预约演示

更新于：2025-01-23

Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

四价流感病毒裂解疫苗(Sanofi)

更新于：2025-01-23

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

在研机构

非在研机构

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-

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关联

118

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2024-12-09

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

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

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100 项与四价流感病毒裂解疫苗(Sanofi) 相关的转化医学

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100 项与四价流感病毒裂解疫苗(Sanofi) 相关的专利（医药）

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114

项与四价流感病毒裂解疫苗(Sanofi) 相关的文献（医药）

2024-10-01·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: Greenberg, Harry ; Belshe, Robert ; Rhee, Margaret ; Murray, Bryan ; Bilsel, Pamuk ; Fierro, Carlos ; Marshall, David ; Neumann, Gabriele ; Coelingh, Kathleen ; Moser, Michael J ; Herber, Renee ; Eiden, Joseph ; Kawaoka, Yoshihiro ; Turner, Mark ; Davis, Matthew ; Aitchison, Roger ; White, Alexander

BACKGROUND:

Older 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.

METHODS:

In 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.

FINDINGS:

Between 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.

INTERPRETATION:

The 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.

FUNDING:

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

Abstract:

Background:

Cell-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.

Methods:

In 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.

Results:

Cell-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.

Conclusions:

These 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·Journal of immunology (Baltimore, Md. : 1950)

Distinct Functional Humoral Immune Responses Are Induced after Live Attenuated and Inactivated Seasonal Influenza Vaccination

Article

作者: Lingwood, Daniel ; Alter, Galit ; Deng, Yixiang ; Tong, Xin ; Cizmeci, Deniz ; Fontana, Laura ; Ross, Ted M. ; Hanley, Hannah B. ; Carlock, Michael A. ; McNamara, Ryan P.

Abstract:

Influenza viruses infect 5–30% of the world’s population annually, resulting in millions of incidents of hospitalization and thousands of mortalities worldwide every year. Although annual vaccination has significantly reduced hospitalization rates in vulnerable populations, the current vaccines are estimated to offer a wide range of protection from 10 to 60% annually. Such incomplete immunity may be related to both poor antigenic coverage of circulating strains, as well as to the insufficient induction of protective immunity. Beyond the role of hemagglutinin (HA) and neuraminidase (NA), vaccine-induced Abs have the capacity to induce a broader array of Ab effector functions, including Ab-dependent cellular cytotoxicity, that has been implicated in universal immunity against influenza viruses. However, whether different vaccine platforms can induce functional humoral immunity in a distinct manner remains incompletely defined. In this study, we compared vaccine-induced humoral immune responses induced by two seasonal influenza vaccines in Homo sapiens, the i.m. inactivated vaccine (IIV/Fluzone) and the live attenuated mucosal vaccine (LAIV/FluMist). Whereas the inactivated influenza vaccine induced superior Ab titers and FcγR binding capacity to diverse HA and NA Ags, the live attenuated influenza mucosal vaccine induced a more robust functional humoral immune response against both the HA and NA domains. Multivariate Ab analysis further highlighted the significantly different overall functional humoral immune profiles induced by the two vaccines, marked by differences in IgG titers, FcR binding, and both NK cell–recruiting and opsonophagocytic Ab functions. These results highlight the striking differences in Ab Fc-effector profiles induced systemically by two distinct influenza vaccine platforms.

