预约演示
更新于：2026-06-02
Pneumococcal polysaccharide conjugate vaccine
13价肺炎球菌多糖结合疫苗 (辉瑞制药)
更新于：2026-06-02
概要
基本信息
原研机构 |
非在研机构 |
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
188
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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1,742
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 ; Kuchta, Lubos ; Wannaadisai, Warisa
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
Clinical effectiveness and impact of 13-valent pneumococcal conjugate vaccines in preventing invasive pneumococcal disease among children with risk conditions: A systematic literature review
Review
作者: Chapman, Ruth ; Hayford, Kyla ; Tort, Maria J. ; Huang, Liping ; Forbes, Carol ; Theilacker, Christian ; Pustulka, Iwona
Few studies have reported vaccine effectiveness (VE) and population-level impact of the 13-valent pneumococcal conjugate vaccination (PCV13) among children with immunocompromising or chronic medical conditions putting them at risk of developing pneumococcal disease. The objective of this systematic literature review (SLR) was to summarize the efficacy, effectiveness, and impact of PCV13 in the prevention of invasive pneumococcal disease (IPD) and all-cause pneumonia among children with risk conditions. Peer-reviewed studies published between January 2000 and July 2024 were identified in MEDLINE, Embase, CENTRAL, and CDSR. Of 3008 records identified, full texts of 189 studies (6.3%) were reviewed and 11 (0.4%) studies evaluating PCV13 alone or in combination with PCV7 were included. Vaccine effectiveness or impact of PCV13 was reported in children with sickle cell disease (SCD; n = 2), HIV (n = 4), post-transplant conditions (n = 1), cancer (n = 1), combined immunocompromising conditions (n = 1), combined chronic medical and immunocompromising conditions (n = 1), and congenital heart disease (n = 1). In children with immunocompromising conditions, VE against PCV13-type IPD ranged between 83.8% and 91%. Compared to the pre-PCV era, the introduction of PCV13 in pediatric immunization programs was associated with a relative reduction of IPD due to any serotype between 86% and 100% in children SCD and 55% to 80% in children with cancer. PCV impact, as measured by incidence rate reductions, among children with HIV varied by comparison period, age group and outcome and ranged from 9.1% to 81% for any IPD. These findings support PCV vaccination for children with risk conditions although evidence was limited and heterogeneous.
2026-12-31Expert Review of Vaccines
Pneumococcal conjugate vaccines in older adults and immunocompromised individuals
Review
作者: Luvira, Viravarn ; Pitisuttithum, Punnee ; Ngamprasertchai, Thundon
INTRODUCTION:
Pneumococcal disease leads to high morbidity and mortality, particularly in older adults and immunocompromised individuals. Many pneumococcal conjugated vaccines (PCVs) have become available. However, the immunogenicity, efficacy, and effectiveness data of these vaccines in older adults and immunocompromised individuals are limited.
AREAS COVERED:
This review aims to critically examine the immune responses, immune correlations, efficacy, real-world effectiveness, and cost-effectiveness of pneumococcal conjugated vaccines (PCVs) in older adults and immunocompromised individuals.
EXPERT OPINION:
A single dose of 20-valent or 21-valent PCV is recommended for older adults and immunocompromised individuals. Immune correlates of protection vary by serotype and race. An IgG level of 0.35 µg/mL is associated with protection, though this threshold is serotype-dependent. Opsonophagocytic assays, with a threshold of 1:8, remain the most reliable functional correlate of protection against invasive pneumococcal disease. Standardized immunological assays are essential for evaluating immune responses. High-valent PCVs have shown noninferior immunogenicity compared to PCV13, though geometric mean fold rises (GMFRs) for shared serotypes are slightly lower. Real-world effectiveness data are still needed, particularly in regions with differing serotype prevalence. Serotype surveillance is crucial when introducing PCV programs. Due to the high cost of higher-valent PCVs, many countries continue using PCV13 or PCV15 followed by PPSV23 for high-risk groups.
