20价肺炎球菌结合疫苗（苏州微超生物）(20-valent Pneumococcal Conjugate Vaccine (Suzhou VAC))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗、多价疫苗

+ [1]

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

肺炎球菌感染肺炎

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

Pfizer Inc.

苏州微超生物科技有限公司苏州聚微生物科技有限公司

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

2

项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的临床试验

CTR20230951

/ Active, not recruiting临床1期

评价20价肺炎球菌结合疫苗接种2月龄（最小6周龄）至55周岁健康人群后安全性与初步免疫原性的随机、盲法、阳性疫苗对照I期临床试验

初步观察20价肺炎球菌结合疫苗在2月龄（最小6周龄）至55周岁健康人群中接种的安全性和免疫原性。

开始日期2023-04-07

申办/合作机构

苏州微超生物科技有限公司

[+1]

NCT04546425

/ Completed临床3期

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

开始日期2020-09-09

申办/合作机构

Pfizer Inc.

100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的临床结果

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100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的转化医学

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100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的专利（医药）

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46

项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的文献（医药）

2025-03-01·Drug Safety

Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS)

Article

作者: Ennulat, Carol ; Welsh, Kerry ; Blanc, Phillip ; Oliveira, Mayra ; Nair, Narayan ; Marquez, Paige ; Taminato, Monica ; Moro, Pedro L

BACKGROUNDOn June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20^®, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 years by the US Food and Drug Administration (FDA).OBJECTIVETo describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults.METHODSWe searched the VAERS for reports of adverse events involving persons aged ≥ 19 years who received PCV20 during October 20, 2021, through December 31, 2023. Our evaluation included automated analysis of reports, clinical review of serious reports and pre-specified events of special interest, empirical Bayesian data mining to assess for disproportionate reporting, and estimation of reporting rates for reports of Guillain-Barré syndrome (GBS).RESULTSThe VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events). The most common adverse events among persons aged 19-64 years (n = 798) were injection-site reactions (231, 29%), pain (134, 17%), erythema (118, 15%), and fever (117, 15%). For persons aged ≥ 65 years (n = 1178), the most common adverse events were injection-site reactions (417, 35%), pain (180, 15%), pain in extremity (162, 14%), and erythema (158, 13%). A data mining alert (EB05 = 3.812) for the MedDRA Preferred Term "Guillain-Barre syndrome" was observed for serious reports. Clinical review verified 11 of 20 GBS reports; 7/11 vaccine recipients were aged ≥ 65 years. Among the 11 verified cases, the median time from vaccination to symptom onset was 14 days. Five persons received another vaccine on the same visit. The reporting rate of GBS after PCV20 receipt was 0.5 cases per million doses distributed. No other safety concern was identified.CONCLUSIONSDuring the period of this post-licensure review of PCV20, we found most reports were non-serious and comprised mostly local and systemic (e.g., fever) reactions consistent with prelicensure studies. In serious reports, we also identified a data mining alert for GBS after receipt of PCV20, which Centers for Disease Control and Prevention and the FDA are investigating further. No other new or unexpected safety concern was identified.

2025-02-01·Journal of Infection

Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial

Article

作者: Jorda, Anselm ; Pecho, Theresa ; Pracher, Lena ; Decaminada, Alice ; Weseslindtner, Lukas ; Yildiz, Erdem ; Prager, Marlene ; Ederer, Lena ; Redlberger-Fritz, Monika ; Leutzendorff, Amelie ; Bergmann, Felix ; Yourieva, Schermin ; Jackwerth, Matthias ; Haselwanter, Patrick ; Weber, Maria ; Wiedermann, Ursula ; Al Jalali, Valentin ; Zeitlinger, Markus ; Kammerer, Paula