项与四价流感病毒裂解疫苗(Sanofi) 相关的新闻（医药）

2024-12-27

·生物制品圈

2024最新|WHO关于流感疫苗的系统综述

导读：流感疫苗是预防和控制流感的重要工具。然而，现有流感疫苗由于制备周期较长，使得其每年对疾病的预防、保护能力都较为有限。 2024年10月，世界卫生组织(World Health Organization ,WHO)发表了题目为“Advancing influenza vaccines: A review of next-generation candidates and their potential for global health impact”的综述文章，对当前的流感疫苗和新一代流感疫苗进行了系统比较，今天由菌菌带领大家一起走进这篇最新综述。 01 引言疫苗接种是减轻流感负担的关键公共卫生干预措施，为季节性流行和大流行防范奠定了基础。然而，尽管季节性流感疫苗得到广泛使用，流感仍然在全球范围内造成重大疾病和经济负担，目前可用的流感疫苗的年有效率通常在20%-60%之间。疫苗类型、剂量和佐剂的添加会影响疫苗在不同目标人群中的效果。不同类型疫苗的产生是预防和减轻大流行性流感出现的重要工具。WHO强烈鼓励开发更有效、更适合计划的流感疫苗，呼吁研发机构改进新型和通用的流感疫苗，以扩大保护范围、延长保护时间、增强对严重疾病的有效性并缩短生产时间。图1为WHO提出新一代流感疫苗改进的框架与趋势。图1 新一代流感疫苗改进框架与趋势 02 当前主流的季节性流感疫苗目前获得批准的季节性流感疫苗根据生产特点主要分为三种类型，灭活流感病毒疫苗(Inactivated influenza virus vaccines, IIVs)、减毒流感病毒活疫苗(Live-attenuated influenza virus vaccines, LAIVs)和重组流感疫苗(Recombinant influenza vaccines, RIVs)。上述这些疫苗，在设计制备和疫苗功效上都有着诸多不同。2.1 疫苗的设计与制备目前获得许可的疫苗旨在提供特定毒株的保护。用于季节性疫苗的IIVs大多以分裂病毒粒子或亚基形式制造，但已失活不能复制。LAIV型病毒含有来自目标病毒株的血凝素(Haemagglutinin, HA)和神经氨酸苷酶(Neuraminidase, NA)，是一种减毒活流感病毒。RIV疫苗也以HA为靶向蛋白，最终形式为重组蛋白或病毒样颗粒(Virus-like particle, VLP)。IIV和LAIV生产过程成本相对较低、制造工艺为在已充分发展的鸡胚中制造，但生产周期较长约为6个月，极大地降低了疫苗的有效性。而基于细胞培养的方法理论上可以从冷冻保存的细胞系实现大规模生产。然而，由于知识产权问题、较高的制造成本以及细胞系较难获批使得整个制备较为受限。此外，使用杆状病毒表达载体在昆虫细胞中表达HA蛋白，也已成为获批的RIV制备手段。2.2 疫苗的功效当前主流的流感疫苗，又可以根据佐剂的添加情况与疫苗剂量分为传统型和增强型两大类。近期多份报告对传统和增强型季节性疫苗的效力、有效性和安全性进行了评估，发现重组HA蛋白疫苗的反应原性与传统流感疫苗相似，证明了增强型季节性疫苗的有效安全性（表1）。表1 传统流感疫苗和增强型季节性流感疫苗对比 03 新一代流感候选疫苗新一代流感疫苗技术包括重组蛋白、基于流感病毒的疫苗、VLP、病毒载体、非VLP纳米颗粒和基于核酸（DNA和mRNA）的疫苗。这些产品根据其各自的预期用途、适应症分为通用型疫苗、广泛保护型疫苗、新一代季节性疫苗和联合疫苗。如图2所示，文章对共计纳入了56种新一代候选疫苗，在表达平台、免疫原性、免疫反应、性能等多方面梳理了新一代候选流感疫苗的特性。图2 临床开发中的新型流感疫苗管线3.1 候选疫苗平台通用型或广泛保护型疫苗的产品种类最多，并且大部分是基于流感病毒或非VLP的纳米颗粒技术，然而此类疫苗尚处于Ⅰ/Ⅱ期临床试验中。新一代季节性流感疫苗在是临床管线中的候选数量几乎是通用型或广泛保护型疫苗的两倍，绝大多数由多个团体和合作机构基于mRNA开发，包括大型制药公司和疫苗制造商、生物技术和学术界，目前临床开发阶段尚无基于DNA的疫苗。此外，目前有8种含有流感成分的联合候选疫苗正在临床研发中，其技术和方法与其独立的新一代季节性流感疫苗候选物类似（图3）。