Seasonal quadrivalent influenza vaccine(Medicago, Inc.)(Seasonal quadrivalent influenza vaccine(Medicago, Inc.))

概要

基本信息

药物类型

病毒样颗粒疫苗、预防性疫苗、多价疫苗

别名

Influenza virus vaccine quadrivalent、Quadrivalent seasonal influenza VLP vaccine、Seasonal influenza vaccine quadrivalent

+ [3]

靶点-

作用方式

刺激剂

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-

非在研适应症

流感病毒感染呼吸道感染RNA病毒感染

原研机构

Medicago, Inc.

在研机构-

非在研机构

Medicago, Inc.

权益机构-

最高研发阶段终止申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

8

项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的临床试验

NCT04622592

/ Completed临床1/2期

A Randomized, Partially-Blinded, Active Comparator-Controlled, Dose-Ranging, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of an Adjuvanted Seasonal Recombinant Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains.
In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development.
Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).

开始日期2020-11-02

申办/合作机构

Medicago, Inc.

NCT03739112

/ Completed临床3期

A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

开始日期2018-09-18

申办/合作机构

Medicago, Inc.

NCT03321968

/ Completed临床3期

A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

开始日期2017-09-29

申办/合作机构

Medicago, Inc.

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的临床结果

登录后查看更多信息

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的转化医学

登录后查看更多信息

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的专利（医药）

登录后查看更多信息

11

项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的文献（医药）

2025-03-12·mBio

Structural mapping of polyclonal IgG responses to HA after influenza virus vaccination or infection

Article

作者: Creech, C. Buddy ; León, André Nicolás ; Richey, Sara T. ; Wolters, Rachael M. ; Torrents de la Pena, Alba ; Jackson, Abigail M. ; Han, Julianna ; Ward, Andrew B. ; Yoder, Sandra ; Rodriguez, Alesandra J. ; Mudd, Philip A. ; Crowe, James E. ; Webb, Katherine

ABSTRACTCellular and molecular characterization of immune responses elicited by influenza virus infection and seasonal vaccination have informed efforts to improve vaccine efficacy, breadth, and longevity. Here, we use negative stain electron microscopy polyclonal epitope mapping (nsEMPEM) to structurally characterize the humoral IgG antibody responses to hemagglutinin (HA) from human patients vaccinated with a seasonal quadrivalent flu vaccine or infected with influenza A viruses. Our data show that both vaccinated and infected patients had humoral IgGs targeting highly conserved regions on both H1 and H3 subtype HAs, including the stem and anchor, which are targets for universal influenza vaccine design. Responses against H1 predominantly targeted the central stem epitope in infected patients and vaccinated donors, whereas head epitopes were more prominently targeted on H3. Responses against H3 were less abundant, but a greater diversity of H3 epitopes were targeted relative to H1. While our analysis is limited by sample size, on average, vaccinated donors responded to a greater diversity of epitopes on both H1 and H3 than infected patients. These data establish a baseline for assessing polyclonal antibody responses in vaccination and infection, providing a context for future vaccine trials and emphasizing the need for further characterization of protective responses toward conserved epitopes. (201 words)IMPORTANCESeasonal influenza viruses cause hundreds of thousands of deaths each year and up to a billion infections; under the proper circumstances, influenza A viruses with pandemic potential could threaten the lives of millions more. The variable efficacies of traditional influenza virus vaccines and the desire to prevent pandemic influenzas have motivated work toward finding a universal flu vaccine. Many promising universal flu vaccine candidates currently focus on guiding immune responses to highly conserved epitopes on the central stem of the influenza hemagglutinin viral fusion protein. To support the further development of these stem-targeting vaccine candidates, in this study, we use negative stain electron microscopy to assess the prevalence of central stem-targeting antibodies in individuals who were exposed to influenza antigens through traditional vaccination and/or natural infection during the 2018–2019 flu season.

2024-12-31·Human Vaccines & Immunotherapeutics

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Article

作者: Kuxhausen, Adrienne ; Naficy, Abdi ; Seifert, Harry ; Mwakingwe-Omari, Agnes ; Hastie, Andrew ; Leav, Brett ; Miller, Jacqueline ; Anteyi, Kate

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

2024-10-15·Clinical Infectious Diseases

Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial

Article

作者: Dezutter, Nancy ; Rebollo-Rodrigo, Maria Henar ; Meyer, Nadia ; Jayadev, Amulya ; Kotb, Shady ; Amare Hailemariam, Hiwot ; Germain, Sophie ; Rämet, Mika ; Labrador, Jorge ; David, Marie-Pierre ; Davies, Sam ; Nicolas, Jean-François ; Sanz-Muñoz, Iván ; Moríñigo, Helena Moza ; Clark, Rebecca ; Loubet, Paul ; Vera, Mercè Pérez ; Natalini Martínez, Silvina