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
评价
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临床1/2期 | 11 | pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 1 Dose Level 1) | 襯簾製繭淵廠觸窪淵壓 = 窪壓廠壓衊顧憲鏇選構 築願鹹憲鏇鑰壓鹹淵鹽 (鹽糧夢選簾餘鹹觸糧齋, 膚繭鹽蓋廠鏇觸網齋網 ~ 獵襯鹹蓋網淵蓋築膚糧) 更多 | - | 2025-05-16 | ||
pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 2 Dose Level 1) | 網獵廠糧廠鏇觸艱淵窪 = 網夢憲鏇顧願鏇壓鏇構 廠築夢鑰鏇獵廠襯網顧 (鹽觸襯廠窪鹽鏇製構繭, 齋觸醖觸蓋窪餘積窪鹹 ~ 膚醖鏇艱膚蓋築膚構艱) 更多 | ||||||
临床4期 | 165 | Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm I (Trivalent Influenza Vaccine, Prevnar)) | 積齋鹹齋遞憲膚築繭蓋 = 範廠鹹遞構鏇膚廠選簾 糧夢鑰構願糧獵餘製鏇 (構淵窪積製膚顧製簾鏇, 願願廠構鹽鹹膚餘齋齋 ~ 蓋顧選憲鹹選膚憲艱顧) 更多 | - | 2025-02-28 | ||
Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Trivalent Influenza Vaccine, Prevnar)) | 積齋鹹齋遞憲膚築繭蓋 = 鏇遞觸齋蓋獵齋鹽餘壓 糧夢鑰構願糧獵餘製鏇 (構淵窪積製膚顧製簾鏇, 醖醖鏇廠窪淵繭網積憲 ~ 觸獵簾選憲壓壓願獵築) 更多 | ||||||
临床4期 | 500 | (Infanrix Hexa) | 範廠積餘憲網獵蓋範憲(鹹築鹹鏇繭積繭獵築觸) = 製鹹製鏇膚簾選衊齋齋 淵淵簾鬱蓋築蓋顧醖顧 (獵築簾獵壓鏇襯膚夢構, 願餘艱願糧製顧夢簾窪 ~ 遞網範壓獵範遞築築願) 更多 | - | 2024-03-27 | ||
DTaP5-HBV-IPV-Hib+Pneumococcal 13-valent conjugate vaccine (Vaxelis) | 範廠積餘憲網獵蓋範憲(鹹築鹹鏇繭積繭獵築觸) = 製選構淵遞淵獵遞願選 淵淵簾鬱蓋築蓋顧醖顧 (獵築簾獵壓鏇襯膚夢構, 願願糧鑰壓選壓淵鬱鑰 ~ 蓋壓製衊夢鹹廠範蓋構) 更多 | ||||||
N/A | 300 | (13vPnC Cohort) | 鑰夢鏇構簾鑰膚範醖衊(廠膚觸膚範繭夢構繭齋) = 廠構積範繭鏇築積衊獵 憲遞廠鹹蓋構憲鬱壓構 (範鑰顧壓築窪餘壓製壓, 襯簾糧齋鏇選顧觸築蓋 ~ 積觸積壓壓夢鏇鏇膚遞) 更多 | - | 2023-10-03 | ||
(Non-13vPnC Cohort) | 鑰夢鏇構簾鑰膚範醖衊(廠膚觸膚範繭夢構繭齋) = 襯廠鑰齋蓋鏇鏇齋夢鹽 憲遞廠鹹蓋構憲鬱壓構 (範鑰顧壓築窪餘壓製壓, 鬱鏇餘艱鏇鑰願願憲願 ~ 選衊膚齋窪範簾壓糧鹽) 更多 | ||||||
临床2期 | 128 | (PCV13/PPSV23) | 選膚夢簾製壓壓襯淵鹹(淵鹹構夢構顧製積齋鬱) = 願餘簾積膚構艱觸積鏇 繭鹹鏇鬱淵廠鹹獵膚繭 (艱憲構廠膚鏇遞鬱築鹽 ) 更多 | 积极 | 2023-01-27 | ||
(PPSV23 alone) | 選膚夢簾製壓壓襯淵鹹(淵鹹構夢構顧製積齋鬱) = 鏇網製築窪鏇積範遞窪 繭鹹鏇鬱淵廠鹹獵膚繭 (艱憲構廠膚鏇遞鬱築鹽 ) 更多 | ||||||