图3 新一代流感疫苗的表达平台、适应症和临床开发阶段3.2 免疫原性及对高危人群检测疫苗的免疫原性是指能够刺激机体形成特异抗体的能力，疫苗只有富含免疫原性，才能刺激机体产生特异性免疫学反应。测量免疫原性最常用的检测方法包括HA抑制(HA inhibition, HAI)、病毒中和、酶联免疫吸附实验和酶联免疫吸附斑点实验。由于免疫原性的测量和报告方式各不相同，使不同的候选疫苗之间免疫原性的比较相对较困难。目前仅有五种候选疫苗报告了有效性结果，如Osivax的核蛋白质纳米颗粒疫苗在2021-2022年流感季节对甲型流感感染的保护率达到84%。与接受安慰剂的患者相比，FLU-v疫苗的接种者发生轻中度流感疾病的可能性显著降低。 WHO关于流感疫苗的指导建议考虑在高危人群（如医务人员、患有合并症和基础疾病的人、老年人和孕妇）以及儿童中接种季节性流感疫苗。当前的候选疫苗大部分在≥65岁的老年人中进行了临床试验。而FluGen的H3N2 M2缺失单复制活病毒疫苗是唯一在儿童中进行测试的候选疫苗，目前已经完成了9-17岁儿童的Ⅰ期临床试验。尽管强调流感疫苗适合高危人群，但目前的候选疫苗尚未在大多数这些人群中进行测试，因此必须在所有高危人群中评估新一代流感疫苗，以确保有安全、更有效的疫苗可用，高危人群的发病率。3.3 免疫反应与性能适应性免疫系统需要持续几周时间才能针对特定病原体建立起长期的精准反应，这也是在接种疫苗期间，免疫系统发挥作用的典型机制，而免疫反应的广泛性体现在其能够对多种病原体做出反应。目前只有通用型和广泛保护型疫苗在这两方面进行了研究。基于铁蛋白的纳米颗粒疫苗在甲型流感第1组病毒中表现出异亚型反应，持续至少6个月。嵌合流感病毒减毒活疫苗或佐剂灭活疫苗在第1组中产生了持续420天的异亚型应答。FluGen的H3N2 M2SR疫苗能够诱导对漂移毒株的免疫应答。流感病毒(FLU-v)是一种佐剂重组蛋白疫苗，对甲型流感和乙型流感病毒株都有交叉反应，并与抗体反应一起持续了180天。新一代候选疫苗的主要目标是引发良好的免疫反应，或比目前已获许可的流感疫苗疗效更好。在新一代季节性候选疫苗中，有几种疫苗在引发的免疫反应或保护效力方面优于现有的流感疫苗。Novavax的NanoFlu疫苗已被证明在引发老年人对同源和异源病毒株的抗体和T细胞反应方面不劣于甚至优于四价季节性流感疫苗。Moderna的mRNA-1010的最新Ⅲ期试验结果显示，与标准剂量疫苗对照物相比，A型和B型病毒株的几何平均滴度和血清转化率更高。与增强型季节性流感疫苗相比，mRNA-1010在老年人中诱导更高HAI滴度。辉瑞Ⅲ期四价mRNA候选疫苗尽管仅针对A型病毒株达到了免疫原性终点，但仍显示出非劣性和优效性。在通用型或广泛保护型候选疫苗中，H3N2 M2SR在老年人中的免疫原性与增强型Fluzone疫苗相比，H3N2 M2SR引起分泌IgA抗体和T细胞反应增加。在H3N2 M2SR和Fluzone联合治疗的受试者中，与单独使用高剂量Fluzone相比，受试者的HAI和神经氨酸酶抑制实验反应增加。这些结果表明与现有流感疫苗相比，新一代候选疫苗，如重组蛋白疫苗、mRNA疫苗，不仅引发良好的免疫反应，并且在老年人中表现出良好的性能。 04 结语在全球范围内提高疫苗接种率将降低季节性流感的发病率和死亡率。由于当前流感疫苗难以实现充足的保护和较高的生产效率，在应对病毒变异、及时供应和适用人群等方面面临重大挑战，因此WHO等机构极力呼吁开发新一代季节性流感疫苗来弥补现有疫苗的诸多不足。文章披露的56种候选疫苗正在开发中，其中包括最新的mRNA技术和联合疫苗的使用，以期实现更广泛的交叉保护，显著提高疫苗效力和计划适用性的潜力。参考文献 [1] Taaffe, Jessica et al. “Advancing influenza vaccines: A review of next-generation candidates and their potential for global health impact.” Vaccine, vol. 42,26 126408. 5 Oct. 2024, 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

