A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age

This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

开始日期2022-12-30

申办/合作机构

Novavax, Inc.

NCT04120194 / Completed临床3期

A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age

A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.

开始日期2019-10-14

申办/合作机构

Novavax, Inc.

NCT03293498 / Completed临床1/2期

A Phase 1/2, Randomized, Observer-Blinded, Active-Controlled Trials to Evaluate the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix-M1 Adjuvant (NanoFlu) in Healthy Older Adults

This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age

开始日期2017-09-18

申办/合作机构

Novavax, Inc.

100 项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的临床结果

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100 项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的转化医学

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100 项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的专利（医药）

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102

项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的文献（医药）

2024-12-31·Expert Review of Vaccines

Unpacking adverse events and associations post COVID-19 vaccination: a deep dive into vaccine adverse event reporting system data

Article

作者: Li, Yiming ; Chen, Yong ; Li, Jianfu ; Tao, Cui ; Dang, Yifang ; Tao, Wei ; Lundin, Sori K

INTRODUCTIONThe rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the need for comprehensive monitoring.METHODSThis study analyzed the Vaccine Adverse Event Reporting System (VAERS) data from 2020-2022 using statistical methods such as zero-truncated Poisson regression and logistic regression to assess associations with age, gender groups, and vaccine manufacturers.RESULTSLogistic regression identified 26 System Organ Classes (SOCs) significantly associated with age and gender. Females displayed especially higher odds in SOC 19 (Pregnancy, puerperium and perinatal conditions), while males had higher odds in SOC 25 (Surgical and medical procedures). Older adults (>65) were more prone to symptoms like Cardiac disorders, whereas those aged 18-65 showed susceptibility to AEs like Skin and subcutaneous tissue disorders. Moderna and Pfizer vaccines induced fewer SOC symptoms compared to Janssen and Novavax. The zero-truncated Poisson regression model estimated an average of 4.243 symptoms per individual.CONCLUSIONThese findings offer vital insights into vaccine safety, guiding evidence-based vaccination strategies and monitoring programs for precise and effective outcomes.

2024-11-06·European Heart Journal - Cardiovascular Pharmacotherapy

Cardiac adverse drug reactions to COVID-19 vaccines. A cross-sectional study based on the Europe-wide data

Article

作者: Daniłowicz-Szymanowicz, Ludmiła ; Niedoszytko, Marek ; Romantowski, Jan ; Nazar, Wojciech

AbstractAimsWe aimed to analyse serious cardiac adverse drug reactions to COVID-19 vaccines from the Europe-wide EudraVigilance database.Methods and resultsIn this retrospective, cross-sectional study, the EudraVigilance database was searched to identify suspected serious cardiac post-vaccination adverse drug reactions to COVID-19 vaccines. This data was coupled with the number of total vaccine doses administered in the European Economic Area for Comirnaty (Pfizer BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), Jcovden (Janssen), Nuvaxovid (Novavax), products, available from the European Centre for Disease Prevention and Control ‘Vaccine Tracker’ database. The analysis included 772 228 309 administered doses of eligible vaccines from the ‘Vaccine Tracker’ database and 86 051 eligible records of cardiac adverse drug reactions from the EudraVigilance database. The frequency of most of the investigated adverse drug reactions was very rare (<1/10 000 i.e. <100/1 000 000 doses). The lowest risk of any serious cardiac adverse drug reactions was noticed for vaccination with Comirnaty (135.5 per million doses), while Spikevax, Jcovden, Vaxzevria, and Nuvaxovid were characterized by higher risk (respectively, 140.9, 194.8, 313.6, and 1065.2 per million doses). The most common complications of vaccinations included syncope, arrhythmia, tachycardia, palpitations, angina pectoris, hypertension, myocarditis, thrombosis, and pulmonary embolism.ConclusionThe risk of serious cardiac adverse drug reactions to COVID-19 vaccines is low and the benefit of active immunization against that disease seems to outweigh the potential risk of serious post-vaccination cardiac adverse drug reactions.

2024-10-22·Journal of Virology

Immunogenicity and efficacy of XBB.1.5 rS vaccine against the EG.5.1 variant of SARS-CoV-2 in Syrian hamsters

Article

作者: Darling, Tamarand ; Smith, Gale ; Seehra, Kuljeet ; Ellebedy, Ali H. ; Patel, Nita ; Boon, Adrianus C. M. ; Guebre-Xabier, Mimi ; Suthar, Mehul S. ; Davis-Gardner, Meredith ; Soudani, Nadia ; Bricker, Traci L.

