This study will provide novel insight into the effects of repeat influenza vaccination with Flublok and FluMist on the strength and breadth of immune responses to influenza, the mechanisms underlying heterogeneity in vaccine response and vaccine failure, and biological factors that could explain variation in influenza vaccine effectiveness.

开始日期2025-10-01

申办/合作机构

香港大学

NCT06518577

/ Completed临床4期IIT

Measuring Immunity Against Circulating Influenza Viruses: Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines

This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses.
Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute [<10 days after symptom onset] and convalescent [28 days after acute visit if lab-confirmed positive for influenza]).

开始日期2024-09-09

申办/合作机构

Duke University

[+5]

NCT05409612

/ Completed临床3期IIT

Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.
Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.

开始日期2022-11-07

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

[+2]

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项与重组四价流感疫苗(Protein Sciences) 相关的文献（医药）

2025-10-01·LANCET INFECTIOUS DISEASES

Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study

Article

作者: See, Stephanie ; De Bruijn, Iris ; Kaas-Leach, Kathleen ; Tabar, Cynthia ; Pepin, Stephanie ; Konieczny, Marek ; Folegatti, Pedro M ; Drazan, Daniel ; Essink, Brandon ; Natalini Martínez, Silvina ; Bertoch, Todd ; Talanova, Oxana ; Fries, Katherine

BACKGROUND:

The recombinant influenza vaccine (RIV) is licensed for adults older than 18 years but is not approved for paediatric groups. This study aimed to demonstrate the non-inferior immune responses and safety of RIV in participants aged 9-17 years compared with adults aged 18-49 years.

METHODS:

This was a phase 3, non-randomised, immunobridging, open-label, uncontrolled study conducted at 36 centres in Europe and the USA during the 2022-23 northern hemisphere influenza season. The main exclusion criteria were receipt of an influenza vaccine up to 6 months before enrolment and receipt of any other vaccines within 4 weeks before or after study intervention (except for COVID-19 vaccination, which was allowed at least 2 weeks before or after enrolment). Healthy participants aged 9-49 years received a single dose of quadrivalent RIV and were followed up for 6 months on days 9, 29, and 181. Haemagglutination inhibition (HAI) assays to assess immunogenicity were used to test blood samples obtained at baseline and day 29. The primary outcome was the non-inferiority of immune response at day 29 as assessed by HAI titre ratios and differences in seroconversion rates between the two age groups. The non-inferiority of a geometric mean titre was demonstrated if the lower limit of the two-sided 95% CI of the geometric mean titre (GMT) ratio was above 0·667 for each of the four strains of virus. Similarly, the non-inferiority of seroconversion was demonstrated if the lower limit of the two-sided 95% CI was -10% or above for each of four strains. Safety was monitored throughout the study. This study was registered at ClinicalTrials.gov (NCT05513053) and is complete.

FINDINGS:

Between Oct 27, 2022, and May 1, 2023, a total of 1308 participants were enrolled, all of whom attended the first study visit. 1299 participants (99%) received the study vaccine (641 participants [49%] in the age 9-17 years group and 658 participants [51%] in the age 18-49 years group). The mean age of participants in the age 9-17 years group was 13·0 years (SD 2·5) and was 34·3 years (9·2) in the age 18-49 years group. Overall, 707 participants (54%) were female and 601 participants (46%) were male. Most of the participants were White (1003 [77%] of 1308); the next largest category was Black or African American (255 [19%]); 149 (11%) participants identified as Hispanic or Latino. The HAI GMT ratio between the paediatric and adult groups at day 29 in the per-protocol analysis set was 2·0 (95% CI 1·7 to 2·3), 3·3 (2·8 to 3·9), 1·6 (1·4 to 1·8), and 1·2 (1·1 to 1·4) for A/H1N1, H3N2, B/Victoria, and B/Yamagata, respectively. Differences in seroconversion between the groups were 1·9 (-2·8 to 6·6), -0·6 (-4·4 to 3·2), 3·3 (-1·6 to 8·1), and 14·3 (9·2 to 19·3) for each of the four strains, respectively. The safety profile was comparable in both age groups, except for solicited reactions within 7 days post-vaccination that were fewer in children and adolescents (274 [44%] of 618; 95% CI 40 to 48) than in adults (336 [53%] of 635; 49 to 57). No related serious adverse events, deaths, or adverse events of special interest were reported.

