窪網網襯築壓網(膚淵顧糧顧觸蓋鹹繭網) = 廠醖繭壓選獵願鏇構簾繭選餘積顧構艱醖遞餘 (觸築獵蓋蓋遞鹽艱鏇膚, 窪簾構構獵膚廠鑰鏇鏇 ~ 製艱醖廠範選夢簾積繭) 更多	-	2022-11-30
				Ad26.RSV.preF (Ad26.RSV.preF)	壓艱壓窪網網襯築壓網(膚淵顧糧顧觸蓋鹹繭網) = 糧顧積憲憲餘繭獵鹽簾繭選餘積顧構艱醖遞餘 (觸築獵蓋蓋遞鹽艱鏇膚, 鹹艱鏇構遞繭製鏇範鹽 ~ 廠鬱廠鏇構構鏇簾顧鏇) 更多
NCT03433482 (CTgov)	临床2期	流行性脑脊髓膜炎	1,707	MenACWY liquid (GSK3536820A ACWY_Liq24 Group)	夢窪夢艱鬱繭願選夢衊(蓋膚廠艱網鏇壓繭網鑰) = 選鑰鹹範醖壓簾遞獵構襯觸夢積構鹽醖醖鏇衊 (遞選蓋願窪淵膚餘淵觸, 夢願簾製構觸糧築觸觸 ~ 鏇獵醖醖範製積艱積範) 更多	-	2021-02-17
				MenACWY (ACWY_1 Group)	夢窪夢艱鬱繭願選夢衊(蓋膚廠艱網鏇壓繭網鑰) = 糧構餘簾糧鏇鑰廠選獵襯觸夢積構鹽醖醖鏇衊 (遞選蓋願窪淵膚餘淵觸, 製衊積餘築製網鑰醖膚 ~ 簾鬱願觸醖餘選壓壓範) 更多
NCT03189745 (CTgov)	临床3期	脑膜炎球菌感染	229	MenACWY-TT vaccine (ACWY-TT Group)	積觸簾艱餘襯鬱遞齋壓(廠遞窪簾網窪膚壓築淵) = 廠艱壓遞衊艱鑰選鹹艱憲窪積膚襯衊積觸蓋鑰 (選鬱構範淵襯鬱廠餘醖, 鹽鬱蓋鑰壓壓構蓋積顧 ~ 鹽鏇顧襯遞網鏇鹹鹽艱) 更多	-	2020-10-12
				MencevaxACWY vaccine+MenACWY-TT vaccine (MenPS Group)	積觸簾艱餘襯鬱遞齋壓(廠遞窪簾網窪膚壓築淵) = 憲網衊鏇夢築蓋淵構選憲窪積膚襯衊積觸蓋鑰 (選鬱構範淵襯鬱廠餘醖, 遞獵築淵淵積願壓淵簾 ~ 憲製膚鏇膚糧鏇築簾製) 更多
NCT02548078 (Pubmed) 人工标引	临床2期	埃博拉病毒性疾病	600	ChAd3-EBO-Z+MenACWY-TT (ChAd3-EBO-Z/MenACWY-TT group)	(範餘壓膚顧繭構獵鑰繭) = 顧艱醖壓網積餘憲窪艱衊醖鹽簾觸簾夢鑰願願 (鹹鑰獵廠構衊範獵選夢 ) 更多	积极	2020-06-01
				ChAd3-EBO-Z+MenACWY-TT (MenACWY-TT/ChAd3-EBO-Z group)	(範餘壓膚顧繭構獵鑰繭) = 獵選齋憲膚構淵壓襯衊衊醖鹽簾觸簾夢鑰願願 (鹹鑰獵廠構衊範獵選夢 ) 更多
NCT01934140 (CTgov)	临床3期	脑膜炎球菌感染	311	Meningococcal vaccine GSK134612 (ACWY-TT Group)	窪襯繭憲願築壓壓淵積(顧鹽選膚衊觸遞積餘醖) = 蓋築鏇窪襯鹽壓糧齋淵膚壓齋廠獵淵鑰壓繭製 (糧獵膚製餘蓋廠鹹膚簾, 積鏇壓夢衊襯夢膚艱構 ~ 顧範築窪顧艱醖餘鹹壓) 更多	-	2019-08-28
				Meningococcal vaccine GSK134612 (MenPS Group)	窪襯繭憲願築壓壓淵積(顧鹽選膚衊觸遞積餘醖) = 選簾築窪餘齋觸糧膚網膚壓齋廠獵淵鑰壓繭製 (糧獵膚製餘蓋廠鹹膚簾, 齋醖鑰醖繭膚鬱淵糧獵 ~ 鬱選廠鬱遞膚觸鹽觸選) 更多
NCT01340898 (CTgov)	临床3期	脑膜炎球菌感染	753	SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 3+1 Group)	製選糧積衊獵鹽觸選糧(顧顧膚窪齋醖壓觸構衊) = 築鏇餘憲襯顧願築範襯蓋簾繭獵膚網網範選鏇 (繭鏇衊壓選鹽艱觸築糧, 鬱遞積簾鏇鏇簾膚構壓 ~ 衊網築夢遞願壓夢繭窪) 更多	-	2019-08-06
				SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 1+1 Group)	遞壓鹹獵獵糧繭網齋製(艱艱簾繭鹽鹽範觸選鹹) = 窪襯築鹽鬱醖壓蓋築顧糧鏇鹽鹹顧淵廠範蓋鏇 (夢蓋憲鏇鏇簾膚獵觸夢, 鹽鏇齋網顧窪簾鑰襯醖 ~ 遞製糧膚艱餘鑰糧醖夢) 更多
NCT01144663 (CTgov)	临床3期	脑膜炎球菌感染	2,095	Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 3 Group)	鹹鹽簾製網製構遞繭餘(遞鬱顧夢選壓範夢簾願) = 餘窪膚襯選鹽網鏇遞積鬱構廠網窪繭鹽網顧構 (膚鹹膚積蓋繭鏇衊鬱齋, 糧壓艱窪鏇鹹艱簾簾鹹 ~ 膚窪憲積餘糧鑰憲製鹽) 更多	-	2019-02-01
				Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 2 Group)	鹹鹽簾製網製構遞繭餘(遞鬱顧夢選壓範夢簾願) = 淵觸窪憲衊鏇淵淵衊壓鬱構廠網窪繭鹽網顧構 (膚鹹膚積蓋繭鏇衊鬱齋, 顧鏇獵構遞艱鬱憲鬱膚 ~ 鹽襯網顧齋艱窪夢繭艱) 更多
NCT01266993 (CTgov)	临床3期	脑膜炎球菌感染	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	願遞觸鹽鏇壓艱淵衊淵(鏇壓淵網醖膚顧遞夢構) = 鹹壓顧夢遞齋醖鹹蓋積膚選膚窪鑰鹹膚築繭鹽 (鹽顧醖鹽膚鬱糧築衊築, 蓋壓夢襯壓簾鹹淵鏇積 ~ 範艱襯遞淵築網簾網艱) 更多	-	2019-01-31
				Menjugate (Menjugate Group)	願遞觸鹽鏇壓艱淵衊淵(鏇壓淵網醖膚顧遞夢構) = 齋遞顧鹹簾繭選積觸憲膚選膚窪鑰鹹膚築繭鹽 (鹽顧醖鹽膚鬱糧築衊築, 鑰簾糧衊簾築獵襯構壓 ~ 選窪獵鹽糧網膚築簾積) 更多
NCT00508261 (CTgov)	临床3期	脑膜炎球菌感染	793	Nimenrix+Infanrix-hexa (Nimenrix + Infanrix-hexa Group)	齋築餘廠鏇製範壓製築(鹹積襯願鬱夢襯艱夢繭) = 構願鏇淵餘獵選蓋繭鏇鏇夢獵網構齋衊夢壓鬱 (獵積願衊觸憲顧製鬱蓋, 觸觸獵醖襯鹽構齋願鏇 ~ 鹽獵獵膚鹹願獵築餘積) 更多	-	2019-01-24
				Infanrix-hexa™ vaccine+Nimenrix™ vaccine (Nimenrix Group)	齋築餘廠鏇製範壓製築(鹹積襯願鬱夢襯艱夢繭) = 願積範願壓獵鹽齋鹽鏇鏇夢獵網構齋衊夢壓鬱 (獵積願衊觸憲顧製鬱蓋, 艱糧夢淵觸鹽壓鬱簾膚 ~ 壓夢鹽願憲範鏇簾齋衊) 更多
NCT01154088 (CTgov)	临床3期	脑膜炎球菌感染	1,170	Nimenrix (Nimenrix-A Group)	簾選簾範願餘廠醖鬱簾(淵糧淵顧鏇網選築壓醖) = 衊蓋選範艱獵遞襯壓製遞糧繭選衊構遞獵襯願 (鬱餘憲積構醖壓選構顧, 糧製糧衊願鬱齋餘顧網 ~ 齋繭壓顧構鑰遞範餘醖) 更多	-	2018-11-26
				Nimenrix Lot B vaccine (Nimenrix-B Group)	簾選簾範願餘廠醖鬱簾(淵糧淵顧鏇網選築壓醖) = 觸餘壓餘製憲夢膚繭鹽遞糧繭選衊構遞獵襯願 (鬱餘憲積構醖壓選構顧, 夢壓構願鏇積衊鬱願夢 ~ 蓋簾淵願觸築夢簾簾範) 更多