ABSTRACT The continued emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants necessitates updating coronavirus disease 2019 (COVID-19) vaccines to match circulating strains. The immunogenicity and efficacy of these vaccines must be tested in pre-clinical animal models. In Syrian hamsters, we measured the humoral and cellular immune response after immunization with the nanoparticle recombinant Spike (S) protein-based COVID-19 vaccine (Novavax, Inc.). We also compared the efficacy of the updated monovalent XBB.1.5 variant vaccine with previous COVID-19 vaccines for the induction of XBB.1.5 and EG.5.1 neutralizing antibodies and protection against a challenge with the EG.5.1 variant of SARS-CoV-2. Immunization induced high levels of S-specific IgG and IgA antibody-secreting cells and antigen-specific CD4 + T cells. The XBB.1.5 and XBB.1.16 vaccines, but not the Prototype vaccine, induced high levels of neutralizing antibodies against the XBB.1.5, EG.5.1, and JN.1 variants of SARS-CoV-2. Upon challenge with the Omicron EG.5.1 variant, the XBB.1.5 and XBB.1.16 vaccines reduced the virus load in the lungs, nasal turbinates, trachea, and nasal washes. The bivalent vaccine (Prototype rS + BA.5 rS) continued to offer protection in the trachea and lungs, but protection was reduced in the upper airways. By contrast, the monovalent Prototype vaccine no longer offered good protection, and breakthrough infections were observed in all animals and tissues. Thus, based on these study results, the protein-based XBB.1.5 vaccine is immunogenic and increased the breadth of protection against the Omicron EG.5.1 variant in the Syrian hamster model. IMPORTANCEAs SARS-CoV-2 continues to evolve, there is a need to assess the immunogenicity and efficacy of updated vaccines against newly emerging variants in pre-clinical models such as mice and hamsters. Here, we compared the immunogenicity and efficacy between the updated XBB.1.5, the original Prototype Wuhan-1, and the bivalent Prototype + BA.5 vaccine against a challenge with the EG.5.1 Omicron variant of SARS-CoV-2 in hamsters. The XBB.1.5 and bivalent vaccine, but not the Prototype, induced serum-neutralizing antibodies against EG.5.1, albeit the titers were higher in the XBB.1.5 immunized hamsters. The presence of neutralizing antibodies was associated with complete protection against EG.5.1 infection in the lower airways and reduced virus titers in the upper airways. Compared with the bivalent vaccine, immunization with XBB.1.5 improved viral control in the nasal turbinates. Together, our data show that the updated vaccine is immunogenic and that it offers better protection against recent variants of SARS-CoV-2.