INTERPRETATION:

RIV4 induced non-inferior immune responses in the participants aged 9-17 years compared with those aged 18-49 years. No safety concerns were reported.

FUNDING:

Sanofi.

2025-08-01·VACCINE

Immunogenicity and safety of quadrivalent recombinant influenza vaccine in Korean adults: Phase III, randomized study

Article

作者: Choe, Sunho ; Peng, Lin ; Choi, Won Suk ; Lee, Jacob ; Samson, Sandrine ; Shin, Sooyoun ; Kim, Woo Joo ; Ottaviano, Cecilia

Quadrivalent recombinant influenza vaccine (RIV4) is indicated for active immunization against influenza virus in adults (≥18 years) in countries where it is currently registered. This Phase III, parallel, randomized, modified double-blind, active controlled, multi-center study was designed to compare the immunogenicity and safety of single dose intramuscular RIV4 with a locally-licensed quadrivalent-inactivated influenza vaccine (IIV4, Fluarix® quadrivalent) in participants aged ≥18 years during 2021-22 Northern Hemisphere influenza season at three tertiary care centers in South Korea. Participants were randomized (1:1) to receive single dose intramuscular RIV4 or IIV4. All participants were centrally assigned to randomized study intervention using an interactive response technology (IRT). Participants, investigators, and the staff in-charge of the sampling, safety assessment and immunogenicity assays were blinded. The overall mean age of 300 participants who completed the study was 46.1 years. The post-vaccination geometric mean fold-rise of HAI antibodies were 32.0, 13.2, 6.1, and 5.3 in RIV4 group, and 22.3, 8.0, 4.7, and 3.4 in IIV4 group for the A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage strains, respectively. Seroconversion in RIV4 was comparable or higher than IIV4. Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. Clinical Trial Registration:ClinicalTrials.gov number - NCT05144945.

2025-08-01·AJOG global reports

Corrigendum to ‘Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants’ [AJOG Global Reports Volume 4, Issue 4, November 2024, 100395]

作者: Talanova, Oxana ; Izikson, Ruvim ; Gandhi-Banga, Sonja ; Yee, Arnold ; Lewis, Ned ; Hsiao, Amber ; Klein, Nicola P ; Inamdar, Ajinkya ; Kabler, Heidi ; Fireman, Bruce ; Hansen, John ; Selmani, Alexandre

[This corrects the article DOI: 10.1016/j.xagr.2024.100395.].

