NBP-606(NBP-606) - 在研适应症：肺炎_专利_临床

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

13-valent pneumococcal vaccine conjugate、13vPnC

靶点-

作用方式

刺激剂

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

肺炎

非在研适应症

肺炎球菌感染

原研机构

SK Biopharmaceuticals Co., Ltd.

在研机构

SK Biopharmaceuticals Co., Ltd.

非在研机构

SK Chemicals Co. Ltd.

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 NBP-606 相关的临床试验

NCT02927444

/ Completed临床3期

Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)

This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

开始日期2015-11-04

申办/合作机构

SK Chemicals Co. Ltd.

NCT02201030

/ Completed临床3期

Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants

This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

开始日期2014-09-06

申办/合作机构

SK Chemicals Co. Ltd.

NCT02079207

/ Completed临床3期

Multi-center, Randomized, Double Blinded, Phase III Trial to Assess the Immunogenicity and Safety of NBP606 in Adults 50 Years of Age and Older Who Are naïve to Pneumococcal Vaccine

This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should be naïve of Pneumococcal vaccine.

开始日期2013-12-01

申办/合作机构

SK Chemicals Co. Ltd.

100 项与 NBP-606 相关的临床结果

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100 项与 NBP-606 相关的转化医学

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100 项与 NBP-606 相关的专利（医药）

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55

项与 NBP-606 相关的文献（医药）

2024-12-01·Diagnostic Microbiology and Infectious Disease

Study of pediatric invasive pneumococcal disease in the 13-pneumococcal conjugated vaccine era

Article

作者: López-Hontangas, José Luis ; Pineda-Lucena, Antonio ; Roig-Sena, Francisco Javier ; Pemán, Javier ; Garrido-Jareño, Marta ; Gil-Brusola, Ana ; Pérez-Pérez, Elvira ; Valentín-Gómez, Eulogio

BACKGROUNDInvasive pneumococcal disease (IPD) remains a significant concern among children under 5, despite vaccination efforts. This study assessed IPD prevalence and associated risks in pediatric population.METHODSAn observational, retrospective, multicenter study in Comunidad Valenciana, Spain, of IPD cases in children under 13 from January 2012 to September 2022. Data from the CV Microbiology Surveillance Network (RedMIVA) and medical records were reviewed.RESULTSA total of 379 IPD cases in 377 patients were analyzed, predominantly males (54.11 %) under 5 (81.17 %). PCV13 vaccination notably reduced PCV13-serotypes IPD (p=0.0002), except serotype 3. Pneumonia was common, with half having underlying conditions (50.40 %). Worse outcomes occurred in patients with neurological disorders (ANOVA, p=0.57). Vaccine failures often involved underlying conditions (63 %) and serotypes 3 and 19A. Immunodeficiencies may relate to recurrent IPD, but evidence is limited.CONCLUSIONDespite vaccination, IPD still impacts children, influenced by immunological status, affecting severity and mortality.

2024-11-01·Die Innere Medizin

Aktuelle und neue Impfstoffe gegen Pneumokokken

Article

作者: Rademacher, Jessica

Pneumococcal vaccination plays a crucial role in the prevention of bacterial respiratory infections caused by Streptococcus pneumoniae. Pneumococci are responsible for diseases such as pneumonia, sinusitis and acute otitis media and can cause serious invasive infections such as meningitis and bacteraemia. Pneumococcal pneumonia leads to increased morbidity and mortality, particularly in patients with chronic lung diseases such as chronic obstructive pulmonary disease (COPD). The introduction of 13-valent conjugate vaccines (pneumococcal conjugate vaccine 13 [PCV13]) has significantly reduced the burden of disease. However, infections caused by serotypes not covered by PCV13 continue to occur. Current vaccines such as the 20-valent conjugate vaccine (PCV20) provide extended serotype coverage and have shown a robust immune response in clinical trials. The recently updated recommendations of the German Standing Committee on Vaccination (Ständige Impfkommission, STIKO) include the use of PCV20 for all indication categories in adults, which represents a simplified and more effective vaccination strategy. Future developments include vaccines with even broader serotype coverage and improved immunological properties; these are expected to further reduce the burden of pneumococcal disease. Improving vaccination uptake and increasing vaccination rates, particularly among at-risk groups, remain key objectives to protect public health in the long term.

2023-02-01·Enfermedades Infecciosas y Microbiología Clínica4区 · 医学

Análisis espacial y temporal de la enfermedad neumocócica invasora por serotipos resistentes a eritromicina

4区 · 医学

Article

作者: Ramis Prieto, Rebeca ; Gómez Barroso, Diana ; Fernández Chávez, Abelardo Claudio ; Aranaz Andrés, Jesús María ; Bishofberguer Valdes, Cornelia ; García Comas, Luis ; López Fresneña, Nieves

OBJECTIVESTo study the spatio-temporal distribution of cases of invasive pneumococcal disease (IPD) due to serotypes resistant to erythromycin and its relationship with community consumption of macrolides and childhood vaccination coverage.METHODSWe selected IPD cases in adults over 59 years old, residents in the Community of Madrid (MC), notified in the period 2007-2016. The variables studied were obtained from the Vaccination Information Systems and the Pharmaceutical Service. The cut-off point (minimum inhibitory erythromycin concentration > 0.5 mg/L) of the EUCAST classification was used to define erythromycin resistant serotypes. We used JointPoint to estimate the incidence trends by erythromycin resistant serotypes included in the 13-valent vaccine (STPCV13) and not included in it (STnoPCV13). The association of these incidences with the community consumption of macrolides and vaccination coverage was made using Poisson models. Statistical scanning was used for the detection of temporal-spaces clusters of cases.RESULTS1936 cases were identified, of which 427 erythromycin resistant serotypes were identified. The incidence of all cases due to resistant serotypes was decreasing (AAPC: -5,40%). During the period studied, the incidence of cases due to erythromycin resistant STPCV13 was decreasing with an annual percentage change (APC): -13.8 and was inversely associated with childhood vaccination coverage (IRR 0.641), while that of cases due to erythromycin resistant STnoPCV13 was ascending (APC): 4.5; and was not associated with coverage. 1 cluster was detected by STnoPCV13 and none by STPCV13 after the date of inclusion of the 13-valent in the childhood vaccination calendar.CONCLUSIONSThe decrease in IPD due to resistant STPCV13 was associated with an increase in childhood vaccination coverage. The presence of clusters due to STnoPCV13 after the date of inclusion of the 13-valent vaccine in the childhood vaccination calendar indicates serotypes replacement. The increase in cases of resistant STnoPCV13 could be related to the replacement of vaccine serotypes in nasopharyngeal colonization, facilitated by the consumption of macrolides still at high levels in MC.

100 项与 NBP-606 相关的药物交易

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