Quadrivalent influenza virus vaccine(Green Cross Corp.)(Quadrivalent influenza virus vaccine(Green Cross Corp.))

概要

基本信息

药物类型

预防性疫苗、多价疫苗

别名

GC FLU、GCFlu Quadrivalent、Quadrivalent influenza virus vaccine(GC BioPharma)

+ [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

非在研适应症-

原研机构

Green Cross Holdings Corp.

在研机构

GC Biopharma Corp.

非在研机构

高端疫苗生物制剂股份有限公司

最高研发阶段批准上市

首次获批日期

韩国 (2016-04-01),

流感病毒感染

最高研发阶段(中国)无进展

特殊审评-

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关联

6

项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 相关的临床试验

NCT03285997 / Unknown status临床3期

A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age

If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test or control drug 1 time or 2 times.

开始日期2017-09-30

申办/合作机构

Green Cross Co., Ltd.

NCT02917304 / Completed临床3期

A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

开始日期2016-10-10

申办/合作机构

Green Cross Co., Ltd.

NCT02915809 / Unknown status临床3期

A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults

The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

开始日期2016-10-01

申办/合作机构

Green Cross Co., Ltd.

100 项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 相关的临床结果

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100 项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 相关的转化医学

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100 项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 相关的专利（医药）

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4

项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 相关的文献（医药）

2021-04-01·Vaccine3区 · 医学

Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6–35 months

3区 · 医学

Article

作者: Kim, Hwang Min ; Song, Song Eun ; Kim, Dong Ho ; Kim, Ki Hwan ; Jo, Dae Sun ; Kim, Kwang Nam ; Lee, Kyung Yil ; Kim, Chun Soo ; Choi, Ui Yoon ; Ma, Sang Hyuk ; Lee, Jin ; Eun, Byung Wook ; Kim, Jong-Hyun ; Kang, Jin Han

The inactivated trivalent influenza vaccine (TIV) offers limited protection when two influenza B lineages co-circulate or when there is a vaccine mismatch (i.e., discordance in the predominant circulating B strain and WHO-recommended B strain). Inactivated quadrivalent influenza vaccine (QIV) may reduce the burden of influenza. Here, we report the results of a phase 3 clinical trial that evaluated the immunogenicity and safety of a novel QIV, GC3110A, in Korean children aged 6-35 months, which has been approved and is currently in use in Korea. The study involved two parts. In Part 1, the safety of GC3110A was evaluated in 10 subjects. After none of the subjects reported grade 3 adverse events (AEs), we proceeded to Part 2. Part 2 was a randomized, double-blind, multicenter phase 3 trial wherein we compared the immunogenicity and safety of GC3110A with those of a licensed control TIV. Immunogenicity was evaluated by measuring hemagglutination inhibition titers. The 200 participants enrolled in Part 2 were randomized in a 4:1 ratio to receive GC3110A or control TIV. The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) and secondary (i.e., the lower limit of 95% CI of the seroprotection rate exceeds 70% for four strains) immunogenicity endpoints. There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains. However, the study vaccine group demonstrated significantly higher immunity for the additional strain B/Yamagata. In the safety analysis, there was no significant between-group difference in the proportion of participants with solicited local AEs, solicited systemic AEs, and unsolicited AEs. In conclusion, the results indicate that GC3110A has comparable immunogenicity and safety to those of TIV. Clinical Trial Registry Number: NCT03285997.

2014-10-03·Human Vaccines & Immunotherapeutics3区 · 医学

Phase IV: Randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults

3区 · 医学

Article

作者: Wie, Seong-Heon ; Song, Joon Young ; Park, Dae Won ; Lee, Jacob ; Sohn, Jang Wook ; Choi, Won Suk ; Kee, Sae Yoon ; Noh, Ji Yun ; Kim, Yeon-Sook ; Cheong, Hee Jin ; Jeong, Hye Won ; Kim, Woo Joo ; Park, Kyung-Hwa

Influenza vaccines are the primary method for preventing influenza and its complications. Considering the increasing demand for influenza vaccines, vaccine manufacturers are required to establish large-scale production systems. This phase IV randomized trial was conducted to evaluate the lot consistency of trivalent split influenza vaccines regarding immunogenicity and safety. A total of 1,023 healthy adults aged 18-64 y were enrolled in the study. Subjects were randomly assigned in a 1:1 ratio to receive the GC FLU® Prefilled Syringe or the GC FLU® Injection, and they were further randomized to one of 3 lots of each vaccine in a 1:1:1 ratio. In both GC FLU® Injection and GC FLU® Prefilled Syringe groups, immune responses were equivalent between lots for each of the 3 vaccine strains on day 21. The 2-sided 95% CI of GMT ratios between pairs of lots were between 0.67 and 1.5, meeting the equivalence criteria. After vaccination, all 3 criteria of the European Medicines Agency were met in both GC FLU® Injection and GC FLU® Prefilled Syringe groups. The vaccines showed tolerable safety profiles without serious adverse events. The demonstration of lot consistency, robust immunogenic responses and favorable safety profiles support the reliability of mass-manufacturing systems for the GC FLU® Injection and GC FLU® Prefilled Syringe.

Journal of Korean Medical Science4区 · 医学

Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study

4区 · 医学

ArticleOA

作者: Eun, Byung Wook ; Hong, Young Jin ; Jo, Dae Sun ; Kim, Jong-Hyun ; Kim, Dong Ho ; Kang, Jin Han ; Kim, Chun Soo ; Lee, Kyung-Yil ; Lee, Jin ; Choi, Young Youn ; Kim, Hwang Min ; Ma, Sang Hyuk

BACKGROUNDThe frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013-2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years.METHODSA total of 528 subjects were randomized 4:1 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated.RESULTSThe proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control.CONCLUSIONThe new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines (Registered at the ClinicalTrials.gov NCT02541253).

100 项与 Quadrivalent influenza virus vaccine(Green Cross Corp.) 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

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	韩国	GC Biopharma Corp.	2016-04-01

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
流感病毒感染	药物发现	中国	高端疫苗生物制剂股份有限公司	2018-10-30

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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


NCT03285997 (Pubmed) 人工标引	临床3期	流感病毒感染	200	GC3110A	(夢艱鏇獵鹽獵憲衊齋衊) = There was no significant between-group difference 鬱膚鑰衊襯觸糧夢窪構 (製醖製憲廠築簾齋鹹觸 )	积极	2021-04-08
				trivalent influenza vaccine