项与重组四价流感疫苗(Protein Sciences) 相关的新闻（医药）

2025-11-12

·知乎专栏

生物制品领域杆状病毒表达系统的应用和宿主残留核酸风险控制

杆状病毒（Baculovirus）是一类基因组大小约为80-180 kb的双链环状闭合DNA病毒，属于杆状病毒科（Baculoviridae），有核型多角体（Nucleopolyhedovirus）和颗粒体（Granulovirus）两个病毒属。病毒粒子的形态一般为棍棒状，长度为200-400 nm，宽度为40-110 nm，因病毒核衣壳形似杆状而得名。目前已分离得到600多种杆状病毒，对节肢类动物具有致病性，主要感染膜翅目、双翅目和鳞翅目昆虫。杆状病毒在感染周期产生两种病毒粒子：一种为包埋型病毒粒子（Occlusion-derived virions，ODV），适应于恶劣环境下在虫体之间感染繁殖；另一种为出芽型病毒粒子（Budded virions，BV），能够在虫体内细胞之间进行扩散，也是体外条件下产生重组蛋白的主要病毒粒子类型（见图1）。图1 包埋型（ODV）和出芽型（BV）病毒粒子形态在实验室研究与生物制品生产中，最常用的是苜蓿环纹夜蛾中分离出的苜蓿尺蠖核型多角体病毒（Autographa califomica nuclear polyhedrosis virus，AcNPV），其基因组大小约为130 kb，含154个开放阅读框。AcNPV的多角体蛋白基因Polh（polyhedrin，Polh）和参与多角体膜形成的基因p10带有强启动子，且其编码的蛋白为病毒扩增的非必要组分，可插入外源片段，故用于表达目的蛋白。昆虫细胞杆状病毒的宿主细胞为昆虫细胞，应用较广的昆虫细胞系主要有2种：草地夜蛾细胞系（Spodopteraugerda cell line，Sf），常用Sf21及其分离株Sf9细胞；粉纹夜蛾细胞系（Trichoplusia ni cell line，Tn），常用商品化的High Five™（Hi5）细胞。Sf9细胞更适合于重组病毒扩增及包装，Sf21因细胞直径大更适用于病毒滴度空斑实验观察，而Hi5细胞更适用于分泌蛋白表达。这些昆虫细胞对AcNPV极度敏感，在大规模反应器中可高密度悬浮培养。杆状病毒表达系统杆状病毒表达系统（Baculovirus expression system，BVES）是以杆状病毒作为外源基因载体，以昆虫细胞作为宿主进行外源蛋白生产的真核表达系统。早期的BVES采用同源重组技术得到重组病毒，即将外源基因克隆至AcNPV非必需核型多角体基因的强启动子下游，并与野生型AcNPV DNA共转染昆虫细胞，经同源重组和病毒空斑纯化得到产物。但这种方法重组率较低（0.1%~1.0%），并且需要经过多轮空斑纯化才能得到重组病毒，很大程度上限制了BVES的应用。近年来，新型生物制品行业不断发展，多种BVES（包括Bac-to-bac、MultiBac等）的应用极大地优化了重组病毒构建和筛选的过程。图2 Bac-to-Bac系统产生重组杆状病毒和基因表达优势：生物安全性好：杆状病毒宿主范围极窄，仅感染特定的昆虫，对植物、哺乳动物、鸟类、鱼类和非目标昆虫无感染特性，具有优良的安全性。极晚期表达效率高：杆状病毒基因表达有四个阶段：极早期、早期、晚期和极晚期。BVES适用的Polh和p10启动子属于极晚期强启动子，对外源蛋白表达量为哺乳动物细胞表达量的200倍。蛋白翻译后修饰：昆虫细胞为真核细胞，故相较于原核表达系统来说，其可对外源蛋白进行糖基化、磷酸化、乙酰化和信号肽切除等翻译后修饰，使之在结构及功能上接近天然蛋白，保持目的蛋白的生物活性。外源基因容量大：杆状病毒基因组较大（80-180 kb），最大能接受38 kb或25个外源基因插入，同时具有多个天然强启动子，故可容纳大片段外源基因或同时插入多个外源基因，适合构建复杂结构重组病毒样颗粒（VLP），是理想的克隆载体。生物制品领域BVES的应用BVES具有易于规模化生产、培养成本低、宿主残留对脊椎动物的生物安全性高等优势，已陆续被研究用于生产重组蛋白、rAAV载体、亚单位疫苗、VLP等。1983年，首次使用BEVS-Sf9系统成功表达出人β-干扰素，该方法被证明是一种经济可行的重组蛋白生产平台。2002年，Urabe等通过携带AAV包装基因的重组杆状病毒感染Sf9细胞生产rAAV，产量远高于HEK293表达系统，可达10¹⁴VG (vector genomes)/L，满足临床rAAV载体用量，为rAAV载体的生产提供了一种简单快捷、经济高效的方法。2013年，全球第一支针对流感病毒的三价重组亚单位疫苗（Recombination HA vaccine，rHA vaccine）FluBlok®批准上市，用以预防流感病毒的大面积爆发，该疫苗即以BVES-Sf9作为表达系统。2016年，FDA又通过了覆盖率更高的FluBlok®四价流感疫苗。在新型冠状病毒大流行的背景下，2020年11月英国布里斯托尔大学生物化学学院Christiane Schaffitzel于Science发文表明游离脂肪酸或可干预新型冠状病毒COVID-19，并用杆状病毒感染的Hi5昆虫细胞生成了SARS-CoV-2糖蛋白。截至2021年7月，全球共有32个蛋白亚单元疫苗正在开展临床试验研究；截至2022年09月22日，查找到14个新冠重组疫苗（Sf9细胞）和1个Hi5相关药物提交了临床试验登记。杆状病毒表达宿主残留核酸风险控制目前关于宿主细胞残留DNA（rDNA）的风险研究，主要包括传染性、致癌性、免疫原性等，各国药典对其残留量有着严格的限度要求：美国食品药品监督管理局（FDA）发布的指导原则中指出生物制品宿主细胞DNA残留限度不得超过100 pg/剂，对于大剂量的生物制品（如单克隆抗体），根据其残留DNA来源及给药途径，DNA残留量可放宽至10 ng/剂。