2024-12-12

·PMLiVE

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

Sanofi has announced that its two combination vaccine candidates for COVID-19 and influenza (flu) have been granted fast track designation by the US Food and Drug Administration (FDA) for use in individuals aged 50 years and older. The regulator’s decision comes seven months after Sanofi gained a sole licence to Novavax’s adjuvanted COVID-19 vaccine for use in combination with its own licensed flu vaccines. It is hoped that the combined vaccine approach will alleviate the impact of both respiratory illnesses while simplifying immunisation practices for healthcare providers and patients, potentially leading to higher vaccine uptake. Sanofi’s first vaccine candidate combines its protein-based trivalent flu vaccine Fluzone High-Dose with Novavax’s adjuvanted recombinant COVID-19 vaccine, while the second consists of Sanofi’s recombinant protein-based trivalent flu vaccine Flublok and the Novavax vaccine. The combination vaccines will now benefit from the FDA’s fast-track process, which is designed to support the development and accelerate the review of products that address serious conditions. Clinical trials have shown that Fluzone and Flublok can prevent more flu infections in older adults than standard-dose flu vaccines, Sanofi said, adding that both vaccines have demonstrated significant and consistent reductions in flu-related hospitalisations in real-world evidence studies. Novavax’s COVID-19 vaccine has also been associated with a better tolerability profile than currently available mRNA COVID-19 vaccines when given as a booster dose, and has demonstrated high efficacy against COVID-19 as a primary vaccination in two late-stage studies, the company said. Sanofi has already initiated two separate phase 1/2 studies to evaluate the safety and immune response generated by the combination vaccines. Thomas Triomphe, executive vice president, vaccines at Sanofi, said: “Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the… levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Sanofi and Novavax’s licensing agreement announced in May, worth over $1.2bn, also gave Sanofi a co-exclusive licence to co-commercialise Novavax’s adjuvanted COVID-19 vaccine globally, except in countries that Novavax has existing partnership agreements with, as well as a non-exclusive licence to use the company’s Matrix-M adjuvant in vaccine products and a less than 5% stake in Novavax.

疫苗引进/卖出快速通道临床研究紧急使用授权

2024-12-12

·Pharmaceutical Technology

Sanofi’s combo vaccines gain FDA fast track designation

The two candidates protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. Credit: fizkes/Shutterstock. Sanofi has announced that its two combination vaccine candidates, designed to prevent both influenza and Covid-19 infections in people aged 50 years and above, have received fast track designation from the US Food and Drug Administration (FDA). The candidates merge two existing vaccines that have demonstrated efficacy and favourable tolerability through randomised controlled studies. The first candidate combines the Fluzone high-dose influenza vaccine and the adjuvanted Novavax Covid-19 vaccine. The second merges Flublok, an influenza recombinant protein-based vaccine, with the Novavax vaccine. These influenza vaccines have significantly reduced flu-related hospitalisations in real-world evidence studies. The Novavax COVID-19 vaccine, when used as a booster dose, has a better tolerability profile than currently available mRNA vaccines and has shown high efficacy in two pivotal Phase III trials. Sanofi Vaccines executive vice-president Thomas Triomphe stated: “Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. “Our goal is to develop a combined flu and Covid-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry-leading levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Two separate Phase I/II trials (NCT06695117 and NCT06695130) to assess the immune response and safety of the combo candidates have been commenced by the company. These randomised, parallel, multi-arm, modified double-blind studies are set to provide further insights into the vaccines’ performance. The two candidates aim to protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. The use of combination vaccines could simplify immunisation programmes, offering quicker administration, fewer injections, reduced errors and decreased syringe and vial disposal needs. This announcement follows the European Medicines Agency’s approval in November 2024 of Sanofi/Regeneron’s Dupixent for treating eosinophilic esophagitis.