OBJECTIVESThere is conflicting evidence as to whether the combined administration of two vaccines can lead to poorer immunogenicity and reactogenicity. The co-administration of the Omicron-adapted COVID-19 vaccine from Novavax (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine (PCV20) has not been previously investigated.METHODSIn this randomised, double-blind, placebo-controlled, non-inferiority trial, immunocompetent participants aged ≥60 years were randomised in a 1:1:1:1 ratio to four groups: NVX-CoV2601 plus PCV20 (combination group); NVX-CoV2601 plus placebo (NVX-only group); PCV20 plus placebo (PCV20-only group); or placebo plus placebo (placebo group). The primary outcome was Omicron-specific anti-spike protein IgG ELISA units at day 28 in the combination group compared with the NVX-only group. Non-inferiority was established if the lower limit of the two-sided 95% CI of the geometric mean titre ratio was above the non-inferiority margin of 0.67. Secondary outcomes included anti-pneumococcal capsular polysaccharide (PCP) IgG ELISA units. Solicited local and systemic adverse events were collected for 7 days after vaccination. This study was registered with ClinicalTrials.gov, number NCT05767606, and the EU Clinical Trials Register, EudraCT number 2022-004118-12.RESULTSAll 256 randomised participants completed the study. The baseline characteristics were similar in the four groups. Overall, the median age was 64 (IQR 61 to 69) and 105 (41%) of 256 were male. At day 28, the geometric mean anti-spike protein IgG ELISA units were 534 U/mL (95% CI 432-660) in the combination group and 556 U/mL (95% CI 460-672) in the NVX-only group, resulting in a geometric mean titre ratio of 0.96 (95% CI 0.73-1.27), thereby meeting the criteria for non-inferiority. Anti-PCP IgG ELISA units at day 28 were 507 U/mL (95% CI 416-619) in the combination group and 592 U/mL (95% CI 485-723) in the PCV20-only group. Local and systemic reactogenicity was similar in the three active treatment groups. No safety concerns or serious adverse events were observed.CONCLUSIONSImmunogenicity following co-administration of NVX-CoV2601 with PCV20 was non-inferior to administration of NVX-CoV2601 alone. Given the similar safety and reactogenicity profile, our findings may help to overcome concerns about concomitant vaccination and pave the way for combination vaccines.FUNDINGNovavax.

2024-12-31·Journal of Medical Economics

Cost-effectiveness and impact on infections and associated antimicrobial resistance of 20-valent pneumococcal conjugate vaccine in US children previously immunized with PCV13

Article

作者: Dillon-Murphy, Desmond ; Rozenbaum, Mark H. ; Snow, Vincenza ; Tort, Maria J. ; Chapman, Ruth ; Farkouh, Raymond ; Huang, Liping ; Cane, Alejandro ; Arguedas, Adriano ; Chilson, Erica

AIMThe US Food and Drug Administration approved the 20-valent pneumococcal conjugate vaccine (PCV20) to prevent pneumococcal disease. In the context of routine PCV20 vaccination, we evaluated the cost-effectiveness and public health and economic impact of a PCV20 catch-up program and estimated the number of antibiotic prescriptions and antibiotic-resistant infections averted.MATERIALS AND METHODSA population-based, multi-cohort, decision-analytic Markov model was developed using parameters consistent with previous PCV20 cost-effectiveness analyses. In the intervention arm, children aged 14-59 months who previously completed PCV13 vaccination received a supplemental dose of PCV20. In the comparator arm, no catch-up PCV20 dose was given. The direct and indirect benefits of vaccination were captured over a 10-year time horizon.RESULTSA PCV20 catch-up program would prevent 5,469 invasive pneumococcal disease cases, 50,286 hospitalized pneumonia cases, 218,240 outpatient pneumonia cases, 582,302 otitis media cases, and 1,800 deaths, representing a net gain of 30,014 life years and 55,583 quality-adjusted life years. Furthermore, 720,938 antibiotic prescriptions and 256,889 antibiotic-resistant infections would be averted. A catch-up program would result in cost savings of $800 million. These results were robust to sensitivity and scenario analyses.CONCLUSIONSA PCV20 catch-up program could prevent pneumococcal infections, antibiotic prescriptions, and antimicrobial-resistant infections and would be cost-saving in the US.

100 项与 20价肺炎球菌结合疫苗（苏州微超生物）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3期	挪威	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	俄罗斯	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	捷克	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	爱沙尼亚	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	比利时	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	丹麦	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	芬兰	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	斯洛伐克	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	澳大利亚	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	意大利	Pfizer Inc.	2020-09-09