Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

开始日期2022-09-14

申办/合作机构

National Heart, Lung & Blood Institute

ACTRN12619000792123 / Suspended临床3期

A Phase IIIb-IV, Multicentre, Randomised, Open-label Study to Characterise the Reactogenicity of Afluria Quad Junior in Children 6 Months to Less Than 3 Years, and Afluria Quad in Children 3 Years to Less Than 9 Years Across Three Influenza Seasons

开始日期2019-05-22

申办/合作机构

Seqirus GmbH

NCT02914275 / Completed临床3期

A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.

开始日期2016-09-27

申办/合作机构

Seqirus GmbH

100 项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的临床结果

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100 项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的转化医学

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100 项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的专利（医药）

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项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的文献（医药）

2024-02-01·International journal of biological macromolecules

Synergistic approach for enhanced production of polyhydroxybutyrate by Bacillus pseudomycoides SAS-B1: Effective utilization of glycerol and acrylic acid through fed-batch fermentation and its environmental impact assessment

Article

作者: Goswami, Saswata ; Anjana ; Rawat, Shristhi

The continual rise in the consumption of petroleum-based synthetic polymers raised a significant environmental concern. Bacillus pseudomycoides SAS-B1 is a gram-positive rod-shaped halophilic bacterium capable of accumulating Polyhydroxybutyrate (PHB)-an intracellular biodegradable polymer. In the present study, the optimal conditions for cell cultivation in the seed media were developed. The optimal factors included a preservation age of 14 to 21 days (with 10⁵ to 10⁶ cells/mL), inoculum size of 0.1 % (w/v), 1 % (w/v) glucose, and growth temperature of 30 °C. The cells were then cultivated in a two-stage fermentation process utilizing glycerol and Corn Steep Liquor (CSL) as carbon and nitrogen sources, respectively. PHB yield was effectively increased from 2.01 to 9.21 g/L through intermittent feeding of glycerol and CSL, along with acrylic acid. FTIR, TGA, DSC, and XRD characterization studies were employed to enumerate the recovered PHB and determine its physicochemical properties. Additionally, the study assessed the cradle-to-gate Life Cycle Assessment (LCA) of PHB production, considering net CO₂ generation and covering all major environmental impact categories. The production of 1000 kg of PHB resulted in lower stratospheric ozone depletion and comparatively reduced carbon dioxide emissions (2022.7 kg CO₂ eq.) and terrestrial ecotoxicity (9.54 kg 1,4-DCB eq.) than typical petrochemical polymers.

2024-01-25·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

The Durability of Antibody Responses of Two Doses of High-Dose Relative to Two Doses of Standard-Dose Inactivated Influenza Vaccine in Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial

Article

作者: Grimley, Michael ; Thurber, Joanne ; Potter, Molly ; Dvorak, Christopher ; Bender, Margaret ; Naik, Swati ; Batarseh, Einas ; Harrison, Christopher J ; Schuster, Jennifer E ; Stewart, Laura S ; Stahl, Anna ; Maron, Gabriela ; Haddadin, Zaid ; Halasa, Natasha B ; Moulton, Elizabeth A ; Freedman, Jason L ; Englund, Janet A ; Coffin, Susan E ; Rahman, Herdi ; Williams, Christopher ; Dulek, Daniel E ; Russo, Michael ; Kitko, Carrie L ; Danziger-Isakov, Lara ; Blum, Samantha ; Truong, Kenny ; Wattier, Rachel L ; Ardura, Monica I ; Munoz, Flor M ; Hamdan, Lubna ; Smith, Hannah ; Kalams, Spyros A ; Shoemaker, Lauren ; Paulsen, Grant ; Goyal, Rakesh ; Carpenter, Paul A ; Spieker, Andrew J ; Lacombe, Kirsten ; Allison, Kim J ; McHenry, Rendie ; Bocchini, Claire E ; Barto, Shari

Abstract:

Background:

Our previous study established a 2-dose regimen of high-dose trivalent influenza vaccine (HD-TIV) to be immunogenically superior compared to a 2-dose regimen of standard-dose quadrivalent influenza vaccine (SD-QIV) in pediatric allogeneic hematopoietic cell transplant (HCT) recipients. However, the durability of immunogenicity and the role of time post-HCT at immunization as an effect modifier are unknown.

