白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.)(Diphtheria, tetanus, pertussis and inactivated poliovirus vaccine(Boryung Pharmaceutical Co., Ltd.))

概要

基本信息

药物类型

灭活疫苗、联合疫苗、预防性疫苗

别名

DTaP-IPV combination vaccine

+ [1]

靶点-

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-

原研机构

Boryung Corp.

在研机构

Boryung Corp.

非在研机构-

最高研发阶段批准上市

首次获批日期

韩国 (2016-03-01),

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

2

项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的临床试验

NCT02458183 / Completed临床3期

A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants

The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

开始日期2015-02-02

申办/合作机构

Boryung Corp.

JPRN-JapicCTI-101350 / Unknown status临床3期

Immunogenicity and Safety of the DTaP-IPV (sanofi Pasteur Kitasato) Combined Vaccine (DD-687) given subcutaneously as a three-dose primary and booster vaccination versus commercially available DTaP (Kitasato) and Oral Polio Virus (OPV) Vaccines in Infants in Japan

开始日期2010-10-20

申办/合作机构-

100 项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的临床结果

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100 项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的转化医学

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100 项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的专利（医药）

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16

项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的文献（医药）

2024-01-01·BMJ Open

Is health expenditure on immunisation associated with immunisation coverage in sub-Saharan Africa? A multicountry analysis, 2013–2017

Article

作者: Ouma, Luke ; Ayeni, Gabriel Omoniyi ; Idris, Israel Oluwaseyidayo ; Ayomoh, Francis Ifeanyi ; Tapkigen, Janet

ObjectivesThe designing of contextually tailored sustainable plans to finance the procurement of vaccines and the running of appropriate immunisation programmes are necessary to address the high burden of vaccine-preventable diseases and low immunisation coverage in sub-Saharan Africa (SSA). We sought to estimate the minimum fraction of a country’s health budget that should be invested in national immunisation programmes to achieve national immunisation coverage of 80% or greater depending on the context, with and without donors’ support.DesignMulticountry analysis of secondary data using retrieved publicly available data from the WHO, Global Alliance for Vaccines and Immunization (GAVI) and World Bank databases.SettingData on 24 SSA countries, between 2013 and 2017.MethodsWe model the variations in immunisation coverage across the different SSA countries using a fractional logit model. Three different generalised linear models were fitted to explore how various explanatory variables accounted for the variability in each of the three different vaccines—measles-containing vaccine (MCV)1, diphtheria, pertussis, tetanus (DPT3) and BCG.ResultsWe observed an association between current health expenditure (as a percentage of gross domestic product) and immunisation coverage for BCG (OR=1.01, 95% CI: 1.01 to 1.04, p=0.008) and DPT3 (OR=1.01, 95% CI: 1.0 to 1.02, p=0.020) vaccines. However, there was no evidence to indicate that health expenditure on immunisation (as a proportion of current health expenditure) could be a strong predictor of immunisation coverage (DPT, OR 0.96 (95% CI 0.78 to 1.19; p=0.702); BCG, OR 0.91 (0.69 to 1.19; p=0.492); MCV, OR 0.91 (0.69 to 1.19; p=0.482)). We demonstrate in selected countries that to achieve the GAVI target of 80% in the countries with low DPT3 coverage, health expenditure would need to be increased by more than 45%.ConclusionsThere is a need to facilitate the development of strategies that support African countries to increase domestic financing for national immunisation programmes towards achieving 2030 targets for immunisation coverage.

2020-07-01·Journal of Infection and Chemotherapy4区 · 医学

Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan

4区 · 医学

Article

作者: Tsuzuki, Daisuke ; Nakayama, Tetsuo ; Tsuge, Hiroyuki ; Vidor, Emmanuel ; Nishina, Satoshi ; Sasaki, Toru ; Mizukami, Hideya ; Ishii, Yasunori

BACKGROUNDGlobally, the use of single DTaP-IPV/Hib vaccines that combine DTaP-IPV and Hib is widespread, but in Japan vaccination is usually concomitant at separate sites. The immunogenicity and safety of a primary vaccination series and booster of a combined pentavalent DTaP-IPV/Hib vaccine were evaluated and compared to separate administration of DTaP-IPV and Hib in Japanese infants.METHODSHealthy Japanese infants were administered DTaP-IPV/Hib (Group A: N = 207) or DTaP-IPV + Hib (Group B: N = 207) by the subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route (Group C: N = 10). All subjects received a 3-dose primary vaccination series and a booster. Non-inferiority (Group A versus Group B) was tested post-primary series and subsequent post hoc analyses were performed for anti-Hib. Safety was assessed by parental reports.RESULTSNon-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 μg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 μg/mL, and for pre-booster antibody persistence and the booster response using 0.15 μg/mL and 1.0 μg/mL. The immune response was similar for each antigen following SC or IM administration. There were no safety concerns in any group, and a lower incidence of injection sites for the IM route was observed as expected.CONCLUSIONSThese data show the good immunogenicity and safety profile of the DTaP-IPV/Hib vaccine as a 3-dose infant primary series followed by a booster in the second year of life in Japan.

2020-01-01·Japanese Journal of Infectious Diseases

A Novel Reporter Gene Assay for Pyrogen Detection

Article

作者: Wang, Lan ; Du, Ying ; Ni, Yongbo ; He, Qing ; Zhang, Heng ; Wang, Junzhi ; Yu, Chuanfei ; Gao, Hua

Fever is a systemic inflammatory response of the body to pyrogens. Nuclear factor κB (NF-κB) is a central signaling molecule that causes the excessive secretion of various pyrogen-induced pro-inflammatory factors. This study explored the feasibility of a novel reporter gene assay (RGA) for pyrogen detection using RAW264.7 cells stably transfected with the NF-κB reporter gene as a pyrogenic marker. The RGA could detect different types of pyrogens, including the lipopolysaccharide of gram-negative bacteria, the lipoteichoic acid of gram-positive bacteria, and the zymosan of fungi, and a good dose-effect relationship was observed in terms of NF-κB activity. The limits of detection of the RGA to those pyrogens were 0.03 EU/ml, 0.001 μg/ml, and 1 μg/ml, respectively. The method had good precision and accuracy and could be applied to many molecules (e.g., nivolumab, rituximab, bevacizumab, etanercept, basiliximab, Haemophilus influenzae type b conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, group A and group C meningococcal conjugate vaccine, diphtheria, tetanus, pertussis [acellular, component], poliomyelitis [inactivated] vaccine, and imject alum adjuvant). The results of this study suggest that the novel RGA has a wide pyrogen detection spectrum and is sufficiently sensitive, stable, and accurate for various applications.

100 项与白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	白喉/破伤风/百日咳/灭活脊髓灰质炎病毒疫苗(Boryung Pharmaceutical Co., Ltd.)	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	韩国	Boryung Corp.	2016-03-01
脊髓灰质炎	韩国	Boryung Corp.	2016-03-01
破伤风	韩国	Boryung Corp.	2016-03-01
百日咳	韩国	Boryung Corp.	2016-03-01

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
白喉	申请上市	泰国	Boryung Corp.	2015-02-01
脊髓灰质炎	申请上市	泰国	Boryung Corp.	2015-02-01
破伤风	申请上市	泰国	Boryung Corp.	2015-02-01
百日咳	申请上市	泰国	Boryung Corp.	2015-02-01