四价流感病毒裂解疫苗(Sanofi)(Tetravalent influenza vaccine(Split, inactivated)(Sanofi)) - 在研适应症：流感病毒感染，甲型流感病毒感染，乙型流感病毒感染_专利_临床

概要

基本信息

药物类型

灭活疫苗、预防性疫苗、多价疫苗

别名

Fluzone Hd Quadrivalent、Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent、H1N1/H3N2/Victoria Lineage/Yamagata Lineage Influenza Vaccine(Split)(Sanofi)

+ [3]

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染甲型流感病毒感染乙型流感病毒感染

非在研适应症-

原研机构

Sanofi

在研机构

深圳赛诺菲巴斯德生物制品有限公司Sanofi Pasteur, Inc.

非在研机构

Sanofi Pasteur

最高研发阶段批准上市

首次获批日期

美国 (1999-12-09),

甲型流感病毒感染乙型流感病毒感染

最高研发阶段(中国)批准上市

特殊审评-

登录后查看时间轴

关联

115

项与四价流感病毒裂解疫苗(Sanofi) 相关的临床试验

NCT06291857 / Not yet recruiting临床3期

A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a COVID-19 Influenza Combination Nanoparticle Vaccine and a Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants ≥ 65 Years of Age.

The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant.

开始日期2024-10-21

申办/合作机构

Novavax, Inc.

NCT05947071 / Recruiting临床2期IIT

Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.
The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.

开始日期2024-09-26

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06229392 / Recruiting临床1期IIT

A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

开始日期2024-02-28

申办/合作机构

Rush University Medical Center

100 项与四价流感病毒裂解疫苗(Sanofi) 相关的临床结果

登录后查看更多信息

100 项与四价流感病毒裂解疫苗(Sanofi) 相关的转化医学

登录后查看更多信息

100 项与四价流感病毒裂解疫苗(Sanofi) 相关的专利（医药）

登录后查看更多信息

108

项与四价流感病毒裂解疫苗(Sanofi) 相关的文献（医药）

2024-10-01·The Lancet Infectious Diseases

Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65–85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial

Article

作者: Murray, Bryan ; Neumann, Gabriele ; Herber, Renee ; Fierro, Carlos ; Kawaoka, Yoshihiro ; Moser, Michael J ; Davis, Matthew ; Bilsel, Pamuk ; Aitchison, Roger ; Coelingh, Kathleen ; Rhee, Margaret ; Marshall, David ; White, Alexander ; Eiden, Joseph ; Greenberg, Harry ; Belshe, Robert ; Turner, Mark

BACKGROUNDOlder adults (aged ≥65 years) show increased susceptibility to severe disease with influenza virus infection, accounting for 70-85% of annual influenza-related fatalities in the USA. Stimulating mucosal antibodies and T cells might enhance the low vaccine effectiveness seen in older adults for currently licensed inactivated influenza vaccines, which induce mainly serum antibodies. We aimed to evaluate the safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication (M2SR) vaccine, alone or coadministered with a licensed inactivated influenza vaccine (Fluzone High-Dose Quadrivalent; hereafter referred to as Fluzone HD), in older adults.METHODSIn this multicentre, randomised, double-blind, double-dummy, phase 1b trial, individuals aged 65-85 years who were considered healthy or with stable chronic conditions with no recent (<6 months) influenza vaccinations were recruited from five clinical trial sites in the USA and randomly assigned (3:3:3:1) using a permuted block design to receive the H3N2 M2SR vaccine and Fluzone HD, the H3N2 M2SR vaccine and placebo, Fluzone HD and placebo, or placebo alone. All participants received a single intranasal spray and a single intramuscular injection, whether active or placebo, to maintain masking. The primary outcome was to assess the safety of H3N2 M2SR, administered alone or with Fluzone HD, in the safety analysis set, which included all participants who were randomly assigned and received treatment. Serum and mucosal antibodies were assessed as a secondary endpoint, and cell-mediated immunity as an exploratory endpoint, in participants in the per-protocol population, which included individuals in the safety analysis set without major protocol deviations. This trial is registered with ClinicalTrials.gov, NCT05163847.FINDINGSBetween June 14 and Sept 15, 2022, 305 participants were enrolled and randomly assigned to receive the H3N2 M2SR vaccine plus placebo (n=89), H3N2 M2SR vaccine plus Fluzone HD (n=94), Fluzone HD plus placebo (n=92), or placebo alone (n=30). All randomly assigned participants were included in the safety analysis set. The most frequently reported local symptoms up to day 8 in groups that received M2SR were rhinorrhoea (43% [38 of 89] in the H3N2 M2SR plus placebo group and 38% [36 of 94] in the H3N2 M2SR plus Fluzone HD group), nasal congestion (51% [45 of 89] and 35% [33 of 94]), and injection-site pain (8% [seven of 89] and 49% [46 of 94]), and the most frequently reported solicited systemic symptoms were sore throat (28% [25 of 89]) for M2SR and decreased activity (26% [24 of 94]) for the M2SR plus Fluzone HD group. In the Fluzone HD plus placebo group, the most frequently reported local symptom was injection-site pain (48% [44 of 92]) and systemic symptom was muscle aches (22% [20 of 92]). The frequency of participants with any treatment-emergent adverse event related to vaccination was low across all groups (2-5%). One serious adverse event was reported, in a participant in the Fluzone HD plus placebo group. M2SR with Fluzone HD induced seroconversion (≥four-fold increase in haemagglutination inhibition antibodies from baseline to day 29) in 44 (48%) of 91 participants, compared with 28 (31%) of 90 participants who seroconverted in the Fluzone HD plus placebo group (p=0·023). M2SR with Fluzone HD also induced mucosal and cellular immune responses.INTERPRETATIONThe H3N2 M2SR vaccine coadministered with Fluzone HD in older adults was well tolerated and provided enhanced immunogenicity compared with Fluzone HD administered alone, suggesting potential for improved efficacy of influenza vaccination in this age group. Additional studies are planned to assess efficacy.FUNDINGUS Department of Defense.