Methods:

This phase II, multi-center, double-blinded, randomized controlled trial compared HD-TIV to SD-QIV in children 3–17 years old who were 3–35 months post-allogeneic HCT, with each formulation administered twice, 28–42 days apart. Hemagglutination inhibition (HAI) titers were measured at baseline, 28–42 days following each dose, and 138–222 days after the second dose. Using linear mixed effects models, we estimated adjusted geometric mean HAI titer ratios (aGMR: HD-TIV/SD-QIV) to influenza antigens. Early and late periods were defined as 3–5 and 6–35 months post-HCT, respectively.

Results:

During 3 influenza seasons (2016–2019), 170 participants were randomized to receive HD-TIV (n = 85) or SD-QIV (n = 85). HAI titers maintained significant elevations above baseline for both vaccine formulations, although the relative immunogenic benefit of HD-TIV to SD-QIV waned during the study. A 2-dose series of HD-TIV administered late post-HCT was associated with higher GMTs compared to the early post-HCT period (late group: A/H1N1 aGMR = 2.16, 95% confidence interval [CI] = [1.14–4.08]; A/H3N2 aGMR = 3.20, 95% CI = [1.60–6.39]; B/Victoria aGMR = 1.91, 95% CI = [1.01–3.60]; early group: A/H1N1 aGMR = 1.03, 95% CI = [0.59–1.80]; A/H3N2 aGMR = 1.23, 95% CI = [0.68–2.25]; B/Victoria aGMR = 1.06, 95% CI = [0.56–2.03]).

Conclusions:

Two doses of HD-TIV were more immunogenic than SD-QIV, especially when administered ≥6 months post-HCT. Both groups maintained higher titers compared to baseline throughout the season.

Clinical Trials Registration:

NCT02860039.

2023-12-31·Journal of medical economics

Cost-effectiveness of influenza vaccination with a high dose quadrivalent vaccine of the elderly population in Belgium, Finland, and Portugal

Article

作者: Borms, Matthias ; Alvarez, Fabián P ; Chevalier, Pierre ; Sainio, Tatu ; Soininen, Anu ; Petit, Christine ; de Courville, Caroline ; Bricout, Hélène ; Marques, Catia

BACKGROUND:

Seasonal influenza may result in severe outcomes, resulting in a significant increase of hospitalizations during the winter. To improve the protection provided by the standard dose influenza quadrivalent vaccine (SDQIV), a high-dose vaccine (HDQIV) has been developed specifically for adults aged 60 and older who are at higher risk of life-threatening complications.

OBJECTIVES:

The aim of this study was to determine the cost-effectiveness of HD QIV vs. SD-QIV in the recommended population of three European countries: Belgium, Finland and Portugal.

METHODS:

A cost-utility analysis comparing HDQIV vs. SDQIV was conducted using a decision tree estimating health outcomes conditional on influenza: cases, general practitioner and emergency department visits, hospitalizations and deaths. To account for the full benefit of the vaccine, an additional outcome-hospitalizations attributable to influenza-was also evaluated. Demographic, epidemiological and economic inputs were based on the respective local data. HDQIV relative vaccine efficacy vs. SDQIV was obtained from a phase IV efficacy randomized clinical trial. The incremental cost-effectiveness ratios (ICER) were computed for each country, and a probabilistic sensitivity analysis (1,000 simulations per country) was performed to assess the robustness of the results.

RESULTS:

In the base case analysis, HDQIV resulted in improved health outcomes (visits, hospitalizations, and deaths) compared to SDQIV. The ICERs computed were 1,397, 9,581, and 15,267 €/QALY, whereas the PSA yielded 100, 100, and 84% of simulations being cost-effective at their respective willingness-to-pay thresholds, for Belgium, Finland, and Portugal, respectively.

