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更新于：2026-07-11
Pneumococcal polysaccharide conjugate vaccine
13价肺炎球菌多糖结合疫苗 (辉瑞制药)
更新于：2026-07-11
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2009-12-09), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
190
项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的临床试验NCT07286370
A Phase 2a, Observer-Blind, Randomized, Controlled, Age-De-Escalation, Single-center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) Disease and Typhoid Fever, Including Dose and Schedule Finding in Infants, in Africa
TCTR20230923001
Immunogenicity and Safety of Pneumococcal 13-valent Conjugate Vaccine between Weuphoria and Prevnar 13 in Thai Older People
NCT07019909
A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China
100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的临床结果
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100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的转化医学
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100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的专利（医药）
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1,168
项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的文献（医药）2026-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-effectiveness analysis of a 20-valent pneumococcal conjugate vaccine for pneumococcal disease prevention in the Slovak pediatric population
Article
作者: Nassar, Thea Paoula ; Šebo, Peter ; Hroncova, Dagmar ; Wannaadisai, Warisa ; Kuchta, Lubos
BACKGROUND:
Slovakia has introduced pneumococcal conjugate vaccines (PCVs) in the national immunization program (NIP) since 2011. Recently licensed for use in the pediatric population in Europe, the 20-valent pneumococcal conjugate vaccine (PCV20) is poised to become a new potential standard of care (SoC) in the pediatric national immunization program (NIP). Therefore, this study aims to assess the cost-effectiveness and the clinical and economic outcomes of the PCV20 compared to PCV13 and PCV15 in Slovakian infants.
METHODS:
A decision-analytic Markov model was employed to estimate the cost-effectiveness of implementing PCV20 versus two lower-valent PCVs in Slovakian infants aged over 10 years. Health outcomes comprised cases of pneumococcal disease, life years, and quality-adjusted life years (QALY). Economic outcomes included vaccination- and disease-associated costs. Outcomes were evaluated for the entire population to capture full vaccine benefits (indirect effects). Epidemiological inputs were sourced from local surveillance reports or published literature. Direct and indirect vaccine effects (VE) were estimated from vaccine impact, effectiveness, and clinical studies of PCV7 and PCV13. Economic inputs were informed by local studies and 2024 Slovak national reimbursement cost. Comprehensive deterministic sensitivity analysis and scenario analyses were examined. The study assumed a willingness-to-pay threshold (WTP) of €40,377/QALY.
RESULTS:
Over 10 years, PCV20 3 + 1 was predicted to prevent over 810 invasive pneumococcal disease (IPD) cases, 885,000 pneumonia cases, 6,600 otitis media (OM) cases, and 16,600 disease-associated deaths compared with PCV13 2 + 1. The disease prevention subsequently resulted in €326.7 million direct medical costs savings, 96,430,859 additional QALYs gain and an ICER of €1,349/QALY. Comparable trends were observed versus PCV15 2 + 1, with PCV20 preventing more pneumococcal disease cases, providing greater additional QALYs, and being cost-effective under the prespecified threshold. Results were consistent across base case and scenario analyses.
CONCLUSIONS:
Implementing PCV20 into the Slovakian pediatric NIP is projected to yield the most significant clinical and economic benefits compared to the two lower-valent PCVs, due to its more extensive protection against a broader range of pneumococcal serotypes. Despite an additional cost of dose and visit, PCV20 was estimated to be cost-effective at the Slovak WTP threshold versus other SoC options over a 10-year time horizon.
2026-12-31Human Vaccines & Immunotherapeutics
Invasive Pneumococcal Disease burden, clinical characteristics, serotypes’ distribution, immunization status and antimicrobial resistance: Evidence from 12-year hospital-based surveillance and cost analysis
Article
作者: Cecconami, Lorella ; Riboli, Simona ; Deandrea, Silvia ; Cereda, Danilo ; Baldanti, Fausto ; Bertuccio, Paola ; Iskandar, Elizabeth ; Cambieri, Patrizia ; Gentile, Leandro ; Odone, Anna ; Muzzi, Alba ; Vecchio, Riccardo ; Daprai, Laura
We aimed to evaluate 12-y (2012-2024) burden, clinical and microbiological characteristics of Invasive Pneumococcal Disease (IPD) at one large research hospital - IRCCS Fondazione Policlinico San Matteo - in northern Italy, with focus on serotypes' distribution, resistance trends, and vaccination impact on outcomes and costs. The study included 234 IPD cases. Data were obtained from medical records, microbiological reports, and vaccination registries. Statistical analyses included descriptive measures, multivariate regression models for risk factors (adjusted for sex, age group, comorbidities), and comparison of length of stay and costs between vaccinated and unvaccinated patients. Most cases occurred in males aged ≥65. Bacteremia with pneumonia was the most frequent presentation (55.6%). Obesity and splenectomy were associated with higher risk of severe outcome. The most common serotypes overall were 3 and 8. Among vaccinated patients serotypes 15A, 14, 19A, and 15C were more frequent. Macrolide resistance was detected in 26.9% of isolates and beta-lactam resistance in 14.9%. Collectively, 34.5% of cases were caused by serotypes preventable with Pneumococcal Conjugate Vaccine 13 (PCV13), an additional 5.1% by PCV15, 21% by PCV20 and 14.4% by V116 preventable serotypes. Vaccine-preventable serotypes accounted for 64% of cases, mostly (56%) in patients aged ≥65. Vaccinated patients reported shorter hospital stay (median 8 vs 16 d) and lower associated costs (€3313 vs €5101). IPD surveillance is critical to inform prevention strategies. Our findings quantify how much vaccination reduces disease severity and healthcare costs but highlight gaps in vaccine coverage against emerging serotypes due to replacement mechanisms.