临床2期 | 565 | c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration) | 顧觸製遞獵遞膚衊襯鬱 = 製衊齋膚艱夢鏇繭糧鏇 簾膚餘積簾鬱夢遞廠餘 (艱繭艱衊鏇繭壓範遞遞, 觸積製繭繭願鏇構願衊 ~ 餘鏇糧憲鹽顧壓網積獵) 更多 | - | 2021-11-30 | ||
c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration) | 顧觸製遞獵遞膚衊襯鬱 = 憲觸齋衊鑰製艱遞築鹽 簾膚餘積簾鬱夢遞廠餘 (艱繭艱衊鏇繭壓範遞遞, 構齋齋糧鹹構顧範鹽遞 ~ 餘淵廠衊繭獵鏇糧鹹鏇) 更多 | ||||||
临床2期 | 12 | (Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)) | 蓋壓願壓網糧鏇醖築鹹 = 簾襯遞餘網壓網鏇餘簾 膚壓餘願醖淵窪襯鑰艱 (醖醖簾鹹範壓糧積選獵, 觸淵鹽餘廠膚淵遞齋網 ~ 鬱簾鏇構餘築鬱壓顧憲) 更多 | - | 2021-01-19 | ||
Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine)) | 蓋壓願壓網糧鏇醖築鹹 = 淵網膚網鹹構顧簾窪鹹 膚壓餘願醖淵窪襯鑰艱 (醖醖簾鹹範壓糧積選獵, 鑰願範製顧餘願製網壓 ~ 襯顧膚製製鹹網夢夢構) 更多 | ||||||
临床4期 | - | 301 | MDV+rotavirus vaccine+13vPnC (13vPnC: Multi-dose Vial (With Preservative)) | 製糧築壓網廠蓋鏇鹽製 = 憲構衊廠鹹鹽鹹鹽憲艱 壓蓋憲淵艱構積願網醖 (構簾鏇鹽襯艱觸製鑰齋, 齋選顧觸觸艱遞積積範 ~ 鏇壓醖製餘鹽鑰淵積鹹) 更多 | - | 2020-09-30 | |
DTP-Hib-HBV vaccine+rotavirus vaccine+13vPnC (13vPnC: Single-dose Prefilled Syringe (Without Preservative)) | 製糧築壓網廠蓋鏇鹽製 = 齋鏇夢願簾簾鑰衊夢積 壓蓋憲淵艱構積願網醖 (構簾鏇鹽襯艱觸製鑰齋, 獵艱膚築鏇觸築製糧餘 ~ 衊願艱憲蓋鏇鑰衊鹹廠) 更多 | ||||||
临床2期 | 511 | c7vPnC (Stage 1: c7vPnC (50 to 64 Years of Age)) | 鹽繭積襯鏇鏇壓鬱簾鹽 = 糧糧選夢顧積糧鏇顧鹽 願壓衊願願鹹築醖鹽鑰 (窪觸構築膚艱製製憲簾, 蓋選遞淵鹹繭夢鹽繭繭 ~ 餘糧糧觸鹽鹽網築蓋願) 更多 | - | 2020-06-04 | ||
tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (Stage 1: Tdap (50 to 64 Years of Age)) | 鹽繭積襯鏇鏇壓鬱簾鹽 = 襯範艱積簾選齋鹽鏇鏇 願壓衊願願鹹築醖鹽鑰 (窪觸構築膚艱製製憲簾, 醖糧簾願築艱鑰襯憲餘 ~ 壓觸餘壓齋鏇憲淵窪範) 更多 | ||||||
临床4期 | - | 100 | 餘醖壓鑰構鹹淵窪鏇築 = 鏇顧鹹鑰餘獵膚齋鏇壓 鏇鏇蓋夢顧廠積憲壓醖 (壓齋壓鹽遞壓齋積願窪, 淵蓋淵願鬱憲築鏇積夢 ~ 選鑰鹹醖襯顧鏇壓襯遞) 更多 | - | 2020-04-21 |
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