DPT-IPV-Hib vaccine(Biken Techno Corp.)(DPT-IPV-Hib vaccine(Biken Techno Corp.)) - 在研适应症：嗜血杆菌感染_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

DPT-IPV-Hib vaccine

+ [2]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Mitsubishi Tanabe Pharma Corp.

Biken Techno Corp.

非在研机构-

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 DPT-IPV-Hib vaccine(Biken Techno Corp.) 相关的临床试验

NCT03891758

/ Completed临床3期

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

开始日期2019-04-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

[+1]

NCT03188692

/ Completed临床3期

Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

开始日期2017-06-23

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

[+1]

NCT02992925

/ Completed临床3期

Phase 3 Study of BK1310 in Healthy Infants

The purpose of this study is to:
* (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
* (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

开始日期2016-11-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

[+1]

100 项与 DPT-IPV-Hib vaccine(Biken Techno Corp.) 相关的临床结果

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100 项与 DPT-IPV-Hib vaccine(Biken Techno Corp.) 相关的转化医学

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100 项与 DPT-IPV-Hib vaccine(Biken Techno Corp.) 相关的专利（医药）

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6

项与 DPT-IPV-Hib vaccine(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 ; Nakano, Takashi ; Endo, Mai

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).

2019-04-03·Human Vaccines & Immunotherapeutics3区 · 医学

Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study

3区 · 医学

Article

作者: Kuroki, Haruo ; Gillard, Paul ; Morikawa, Yoshiyuki ; Tamura, Tsuyoshi ; Parra, Jose ; Moerman, Leentje ; Okamasa, Arisa ; Mihara, Kazuko ; Kitamura, Yurina

Rotavirus infections have been reported to account for 40-50% of all hospitalized acute gastroenteritis cases in young children (<5 years) in Japan. Since 2011, Rotarix containing the live attenuated human rotavirus RIX4414 strain (HRV) has been licensed in Japan for infants. Vaccination against rotavirus is optional in Japan whereas administration of diphtheria, pertussis, tetanus, and inactivated poliovirus (DPT-IPV) vaccine is part of the national routine immunization program. In this open-label, randomized, controlled, multicenter study, we evaluated the immunogenicity and safety of the DPT-IPV vaccine (Squarekids) administered concomitantly or staggered with the liquid HRV (Rotarix) vaccine in healthy Japanese infants. A total of 292 infants aged 6-12 weeks were randomly assigned to receive DPT-IPV vaccine and HRV vaccine co-administered (n = 147) or staggered (n = 145). Immune responses to DPT-IPV vaccine were evaluated by measuring the post-vaccination serum antibody titers/concentrations to each antigen at one month following the third dose of DPT-IPV vaccine. Seroprotection/seropositivity against each of the diphtheria, pertussis (pertussis toxin and filamentous hemagglutinin), tetanus, and poliovirus type 1, 2 and 3 antigens was 92.8% or higher in both groups. In terms of immunogenicity, DPT-IPV vaccine co-administered with HRV vaccine was shown to be non-inferior to DPT-IPV vaccine with a staggered administration. The safety profile was comparable in the two vaccine groups with no vaccine-related serious adverse events, no deaths and no cases of intussusception. These results support co-administration of HRV vaccine with DPT-IPV vaccine in Japan. ClinicalTrials.gov NCT02907216.

2012-12-01·Journal of the Formosan Medical Association3区 · 医学

Haemophilus influenzae type b combination vaccines and atopic disorders: A prospective cohort study

3区 · 医学

ArticleOA

作者: Li-Min Huang ; Pau-Chung Chen ; I-Jen Wang ; Wu-Shiun Hsieh ; Yueliang Leon Guo ; Tien-Jen Lin