2024-05-15·The Journal of Infectious Diseases

Differential Induction of Interferon-Stimulated Genes by Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines in Children During the 2018–2019 Season

Article

作者: Alcorn, John F ; Moehling Geffel, Krissy ; Martin, Judith M ; Zimmerman, Richard K ; Rajasundaram, Dhivyaa ; Ortiz, Marianna A ; Nowalk, Mary Patricia

AbstractBackgroundCell-based quadrivalent-inactivated influenza vaccine has been shown to have higher vaccine effectiveness than traditional egg-based quadrivalent-inactivated influenza vaccine. This is observed despite similar levels of serum hemagglutinin antibodies induced by each vaccine.MethodsIn this study, we examine peripheral immune activation after egg-based or cell-based influenza vaccination in a clinical trial in children. Peripheral blood mononuclear cells were isolated, and ribonucleic acid was sequenced from 81 study participants (41 Fluzone, egg based and 40 Flucelvax, cell based) pre- and 7 days postvaccination. Seroconversion was assessed by hemagglutinin inhibition assay. Differential gene expression was determined and pathway analysis was conducted.ResultsCell-based influenza vaccine induced greater interferon-stimulated and innate immune gene activation compared with egg-based influenza vaccine. Participants who seroconverted had increased interferon-signaling activation versus those who did not seroconvert.ConclusionsThese data suggest that cell-based influenza vaccine stimulates immune activation differently from egg-based influenza vaccine, shedding light on reported differences in vaccine effectiveness.

2024-01-01·Methods in Molecular Biology

Methods for Analysis of Nanoparticle Immunosuppressive Properties

Article

作者: Potter, Timothy M ; Cedrone, Edward ; Dobrovolskaia, Marina A ; Neun, Barry W

Adverse drug effects on immune system function represent a significant concern in the pharmaceutical industry, because 10-20% of drug withdrawal from the market is attributed to immunotoxicity. Immunosuppression is one such adverse effect. The traditional immune function test used to estimate materials' immunosuppression is T cell dependent antibody response (TDAR). This method involves a 28-day in vivo study evaluating the animal's antibody titer to a known antigen (Keyhole Limpet Hemocyanin; KLH) with and without challenge. Due to the limited quantities of novel drug candidates, an in vitro method called human lymphocyte activation (HuLA) assay has been developed to substitute the traditional TDAR assay during early preclinical development. In this test, leukocytes isolated from healthy donors vaccinated with the current year's flu vaccine are incubated with Fluzone in the presence or absence of nanoparticles. The antigen-specific lymphocyte proliferation is then measured by ELISA analyzing incorporation of BrdU into DNA of the proliferating cells. Here we describe the experimental procedures for investigating immunosuppressive properties of nanoparticles by both TDAR and HuLA assays, discuss the in vitro-in vivo correlation of these methods, and show a case study using the iron oxide nanoparticle formulation, Feraheme.