项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的新闻（医药）

2024-11-15

·生物制品圈

挥别1.0迎接2.0时代？中国流感疫苗市场既要破局也要进阶

目前中国已获批上市的流感疫苗至少有十余款，在接种率瓶颈下，除了鼻喷流感疫苗和亚单位流感疫苗外，其余流感疫苗在工艺、保护效果上的同质化严重（内卷），即呈现无细胞生产、无创新佐剂、无重组工艺、无高剂量的特点，指南也没有针对人群的优先使用推荐。目前企业对流感疫苗的研发可能存在两种分歧：价格战下继续开发雷同疫苗可能卷不动了，开发其他创新疫苗的思路在何方？对于一款全球服役了数十年的疫苗来说，流感疫苗在中国还很年轻，远远未到“躺平”的时候。改进流感疫苗效果可能会有助于打破现有的价格战僵局，尤其是在后疫情时代公众对疫苗有效性期望更高的情况下，并有望加快实现流感疫苗的市场分层。近日Vaccine发表了一项关于未来几年流感疫苗研发方向或思路的综述，为我国流感企业走出内卷可提供思路借鉴。内容摘选如下：当前流感疫苗市场现状目前可用的流感疫苗的年有效性通常在<20%-60%之间，疫苗类型、剂量和佐剂的加入会影响疫苗在不同目标人群中的效果。如果疫苗株与流行毒株没有表现出高度的抗原相似性，那么在推荐疫苗株后（北半球季节为 2 月，南半球季节为 9 月）出现季节性流感病毒“漂移”也可能降低疫苗有效性。在既定的流感流行季，有效性通常因流感病毒亚型/谱系而异，尤其是H3N2亚型，它在疫苗病毒中往往表现最差，甚至在单个季节内H3N2病毒的不同系统发育亚群或变体之间可能存在有效性差异。此外，人群中不同的免疫力和/或既往通过疫苗接种或自然感染暴露于流感病毒，可能会影响流感疫苗的有效性。全球季节性流感疫苗市场很稳定，2022 年各国采购了约7.6 亿剂，中低收入国家使用受限，主要由中高收入国家使用。目前的流感疫苗制造商不一定受到市场的激励来增加现有疫苗的产量，比如2019 年季节性流感疫苗的最大年生产能力为15 亿剂，但同年全球分发约5.31亿剂流感疫苗就侧面说明了这一问题。据估计，2024 年全球需求量为 8.5 亿剂。由明尼苏达大学传染病研究与政策中心（CIDRAP）领导的流感疫苗研发路线图（IVR），该路线图是29个国家的100 多个利益相关者合作的结果，开发了通用流感疫苗技术布局。左侧蓝色象限为增强型季节性流感疫苗路线，右侧紫色象限为下一代流感疫苗技术路线。什么是增强型季节性流感疫苗？旨在改进传统标准剂量流感疫苗的任何流感疫苗，包括持久性、功效、保护范围或规划适用性，增强型季节性流感疫苗和下一代流感疫苗都被认为是改进的流感疫苗。增强型季节性流感疫苗：基于目前获得许可的传统流感疫苗（即针对来自流行的季节性流感病毒的HA的基于鸡蛋和细胞的灭活疫苗和LAIV 疫苗）的技术和方法的任何流感疫苗商品，该类疫苗商品通过佐剂、剂量或制造工艺（即重组技术）进行了增强，以提供比传统标准剂量季节性流感疫苗更高的免疫原性、疗效和/或有效性。佐剂在内的佐剂灭活流感疫苗：主要是CSL公司生产的MF59佐剂的流感疫苗；高剂量灭活流感疫苗（与标准剂量疫苗相比，每种毒株的HA含量更高）：主要是Sanofi生产的高剂量剂型的Fluzone。重组季节性流感疫苗：重组HA蛋白流感疫苗（RIV，例如Sanofi的Flublok、Supemtek，昆虫细胞干状病毒表达）、病毒样颗粒疫苗（Cadiflu-S，仅印度）。 