CONCLUSION:

In three European countries with different healthcare systems, HD-QIV would contribute to a significant improvement in the prevention of influenza health outcomes while being cost-effective.

项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的新闻（医药）

2024-05-30

·FiercePharma

CSL Seqirus scores 4th award from US government for bird flu pandemic preparedness

The U.S. government has expanded its bird flu pandemic preparedness partnership with CSL Seqirus. It is the fourth award from the Biomedical Advanced Research and Development Authority (BARDA) to the company. The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist to complete the fill-finish process for the shots. Execution of this stage will increase the arsenal of vaccines acquired by the Biomedical Advanced Research and Development Authority (BARDA) under its National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. It is the fourth award from BARDA to CSL Seqirus related to preparations for a potential outbreak of avian influenza (HPAI) virus, which has been detected in wild birds and livestock throughout the U.S. With this agreement, CSL Seqirus will deliver 4.8 million vaccine doses that are matched to the current H5N1 strain of the virus. On Thursday, the CDC reported on the spread of H5N1 in dairy cattle and two cases of humans contracting the virus. “The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners,” Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, said in a release. CSL will provide the vaccines from its massive manufacturing site in Holly Springs, N.C. which was built through a public-private partnership between the company and BARDA 15 years ago. The facility can deliver up to 150 million doses within six months of the declaration of a pandemic, CSL Seqirus said, with a second phase of manufacturing enabling more vaccines as needed. Two years ago, CSL Seqirus gained a “ready to respond” designation, meaning that in the case of a pandemic, it would immediately shift from its usual production of seasonal flu shots to the manufacture of those for the emergency. Of the potential $2 billion award amount from the government to CSL Seqirus, BARDA has obligated $1.1 billion to the company, with $139 million of that paid for, according to USASpending.com. In October 2022, CSL Seqirus scored a $30 million contract from BARDA to conduct a phase 2 trial of its avian flu candidate. In August of last year, BARDA awarded a $46.3 million contract to the company for one bulk lot of HPAI vaccines.

疫苗临床2期

2024-05-30

·PRNewswire

CSL Seqirus, a Proud Champion of Pandemic Preparedness, Announces U.S. Government Award in Response to Avian Influenza