临床3期疫苗快速通道临床结果上市批准

100 项与四价流感病毒裂解疫苗(Sanofi) 相关的药物交易

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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,

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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,

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适应症	最高研发状态	国家/地区	公司	日期
白喉	临床3期	法国	Sanofi Pasteur	2010-10-01
白喉	临床3期	德国	Sanofi Pasteur	2010-10-01
脊髓灰质炎	临床3期	法国	Sanofi Pasteur	2010-10-01
脊髓灰质炎	临床3期	德国	Sanofi Pasteur	2010-10-01
破伤风	临床3期	法国	Sanofi Pasteur	2010-10-01
破伤风	临床3期	德国	Sanofi Pasteur	2010-10-01
百日咳	临床3期	法国	Sanofi Pasteur	2010-10-01
百日咳	临床3期	德国	Sanofi Pasteur	2010-10-01

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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


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)	遞壓製鹹窪窪願鑰鑰醖(獵夢蓋齋網壓鹹積齋製) = 醖製繭餘遞製簾醖餘鹹鹹鹹選築淵顧廠鬱衊糧 (襯築鏇築鬱鏇膚觸衊餘, 廠齋鏇醖顧鬱鬱網鹹鑰 ~ 鬱齋齋積窪遞鏇築襯構) 更多	-	2024-08-13
				HD-TIV (High Dose Influenza Vaccine)	遞壓製鹹窪窪願鑰鑰醖(獵夢蓋齋網壓鹹積齋製) = 憲糧憲鏇遞範製壓製範鹹鹹選築淵顧廠鬱衊糧 (襯築鏇築鬱鏇膚觸衊餘, 襯網鏇繭觸顧壓製襯醖 ~ 膚選壓觸壓醖顧壓鹽襯) 更多
NCT03722589 (CTgov)	临床4期	流感病毒感染	944	Flublok (Flublok (Recombinant))	繭壓鹽醖壓顧鹹窪鹽網(築淵網觸構鑰遞獵壓鹽) = 遞願簾積淵築網鬱製壓遞蓋襯艱製願壓鏇淵觸 (繭淵憲繭構願選顧壓壓, 繭鬱衊網夢醖繭窪願簾 ~ 鏇鹽築選繭獵觸獵選築) 更多	-	2024-07-22
				Flucelvax (Flucelvax (Cell-based))	繭壓鹽醖壓顧鹹窪鹽網(築淵網觸構鑰遞獵壓鹽) = 遞糧簾衊鹽網鹽淵遞選遞蓋襯艱製願壓鏇淵觸 (繭淵憲繭構願選顧壓壓, 憲網憲範鬱淵衊餘遞範 ~ 範鹽遞鑰艱壓積淵廠鏇) 更多
AAI2024	N/A	老化	37	High-dose seasonal influenza vaccine (Fluzone)	選衊窪鑰憲網鑰壓鏇觸(壓觸醖觸醖醖醖夢齋願) = 醖壓艱獵繭網窪衊遞簾廠襯選艱糧醖餘醖廠鏇 (網簾範顧艱觸範蓋齋衊 )	-	2024-05-01
NCT05007041 (CTgov)	临床4期	疼痛 \| 带状疱疹 \| 注射部位反应 ... 更多	267	Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine)	鑰網憲簾壓膚範網鹹襯(願淵齋築淵衊鹽夢廠選): Difference in proportions = -0.96 (95% CI, -8.94 ~ 7.10), P-Value = 0.0037 更多	-	2024-05-01
				Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine)
NCT03694808 (CTgov)	临床4期	流感病毒感染	478	Fluad Vaccine (Fluad Vaccine)	窪壓艱鹹襯鏇構齋獵淵(築壓鹹鹹鑰憲憲鏇壓鏇) = 獵壓築齋膚簾壓艱構積觸醖衊鹹鏇憲窪鹹獵鬱 (淵願廠膚鹹襯衊艱範繭, 鏇憲鬱選網顧鑰顧齋鑰 ~ 構膚衊築觸齋艱齋糧鹽) 更多	-	2024-04-30
				Fluzone HD Vaccine (Fluzone Vaccine)	窪壓艱鹹襯鏇構齋獵淵(築壓鹹鹹鑰憲憲鏇壓鏇) = 築膚選築鏇窪廠築範糧觸醖衊鹹鏇憲窪鹹獵鬱 (淵願廠膚鹹襯衊艱範繭, 糧糧蓋獵製鏇製餘鹽製 ~ 窪鏇鏇範窪獵願網夢餘) 更多
NCT03603509 (CTgov)	临床4期	流感病毒感染	241	Fluad Vaccine (Fluad Vaccine)	鏇遞繭襯範製窪蓋衊鏇(製鏇簾獵廠廠鹹壓製膚) = 憲醖築繭襯鹽積蓋鬱鹹積憲壓網襯獵窪選築壓 (選鬱鬱繭壓願顧網蓋繭, 鬱網鑰衊醖繭壓獵醖壓 ~ 遞襯窪糧繭遞範鏇鹽鹹) 更多	-	2023-05-16
				Fluzone High-Dose (Fluzone Vaccine)	鏇遞繭襯範製窪蓋衊鏇(製鏇簾獵廠廠鹹壓製膚) = 網獵構積獵蓋膚餘顧鬱積憲壓網襯獵窪選築壓 (選鬱鬱繭壓願顧網蓋繭, 範壓築鑰觸醖餘淵襯餘 ~ 衊網願夢繭鬱夢憲廠鑰) 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)	觸繭餘糧襯窪餘糧鹽蓋(顧獵鹹顧繭築鹹夢艱積) = 壓鑰觸廠製鹹夢鹽鹹鹽網構夢醖鬱鏇夢糧範製 (壓襯壓襯觸鹽廠顧壓壓, 獵獵觸選製鬱淵願齋鏇 ~ 築構淵願觸構網窪糧糧) 更多	-	2022-11-04
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	觸繭餘糧襯窪餘糧鹽蓋(顧獵鹹顧繭築鹹夢艱積) = 鹹繭憲衊蓋餘醖選遞遞網構夢醖鬱鏇夢糧範製 (壓襯壓襯觸鹽廠顧壓壓, 夢鬱製糧膚網襯蓋憲願 ~ 醖壓壓繭範蓋鹽簾獵觸) 更多
NCT04077424 (single cell, CTgov)	临床4期	流感病毒感染	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	齋壓齋鬱鹽積繭膚艱壓(夢鑰夢觸窪選淵糧網壓) = 簾網齋壓蓋願憲淵繭構餘選衊齋構衊鑰獵廠鬱 (壓鑰鹹繭襯醖繭選顧繭, 築窪鬱淵鏇夢憲衊繭範 ~ 鹽願窪選網糧簾觸簾製) 更多	-	2022-07-12
				Fluad (Fluad)	齋壓齋鬱鹽積繭膚艱壓(夢鑰夢觸窪選淵糧網壓) = 襯鏇遞鑰顧壓衊蓋鏇顧餘選衊齋構衊鑰獵廠鬱 (壓鑰鹹繭襯醖繭選顧繭, 齋鏇壓餘窪築願鏇襯鹹 ~ 膚築壓遞糧廠顧築願範) 更多
NCT03068949 (CTgov)	临床4期	流感病毒感染	413	FluBlok (FluBlok)	廠觸遞獵艱網壓範範窪(艱顧餘選觸獵構鑰網夢) = 衊繭憲艱憲選顧鏇夢鏇遞選鹽範壓積餘壓繭鹹 (製膚鹽範簾鹽願糧遞簾, 衊壓壓齋願醖觸築鑰衊 ~ 觸蓋醖蓋積膚蓋鬱鏇夢) 更多	-	2021-11-30
				Fluzone (Fluzone)	廠觸遞獵艱網壓範範窪(艱顧餘選觸獵構鑰網夢) = 鹽齋齋願觸窪夢餘鹹窪遞選鹽範壓積餘壓繭鹹 (製膚鹽範簾鹽願糧遞簾, 艱鹽艱鑰憲鹹糧鹽獵憲 ~ 鑰鬱壓鹽繭鹹網鑰選蓋) 更多
NCT03183908 (CTgov)	临床4期	疼痛 \| 注射部位反应 \| 药物不良反应 ... 更多	757	FLUAD® (Adjuvanted Influenza Vaccine (FLUAD®))	繭衊遞網廠鹽淵壓襯製(糧餘鏇衊獵艱鹹顧鏇膚): 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))