HA = 血凝素;IIV = 灭活流感病毒;LAIV = 流感病毒减毒活疫苗;N/A = 不适用;SAGE = 战略咨询专家组。目前证据显示，高剂量和佐剂IIV可为65岁以上的成人提供更好的保护，其次是基于细胞的IIV和RIV。什么能称为下一代流感疫苗？下一代流感疫苗，是指在设计中使用与当前许可疫苗不同的方法或技术的任何疫苗商品，主要目标是引发更好的免疫反应，或者比目前获得许可的流感疫苗更有效，或者至少表现出不劣于目前许可的流感疫苗。包括：通用流感疫苗：对甲型和乙型流感病毒的任何流感毒株具有保护作用，与亚型、变化或漂移无关。广谱保护的流感疫苗：对多种流感病毒具有保护作用，但不符合通用疫苗的标准：亚型特异性（例如，仅 H1 型）、单个组中的多个子类型、泛组（所有 1 组或 2 组甲型流感）、所有乙型流感病毒。下一代季节性流感疫苗：疫苗包含基于 WHO 推荐菌株的配方和/或专为季节性保护而设计的疫苗，比目前批准的季节性流感疫苗提供更好（更持久或更有效）的季节性流感疫苗，使用较多工艺为基于mRNA平台的流感疫苗。 Moderna的mRNA-1010的最新3期试验结果表明，与获得许可的标准剂量疫苗对照相比，甲型和乙型毒株的GMT和血清转化率更高。与增强型季节性流感疫苗（Fluzone High-Dose）相比，mRNA-1010还在老年人中诱导更高（甲型流感毒株和 B/Victoria）或类似（B/Yamagata）的HAI滴度。辉瑞的3期四价mRNA 候选疫苗与获批流感疫苗相比表现出非劣效性，针对甲型流感表现出更好的免疫原性终点。与其他呼吸道疾病联合的流感疫苗：包含流感成分和另一种呼吸道病原体的疫苗，Novavax、Moderna 和 Pfizer 正在开发SARS-Cov-2/流感联合候选疫苗，且均处于III期阶段。此外辉瑞和Moderna 都在开发SARS-CoV-2/流感和RSV/流感mRNA联合疫苗，目前三种组合产品正处于3期试验中。数据显示，辉瑞的SARS-CoV-2和流感候选疫苗联合疫苗在所有疫苗匹配毒株中，相对于已获批的四价流感疫苗，其HAI GMT比值均大于1。对于所有四种流感疫苗株，相对于获得许可的四价流感疫苗，Moderna的mRNA-1083 在 50-79 岁成人中的HAI GMT比率同样大于1。（A）每个疫苗平台在临床开发中所有下一代流感候选疫苗中的份额（B）按疫苗平台划分的通用或广泛保护性、下一代季节性和联合流感疫苗的候选疫苗数量（C）正在或已经完成I/II/III期临床试验的候选疫苗数量。下一代进入临床试验的候选季节性流感疫苗几乎是正在开发的通用或广泛保护产品的两倍，技术路线主要集中在mRNA领域。三种下一代季节性产品正处于 3 期临床试验中，特别是辉瑞的四价流感modRNA 疫苗、Moderna的 mRNA-1010以及Novavax和Emergent BioSolutions的NanoFlu。资料来源：Taaffe J, Ostrowsky JT, Mott J, et al. Advancing influenza vaccines: A review of next-generation candidates and their potential for global health impact. Vaccine. 2024 Oct 5;42(26):126408. doi: 10.1016/j.vaccine.2024.126408. 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。