CSL Seqirus to complete the fill and finish process for pre-pandemic vaccine to support the U.S. government's outbreak and preparedness response. Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and livestock have been reported in the U.S. Fourth avian influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA). SUMMIT, N.J., May 30, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to complete the fill and finish process of pre-pandemic vaccine for the U.S. government as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This acquisition of pre-pandemic vaccine will increase BARDA's stockpile of vaccine to support the U.S. government's pre-pandemic response. "The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic. "This agreement, building upon prior agreements with BARDA, will help support the U.S. government's ability to respond swiftly in the event that the current avian flu situation changes." Under the terms of the agreement, CSL Seqirus will deliver approximately 4.8 million doses of pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain. This is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza (HPAI) activity. "As a global leader and proud champion of pandemic preparedness, CSL Seqirus welcomes the BARDA award to fill-finish and deliver pre-pandemic vaccine," said Dave Ross, General Manager of CSL Seqirus. "Alongside our partners, we embrace pandemic preparedness as a critical part of public health protection, and understand that together with surveillance and testing, vaccine protection provides pandemic preparedness reassurance to governments and populations alike." CSL Seqirus' manufacturing facility in Holly Springs, NC, built through a public-private partnership established in 2009 with BARDA, is the largest cell-based influenza vaccine producer in the world and is the first such domestic facility. It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration. After this, a second wave of manufacturing could be enabled to provide further pandemic vaccine as needed. Seasonal vaccine manufacturing provides an essential "warm base" alongside ongoing R&D activity with influenza strains of pandemic potential, component and raw material stockpiles, seed libraries and technological know-how to be pandemic ready and manufacture at scale. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100200900101C and 75A50122D00004. About Pandemic Influenza Influenza is a contagious airborne respiratory disease.1,2 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the novel virus in the human population.3 The timing and severity of pandemic influenza is unpredictable.4 Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, with an estimated mortality of up to 50 million people worldwide.4 Strain-matched pandemic influenza vaccines are manufactured in response to the declaration of a pandemic.5 Pre-pandemic (also called zoonotic) influenza vaccines are available in the inter-pandemic period to help protect against influenza strains with pandemic potential; these vaccines can be deployed under government guidance to mitigate the risk of an outbreak or provide a first line of defense in advance of a pandemic vaccine if a pandemic were to be declared.5 About Avian Influenza Avian influenza is an infectious type of influenza that spreads predominantly among birds.6 Avian influenza viruses do not normally infect humans, however, in rare cases humans have been infected with avian influenza viruses.7 Illness in humans from avian influenza has varied in levels of severity, from no symptoms or mild illness to severe disease and death.7 The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.7 The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1).8 CSL Seqirus recommends referring to the WHO statement, and CDC, ECDC or national guidance to gauge the levels of concern regarding the high levels of HPAI activity.8,9,10 About CSL Seqirus CSL Seqirus is part of CSL (ASX:CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit CSL.com. About CSL CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/we-are-csl/vita-original-stories and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. MEDIA CONTACT Em Dekonor +44 (0)7920500496 [email protected] USA-PAN-24-0001 1 Centers for Disease Control and Prevention (CDC). Pandemic Basics. Retrieved from: . [Accessed May 2024] 2 CDC. Key Facts About Influenza (Flu). Retrieved from: . [Accessed May 2024] 3 WHO. How pandemic influenza emerges. Retrieved from: . [Accessed May 2024] 4 WHO. Pandemic Influenza Risk Management: A WHO guide to inform and harmonize national and international pandemic preparedness and response. Retrieved from: . [Accessed May 2024] 5 European Medicines Agency (EMA). Vaccines for pandemic influenza. Retrieved from: . [Accessed May 2024] 6 CDC. Avian Flu, Information on bird flu. Retrieved from: . [Accessed May 2024] 7 CDC. Avian Flu, Bird Flu Virus Infections in Humans. Retrieved from: . [Accessed May 2024] 8 CDC. H5N1 Bird Flu: Current Situation Summary. Retrieved from: . [Accessed May 2024] 9 WHO. Ongoing avian influenza outbreaks in animals pose risk to humans. Retrieved from: . [Accessed May 2024] 10 European Centre for Disease Prevention and Control (ECDC). Avian influenza overview April – June 2023. Retrieved from: . [Accessed May 2024] SOURCE CSL Seqirus