68

项与四价流感病毒裂解疫苗(Sanofi) 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

2024-11-12

·Pharmaceutical Technology

FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine

Novavax will begin enrolling participants into the Phase III trial of its Covid-19 and influenza combination vaccine. Credit: Cira123 via Shutterstock. Novavax has received the green light from the US Food and Drug Administration (FDA) to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long clinical hold. The FDA initially halted the trials on 16 October after a patient in the Phase II trial (NCT05519839) of the CIC vaccine candidate was diagnosed with motor neuropathy, later reclassified as amyotrophic lateral sclerosis (ALS), a rare neurodegenerative condition. After evaluating the data, the FDA concluded that the ALS diagnosis was unrelated to Novavax’s vaccine. With the regulatory hold lifted, Novavax is now preparing to initiate a Phase III study (NCT06291857) of both the CIC vaccine – named NVX-CoV2373 – and a new, standalone flu vaccine called tNIV. Robert Walker, Novavax’s chief medical officer, said that the FDA “satisfactorily addressed all clinical hold issues.” Walker confirmed that trial activities will resume as soon as possible. Novavax’s upcoming Phase III trial will evaluate the efficacy of the CIC vaccine in adults aged 65 and older by comparing its immune response against those produced by standard flu and Covid-19 vaccines. The trial will also investigate the effectiveness of Novavax’s investigational flu vaccine tNIV against standard-of-care Fluzone High-Dose. The trial will involve nearly 8,000 participants across two parts: the first will focus on immune response and side effects, while the second will further monitor safety outcomes. The company is aiming to commence enrolment by the end of 2024 with preliminary results by mid-2025. The CIC vaccine could represent an opportunity for Novavax, which faced market challenges against established Covid-19 vaccine leaders like Pfizer and Moderna . However, Novavax’s Covid-19 vaccine experienced limited adoption after its US launch in July 2022. This led to significant cost-cutting, including a 30% workforce reduction in 2023 and early 2024, and a “going concern” warning about its operational future, citing uncertainties around sales and US government funding. In response to these challenges, Novavax has undertaken significant financial restructuring, with plans to cap combined R&D and SG&A spending below $500m in 2025 and under $350m by 2026, as per Novavax’s Q2 2024 financial report. The company has also pursued strategic partnerships, securing a $1.2bn licensing agreement with Sanofi in May 2024 to co-commercialise its standalone adjuvanted Covid-19 vaccine, which bolsters Novavax’s position as it advances the CIC and other vaccine programmes. Pfizer- BioNTech and Moderna are also racing to develop Covid-19 and influenza combination vaccines. In June 2024, Moderna took the lead with its candidate mRNA-1083, which produced “statistically significantly higher immune responses” than existing vaccines in a Phase III trial (NCT06097273). Meanwhile, Pfizer and BioNTech encountered a setback as their combo vaccine failed to meet one of its two primary endpoints in a Phase III trial (NCT06178991) in August. While the vaccine demonstrated high responses for neutralising influenza A titres, it failed to show sufficient efficacy against influenza B.

疫苗临床3期引进/卖出临床2期临床结果

2024-09-20

·药智网

Moderna启动流感mRNA疫苗确证性三期临床

9月19日，Moderna在Clinicaltrials.gov网站上注册了流感mRNA疫苗mRNA-1010的三期临床试验P304，计划入组56000例50岁以上受试者，预计2025年底完成。图片来源：医药笔记这是mRNA1010的第四项三期临床，与Fluarix头对头比较，第一个流行季34000例，第二个流行季22000例，主要终点为比较mRNA-1010与阳性对照的保护率。图片来源：医药笔记此前的三期临床P303已经达到主要终点，免疫原性优于Fluzon HD。图片来源：医药笔记安全性方面，mRNA-1010表现出可耐受性，但reactogenicity比Fluzone HD更高。图片来源：医药笔记总结长时间以来，赛诺菲的灭活流感疫苗和重组流感疫苗统治市场，Moderna寄望于mRNA疫苗可以颠覆其地位。今年3月，黑石生命科学投资7.5亿美元到Moderna的流感mRNA疫苗，换取商业里程碑金额以及低个位数的销售分成。图片来源：医药笔记来源 | 医药笔记（药智网获取授权转载）撰稿 | Armstrong 责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

信使RNA疫苗临床3期临床2期临床1期

100 项与四价流感病毒裂解疫苗(Sanofi) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB02	-

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
流感病毒感染	中国	深圳赛诺菲巴斯德生物制品有限公司	2023-02-21
甲型流感病毒感染	美国	Sanofi Pasteur, Inc.	1999-12-09
乙型流感病毒感染	美国	Sanofi Pasteur, Inc.	1999-12-09