疫苗带量采购

2024-05-15

·药时代

后疫情时代，赛诺菲的“反季购物”

正文共：2418字 5图预计阅读时间：6分钟2024年，原本近乎布满每个路口的“核酸采样亭"难觅踪影，口罩也不再是随处可见。医药行业关于新冠疫苗、口服药的研发竞速被按下慢速键，烟火气开始回归。更多药企将视野转向其他热门赛道，如ADC、GLP-1等。然而，总会有药企“怀旧"，选择“反季购物”。2024年5月10日，赛诺菲宣布斥资12.7亿美元与Novavax达成合作，共同开发非mRNA流感-新冠组合疫苗。01反季购物在2024JPM周期间，辉瑞的会议PPT上关于疫苗管线的介绍只有短短两页。公司话事人Albert Bourla更是公开吐槽“政府毁约”，即原本各国政府采购的订单需重新协商。如何清理库存，难为住了这位年薪2000万美元的大佬。不同国家，相同境遇。腾盛博药2023年3月宣布，旗下新冠中和抗体联合治疗药物停产；康希诺上海新冠疫苗生产基地，疑似停产；斯微生物天慈工厂暂停试运行；北京科兴中维的新冠疫苗也于今年1月被确认停产。如此大环境下，赛诺菲选择“反季购物”，意在何处？细看交易。12.7亿美元的交易具体包括：赛诺菲将与Novavax共同商业化后者的新冠疫苗(NVX-CoV2373);赛诺菲将获得NVX-CoV2373与自家流感疫苗联合开发的独家权益;赛诺菲将获得Matrix-M佐剂的非独家许可;赛诺菲将对Novavax进行占股<5%的股权投资。首先，赛诺菲自己手中就有新冠疫苗（与GSK共同研发的VAT02、VAT08）,且NVX-CoV2373也是蛋白重组疫苗，商业化该如何进行？其次，关于流感-新冠组合疫苗，Novavax就有现成的，且计划今年下半年启动三期临床。但赛诺菲并未选择现货，而是在已有SP0273、SP0256等多款用于流感的mRNA在研疫苗的情况下，选择了研发非mRNA二联疫苗。理论上，做重组蛋白联用疫苗相较于mRNA联用疫苗并不讨好，特别是在新冠变异株快速迭代的情况下。今年5月10日（同一天），美国疾病控制与预防中心（CDC）发布数据称，一种被命名为KP.2的新冠变异株目前已经取代JN.1，成为美国的主要流行株。对此，mRNA疫苗可直接指导细胞生成病毒的特定抗原蛋白，如果病毒的抗原区域发生变异，理论上只需修改mRNA序列即可快速针对新变异株设计疫苗，保持疫苗的有效性。而重组蛋白疫苗则可能需要重做整个工艺，费时费力。那花费12.7亿美元，又是何故？02赛诺菲更懂Novavax去年2019年，Paul Hudson在接任赛诺菲CEO一职后不久，便推出了“Play to Win”战略。其中包括，增加公司疫苗产品线以及加速其潜在的变革性疗法组合：2025年计划推出10款候选疫苗进入临床，其中6款为mRNA疫苗。本次交易，便是对该战略的持续践行。其次，赛诺菲此前相继并购了Translate Bio、Origimm Biotechnology等多家mRNA药企，mRNA布局相对完善。此次获得了Matrix-M佐剂专利许可，归属于差异化技术补充。最后值得一提的就是，交易双方拥有共同际遇。在新冠流行期间，赛诺菲/GSK的新冠疫苗在欧洲获批时间较晚，错失良机，且未能如愿在美国获批。一个关键节点就是在其1/2期中期数据中，因老年人免疫应答弱，被迫推迟上市时间。原因不排除佐剂未达预期效果，而该疫苗的佐剂便是由GSK提供。至于Novavax，旗下新冠疫苗NVX-CoV2373的研发进度原本属于第一梯队。Moderna于2020年8月启动临床三期，而Novavax则于在2020年12月启动临床三期，相隔仅4个月。不过后来，Novavax因试验地点选择错误（南非而不是美国）、产能供给限制等因素，错失了抢先机会，以至于后续商业化不尽人意。Novavax的现金流也从2021年的15.15亿美元，快速缩水至2023年末的5.69亿美元。且由于连年亏损，公司在2023年初还收到了SEC的持续经营警告，面临退市风险。或许，赛诺菲很能够理解在此处境下的Novavax。此次“施以援手”，算是为这家老牌药企“吊住了一口气”。5月10日，Novavax盘后大涨120%，截止日前，报13.48美元/股。03“赢一次”与“再赢一次”揆诸当下，将视野聚焦在新冠、流感、RSV联合疫苗的玩家不在少数，包括辉瑞/BioNTech、Moderna、GSK等。2023年10月，Moderna宣布旗下新冠/流感二联疫苗mRNA-1083完成临床三期首例患者给药。2023年12月，辉瑞和BioNTech在Clinicaltrials.gov网站上注册了新冠/流感二联mRNA疫苗的三期临床试验。2024年4月18日，GSK在Clinicaltrials.gov网站上注册了RSV重组蛋白疫苗+新冠mRNA疫苗联合免疫的三期临床试验。竞速从未停止，后疫情时代的新冠疫苗研发之路就是以进为退。在新冠大流行期间“赢过一次”的药企，想要继续赢下去；而没有赢的药企，则想要赢一次。参考资料：1.Novavax官网2.赛诺菲官网3.莫德纳官网4.雪球5.交易细节 | 赛诺菲何故13亿美元引进新冠疫苗？（华义文随笔）6.赛诺菲再为意难平刷火箭，14亿美金买新冠疫苗（大药时记）7.其他公开资料封面图来源：pixabay版权声明/免责声明本文为药时代原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn全年多项重磅NDA，诺诚健华的商业化蓝图mRNA疫苗“巨头”最近不太顺5例患者死亡，股价大跌77%！B7H3 ADC再生事端点击阅读原文，了解更多！