疫苗

2024-05-28

·药智网

流感疫苗一夜变天

继二价HPV疫苗价格大跳水之后，四价流感疫苗也开始降价。近日，江苏省对国药集团下属的长春所、武汉所、上海所四价流感病毒裂解疫苗的供应价格进行了调整，中标价格从128元/支降到88元/支。此前，我国四价流感疫苗份额主要被华兰生物所占领，随着越来越多的四价流感疫苗获批上市，降价会抢夺更多市场份额，国内的四价流感疫苗竞争格局“一夜变天”。01跌破百元，市场格局变动流感疫苗是全球疫苗产业界的重磅品种，全球市场份额超百亿元，流感疫苗巨头赛诺菲2022年和2023全球销售额分别为29.77亿欧元（约32.1亿美元）和26.69亿欧元（约28.8亿美元），GSK的流感疫苗2022年和2023全球销售额分别为7.14亿英镑（8.8亿美元）和5.04亿英镑（6.2亿美元）。然而，由于接种意识较弱、产业供应量不足、自费接种等原因，国内流感疫苗渗透率低，截至2020年，国内流感疫苗批签发总量5765万剂次，若按照2020年末全国总人口141212万人来计算，即便当年签发的疫苗实现全部接种，全人群接种率也仅有4.08%，与发达国家以及WHO建议的流感疫苗目标接种率75%相差甚远，国内仍有巨大成长空间。近些年，随着行业持续发展以及新冠疫情的爆发等，国内民众接种疫苗的意愿大幅增强，有望提高我国流感疫苗整体渗透率。据华兴证券的测算，我国流感疫苗市场有望由2020年的64亿元增长至2025年的197亿元。目前，我国流感疫苗主要供应商包括华兰生物、金迪克生物、科兴生物、长春所、武汉所和上海所等。华兰生物是国内流感疫苗领域的领军企业，2020年华兰疫苗流感疫苗年批签发数量分别为2,315.3万剂，占比达到41.77%，居国内首位，其次是科兴生物和赛诺菲巴斯德，占比分别为19.37%和16.10%。流感疫苗种类繁多，我国批准上市的流感疫苗包括三价灭活疫苗（IIV3）、三价减毒活疫苗（LAIV3）和四价灭活疫苗（IIV4），其中IIV3和IIV4有裂解疫苗和亚单位疫苗，目前四价流感病毒疫苗是我国主要流感疫苗，2020年批签发量为3358.23万支/瓶，与2019年相比同比大幅增长246%。此前，四价流感疫苗的供应价一直维持在百元以上，以2023年北京疾控中心非免疫规划流感疫苗采购项目为例，适用于36月龄以上人群的三价流感病毒裂解疫苗的单支价格为53元—65元，四价流感病毒裂解疫苗的单支价格为128元。而近期江苏省对部分疫苗的供应价格进行了调整。其中，国药集团下属的长春所、武汉所、上海所四价流感病毒裂解疫苗中标价格从128元/支降到88元/支，跌破百元。国药集团下属的这三家的四价流感疫苗于2022年底开始陆续获批，2023年逐步投放市场，如去年6月，武汉生物制品研究所和长春生物制品研究所生产的首批四价流感病毒裂解疫苗获得批签发证明。此次国药集团率先发动价格战，受到影响最大的预计会是四价流感疫苗之王华兰疫苗，2020年华兰生物四价流感疫苗签发量为2,062.4万剂，占国内总四价流感疫苗签发量61.41%。如果华兰生物、金迪克生物等疫苗主要供应商后续不降价，国药集团势必会通过低价抢占更多市场份额，国药集团此次降价有望扩增接种人数，也给后续研发四价流感疫苗的公司一定的压力。02全球已上市流感疫苗在美国，流感疫苗接种率较高，据预计2021~2022年的流感季，6个月至17岁的儿童接种≥1剂流感疫苗的比例为57.8%，18≥岁的成年人流感疫苗接种覆盖率为49.4%，65岁以上的老年人流感疫苗接种覆盖率则达到73.9%。