《欧洲药典》（EP10.0）通则规定的生物制品残留DNA限度大多为不超过10 ng/剂。2020年版《中国药典》三部规定，以细胞基质生产的生物制剂DNA残留量不能超过100 pg/剂。在生物制品领域杆状病毒表达应用逐步提升的大背景下，亟需建立合适的检测方法监测生产工艺，控制Sf9细胞、Hi5细胞等宿主昆虫细胞残留核酸限度，以确保产品的安全性和质量。--湖州申科提供Sf9&AcNPV残留DNA检测试剂盒（多重PCR-荧光探针法）和Hi5&AcNPV残留DNA检测试剂盒（多重PCR-荧光探针法），用于定量检测BVES来源的生物制品中残留昆虫细胞（Sf9/Hi5）DNA和杆状病毒（AcNPV）DNA，助力生物制品制造。货号产品名称规格1101101Sf9&AcNPV残留DNA检测试剂盒（多重PCR-荧光探针法）100 Reactions1101102Hi5&AcNPV残留DNA检测试剂盒（多重PCR-荧光探针法）100 Reactions参考文献：[1] Luckow V A , Lee S C , Barry G F , et al. Efficient generation of infectious recombinant baculoviruses by site-specific transposon-mediated insertion of foreign genes into a baculovirus genome propagated in Escherichia coli.[J]. Journal of Virology, 1993, 67(8):4566-4579.[2] USAMI A, ISHIYAMA S, ENOMOTO C, et al. Comparison of recombinant protein expression in a baculovirus system in insect cells (Sf9) and silkworm [J]. Journal of Biochemistry, 2011, 149(2): 219-27.[3] SHEN X, HACKER D L, BALDI L, et al. Virus-free transient protein production in Sf9 cells [J]. Journal of Biotechnology, 2014, 171: 61-70.[4] URABE M, DING C, KOTIN R M. Insect cells as a factory to produce adeno-associated virus type 2 vectors [J]. Human Gene Therapy, 2002, 13(16): 1935-43.[5] CHEN H. Intron Splicing–mediated Expression of AAV Rep and Cap Genes and Production of AAV Vectors in Insect Cells [J]. Molecular Therapy, 2008, 16(5): 924-30.[6] THOMPSON C M, PETIOT E, MULLICK A, et al. Critical assessment of influenza VLP production in Sf9 and HEK293 expression systems [J]. Bmc Biotechnology, 2015, 15(1): 1-12.[7] SMITH G E, FRASER M J, SUMMERS M D. Molecular Engineering of the Autographa californica Nuclear Polyhedrosis Virus Genome: Deletion Mutations Within the Polyhedrin Gene [J]. Journal of Virology, 1983, 46(2): 584-93.[8] COX M, PATRIARCA P A, TREANOR J. FluBlok, a recombinant hemagglutinin influenza vaccine [J]. Influenza & Other Respiratory Viruses, 2010, 2(6): 211-9.[9] Oers M. Opportunities and challenges for the baculovirus expression system[J]. Journal of Invertebrate Pathology, 2011.[10] 曹翠平, 吴小锋. 重组昆虫杆状病毒构建和筛选技术进展[J]. 昆虫学报, 2004, 47(6):7.[11] 张帅. 杆状病毒表达系统载体优化及初步应用[D]. 河南农业大学.[12] 国家药典委员会. 中华人民共和国药典2020年版三部 [M]. 北京：中国医药科技出版社, 2020.[13] 国家药品监督管理局药品审评中心. 基因治疗产品药学研究与评价技术指导原则（征求意见稿） [Z]. 2020.[14] 闫璐瑶. 生物制品中宿主细胞残留DNA检测的研究进展 [J]. 国际生物制品学杂志, 2021, 44(3): 5.更多生物制品质控相关问题，欢迎咨询湖州申科生物技术股份有限公司！搜索关注“湖州申科”公众号，查看更多相关资讯！

