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更新于：2025-05-07

13-valent pneumococcal conjugate vaccine(Suzhou VAC)

13价肺炎球菌结合疫苗 (苏州超微)

更新于：2025-05-07

概要

基本信息

药物类型

预防性疫苗、多价疫苗、结合疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

肺炎球菌感染

非在研适应症-

原研机构

苏州微超生物科技有限公司

在研机构

苏州微超生物科技有限公司

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

项与 13价肺炎球菌结合疫苗 (苏州超微) 相关的临床试验

CTR20220680

/ Active, not recruiting临床1期

评价13价肺炎球菌结合疫苗接种2月龄（最小6周龄）至49周岁健康人群后安全性与免疫原性的随机、盲法、阳性疫苗对照Ⅰ期临床试验

初步观察13价肺炎球菌结合疫苗在2月龄（最小6周龄）至49周岁健康人群中接种的安全性和免疫原性。

开始日期2022-03-23

申办/合作机构

苏州微超生物科技有限公司

100 项与 13价肺炎球菌结合疫苗 (苏州超微) 相关的临床结果

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100 项与 13价肺炎球菌结合疫苗 (苏州超微) 相关的转化医学

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100 项与 13价肺炎球菌结合疫苗 (苏州超微) 相关的专利（医药）

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148

项与 13价肺炎球菌结合疫苗 (苏州超微) 相关的文献（医药）

2025-04-01·Vaccine

A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine

Article

作者: Bickham, Kara ; Peng, Yahong ; Trammel, James ; Tamimi, Noor ; Martinez, Silvina Natalini ; Gruber, William C ; Martinón-Torres, Federico ; Watson, Wendy ; Giardina, Peter C ; Kline, Mary J ; Drozd, Jelena

This phase 3, randomized, partially double-blind study investigated the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine (PCV20) in healthy toddlers ≥12-<24 months of age who had previously received 2 infant doses of 13-valent PCV (PCV13). Participants were randomized to receive 1 or 2 doses of PCV20 (the second dose was administered 56-70 days after the first dose), or 1 dose of PCV13. The primary pneumococcal immunogenicity endpoint was the percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations (≥0.35 μg/mL) for the 7 additional serotypes 1 month after the last vaccination. Percentages of participants with predefined IgG concentrations for the 13 matched serotypes, IgG geometric mean concentrations, and opsonophagocytic activity (OPA) geometric mean titers were also evaluated for all 20 vaccine serotypes. Safety endpoints included local reactions, systemic events, adverse events, and serious adverse events. Overall, 356 participants were randomized (2-dose PCV20, n = 121; 1-dose PCV20, n = 118; PCV13, n = 117). One month after 1 PCV20 dose, ≥75.9 % of participants had IgG concentrations ≥0.35 μg/mL for all 7 additional serotypes, except serotype 12F (54.6 %). After 2 PCV20 doses, the percentage of participants with IgG concentrations ≥0.35 μg/mL for the 7 additional serotypes was ≥91.2 %. PCV20 elicited IgG and OPA responses for all 20 serotypes including serotype 12F. IgG distributions were well differentiated and substantially higher in PCV20 groups than the PCV13 group for the 7 additional serotypes, and generally similar between all groups for the 13 matched serotypes. In conclusion, a single toddler dose of PCV20 after 2 infant PCV13 doses elicited immune responses expected to help provide protection against the 7 additional serotypes and to provide similar protection against the 13 matched serotypes as PCV13. These data support a transition from PCV13 to PCV20 at the toddler dose. The safety and tolerability profile of PCV20 was similar to PCV13. Trial registration:Clinicaltrials.gov, NCT05408429.

2025-01-12·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Chinese expert consensus on the diagnosis and treatment of pneumonia in the elderly (2024 Edition)].

