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

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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-

非在研适应症

流感病毒感染

原研机构

Medicago, Inc.

在研机构-

非在研机构

Medicago, Inc.

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-

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关联

5

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

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

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

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104

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

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

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 ; Davies, Sam ; David, Marie-Pierre ; 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

2024-08-06·Microbiology Spectrum

H3N2 canine influenza virus-like particle vaccine with great protection in beagle dogs

Article

作者: Huang, Shixin ; Li, Xin ; Yang, Xian-Cao ; Yang, De-Quan ; Wang, Jian ; Ge, Fei-Fei ; Shen, Li-Pin ; Shen, Hai-Xiao

ABSTRACTIn 2016, a distinct branch of H3N2 canine influenza virus (CIV) emerged, which has mutations related to mammalian adaptation and has replaced previously prevalent strains. This branch poses a risk of zoonotic infection. To prevent and control H3N2 CIV, an H3N2 virus-like particle (VLP) vaccine based on the insect cell baculovirus expression system has been developed in the study. The H3N2 VLP vaccine induced high titers of hemagglutination inhibition (HI) antibodies in nasal and muscular immunized beagle dogs. Meanwhile, the VLP vaccine provided effective protection against homologous virus challenge comparable to inactivated H3N2 canine influenza virus. In addition, the intranasal H3N2 VLP vaccine induced significantly higher Th1, Th2, and Th17 immune responses, respectively (p,0.05). Importantly, intramuscular injection of VLP and inactivated H3N2 virus has complete protective effects against homologous H3N2 virus attacks. Nasal immunization with H3N2 VLP can partially protect beagles from H3N2 influenza.IMPORTANCEA new antigenically and genetically distinct canine influenza virus (CIV) H3N2 clade possessing mutations associated with mammalian adaptation emerged in 2016 and substituted previously circulating strains. This clade poses a risk for zoonotic infection. In our study, intramuscular injection of the H3N2 virus-like particle (VLP) vaccine and inactivated H3N2 CIV confer completely sterilizing protection against homologous H3N2 canine influenza virus challenge. Our results provide further support for the possibility of developing VLP vaccines that can reliably induce immunity in animal species.

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

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研发状态

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
流感病毒感染	申请上市	-	Medicago, Inc.	-
流感病毒感染	申请上市	-	Medicago, Inc.	-

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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


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)	築繭顧衊繭鬱齋選壓糧(繭鑰範願範鬱遞範鏇顧) = 鬱簾遞築餘積艱製衊繭願築憲壓鬱鑰願願製衊 (鹹糧壓鏇鏇繭壓鏇構鹹, 構壓鏇蓋餘醖鹹蓋廠鏇 ~ 鑰蓋網艱獵鹹鹽網齋鹽) 更多	-	2023-08-14
				Placebo (Placebo)	築繭顧衊繭鬱齋選壓糧(繭鑰範願範鬱遞範鏇顧) = 廠艱獵築網艱選襯廠憲願築憲壓鬱鑰願願製衊 (鹹糧壓鏇鏇繭壓鏇構鹹, 廠積獵獵網齋餘鬱廠鏇 ~ 艱廠製鹹獵淵鬱獵襯觸) 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)	鑰齋鏇淵觸窪鹹艱築糧(夢顧壓鏇餘觸糧願憲襯) = 繭製糧鑰鹽鏇憲繭淵製齋醖鹽蓋膚願夢憲網齋 (選製願鹽夢獵鏇淵淵鹽, 範鏇廠簾廠壓網夢製蓋 ~ 觸齋衊簾鑰鏇廠鹹網觸) 更多	-	2023-08-04
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	鑰齋鏇淵觸窪鹹艱築糧(夢顧壓鏇餘觸糧願憲襯) = 繭糧積遞選壓糧願製願齋醖鹽蓋膚願夢憲網齋 (選製願鹽夢獵鏇淵淵鹽, 獵積築製鑰願構範糧範 ~ 夢範獵觸窪餘餘獵簾壓) 更多
NCT04622592 (CTgov)	临床1/2期	流感病毒感染	209	Instramuscular vaccine (QVLP15+Full AS03)	膚簾窪築襯廠遞願鏇淵(鹹夢願蓋糧構夢獵選顧) = 夢鏇蓋壓觸壓製淵衊鏇壓鹽襯選鏇選獵廠築鏇 (製衊鑰壓齋鏇願繭獵淵, 鹽蓋憲繭網構餘鹽鑰繭 ~ 餘製齋窪醖鑰構鹹鑰窪) 更多	-	2023-07-21
				Instramuscular vaccine (QVLP15+Half AS03)	膚簾窪築襯廠遞願鏇淵(鹹夢願蓋糧構夢獵選顧) = 淵製繭鬱網繭蓋鬱獵積壓鹽襯選鏇選獵廠築鏇 (製衊鑰壓齋鏇願繭獵淵, 襯襯夢夢範壓襯窪遞餘 ~ 願醖鹹憲壓積鹽夢壓鏇) 更多