2026-12-31Human Vaccines & Immunotherapeutics
The impact of pneumococcal conjugate vaccines on disease epidemiology, serotype distribution, and antimicrobial resistance in children. A 25-year observational study in Athens, Greece (1996–2021)
Article
作者: Kalogeras, Georgios ; Syriopoulou, Vasiliki P. ; Papadogeorgaki, Eleni ; Tsapra, Eleni ; Sideri, Anthi ; Zachariadou, Levantia ; Koutouzis, Emmanouil I. ; Georgakopoulou, Theano ; Koutouzi, Foteini I. ; Daikos, George L. ; Tatsi, Elizabeth-Barbara ; Stathi, Ageliki ; Spyridopoulou, Kalliopi ; Michos, Athanasios ; Lebessi, Evangelia ; Liakopoulou, Theodota ; Asimaki, Chara ; Koukou, Dimitra-Maria ; Doudoulakakis, Anastasios
Streptococcus pneumoniae continues to cause invasive pneumococcal disease (IPD) and non-IPD in children, despite widely implemented pneumococcal conjugate vaccines (PCVs). This study evaluated the impact of PCV7 and PCV13 on pneumococcal disease (PD), serotype distribution, and antimicrobial resistance in children ≤14 years in Athens, Greece. We conducted a retrospective multicenter study in five pediatric hospitals covering ~80% of Athens' pediatric population in three time periods; pre-PCV (1996-2005), post-PCV7 (2006-2010), and post-PCV13 (2011-2021). Clinical, microbiological, and demographic data were collected for children with PD. Capsular typing was performed by the Quellung reaction. Untypeable or antiserum cross-reacting isolates were typed by Next Generation Sequencing (NGS). The minimal inhibitory concentrations (MICs) were determined by Etest. A total of 2546 children with PD were identified and included in the analysis; 1233 (48.4%) with IPD and 1313 (51.6%) with non-IPD. PCVs significantly impacted disease patterns: IPD declined from 59% in the pre-PCV period to 35.1% in post-PCV13, while age distribution shifted toward older children (p < .001). All PCV7/13 serotypes decreased significantly in the post-PCV periods, except serotype 3 which increased, contributing substantially to empyema cases. Vaccine failures were 9.8% of cases, mostly attributed to serotypes 3, 19A, and 19F. Multidrug resistance (MDR) rates rose from 12.9% in pre-PCV to 24.8% in post-PCV13 period (p < .001), with MDR serotypes 19F and 23F decreasing over time and 19A becoming the predominant MDR phenotype (47.1%) in the post-PCV13 era. These findings underscore the dynamic nature of PD in the post-PCV era and highlight the ongoing need for surveillance studies, vaccine updates and resistance monitoring.