2025-10-14

·EINPresswire

2025 Biological License Application Supplement Noteworthy Approvals

Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived) Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment. 125396/21 Stanford Blood Center 3373 Hillview Avenue Palo Alto, CA 94304 10/10/2025 VYJUVEK beremagene geperpavec-svdt Expand the indication to treat wounds in adults and pediatric patients (0 to 16 years of age) with dystrophic epidermolysis bullosa, and to allow application of VYJUVEK in home setting by a healthcare professional, patient or caregiver. 125774/89 Krystal Biotech, Inc. 2100 Wharton Street Suite 701 Pittsburgh, PA 15203 Lic. # 2301 9/12/2025 VONVENDI von Willebrand Factor (Recombinant) To expand the current approved adult prophylaxis indication for type 3 von Willebrand disease (VWD) to include adults with type 1 and type 2 VWD and to expand the use to pediatric patients with VWD for on demand treatment and control of bleeding episodes and perioperative management of bleeding. 125577/691 Takeda Pharmaceuticals USA, Inc 500 Kendall Street Cambridge, MA 02142 Lic. # 1898 9/5/2025 NUVAXOVID COVID-19 Vaccine, Adjuvanted To include the 2025-2026 Formula and associated labeling revisions. 125817/6 Novavax, Inc. 700 Quince Orchard Road Gaithersburg, MD 20878 Lic. # 2349 8/27/2025 MNEXSPIKE COVID-19 Vaccine, mRNA To include the 2025-2026 Formula and associated labeling revisions for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. 125835/6 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 8/27/2025 SPIKEVAX COVID-19 Vaccine, mRNA To include the 2025-2026 Formula and associated labeling revisions. 125752/305 Moderna TX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 8/27/2025 COMIRNATY COVID-19 Vaccine, mRNA To include: 10 mcg drug product (2025-2026 Formula) in the single-dose vial presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals 5 years through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19; and 30 mcg drug product (2025-2026 Formula) in the single-dose prefilled syringe presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. 125742/656 BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229 8/27/2025 AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted To include data on the safety and efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease in individuals 60 years of age and older over three RSV seasons following administration of a single dose. 125775/297 GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 8/8/2025 CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine To update Section 8 "Use in Specific Populations", Section 6 “Clinical Trials Experience”, and Section 14 “Clinical Studies” of the package insert for the inclusion of individuals living with HIV (V116-007) and individuals at increased risk of pneumococcal disease (V116-008). 125814/149 Merck Sharp & Dohme LLC P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 Lic. # 0002 7/31/2025 Imovax Rabies Rabies Vaccine To update the package insert to include a 2-dose pre-exposure prophylaxis dosing regimen in addition to the currently approved 3-dose regimen. 103931/5342 Sanofi Pasteur SA Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1724 7/24/2025 SPIKEVAX COVID-19 Vaccine To prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and to include a new 0.25 mL pre-filled syringe presentation. 125752/276 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 7/9/2025 GAMMAGARD LIQUID ERC Immune globulin infusion (human) 10% solution For the indication of a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. 125105/2184 Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 6/27/2025 MRESVIA Respiratory Syncytial Virus Vaccine To revise the indication and usage to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. 125796/37 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 6/12/2025 ABRYSVO Respiratory Syncytial Virus Vaccine To update the Package Insert to include safety and efficacy data from two full Respiratory Syncytial Virus (RSV) seasons from the Phase 3 clinical study C3671013, and the final safety data from the Phase 3 study C3671008. 125769/277 Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2001 6/9/2025 MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine To update the Package Insert to include safety and effectiveness data from postmarketing requirement (PMR) studies MET41, MET42 and MET61 that support lowering the age for use to include individuals 6 weeks through 23 months of age. 125701/262 Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1725 5/23/2025 AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted To update the Package Insert to include data from two clinical studies of concomitant administration of AREXVY with influenza vaccines in individuals 65 years of age and older. 125775/247 GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 5/23/2025 Jivi Antihemophilic Factor (recombinant), PEGylated-aucl To revise the indication to include pediatric patients 7 to <12 years of age. 125661/972 Bayer HealthCare LLC 100 Bayer Boulevard, P.O. Box 915 Whippany, NJ 07981-0915 Lic. # 0008 5/14/2025 FluBlok Influenza Vaccine To update the product labeling to include data and results from PREA PMR studies VAP00026 (3-8 year olds) and VAP00027 (9-17 and 18-49 year olds), and to use data from VAP00027 to support extending the Flublok indication to individuals 9 through 17 years of age, and to fulfill (PREA) PMR #1 and (PREA) PMR #2 (125285/471). 125285/613 Protein Sciences Corporation Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. #1795 03/31/2025 JYNNEOS Smallpox and Mpox Vaccine, Live, Non-replicating To include a two-vial presentation of JYNNEOS that consists of a Lyophilized Antigen Component vial and a Diluent Component vial. 125678/119 Bavarian Nordic A/S Bavarian Nordic Inc. 1005 Slater Road, Suite 101 Durham, NC 27703 Lic. #2096 03/31/2025 SHINGRIX Zoster Vaccine Recombinant, Adjuvanted To update the US Prescribing Information to include information from Study Zoster-049 on long term effectiveness of SHINGRIX. 125614/1022 GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. #1617 03/21/2025 ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract To include use in children 5 through 11 years of age. 125592/218 ALK-Abello A/S ALK-Abello Inc. 135 Route 202/206 Suite 16 Bedminster, NJ 07921 Lic. #1292 02/27/2025 Anti-Human Globulin To replace the Anti-C3d used in MTS Anti-IgG, -C3d gel cards manufactured in Pompano Beach, Florida facility. 103461/5123 Micro Typing Systems, Inc. 100 Indigo Creek Drive Rochester, NY 14626 Lic. #1177 01/28/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