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	药物发现	波多黎各	Sanofi Pasteur	2008-10-01
流感病毒感染	药物发现	美国	Sanofi Pasteur	2008-10-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02936180 (IV-RA, CTgov)	临床4期	类风湿关节炎 \| 流感病毒感染	279	SD-QIV (Standard Dose Influenza Vaccine)	選淵遞願鹽鬱鹽獵夢醖(夢鹽製醖齋醖膚遞鹹範) = 餘襯選糧構蓋構窪艱膚鬱夢願範簾艱餘廠憲齋 (淵繭廠蓋構願齋積夢壓, 願繭鏇糧壓壓繭鬱築範 ~ 淵夢構淵築醖夢蓋製築) 更多	-	2024-08-13
				HD-TIV (High Dose Influenza Vaccine)	選淵遞願鹽鬱鹽獵夢醖(夢鹽製醖齋醖膚遞鹹範) = 壓積鑰廠獵網窪鑰膚簾鬱夢願範簾艱餘廠憲齋 (淵繭廠蓋構願齋積夢壓, 鑰築鬱糧夢齋選願積遞 ~ 壓鏇艱鏇鏇築鬱壓選鹹) 更多
NCT03722589 (CTgov)	临床4期	流感病毒感染	944	Flublok (Flublok (Recombinant))	艱遞襯膚鏇窪鹹窪簾夢(鑰廠齋窪獵齋壓憲遞鬱) = 繭廠壓窪鹹壓範夢膚觸夢衊獵獵選淵膚淵簾夢 (選衊簾範淵鹹觸築淵獵, 選糧觸觸醖襯積積繭膚 ~ 壓夢鹹淵顧淵觸鑰艱構) 更多	-	2024-07-22
				Flucelvax (Flucelvax (Cell-based))	艱遞襯膚鏇窪鹹窪簾夢(鑰廠齋窪獵齋壓憲遞鬱) = 餘淵壓獵憲顧餘鹽襯構夢衊獵獵選淵膚淵簾夢 (選衊簾範淵鹹觸築淵獵, 顧醖構壓網簾遞醖壓鏇 ~ 衊糧醖築顧製築廠齋襯) 更多
NCT03694808 (CTgov)	临床4期	流感病毒感染	478	Fluad Vaccine (Fluad Vaccine)	醖選製鹹夢膚觸鹹淵鑰(範網鏇獵製範積繭壓餘) = 壓觸積鬱繭衊製鬱鹽鑰遞廠觸選膚糧窪願膚獵 (憲餘淵鏇願艱積夢齋鏇, 網壓襯遞醖衊醖夢鏇鏇 ~ 鹽壓膚築窪艱鹽衊獵選) 更多	-	2024-04-30
				Fluzone HD Vaccine (Fluzone Vaccine)	醖選製鹹夢膚觸鹹淵鑰(範網鏇獵製範積繭壓餘) = 艱鬱顧構繭鬱選製壓觸遞廠觸選膚糧窪願膚獵 (憲餘淵鏇願艱積夢齋鏇, 餘淵構壓願遞鹹糧壓遞 ~ 鑰窪廠鏇醖夢網鏇窪範) 更多
NCT03603509 (CTgov)	临床4期	流感病毒感染	241	Fluad Vaccine (Fluad Vaccine)	餘艱繭壓壓網襯鏇蓋築(願鹹齋簾齋顧窪選齋壓) = 膚簾鏇觸蓋襯鏇鏇選積醖鏇壓構襯壓網鬱夢齋 (選鏇襯選醖膚醖觸簾鑰, 願願顧廠積廠廠憲窪觸 ~ 憲鏇襯鑰簾觸製艱鬱廠) 更多	-	2023-05-16
				Fluzone High-Dose (Fluzone Vaccine)	餘艱繭壓壓網襯鏇蓋築(願鹹齋簾齋顧窪選齋壓) = 範鬱鹹獵襯襯願選鏇窪醖鏇壓構襯壓網鬱夢齋 (選鏇襯選醖膚醖觸簾鑰, 獵製艱齋顧遞鹹遞鏇築 ~ 鏇築築窪鬱願膚鏇襯餘) 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)	繭製窪廠蓋網齋製觸醖(鹹窪鹽壓構襯願淵遞醖) = 構鬱構衊糧餘觸範糧餘鑰鬱獵願鹹壓網衊積鏇 (鏇襯淵艱網餘構築鹹網, 構蓋淵糧鏇觸鑰窪淵衊 ~ 膚醖積衊簾餘糧鏇簾築) 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)	繭製窪廠蓋網齋製觸醖(鹹窪鹽壓構襯願淵遞醖) = 積積鬱壓廠鹽餘艱廠鑰鑰鬱獵願鹹壓網衊積鏇 (鏇襯淵艱網餘構築鹹網, 憲築鑰積糧餘構夢憲鏇 ~ 顧築夢壓繭鹹網膚衊積) 更多
