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-

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

2

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]

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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31

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 ; 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).

2023-10-12·Children (Basel, Switzerland)

Mobile Vaccination Teams for Improving Vaccination Coverage in the Kyrgyz Republic: Results of a National Health System-Strengthening Project during the First Two Years of the COVID-19 Pandemic.

Article

作者: Kosbayeva, Alyia ; Lazzerini, Marzia ; Monolbaev, Kubanychbek

(1) Background: This implementation study reports on the results of the mobile vaccination teams' (MVTs) activities during the first two years of the COVID-19 pandemic in Kyrgyzstan, when other vaccination services were disrupted. (2) Methods: Through a national health system-strengthening project under an order of the Ministry of Health, in 2020, the number of MVTs was increased, focusing on internal immigrant settlements around the cities of Bishkek and Osh and geographically remote areas. MVTs provided free vaccination services. (3) Results: MVTs vaccinated a total of 125,289 and 158,047 children in 2020 and 2021, respectively. The higher contribution of MVTs to vaccination coverage was in children under 5 years of age, with the three top vaccines being IPV (8.9%), MMR (7%), and PCV (6.6%). In 2021, 13,000 children who had not received an IPV vaccination and 8692 children who had not received the Pentavalent vaccine (DPT-HBV-Hib) were reached. The number of cases of vaccine-preventable disease reported in official statistics has reduced over time. (4) Conclusions: MVTs increased vaccination coverage in Kyrgyzstan, in particular in remote regions and migrant settlements, where it accounted for a considerable proportion of the vaccinated. This study adds to previous evidence in the literature of the role of MVTs as a strategy to improve immunization in hard-to-reach populations, particularly children.

2023-01-01·Frontiers in pediatrics

Vaccination following the expanded programme on immunization schedule could help to reduce deaths in children under five hospitalized for pneumonia and severe pneumonia in a developing country.

Article

作者: Sultana, Mst Shahin ; Shahid, Abu Sadat Mohammed Sayeem Bin ; Afroze, Farzana ; Rahman, Ahmed Ehsanur ; Shahunja, K M ; Chisti, Mohammod Jobayer ; Ackhter, Mst Mahmuda ; Chowdhury, Fahmida ; Saha, Haimanti ; Islam, Shoeb Bin ; Ahmed, Tahmeed ; Nuzhat, Sharika ; Shahrin, Lubaba ; Alam, Tahmina ; Parvin, Irin ; Sarmin, Monira

BackgroundWorldwide, pneumonia is the leading cause of mortality in children under the age of five. An expanded program on immunization (EPI) is one kind of evidence-based tool for controlling and even eradicating infectious diseases.ObjectivesThis study aimed to explore the impact of EPI vaccination, including BCG, DPT-Hib-Hep B, OPV, IPV, and PCV-10, among children from the age of 4 to 59 months hospitalized for pneumonia and severe pneumonia. Additionally, we evaluated the role of 10 valent pneumococcal conjugate vaccines alone on clinical outcomes in such children.MethodsIn this retrospective chart review, children from the age of 4 to 59 months with WHO-defined pneumonia and severe pneumonia admitted to the Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b) between August 2013 and December 2017 who had the information on immunization as per EPI schedule by 4 months of age were included in the analysis. A comparison was made between the children who were fully immunized (immunization with BCG, DPT-Hib-Hep B, OPV, and IPV from 2013 to 2015 and PCV-10 from 2015 to 2017) and who were not immunized (consisting of partial immunization and no immunization) during the study period.ResultsA total of 4,625 children had pneumonia and severe pneumonia during the study period. Among them, 2,605 (56.3%) had received the information on immunization; 2,195 (84.3%) were fully immunized by 4 months of age according to the EPI schedule and 410 were not immunized. In the log-linear binomial regression analysis, immunization of children from 4 to 59 months of age was found to be associated with a lower risk of diarrhea (p = 0.033), severe pneumonia (p = 0.001), anemia (p = 0.026), and deaths (p = 0.035). Importantly, the risk of developing severe pneumonia (1054/1,570 [67%] vs. 202/257 [79%], p < 0.001) and case-fatality rate (57/1,570 [3.6%] vs. 19/257 [7.4%], p = 0.005) was still significantly lower among those who were immunized with PCV-10 than those who were not.ConclusionChildren immunized as per the EPI schedule were at a lower risk of diarrhea, severe pneumonia, anemia, and death, compared to unvaccinated children. In addition, PCV-10 was found to be protective against severe pneumonia and deaths in vaccinated children. The overall results underscored the importance of the continuation of immunization, scrupulously adhering to the EPI schedule to reduce the risk of morbidities and mortalities in children, especially in resource-limited settings.

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

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
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1期	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
细菌性脑膜炎	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
脊髓灰质炎	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
破伤风	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01
百日咳	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01