BACKGROUND/PURPOSEEpidemiologic evidence for an association between vaccinations and atopy development is inconsistent. We evaluated the influence of Haemophilus influenzae type b (Hib) combination vaccines in 6-month-old infants on the prevalence of atopic disorders in 18-month-old children.METHODSWe used multistage, stratified systematic sampling to recruit 24,200 mother-newborn pairs from the Taiwan national birth registration in 2005. Vaccination status was ascertained through official vaccine cards, while risk factors for atopic disorders were gathered by questionnaires at 6 months of age. Information about development of atopic dermatitis (AD) and recurrent wheezing was collected at 18 months of age. The relationship between atopic disorders and Hib combination vaccines, diphtheria-pertussis-tetanus-Hib and oral poliomyelitis vaccines (DPT-Hib&OPV) and DPT-Hib-inactivated poliomyelitis vaccines (DPT-Hib-IPV), were estimated by multiple logistic regression.RESULTSA total of 19,968 children completed the follow-up and participated in the study. AD was noted in 1584 (7.9%) infants while recurrent wheezing was found in 1220 (6.1%) infants. The adjusted odds ratios (ORs) (95% CI) for the development of AD in the DPT-Hib&OPV and DPT-Hib-IPV vaccination groups were given as 1.38 (1.15-1.65) and 1.49 (1.29-1.72), compared to those without Hib vaccination (DTP&OPV vaccination). However, the association between DPT-Hib&OPV and DPT-Hib-IPV vaccinations and recurrent wheezing failed to reach statistical significance.CONCLUSIONThere is a potential risk for AD after receiving Hib combination vaccines. Hib vaccination is important to the public health, and therefore the observation requires further investigations.

100 项与 DPT-IPV-Hib vaccine(Biken Techno Corp.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
嗜血杆菌感染	临床3期	-	Biken Techno Corp.	-
嗜血杆菌感染	临床3期	-	Mitsubishi Tanabe Pharma Corp.	-
白喉	临床前	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
细菌性脑膜炎	临床前	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
脊髓灰质炎	临床前	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
破伤风	临床前	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
百日咳	临床前	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


NCT02992925 (CTgov)	临床3期	接种疫苗	370	DPT-IPV-Hib-High (BK1310-High)	窪壓廠淵築願蓋簾簾憲(蓋顧鹽觸網壓願餘繭餘) = 醖糧艱顧簾齋鏇鏇淵艱窪鏇夢簾艱夢願築鏇觸 (鹽製鏇製鏇齋餘獵窪艱, 憲製膚蓋鹽壓齋艱鹽範 ~ 構廠襯築繭簾醖艱繭遞) 更多	-	2025-01-07
NCT02992925 (CTgov)	临床3期	接种疫苗	370	DPT-IPV-Hib (BK1310-Low)	窪壓廠淵築願蓋簾簾憲(蓋顧鹽觸網壓願餘繭餘) = 襯淵鬱蓋糧衊鏇襯鏇艱窪鏇夢簾艱夢願築鏇觸 (鹽製鏇製鏇齋餘獵窪艱, 積蓋艱餘顧鑰襯衊糧淵 ~ 遞衊糧齋餘鹽築願襯壓) 更多	-	2025-01-07
NCT03891758 (CTgov)	临床3期	白喉 \| 百日咳 \| 破伤风 \| 细菌性脑膜炎 \| 脊髓灰质炎	267	DPT-IPV-Hib	選構窪獵膚憲夢顧簾願(鬱鹽壓艱網壓積鬱艱衊) = 壓網構壓願遞憲觸製窪鹽鹽遞窪壓艱顧衊艱襯 (鏇鏇構網壓鹽醖鬱鏇齋, 壓鹽網窪鑰鬱積夢窪鹹 ~ 壓糧壓選鹹窪鏇觸鹹糧) 更多	-	2025-01-06
NCT03188692 (CTgov)	临床3期	-	33	DPT-IPV-Hib	餘鏇鹹鑰糧積壓淵鹽鑰(簾蓋憲憲範構顧憲廠鹹) = 選窪鑰簾築簾憲鹽憲獵夢構衊簾構淵顧選願夢 (膚鏇齋糧遞襯選鹽壓憲, 壓膚淵壓蓋簾蓋網顧範 ~ 築遞憲觸壓簾艱鏇網夢) 更多	-	2025-01-03