吸附型四价联合疫苗(Biken Techno Corp.)(Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio(Sabin strain)Combined Vaccine(Minimum Requirements for Biological Products))

概要

基本信息

药物类型

联合疫苗、预防性疫苗、多价疫苗

别名

Combined vaccine(Biken Techno Corp.)、DTP-poliovirus vaccine、テトラビック皮下注シリンジ

+ [6]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病呼吸系统疾病+ [1]

在研适应症

白喉脊髓灰质炎破伤风+ [1]

非在研适应症

细菌性脑膜炎

原研机构-

在研机构

Research Fdn for Microbial Diseases of Osaka University

非在研机构

Mitsubishi Tanabe Pharma Corp.

最高研发阶段批准上市

首次获批日期

日本 (2012-07-27),

白喉脊髓灰质炎破伤风+ [1]

最高研发阶段(中国)-

特殊审评-

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关联

4

项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的临床试验

NCT02140047

/ Completed临床2期

Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)

The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.

开始日期2014-04-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

JPRN-UMIN000022692

/ CompletedN/A

Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety - Study of interchangeability between polio vaccines

开始日期2011-11-15

申办/合作机构

College of Healthcare Management

JPRN-jRCT2080221090

/ Unknown status临床3期IIT

Confirmatory study of BK-4SP in healthy infants.

开始日期2010-05-25

申办/合作机构-

100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的临床结果

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100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的转化医学

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100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的专利（医药）

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8

项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的文献（医药）

2024-04-01·Vaccine

Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

Article

作者: Matsuda, Keiko ; Hasegawa, Masumi ; Tamai, Hoshio ; Endo, Mai ; Nakano, Takashi

OBJECTIVEThis study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.METHODSThis study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.RESULTSIn 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.CONCLUSIONA single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

2011-09-01·Nihon rinsho. Japanese journal of clinical medicine

[Inactivated poliovirus vaccine].

Review

作者: Shimizu, Hiroyuki

During the final stage of global polio eradication program, universal use of inactivated poliovirus vaccine (IPV) is the most feasible option to minimize the inherent risk of oral poliovirus vaccine (OPV), such as vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to vaccine-derived polioviruses. Introduction of diphtheria, pertussis, tetanus, IPV (DPT-IPV) products, instead of OPV, to routine polio immunization should be seriously and urgently considered to minimize ongoing risk of VAPP in Japan. Accordingly, a further polio immunization strategy, including the immunization schedule using DPT-IPV, interchangeability of different DPT-IPV products, intensified polio surveillance activities, and appropriate polio vaccine stockpile, should be developed to maintain polio-free status in Japan prior to the introduction of DPT-IPV.

1999-02-01·Vaccine3区 · 医学

A comparative study of PENTA™ vaccine booster doses given at 12, 15 or 18 months of age

3区 · 医学

Article

作者: David W Scheifele ; Pierre Lavigne ; Roland Guasparini

For infants immunized with Haemophilus influenzae type b conjugate vaccines, booster immunization is usually recommended in the second year of life, typically between 12 and 18 months. This study assessed the effect of age at booster immunization on pre-immunization antibody trough levels and on subsequent responses, for a PRP-T conjugate vaccine. Subjects were healthy children who had received PENTA vaccine (DPT-IPV/PRP-T combination) as infants. They were enrolled and given measles-mumps-rubella vaccine (MMR) at 12 months of age, then randomly assigned to receive PENTA vaccine concurrently with MMR or at 15 or 18 months of age. Parents were asked to note any adverse effects after PENTA vaccination. Blood samples were obtained prior to PENTA vaccination and 4 weeks later, and tested for antibodies to each antigen. In total 253 children received PENTA vaccine: 86 at 12 months, 85 at 15 months and 82 at 18 months. Injection site redness and swelling were least extensive in the youngest group (p < 0.001) but their rates of occurrence did not differ with age. Anti-PRP levels were similar in each age group prior to immunization; post-booster geometric mean concentrations (GMCs) ranged from 13.0 microg/ml in the youngest to 33.9 microg/ml in the oldest subjects (p < 0.0001). For each of the other antigens examined, booster responses were strongest at 18 months. We conclude that anti-PRP levels are stable between 12 and 18 months in children previously given PRP-T vaccine. PENTA boosters given at 12 months appear to cause milder injection site morbidity whereas those given at 18 months result in stronger responses to virtually every constituent antigen, although each age group responded satisfactorily.

100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA02	-

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
白喉	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
脊髓灰质炎	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
破伤风	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
百日咳	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27

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
细菌性脑膜炎	药物发现	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01

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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


NCT02140047 (CTgov)	临床2期	嗜血杆菌感染	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	蓋廠鏇觸獵憲壓願襯齋(簾繭壓窪餘獵觸願鹽憲) = 繭顧鏇壓鹽願構壓壓糧選鏇廠鹹膚遞鏇襯積構 (蓋積築憲夢觸繭觸衊鹽, 製鹽夢壓餘醖觸鏇鹹遞 ~ 獵膚構鏇範膚顧繭淵積) 更多	-	2024-09-19
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	蓋廠鏇觸獵憲壓願襯齋(簾繭壓窪餘獵觸願鹽憲) = 壓艱膚繭鹹齋齋鏇鬱膚選鏇廠鹹膚遞鏇襯積構 (蓋積築憲夢觸繭觸衊鹽, 鑰廠製獵鏇獵壓鑰築範 ~ 齋窪襯夢鏇觸鏇餘窪餘) 更多
WCLC2019	N/A	晚期非小细胞肺癌三线	158	S-1 monotherapy	(構衊願鹹構觸願齋鏇衊) = 願醖鹹範簾積膚觸願齋蓋廠窪獵餘製範遞齋遞 (積鹹鑰淵壓餘蓋廠願鬱 ) 更多	积极	2019-09-08
				Combined regimens	(醖積繭夢鏇範觸範窪醖) = 襯鏇淵獵遞繭壓構簾艱糧齋製衊艱鹽廠鑰蓋淵 (範糧顧鏇憲淵遞餘築廠 )