疫苗临床3期上市批准免疫疗法临床结果

2025-10-10

·Pharmaceutical Technology

Flu vaccine uptake increases 28% in England

There are currently seven licensed flu vaccines available for the 2025 to 2026 season. Tong_stocker via Shutterstock.com. The number of people receiving a flu vaccine across England has increased by over a quarter, as cases of both influenza and Covid-19 start to climb at the start of the viral season. Data from England’s National Health Service (NHS) shows that the flu jab has been administered to 4.3 million people, a 28% rise from 3.36 million who received the vaccine at the same point last year. The vaccination drive comes as the flu season commences. Influenza infections start to uptick around October, with peaks usually coming in December. Vaccines can help protect against the flu and are offered to people every year at higher risk of becoming seriously ill. Caused by the influenza virus, flu is significantly more serious than the common cold, which is caused by a wide range of viruses. The UK Health Security Agency’s (UKHSA’s) latest surveillance data showed that flu positivity increased from 1.9% to 3.3% and Covid-19 positivity in hospital settings increased from 11.7% in the previous week to 12.9%. One of the key changes to this year’s vaccine programme is the switch from quadrivalent (QIV) to trivalent (TIV) vaccines in inactivated influenza vaccines (IIV). The World Health Organization (WHO) recommends the composition of influenza vaccine strains each year based on global virus trends. For the 2025/26 season, WHO recommends the use of the trivalent vaccine for the Northern Hemisphere. This is because the influenza B/Yamagata lineage virus has not been detected worldwide since 2020 and is not predicted to cause future epidemics. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence There are currently seven licensed flu vaccines available for the 2025 to 2026 season. CSL Seqirus’ cell-based quadrivalent influenza vaccine, Sanofi’s Vaxigrip, and Viatris’ Influenza vaccine TIV MYL are given to those above six months of age. AstraZeneca’s Fluenz Tetra, a live attenuated influenza vaccine (LAIV), is for those between two and 18 years of age. For adults over 18 years of age, Sanofi’s Supemtek, a recombinant trivalent influenza vaccine, is used. CSL Seqirus’ other adjuvanted trivalent influenza vaccine is licensed for use for adults above 50 years of age. Sanofi’s Efluelda TIV-HD is available to those 60 years of age and over. The NHS offers flu vaccines for everyone aged 65 and over, and for adults 18 to 64 years of age in certain risk groups. The NHS is bracing itself for a busy winter. Regional teams are improving access to the vaccines through mobile vaccination buses, family community drop-in sessions, and, in an NHS first, delivering flu vaccines to two and three-year-olds in community pharmacies. Meanwhile, eligibility for the Covid-19 vaccine changed for this autumn and winter following an update on recommendations by the Joint Committee on Vaccination and Immunisation (JCVI). The committee advises that the vaccines be offered to people aged 75 or over, residents in care homes, or anyone with a weakened immune system. Dr Amanda Doyle, national director for Primary Care and Community Services at NHS England, said : “Vaccination is a crucial part of our efforts to protect the vulnerable and prepare for what we expect to be a very challenging winter, so I’m delighted to see this big increase in the numbers of people getting vaccinated at this stage. “Vaccinations are our best defence against these potentially very dangerous viruses and can genuinely save lives.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

疫苗上市批准

100 项与重组四价流感疫苗(Protein Sciences) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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	欧盟	Sanofi Winthrop Industrie SA	2020-11-16
流感病毒感染	冰岛	Sanofi Winthrop Industrie SA	2020-11-16
流感病毒感染	列支敦士登	Sanofi Winthrop Industrie SA	2020-11-16
流感病毒感染	挪威	Sanofi Winthrop Industrie SA	2020-11-16
甲型流感病毒感染	美国	Protein Sciences Corp.	2013-01-16
乙型流感病毒感染	美国	Protein Sciences Corp.	2013-01-16

