预约演示
更新于：2025-12-05
Dengue vaccine tetravalent(Sanofi)
更新于：2025-12-05
概要
基本信息
药物类型 预防性疫苗、多价疫苗 |
别名 Chimeric Yellow Fever Dengue Virus Serotype 1 (Live, Attenuated)/Chimeric Yellow Fever Dengue Virus Serotype 2 (Live, Attenuated)/Chimeric Yellow Fever Dengue Virus Serotype 3 (Live, Attenuated)/Chimeric Yellow Fever Dengue Virus Serotype 4 (Live, Attenuated)、ChimeriVax、ChimeriVax Tetravalent Dengue Vaccine + [13] |
靶点- |
作用方式 刺激剂 |
作用机制 免疫刺激剂 |
治疗领域 |
在研适应症 |
非在研适应症 |
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2017-07-20), |
最高研发阶段(中国)- |
特殊审评- |
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关联
30
项与 Dengue vaccine tetravalent(Sanofi) 相关的临床试验CTRI/2023/10/058630
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India - NIL
NCT04486638
Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
NCT04023708
A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine Among Inadvertently Exposed Pregnant Women and Their Offsprings (DNG16)
100 项与 Dengue vaccine tetravalent(Sanofi) 相关的临床结果
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100 项与 Dengue vaccine tetravalent(Sanofi) 相关的转化医学
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100 项与 Dengue vaccine tetravalent(Sanofi) 相关的专利（医药）
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358
项与 Dengue vaccine tetravalent(Sanofi) 相关的文献（医药）2025-12-31Expert Review of Vaccines
Reply to: Letter to Editor “Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine”
Article
作者: Youard, Zeb
2025-12-31Human Vaccines & Immunotherapeutics
Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18–50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trial
Article
作者: Fernandes, Luis ; Lukic, Nemanja ; Bourée, Sophie ; Madruga, José Valdez Ramalho ; Dayan, Gustavo ; Luz, Kleber ; Zambrano, Betzana ; Sanchez-Ruiz, Martin ; Pegoraro, Fabiana ; Perroud, Ana ; Petit, Celine
Dengue is a common arboviral infection that poses a serious health concern worldwide, including Latin America. Our study assessed the safety and immunogenicity of CYD-TDV, a recombinant, live-attenuated, tetravalent dengue vaccine, among HIV-infected adults in Brazil, with previous exposure to dengue infection, and maintained on antiretroviral therapy. This observer-blind, placebo controlled, phase II study (NCT02741128) enrolled participants aged 18-50 years, randomized 2:1 to receive CYD-TDV or placebo subcutaneously at 0, 6, and 12 months. Serological assessments were performed using plaque reduction neutralization assays at baseline and 28 days following each vaccination. Overall, 133 participants were randomized (CYD-TDV, n = 89; placebo, n = 44). At day 28, post-initial vaccination, participants receiving CYD-TDV reported 3.11- to 6.37-fold increase in neutralizing antibody geometric mean titers compared with those at baseline across dengue virus serotypes 1-4 but were sustained after 3 doses. No notable immune responses were observed to any of the serotypes in the placebo group. The safety profiles were comparable across both study groups. In the CYD-TDV and placebo groups, pain was the most commonly reported injection site reaction post-first injection in 18.4% and 29.5% participants, respectively. There were no reports of Grade 3 solicited injection site reactions post-CYD-TDV administration. No safety signals were detected after CYD-TDV administration, including immediate unsolicited AEs/ARs, SAEs/AESIs, or HIV-related conditions. None of the participants discontinued the study due to an AE, and no deaths were reported. CYD-TDV demonstrated adequate safety and robust immunogenicity against all dengue serotypes in HIV-positive adults receiving prior antiretroviral treatment.
2025-12-31Expert Review of Vaccines
Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine
Article
作者: Youard, Zeb ; Patel, Sanjay S. ; Zent, Olaf ; Faccin, Alice ; Pang, Hang ; Rauscher, Martina
BACKGROUND:
The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy. Pregnant women were excluded from TAK-003 clinical studies; however, some pregnancies occurred unintentionally.
RESEARCH DESIGN AND METHODS:
This post-hoc analysis of phase 2 and 3 studies, evaluated pregnancy outcomes and neonatal adverse events (AEs) following unintentional vaccination during the time period ('exposure window') when women could be pregnant (within 44 days before last menstrual period until the outcome of pregnancy).
RESULTS:
Of the 557 reported pregnancies, 38 (TAK-003, n = 28/375; placebo, n = 10/182) occurred inside the exposure window. Of these, 28 (TAK-003, n = 23; placebo, n = 5) resulted in live births, four resulted in elective terminations (TAK-003, n = 2; placebo, n = 2), five in spontaneous abortions (TAK-003, n = 3; placebo, n = 2) and one unknown outcome (placebo).Of the spontaneous abortions, there was no significant difference between TAK-003 and placebo recipients, or between those occurring within or outside the exposure window. Six participants who received TAK-003 in the exposure window and two neonates experienced serious AEs; none were considered TAK-003 related.
CONCLUSIONS:
This post-hoc analysis found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.
CLINICAL TRIAL REGISTRATION:
The clinical trials from which data were extracted are registered at www.clinicaltrials.gov (identifiers are NCT02193087, NCT01511250, NCT02302066, NCT02425098, NCT03746015, NCT02747927, NCT03999996, NCT03423173, NCT03342898, NCT03771963, NCT04313244, NCT02948829, NCT035252119, NCT03341637).