Article

中国已经进入老年化社会，而老年人是罹患肺炎的高危人群。老年肺炎具有起病隐匿、进展迅速、合并症多、预后差、发病率和病死率高等特点，需要引起临床医师的重点关注，制定更为精细的诊治策略，最大程度地保证个体化治疗。为加强对老年肺炎的防治与管理，本共识参照国内外最新相关指南与共识，结合该研究领域的最新进展，以问答的方式阐述了17个临床诊断、治疗和预防的问题，提出了13条推荐意见，从老年肺炎的病因及发病机制、诊断、病情评估、治疗和预防等方面提出意见和建议，以期为防治老年肺炎，改善老年患者的生活质量，降低住院及病死率，促进健康老龄化提供参考。.

2025-01-01·Vaccine

Effectiveness of 13-valent pneumococcal conjugate vaccine against vaccine-type invasive pneumococcal disease in older adults

Article

作者: Klein, Nicola P ; Timbol, Julius ; Suaya, Jose A ; Alexander-Parrish, Ronika ; Grant, Lindsay R ; Hansen, John ; Gessner, Bradford D ; Lewis, Ned ; Hsiao, Amber

BACKGROUNDIn 2014, the Advisory Committee on Immunization Practices recommended routine use of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults age ≥ 65 years. Incidence of most PCV13-serotype cases declined, however serotype 3 cases have persisted. We estimated PCV13 vaccine effectiveness (VE) against PCV13-serotypes and serotype 3 invasive pneumococcal disease (IPD) among Kaiser Permanente Northern California (KPNC) adults.METHODSThis observational study included adults ≥65 years between September 1, 2014-December 31, 2020. We used active laboratory-based surveillance to identify and serotype all Streptococcus pneumoniae isolates obtained from normally-sterile sites. We estimated the odds ratio (OR) of vaccine-type IPD using conditional logistic regression stratified by age and calendar day, adjusting for sex, age, race, ethnicity, influenza vaccine receipt, 23-valent pneumococcal polysaccharide vaccine receipt since age 65, pneumonia risk factors, healthcare utilization, and KPNC service area. We estimated VE_Adjusted as (1-OR_Adjusted) × 100 %.RESULTSThere were 610,576 adults ≥65 years in the study population. By the end of the study period, PCV13 coverage was nearly 80 %. There were 307 IPD cases during the study period, of which 98 (31.9 %) were serotype 3. PCV13 was associated with a VE_Adjusted of 61.5 % (95 % CI: 36.2, 76.7; p < 0.001) against PCV13-serotype IPD and 46.3 % (95 % CI: -2.4, 77.9; p = 0.06) against serotype 3 IPD.CONCLUSIONSPCV13 vaccination protected adults ≥65 years against IPD due to PCV13 serotypes. Continued surveillance will be critical in the ≥65-year-old population to assess the impact of higher valent PCVs on IPD serotype distribution, including individual serotypes such as serotype 3.

100 项与 13价肺炎球菌结合疫苗 (苏州超微) 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
肺炎球菌感染	临床1期	中国	苏州微超生物科技有限公司	2022-03-23

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ACR2017	N/A	类风湿关节炎	24	PCV1313-Valent Pneumococcal Conjugate VaccinePPV23umococcal Conjugate Vaccine (PCV13 + PPV23 prime-boost revaccination)	膚壓鏇鹽襯憲夢廠願夢(繭網鏇壓繭鏇簾糧膚衊) = 網淵餘鏇願願廠選積壓繭鑰網構壓鑰獵艱構窪 (艱衊觸蓋鬱築蓋選選積 )	不佳	2017-11-07
				13-Valent Pneumococcal Conjugate VaccinePPV23lent Pneumococcal Conjugate Vaccine (PPV23 alone)	膚壓鏇鹽襯憲夢廠願夢(繭網鏇壓繭鏇簾糧膚衊) = 壓鬱鹹積構齋範繭繭鹽繭鑰網構壓鑰獵艱構窪 (艱衊觸蓋鬱築蓋選選積 )