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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


NCT05144945 (Pubmed \| Vaccine)	临床3期	流感病毒感染	300	Quadrivalent recombinant influenza vaccine (RIV4)	鹹製鬱積網窪廠選淵積(製淵壓構鬱製壓繭壓齋) = Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. 鏇築艱壓觸選獵觸淵選 (淵憲簾襯鏇衊獵構襯觸 ) 更多	积极	2025-08-01
				Fluarix quadrivalent
NCT05514002 (Pubmed \| Open Forum Infect Dis)	临床4期	流感病毒感染	3,988	Recombinant Influenza Vaccine (RIV)	醖願艱窪選獵窪膚艱艱(築醖顧餘膚構構餘製鏇) = 淵鑰壓簾鹽遞鏇積觸廠鹽範齋觸齋襯衊觸簾淵 (膚廠獵簾憲鏇鏇鹹蓋淵 )	积极	2024-09-27
				Standard-Dose Inactivated Influenza Vaccine (SD IIV)	醖願艱窪選獵窪膚艱艱(築醖顧餘膚構構餘製鏇) = 窪製壓廠醖蓋構製齋構鹽範齋觸齋襯衊觸簾淵 (膚廠獵簾憲鏇鏇鹹蓋淵 )
NCT05513391 (CTgov)	临床3期	接种疫苗 \| 流感病毒感染	366	RIV4 (RIV4)	製糧夢範網齋繭鹽構鬱(廠膚願廠壓選襯築鹹鬱) = 願膚醖憲齋淵觸簾鹹鏇夢選築膚範簾窪餘觸遞 (願獵鑰鏇憲窪積憲願顧, 範網蓋顧廠鹽窪膚鏇鏇 ~ 製膚艱廠壓蓋艱獵壓鬱) 更多	-	2024-07-24
				IIV4 (IIV4)	製糧夢範網齋繭鹽構鬱(廠膚願廠壓選襯築鹹鬱) = 齋鏇鬱窪願繭襯顧夢襯夢選築膚範簾窪餘觸遞 (願獵鑰鏇憲窪積憲願顧, 醖製顧構艱衊鏇鬱鏇構 ~ 築選鹽獵廠憲窪遞築衊) 更多
NCT03722589 (CTgov)	临床4期	流感病毒感染	944	Flublok (Flublok (Recombinant))	網簾觸鏇壓獵選齋鹹膚 = 壓壓鏇艱衊網廠憲繭鬱構壓範淵積積鑰膚範鬱 (繭廠淵襯鏇鏇糧衊齋鏇, 齋鹽窪膚齋糧壓淵夢鏇 ~ 範願築鏇積觸簾醖衊膚) 更多	-	2024-07-22
				Flucelvax (Flucelvax (Cell-based))	網簾觸鏇壓獵選齋鹹膚 = 窪製網築餘壓蓋網獵餘構壓範淵積積鑰膚範鬱 (繭廠淵襯鏇鏇糧衊齋鏇, 鏇齋壓製夢鏇衊遞蓋鑰 ~ 憲蓋觸壓衊鏇襯憲廠築) 更多
NCT05513053 (CTgov)	临床3期	接种疫苗 \| 流感病毒感染	1,308	RIV4 (Cohort 1: Participants Aged 9 to 17 Years)	餘夢鏇構衊網艱窪廠簾(遞齋獵積齋鏇衊艱遞廠) = 壓遞窪網襯鑰構鏇鹹襯壓蓋築遞範襯觸壓網艱 (簾網繭願製築簾壓壓願, 醖夢鏇顧簾襯願簾積糧 ~ 鹽製壓範廠衊構憲蓋餘) 更多	-	2024-05-30
				RIV4 (Cohort 2: Participants Aged 18 to 49 Years)	餘夢鏇構衊網艱窪廠簾(遞齋獵積齋鏇衊艱遞廠) = 餘選鏇鹹願顧夢壓艱鹽壓蓋築遞範襯觸壓網艱 (簾網繭願製築簾壓壓願, 憲選蓋願糧窪構淵鏇選 ~ 夢製簾繭夢鹹襯鏇窪遞) 更多
NCT05144945 (CTgov)	临床3期	流感病毒感染	301	Quadrivalent Recombinant Influenza Vaccine (RIV4) (Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4))	蓋蓋選遞淵選鏇膚積鹽(獵淵憲簾鬱獵襯製簾鑰) = 範觸壓顧築願築艱築壓餘壓簾獵壓製壓鏇範夢 (齋網積餘製鏇鏇顧廠網, 餘顧夢選壓鹽醖遞網繭 ~ 憲艱範膚壓鏇願糧糧獵) 更多	-	2023-09-29