美国市场上主要应用的流感疫苗如表1所示，澳大利亚生物医药巨头CSL集团旗下公司Seqirus是全球流感预防领域的领导者，该公司上市的流感疫苗主要有Afluria、Fluvirin、Agriflu、Flucelvax和Fluad，都是通过肌肉注射的四价流感病毒裂解疫苗，覆盖6个月以上各个年龄层（表1）。表1 美国市场上主要应用的流感疫苗数据来源：参考文献3赛诺菲的Fluzone、Fluzone High Dose和Fluzone Intradermal应用也很广泛，Fluzone和Fluzone High Dose是通过肌肉注射的四价流感病毒裂解疫苗，Fluzone Intradermal是通过皮内注射的四价流感病毒裂解疫苗。目前，我国有超10款三价流感疫苗和超5款四价流感疫苗上市，生产厂商主要包括华兰疫苗、金迪克、科兴生物、长春所、武汉所和上海所等，大多通过肌肉注射给药。其中，长春百克生物研制的冻干鼻喷流感减毒活疫苗上市申请于2020年2月获批，采用鼻腔喷雾给药方式接种，是我国首个国产鼻喷剂型的流感减毒活疫苗，适用于3-17岁儿童和青少年人群。四价流感疫苗因比三价流感疫苗多覆盖一下乙型株而应用更广泛（表2），2018年，华兰生物自研四价流感病毒裂解疫苗上市，成为国内首批获得上市批准的四价流感病毒裂解疫苗产品，随后2022年2月，华兰生物成为首家取得四价流感疫苗（儿童剂型）的《药品注册证书》，该产品可用于6-36个月龄儿童接种，填补了国内市场空白。表2 国内部分四价流感疫苗信息数据来源：参考文献403国内在研四价流感疫苗除了已获批上市的流感疫苗，国内有多款在研的流感疫苗，大多属于四价流感疫苗，其中复星医药子公司雅立峰生物、步长制药子公司浙江天元的四价流感疫苗生产注册均已获受理，智飞生物和康润生物四价流感病毒裂解疫苗目前处于申报上市阶段，正在审评中（表3）。表3 国内部分在研四价流感疫苗数据来源：公开资料整理据不完全统计，至少有6款四价流感病毒裂解疫苗处于临床3期试验阶段，如武汉生物、中逸安科生物、康泰生物、成大生物等，其中武汉生物的四价流感病毒裂解疫苗采用MDCK细胞进行病毒培养，相比于传统的鸡胚培养具有多项优势，如生产周期更短以及不存在原材料供应不稳定的问题等。还有一些四价流感病毒裂解疫苗处于早期开发阶段，如今年3月，国内疫苗龙头公司艾美疫苗已经提交了其四价MDCK细胞流感疫苗临床试验预申请、5月欧林生物宣布其四价流感病毒裂解疫苗获国家药品监督管理局批准开展临床试验以及康泰生物公告称其四价流感病毒裂解疫苗新增6-35月龄人群临床试验申请获得受理。04结语国内人口基数大，流感疫苗接种率低，存在巨大成长空间，吸引无数药企加入布局，价格战不仅对已上市的疫苗产生影响，也对在研的流感疫苗产生影响，但是国内人口基数大，降价也会惠及更多民众，为行业大势所趋。参考文献1.市场资讯：Q3业绩大涨167%！「流感疫苗之王」的突围2.红星新闻网：国产疫苗价格大跳水！四价流感疫苗降至88元二价HPV疫苗降至63元3.https://www-cas-org.libproxy1.nus.edu.sg/zh-hans/resource/blog/covid19-flu-vaccine4.生物制品圈：深度梳理：国内外流感疫苗研究的最新动向声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 德清君转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