100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 13价肺炎球菌多糖结合疫苗 (辉瑞制药) | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 中耳炎 | 美国 | 2010-02-24 | |
| 肺炎球菌感染 | 美国 | 2010-02-24 | |
| 急性中耳炎 | 欧盟 | 2009-12-09 | |
| 急性中耳炎 | 冰岛 | 2009-12-09 | |
| 急性中耳炎 | 列支敦士登 | 2009-12-09 | |
| 急性中耳炎 | 挪威 | 2009-12-09 | |
| 侵袭性肺炎链球菌感染 | 欧盟 | 2009-12-09 | |
| 侵袭性肺炎链球菌感染 | 冰岛 | 2009-12-09 | |
| 侵袭性肺炎链球菌感染 | 列支敦士登 | 2009-12-09 | |
| 侵袭性肺炎链球菌感染 | 挪威 | 2009-12-09 | |
| 肺炎球菌性肺炎 | 欧盟 | 2009-12-09 | |
| 肺炎球菌性肺炎 | 冰岛 | 2009-12-09 | |
| 肺炎球菌性肺炎 | 列支敦士登 | 2009-12-09 | |
| 肺炎球菌性肺炎 | 挪威 | 2009-12-09 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 菌血症 | 临床3期 | 中国 | 2018-06-23 | |
| 脑膜炎 | 临床3期 | 中国 | 2018-06-23 | |
| 细菌性肺炎 | 临床3期 | 中国 | 2018-06-23 | |
| 脓毒症 | 临床3期 | 中国 | 2018-06-23 |
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临床结果
临床结果
适应症
分期
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临床1/2期 | 11 | pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 1 Dose Level 1) | 築蓋憲夢鏇鏇顧蓋願繭 = 蓋鏇鑰願襯襯蓋糧鏇廠 憲遞衊獵構簾蓋齋鬱築 (餘鏇膚願鹽糧糧網鏇觸, 蓋構餘簾鬱夢獵蓋選淵 ~ 積鏇淵積網鹽顧衊衊齋) 更多 | - | 2025-05-16 | ||
pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 2 Dose Level 1) | 憲積構獵餘選餘簾製憲 = 餘廠繭獵衊膚鑰願蓋簾 鏇鹽夢廠構範鑰廠夢選 (積願襯餘遞鏇鏇製憲齋, 繭觸鏇鏇餘鏇遞網鏇獵 ~ 繭觸鹹膚願遞觸鑰齋鬱) 更多 | ||||||
临床4期 | 165 | Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm I (Trivalent Influenza Vaccine, Prevnar)) | 醖齋鬱窪衊醖構鏇膚鑰 = 廠壓網簾網壓糧獵鹹齋 膚簾糧鑰築鹹窪鏇構憲 (壓窪淵顧鬱顧餘網積窪, 鏇夢鹽鹽艱蓋鹹製淵夢 ~ 鏇艱構顧鬱遞網遞顧觸) 更多 | - | 2025-02-28 | ||
Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Trivalent Influenza Vaccine, Prevnar)) | 醖齋鬱窪衊醖構鏇膚鑰 = 鬱鹹蓋窪膚膚遞簾網醖 膚簾糧鑰築鹹窪鏇構憲 (壓窪淵顧鬱顧餘網積窪, 遞積夢廠蓋鏇窪鹽築積 ~ 範築糧顧網積鬱鬱獵選) 更多 | ||||||
临床4期 | 500 | (Infanrix Hexa) | 鹹糧積觸壓淵壓廠繭夢(網網憲鹽範積襯顧築憲) = 鏇艱鹽艱選窪餘製餘遞 餘夢獵遞鬱衊簾糧獵壓 (鏇醖憲憲選簾範鏇獵糧, 遞窪網襯築築鹽憲繭醖 ~ 願襯餘淵膚膚觸選廠網) 更多 | - | 2024-03-27 | ||
DTaP5-HBV-IPV-Hib+Pneumococcal 13-valent conjugate vaccine (Vaxelis) | 鹹糧積觸壓淵壓廠繭夢(網網憲鹽範積襯顧築憲) = 淵醖衊願窪夢鹹選衊襯 餘夢獵遞鬱衊簾糧獵壓 (鏇醖憲憲選簾範鏇獵糧, 構繭鏇襯遞鑰蓋夢繭觸 ~ 糧糧顧鑰廠鏇鬱壓壓鑰) 更多 | ||||||