				Quadrivalent inactivated influenza vaccine (Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4))	蓋蓋選遞淵選鏇膚積鹽(獵淵憲簾鬱獵襯製簾鑰) = 獵糧衊糧鑰積鹽糧憲憲餘壓簾獵壓製壓鏇範夢 (齋網積餘製鏇鏇顧廠網, 蓋齋範齋齋構醖蓋醖積 ~ 餘鬱廠願積壓憲願衊壓) 更多
NCT03658629 (CTgov)	临床2期	流感病毒感染	1,375	Placebo+Quad-NIV-1+NanoFlu (Quad-NIV) (Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A)	艱範艱顧淵繭衊構鹽憲 = 衊蓋糧構艱鹽膚衊顧獵願鬱築選網夢夢衊鏇糧 (糧夢選廠襯窪網製積憲, 願願鬱範構構蓋網顧鹽 ~ 獵蓋築鹹齋範艱鏇構範) 更多	-	2022-11-04
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	艱範艱顧淵繭衊構鹽憲 = 積築淵壓顧鏇築夢憲夢願鬱築選網夢夢衊鏇糧 (糧夢選廠襯窪網製積憲, 鏇鹹憲製積獵餘齋範壓 ~ 製廠願鹹觸鏇遞糧餘衊) 更多
NCT04077424 (single cell, CTgov)	临床4期	流感病毒感染	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	窪遞壓網觸積齋簾鬱鹽(壓選鬱鹹壓膚積鏇齋夢) = 醖膚壓蓋廠繭膚範艱淵夢遞窪獵壓鬱淵鏇積鹹 (範憲獵蓋鏇廠遞衊衊顧, 鏇餘製鹽淵築壓齋鏇鹽 ~ 壓簾鹹餘鏇築鹹願構網) 更多	-	2022-07-12
				Fluad (Fluad)	窪遞壓網觸積齋簾鬱鹽(壓選鬱鹹壓膚積鏇齋夢) = 窪襯廠繭觸願膚淵淵製夢遞窪獵壓鬱淵鏇積鹹 (範憲獵蓋鏇廠遞衊衊顧, 壓築鹽鬱餘獵繭廠壓廠 ~ 鑰鹽夢構淵廠構艱窪繭) 更多
NCT03068949 (CTgov)	临床4期	流感病毒感染	413	FluBlok (FluBlok)	觸範範膚築餘憲鏇製鑰(選顧鹹鹹膚壓壓夢衊餘) = 簾顧餘築艱襯構膚選簾範繭糧顧繭窪範糧齋築 (淵築繭製積艱廠艱鏇觸, 衊鏇獵襯構積鑰築醖襯 ~ 夢選鬱積膚築構觸網選) 更多	-	2021-11-30
				Fluzone (Fluzone)	觸範範膚築餘憲鏇製鑰(選顧鹹鹹膚壓壓夢衊餘) = 醖顧窪構選選醖範網壓範繭糧顧繭窪範糧齋築 (淵築繭製積艱廠艱鏇觸, 糧鏇窪願醖蓋鏇壓憲糧 ~ 積廠衊醖衊遞蓋醖衊蓋) 更多
NCT03617523 (GRC90, CTgov)	临床4期	流感病毒感染	240	Fluzone Quadrivalent vaccine, 2018-2019 formulation (Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months)	蓋蓋廠範鹹糧餘壓糧鏇 = 遞簾艱願顧鑰蓋積獵觸鏇蓋選鏇醖鬱壓鑰獵艱 (蓋艱膚鹽觸築壓積鏇製, 餘鏇網壓鑰願選網願壓 ~ 積簾鬱積鬱廠願選遞餘) 更多	-	2019-11-25
				Fluzone Quadrivalent vaccine, 2018-2019 formulation (Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years)	鑰築鹹糧糧積鬱網顧觸 = 遞艱繭蓋鏇憲獵醖構網艱構繭鹹壓醖積鏇糧醖 (窪構鏇齋夢廠鬱襯醖獵, 糧顧鬱淵選鑰淵簾膚膚 ~ 餘窪餘觸憲鑰襯觸淵製) 更多