疫苗上市批准核酸药物带量采购

100 项与 Inactivated quadrivalent influenza vaccine (Seqirus GmbH) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

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	澳大利亚	Seqirus Pty Ltd.	2016-07-22
甲型流感病毒感染	美国	Seqirus Pty Ltd.	2007-09-28
乙型流感病毒感染	美国	Seqirus Pty Ltd.	2007-09-28

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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


NCT02255409 (CTgov)	临床3期	流感病毒感染	607	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	醖齋積遞鹽遞襯憲衊鏇(夢積艱醖憲構鬱餘壓構) = 夢廠鏇築選憲鏇簾積構鑰餘鹽夢鹽膚築夢鹽簾 (鹽廠遞鹹獵網蓋鹽鬱襯, 窪憲選衊夢獵遞願顧糧 ~ 繭鹹膚糧構願鏇壓獵構) 更多	-	2023-03-15
NCT02914275 (CTgov)	临床3期	流感病毒感染	2,250	Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort A)	蓋顧製構鏇觸衊壓顧鹽(蓋鬱鹹簾簾鬱積網獵窪) = 鹹遞窪觸觸齋餘廠淵網繭窪範遞鹹選憲淵艱獵 (製窪艱鏇選鏇鹽憲觸觸, 齋願襯鹹壓糧餘願壓壓 ~ 獵顧壓網夢齋憲醖選憲) 更多	-	2019-01-23
				Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort B)	蓋顧製構鏇觸衊壓顧鹽(蓋鬱鹹簾簾鬱積網獵窪) = 鹽願觸範繭築鬱壓選醖繭窪範遞鹹選憲淵艱獵 (製窪艱鏇選鏇鹽憲觸觸, 遞製繭範壓製積願憲鹽 ~ 憲壓夢遞鏇膚鹹製糧簾) 更多
NCT01857297 (CTgov)	临床4期	流感病毒感染	120	CSL Influenza Vaccine (Adults (18 to 59 Years))	醖構夢願糧窪衊鏇網憲(壓遞網蓋艱艱簾衊範憲) = 衊遞憲襯膚願積遞蓋遞鑰餘憲鏇願壓壓積鏇餘 (獵艱蓋廠齋衊獵築糧鑰, 糧蓋夢顧鹽鹹鬱鑰繭顧 ~ 餘鹹膚簾窪構鬱艱網製) 更多	-	2014-01-15
				CSL Influenza Vaccine (Older Adults (60 Years or Older))	醖構夢願糧窪衊鏇網憲(壓遞網蓋艱艱簾衊範憲) = 窪餘糧鬱鏇鹹膚鹽築鑰鑰餘憲鏇願壓壓積鏇餘 (獵艱蓋廠齋衊獵築糧鑰, 遞夢網鏇製鏇鏇獵願築 ~ 憲蓋襯糧膚齋衊積網鬱) 更多
NCT01591837 (CTgov)	临床4期	流感病毒感染	120	CSL Influenza Vaccine (Adults)	簾網夢遞鹹獵壓鬱淵鏇(鏇蓋範鹹襯糧蓋廠壓艱) = 窪齋顧糧艱獵選齋鬱鹽襯廠襯鏇觸顧艱簾獵夢 (蓋艱夢鬱獵遞廠製製鏇, 鹽餘觸範構齋獵襯醖獵 ~ 餘憲網醖顧膚餘憲鏇觸) 更多	-	2013-11-18
				CSL Influenza Vaccine (Older Adults)	簾網夢遞鹹獵壓鬱淵鏇(鏇蓋範鹹襯糧蓋廠壓艱) = 艱獵衊鹹遞餘網選鹽膚襯廠襯鏇觸顧艱簾獵夢 (蓋艱夢鬱獵遞廠製製鏇, 積構顧網糧積遞膚鑰繭 ~ 觸遞廠範構製製構蓋鬱) 更多
NCT01113580 (CTgov)	临床4期	流感病毒感染	120	CSL's 2010/2011 Formulation of Enzira® Vaccine (Adults)	蓋憲鬱齋鹹廠壓簾網壓(顧遞淵鹹製鬱構壓鹽網) = 糧衊憲廠製醖廠膚鑰鏇膚鹽淵網網壓鹽窪艱築 (鏇積夢廠醖顧糧獵淵膚, 糧鏇鑰範遞顧鑰製醖壓 ~ 糧餘獵糧糧醖簾壓淵蓋) 更多	-	2012-07-18
				CSL's 2010/2011 Formulation of Enzira® Vaccine (Older Adults)	蓋憲鬱齋鹹廠壓簾網壓(顧遞淵鹹製鬱構壓鹽網) = 構選積範觸獵繭鹽願醖膚鹽淵網網壓鹽窪艱築 (鏇積夢廠醖顧糧獵淵膚, 願憲醖鹽醖願淵鏇膚遞 ~ 齋廠壓願簾積簾壓願簾) 更多
NCT00959049 (CTgov)	临床3期	流感病毒感染	1,474	CSL's Influenza Virus Vaccine (Afluria) (Afluria Cohort A)	鏇製築餘廠簾憲積範獵(構獵夢齋廠淵選築蓋範) = 構範憲築願鑰鏇遞醖壓醖積襯製膚製鹽顧製廠 (觸齋餘選鹹遞範顧願壓, 選齋壓築淵願顧膚憲鬱 ~ 糧繭鹽膚願鹹餘製繭鏇) 更多	-	2011-07-29
				Influenza Virus Vaccine (Fluzone) (Fluzone Cohort A)	鏇製築餘廠簾憲積範獵(構獵夢齋廠淵選築蓋範) = 艱積蓋選廠鹹範獵壓鑰醖積襯製膚製鹽顧製廠 (觸齋餘選鹹遞範顧願壓, 網衊衊壓蓋夢觸淵製選 ~ 遞鹽糧選廠簾窪範淵顧) 更多