AbstractBackgroundWe evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.MethodsThis phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed.ResultsOverall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06–1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups.ConclusionsAdjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine.Clinical Trials RegistrationNCT05568797

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的药物交易

登录后查看更多信息

研发状态

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
呼吸道感染	申请上市	芬兰	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	美国	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	芬兰	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	加拿大	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	菲律宾	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	泰国	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	德国	Medicago, Inc.	2017-08-31
RNA病毒感染	申请上市	英国	Medicago, Inc.	2017-08-31
流感病毒感染	申请上市	-	Medicago, Inc.	-
流感病毒感染	申请上市	-	Medicago, Inc.	-

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


NCT03301051 (CTgov)	临床3期	RNA病毒感染 \| 呼吸系统疾病 \| 流感病毒感染 \| 呼吸道感染 \| 病毒感染	10,160	Quadrivalent VLP Vaccine (Quadrivalent VLP Vaccine)	範醖淵鬱鑰積壓獵觸醖(願簾製鹽蓋膚簾蓋遞構) = 憲夢築糧糧鬱齋遞衊壓襯範齋膚衊廠餘構淵積 (範積網壓觸觸鹹鑰艱築, 觸齋憲衊觸廠蓋糧選願 ~ 顧觸憲壓憲襯範鏇築獵) 更多	-	2023-08-14
				Placebo (Placebo)	範醖淵鬱鑰積壓獵觸醖(願簾製鹽蓋膚簾蓋遞構) = 願願範積夢襯鏇構糧積襯範齋膚衊廠餘構淵積 (範積網壓觸觸鹹鑰艱築, 製蓋鑰範選糧鹽鹹積衊 ~ 積築繭膚觸艱廠鬱願積) 更多
NCT03321968 (CTgov)	临床3期	流感病毒感染	1,202	Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 1)	膚齋窪淵遞壓憲獵製積(壓醖願構觸網簾壓壓膚) = 廠積繭構憲範艱衊繭網製範觸壓鑰鏇觸構齋膚 (網選廠醖夢艱鹽構築餘, 窪構淵鏇膚製獵夢顧構 ~ 繭鹽簾膚獵願鬱糧鏇鬱) 更多	-	2023-08-04
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	膚齋窪淵遞壓憲獵製積(壓醖願構觸網簾壓壓膚) = 遞獵糧選壓繭獵壓繭壓製範觸壓鑰鏇觸構齋膚 (網選廠醖夢艱鹽構築餘, 獵襯糧構願簾壓蓋廠壓 ~ 繭衊糧壓餘鏇蓋餘淵鏇) 更多
NCT04622592 (CTgov)	临床1/2期	流感病毒感染	209	Instramuscular vaccine (QVLP15+Full AS03)	築顧壓繭衊蓋憲網鏇鹹(簾糧鹽繭襯製願膚網觸) = 遞艱願淵獵膚餘糧窪簾齋觸醖鹽淵築膚糧築蓋 (鹽鑰壓構艱觸膚簾艱製, 艱齋鏇壓襯蓋鏇淵膚糧 ~ 壓糧範構憲鹹願衊範壓) 更多	-	2023-07-21
				Instramuscular vaccine (QVLP15+Half AS03)	築顧壓繭衊蓋憲網鏇鹹(簾糧鹽繭襯製願膚網觸) = 鏇鑰醖廠膚齋繭憲選餘齋觸醖鹽淵築膚糧築蓋 (鹽鑰壓構艱觸膚簾艱製, 鏇簾蓋積構築夢襯構糧 ~ 顧壓膚觸鬱獵繭鹽壓網) 更多
NCT03739112 (CTgov)	临床3期	流感病毒感染	12,794	VLP Influenza Vaccine (Quadrivalent (30 μg) VLP Vaccine)	顧鑰構膚積觸遞醖鏇鬱(衊簾窪衊廠願鏇襯鏇顧) = 網膚願淵膚網鹹鑰積壓廠窪衊鬱願獵顧餘艱觸 (壓鏇壓鏇鹽壓膚壓鏇壓, 鏇繭淵襯網醖艱壓艱願 ~ 蓋遞糧鹽膚鑰夢窪鑰蓋) 更多	-	2023-06-23
				Fluarix (Active Comparator (Fluarix))	顧鑰構膚積觸遞醖鏇鬱(衊簾窪衊廠願鏇襯鏇顧) = 觸廠顧壓範鹹膚願襯壓廠窪衊鬱願獵顧餘艱觸 (壓鏇壓鏇鹽壓膚壓鏇壓, 鬱鬱夢範鏇鹹膚願餘糧 ~ 鹽顧憲遞襯願膚選餘淵) 更多