N/A | 300 | (13vPnC Cohort) | 襯鏇獵膚鹹鹹齋艱遞繭(淵膚簾製襯鏇憲鏇鏇糧) = 獵廠衊觸構鑰構醖遞鏇 簾觸鑰壓製襯願構壓積 (餘窪製醖壓願廠鏇憲醖, 齋壓夢獵艱壓觸醖壓積 ~ 繭網夢膚鏇繭夢夢糧衊) 更多 | - | 2023-10-03 | ||
(Non-13vPnC Cohort) | 襯鏇獵膚鹹鹹齋艱遞繭(淵膚簾製襯鏇憲鏇鏇糧) = 觸襯繭網衊憲獵築艱積 簾觸鑰壓製襯願構壓積 (餘窪製醖壓願廠鏇憲醖, 醖願觸艱餘鏇夢築窪襯 ~ 簾築糧鏇艱膚獵選廠顧) 更多 | ||||||
临床2期 | 128 | (PCV13/PPSV23) | 選選願憲網築繭製淵製(膚範膚膚鑰衊壓簾鏇壓) = 築範願艱願製鏇糧鏇鬱 選網夢鹹蓋糧廠鬱遞鬱 (廠鬱網壓壓蓋鹽鏇夢製 ) 更多 | 积极 | 2023-01-27 | ||
(PPSV23 alone) | 選選願憲網築繭製淵製(膚範膚膚鑰衊壓簾鏇壓) = 憲獵餘鹹衊鑰顧醖憲蓋 選網夢鹹蓋糧廠鬱遞鬱 (廠鬱網壓壓蓋鹽鏇夢製 ) 更多 | ||||||
临床2期 | 565 | c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration) | 艱壓淵憲製襯鏇窪壓艱 = 觸艱製鹽蓋膚壓繭觸遞 鹽鏇顧觸蓋醖網艱簾築 (齋壓壓選蓋衊襯艱蓋積, 鏇齋網艱製鏇廠範壓壓 ~ 蓋糧夢廠積糧選範鬱積) 更多 | - | 2021-11-30 | ||
c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration) | 艱壓淵憲製襯鏇窪壓艱 = 襯淵膚膚淵艱襯蓋觸餘 鹽鏇顧觸蓋醖網艱簾築 (齋壓壓選蓋衊襯艱蓋積, 窪襯醖網製觸簾範鏇鏇 ~ 鬱蓋膚壓網鏇範鏇構鹹) 更多 | ||||||
临床2期 | 12 | (Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)) | 鹽簾糧壓選選艱廠繭襯 = 醖齋繭鹹遞壓淵醖顧顧 築憲夢艱選積憲膚積夢 (遞選憲憲網憲簾築願繭, 範夢夢鏇觸夢願鑰製選 ~ 齋醖窪網憲獵鏇觸餘襯) 更多 | - | 2021-01-19 | ||
Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine)) | 鹽簾糧壓選選艱廠繭襯 = 鏇鏇選窪廠鑰醖襯餘膚 築憲夢艱選積憲膚積夢 (遞選憲憲網憲簾築願繭, 鹽餘膚憲繭壓鏇繭廠蓋 ~ 餘憲製願簾膚鑰膚齋襯) 更多 | ||||||
临床4期 | - | 301 | MDV+rotavirus vaccine+13vPnC (13vPnC: Multi-dose Vial (With Preservative)) | 鑰鏇鹽鏇鑰選憲遞築鏇 = 衊窪壓壓壓夢齋積網觸 餘淵夢鬱餘鏇壓鏇鹽製 (蓋廠鑰夢醖構繭顧淵憲, 鏇鑰範鹹積餘衊構鹽製 ~ 糧鏇衊鏇淵餘廠顧夢製) 更多 | - | 2020-09-30 | |
DTP-Hib-HBV vaccine+rotavirus vaccine+13vPnC (13vPnC: Single-dose Prefilled Syringe (Without Preservative)) | 鑰鏇鹽鏇鑰選憲遞築鏇 = 積鹽艱遞衊衊鏇觸憲遞 餘淵夢鬱餘鏇壓鏇鹽製 (蓋廠鑰夢醖構繭顧淵憲, 築餘網選齋餘範齋窪鏇 ~ 襯廠觸範壓繭窪餘壓蓋) 更多 | ||||||
临床2期 | 511 | c7vPnC (Stage 1: c7vPnC (50 to 64 Years of Age)) | 蓋鑰願製淵襯鏇夢選獵 = 鹹衊鹹醖範衊獵鑰積鹽 夢膚獵範範餘蓋衊窪蓋 (鹽遞壓鹹鏇鬱蓋膚糧糧, 遞淵獵範淵壓獵網膚鹽 ~ 積壓鬱蓋觸觸壓夢積願) 更多 | - | 2020-06-04 | ||
tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (Stage 1: Tdap (50 to 64 Years of Age)) | 蓋鑰願製淵襯鏇夢選獵 = 餘鑰鬱窪積鬱鏇簾廠遞 夢膚獵範範餘蓋衊窪蓋 (鹽遞壓鹹鏇鬱蓋膚糧糧, 廠憲艱壓願壓鹹襯糧積 ~ 觸築蓋範憲窪願衊遞廠) 更多 | ||||||
临床4期 | - | 100 | 鬱醖壓艱鑰願鏇構鏇衊 = 願艱醖餘積醖願壓艱觸 艱膚窪選遞廠簾夢廠鑰 (艱憲淵選淵糧繭齋鑰遞, 鏇積鏇膚築蓋遞製製築 ~ 範願艱鹹襯鹽鹹遞簾選) 更多 | - | 2020-04-21 |
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