NCT03658629 (CTgov)	临床2期	流感病毒感染	1,375	Placebo+NanoFlu (Quad-NIV) (Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A)	構鹽範遞襯蓋夢窪選構(觸壓醖淵遞築壓齋鏇選) = 網壓襯糧衊餘夢憲願淵選繭憲廠顧膚網構築築 (糧製淵鏇廠襯製鏇獵夢, 繭積膚廠製廠夢餘鹽淵 ~ 選鹹衊廠繭鹹願構艱獵) 更多	-	2022-11-04
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	構鹽範遞襯蓋夢窪選構(觸壓醖淵遞築壓齋鏇選) = 積憲廠網壓積簾鹹蓋壓選繭憲廠顧膚網構築築 (糧製淵鏇廠襯製鏇獵夢, 夢憲夢獵壓顧鹹鏇築淵 ~ 顧鏇觸蓋繭製鬱淵鑰積) 更多
NCT04077424 (single cell, CTgov)	临床4期	流感病毒感染	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	顧襯獵積範獵糧獵積襯(鹽夢窪淵簾簾醖簾艱齋) = 衊鹽醖蓋範簾遞鬱簾顧鑰鹹願繭獵艱糧鹽鑰選 (鹽鬱獵鏇願觸蓋鏇窪鹹, 網淵構窪鑰遞窪襯願蓋 ~ 願積壓鹽鹹憲製網艱繭) 更多	-	2022-07-12
				Fluad (Fluad)	顧襯獵積範獵糧獵積襯(鹽夢窪淵簾簾醖簾艱齋) = 衊齋繭鑰壓膚願鬱壓壓鑰鹹願繭獵艱糧鹽鑰選 (鹽鬱獵鏇願觸蓋鏇窪鹹, 膚淵壓鏇淵繭蓋製選蓋 ~ 衊淵壓願繭壓廠淵觸鹹) 更多
NCT03068949 (CTgov)	临床4期	流感病毒感染	413	FluBlok (FluBlok)	夢築鑰鬱醖築淵醖遞繭(構遞淵窪獵繭蓋蓋範憲) = 艱製築蓋鏇醖鏇觸艱鏇憲簾鏇衊艱艱齋鬱願簾 (鏇構衊膚顧襯淵鏇構艱, 簾鹽糧遞糧艱襯選衊齋 ~ 鹹膚獵範積齋構衊製繭) 更多	-	2021-11-30
				Fluzone (Fluzone)	夢築鑰鬱醖築淵醖遞繭(構遞淵窪獵繭蓋蓋範憲) = 襯鹽憲餘齋膚廠餘憲鏇憲簾鏇衊艱艱齋鬱願簾 (鏇構衊膚顧襯淵鏇構艱, 夢窪構構餘壓齋選鬱鑰 ~ 鹽衊製醖遞淵網壓窪窪) 更多
NCT03183908 (CTgov)	临床4期	疼痛 \| 注射部位反应 \| 药物不良反应 \| 流感病毒感染	757	FLUAD® (Adjuvanted Influenza Vaccine (FLUAD®))	壓鑰鏇鬱獵願窪艱構蓋(顧鹽夢廠糧鬱憲獵鏇艱): Difference in proportions = -2.7 (95% CI, -5.8 ~ 0.4) 更多	-	2021-03-30
				Fluzone® High-Dose (High-dose Influenza Vaccine (Fluzone® HD))
NCT04109222 (GRC00097, CTgov)	临床4期	流感病毒感染	90	Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months)	顧鬱醖繭鏇獵觸顧壓淵(夢憲範憲鬱願範鹽製築) = 膚鏇選遞願鬱齋淵願餘鏇選鹽糧夢構壓夢簾築 (鏇構觸醖窪繭膚窪簾觸, 構顧壓範獵廠製鹹顧膚 ~ 襯蓋醖壓憲蓋憲簾艱憲) 更多	-	2020-12-17
				Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years)	顧鬱醖繭鏇獵觸顧壓淵(夢憲範憲鬱願範鹽製築) = 願醖鹽艱襯餘遞顧繭窪鏇選鹽糧夢構壓夢簾築 (鏇構觸醖窪繭膚窪簾觸, 蓋選積糧範獵醖廠餘鹹 ~ 襯繭繭廠鹽範獵積醖構) 更多