疫苗信使RNA临床3期带量采购

2024-02-27

·Business Wire

Global H3N2 infection Drug Pipeline Landscape Report 2024: Insights on 15+ Companies and 20+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "H3N2 infection - Pipeline Insight, 2024" drug pipelines has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in H3N2 infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the H3N2 infection pipeline landscape is provided which includes the disease overview and H3N2 infection treatment guidelines. The assessment part of the report embraces, in depth H3N2 infection commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, H3N2 infection collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence H3N2 infection R&D. The therapies under development are focused on novel approaches to treat/improve H3N2 infection. H3N2 infection Emerging Drugs Chapters This segment of the H3N2 infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. H3N2 infection Emerging Drugs mRNA-1083: Moderna Therapeutics mRNA-1083 is under development for the prevention of influenza virus infection caused by influenza A/H1N1, A/H3N2, and influenza B/Yamagata and B/Victoria strains and coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in 18 to 79 years of age group. It is a combination vaccine of mRNA-1283, which encodes Receptor Binding Doman (RBD) and N-Terminal Domain (NTD) of the spike protein and mRNA-1010, which encodes hemagglutinin (HA) glycoproteins of influenza A/H1N1, A/H3N2, and influenza B/Yamagata and B/Victoria-lineages. It is administered through intramuscular route in the form of sterile liquid for injection. Currently, the drug is in Phase III stage of its clinical trial for the treatment H3N2 infection. CD-388: Cidara therapeutics CD-388 is under development of the treatment and prevention of influenza virus A, seasonal influenza, pandemic influenza and influenza virus B infections. The drug candidate is a second generation, anti-viral Fc conjugate (AVC). It comprises of two moieties attached through a chemical linker. One is a targeting moiety (TM) that recognizes cell surface target and another is an effector moiety (EM) that is recognized by the immune system. It is administered through intramuscular and subcutaneous route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of H3N2 infection. PF-07845104: Pfizer PF-07845104 is a prophylactic saRNA Vaccine developed by Pfizer. Its therapeutics area include infectious respiratory diseases. Currently, the drug is in phase I stage of its clinical trial for the treatment of H3N2 infection. H3N2 infection: Therapeutic Assessment Major Players in H3N2 infection There are approx. 15+ key companies which are developing the therapies for H3N2 infection. The companies which have their H3N2 infection drug candidates in the most advanced stage, i.e. Phase III include, Moderna Therapeutics. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Product Type H3N2 infection Report Insights H3N2 infection Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs H3N2 infection Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Novartis Vaccines PDS Biotechnology Corporation Sanofi Moderna Therapeutics Pfizer Cidara therapeutics GRDG SCIENECES FluGen Inc. Barinthus Biotherapeutics Key Products NanoFlu PDS0202 MRT-5400 mRNA 1083 PF-07845104 CD 388 Equivir H3N2 M2SR influenza vaccine MVA-NP+M1 For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/kiulgc About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

临床2期疫苗临床3期临床1期

100 项与 Seasonal influenza nanoparticle vaccine (Novavax) 相关的药物交易

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研发状态

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
流感病毒感染	临床3期	美国	Novavax, Inc.	2019-10-14

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临床结果

适应症

分期

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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


NCT04120194 (CTgov)	临床3期	流感病毒感染	2,654	NanoFlu (NanoFlu)	膚築製積鹽衊製選範鑰(襯窪醖艱醖鑰積獵鹽糧) = 鏇選夢膚膚衊壓願簾簾廠鏇壓廠遞構蓋築鏇廠 (築衊獵鹹構製夢壓鹽鹽, 選觸鏇獵顧鑰鏇廠餘願 ~ 夢獵餘艱淵襯範醖鬱蓋) 更多	-	2023-05-06
				Fluzone Quadrivalent (Fluzone Quadrivalent)	膚築製積鹽衊製選範鑰(襯窪醖艱醖鑰積獵鹽糧) = 醖廠鏇範廠醖壓製廠鹹廠鏇壓廠遞構蓋築鏇廠 (築衊獵鹹構製夢壓鹽鹽, 網簾鏇鬱襯膚鬱壓鏇範 ~ 選製鹹齋積獵築膚構選) 更多
NCT03293498 (CTgov)	临床1/2期	流感病毒感染	330	Fluzone+Tri-NIV Vaccine (Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21)	衊製鹹齋獵簾淵繭觸鹹(壓淵繭鹹繭鑰蓋窪鹹夢) = 糧鑰夢餘鏇餘願糧廠廠廠鑰繭糧壓窪製範廠積 (窪構鏇糧築餘範鑰衊鑰, 壓鑰獵積鏇構艱願糧夢 ~ 範選範淵築衊願餘蓋鏇) 更多	-	2022-12-21
				Fluzone+Tri-NIV Vaccine (Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21)	衊製鹹齋獵簾淵繭觸鹹(壓淵繭鹹繭鑰蓋窪鹹夢) = 夢範壓廠蓋顧襯遞顧夢廠鑰繭糧壓窪製範廠積 (窪構鏇糧築餘範鑰衊鑰, 壓憲築餘鬱膚窪積網簾 ~ 窪獵製衊範製繭遞廠齋) 更多