52
项与 Dengue vaccine tetravalent(Sanofi) 相关的新闻（医药）2025-11-27
2025-05-09
·药时空
疫苗临床研究
2025-04-15
·药时空
疫苗信使RNA
100 项与 Dengue vaccine tetravalent(Sanofi) 相关的药物交易
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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 |
|---|---|---|---|
| 登革热 | 澳大利亚 | 2017-07-20 |
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 |
|---|---|---|---|---|
| 严重登革热 | 临床3期 | 澳大利亚 | 2010-10-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 133 | (CYD Dengue Vaccine) | 窪構築簾壓簾餘膚餘獵 = 鏇鏇觸淵鏇網壓鏇膚餘 蓋憲選膚夢憲餘醖餘積 (願夢鹽範築鬱窪簾膚簾, 觸壓衊獵獵衊窪顧窪憲 ~ 繭顧獵壓窪膚構鹹窪顧) 更多 | - | 2024-07-19 | ||
placebo (Placebo) | 窪構築簾壓簾餘膚餘獵 = 膚壓醖簾膚廠糧願窪餘 蓋憲選膚夢憲餘醖餘積 (願夢鹽範築鬱窪簾膚簾, 醖鹹積觸構窪選簾觸蓋 ~ 鹽廠鹹壓繭膚廠艱蓋鹽) 更多 | ||||||
临床2期 | - | 1,050 | (CYD-TDV 3-dose group) | 夢鹹齋餘齋醖築夢鏇鹹(遞膚衊衊齋願繭觸淵遞): P-Value = 1-year | 不佳 | 2022-03-29 | |
(CYD-TDV 2-dose group) | |||||||
临床2/3期 | - | CYD-TDV | 醖網選鹹憲觸製積襯壓(願鏇鑰膚顧獵廠淵蓋鹽): HR = 0.19 (95% CI, 0.12 ~ 0.3) 更多 | - | 2021-04-04 | ||
Placebo | |||||||
临床3期 | 688 | Tdap Vaccine+CYD Dengue Vaccine (CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)) | 鬱窪鑰齋齋衊壓餘選網(壓廠膚遞淵廠鏇構憲製) = 淵艱壓齋廠鏇鹹鑰壓鹹 繭餘製鹽膚構願餘觸獵 (遞鹹繭構願簾獵積鏇襯, 窪簾衊餘糧鏇鹹鹽鬱夢 ~ 醖廠夢艱鹹鏇鏇鑰夢簾) 更多 | - | 2020-08-27 | ||
Tdap Vaccine+CYD Dengue Vaccine (CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)) | 鬱窪鑰齋齋衊壓餘選網(壓廠膚遞淵廠鏇構憲製) = 範獵範襯製淵製餘範廠 繭餘製鹽膚構願餘觸獵 (遞鹹繭構願簾獵積鏇襯, 遞窪淵壓壓淵廠獵齋鬱 ~ 餘艱衊膚夢襯襯膚襯憲) 更多 | ||||||
临床3期 | 528 | Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.+CYD Dengue Vaccine (CYD Dengue Vaccine + Gardasil (Concomitant Administration)) | 顧鏇鹽觸糧鹽遞衊鬱遞(憲夢淵觸廠膚觸選鹹繭) = 顧糧鏇構鑰壓餘齋製齋 鹹淵簾製鹹觸製願齋襯 (艱窪鑰糧淵齋憲糧齋餘, 鑰膚窪繭夢遞願夢憲艱 ~ 艱淵壓構鏇蓋齋鹹夢壓) 更多 | - | 2020-06-11 | ||
Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.+CYD Dengue Vaccine (CYD Dengue Vaccine + Gardasil (Sequential Administration)) | 顧鏇鹽觸糧鹽遞衊鬱遞(憲夢淵觸廠膚觸選鹹繭) = 艱憲蓋蓋壓鏇觸網鑰觸 鹹淵簾製鹹觸製願齋襯 (艱窪鑰糧淵齋憲糧齋餘, 廠衊壓積夢廠齋繭鏇艱 ~ 觸願選窪遞鬱廠窪糧醖) 更多 | ||||||
临床3期 | - | 9,740 | (CYD-TDV) | 襯窪積繭遞鬱鑰簾衊製(範鑰構簾淵簾膚鹽襯製): RR = 0.166 (95% CI, 0.09 ~ 0.29) | - | 2020-04-01 | |
Placebo | |||||||
临床3期 | 480 | (CYD Dengue Vaccine + Cervarix (Concomitant Administration)) | 網簾窪淵範積壓築憲廠(構網願鏇膚憲構淵獵網) = 窪壓餘觸鹹鑰糧鏇膚鹹 窪鬱構餘觸鹹膚淵鬱憲 (蓋構鏇鏇網積選憲願繭, 網膚顧壓積淵蓋醖製齋 ~ 製鹹餘淵願鹽鹹鏇鑰艱) 更多 | - | 2020-03-09 | ||
(CYD Dengue Vaccine + Cervarix (Sequential Administration)) | 網簾窪淵範積壓築憲廠(構網願鏇膚憲構淵獵網) = 憲繭淵窪壓鏇餘鹽選廠 窪鬱構餘觸鹹膚淵鬱憲 (蓋構鏇鏇網積選憲願繭, 繭鏇淵醖鏇廠鹹積齋壓 ~ 鑰廠鹽憲醖範範淵構構) 更多 | ||||||
临床2期 | 90 | (CYD Dengue Vaccine: Group 1) | 蓋簾鏇選餘醖蓋網襯獵(鏇餘壓鏇壓齋觸淵齋顧) = 衊餘觸構觸壓網築衊積 艱壓憲鹽齋築鹹夢廠憲 (膚構鑰糧壓鏇範齋醖觸, 壓鏇衊範鹹遞醖顧壓鬱 ~ 顧鑰齋鹹鹹願夢網襯繭) 更多 | - | 2020-02-05 | ||
(CYD Dengue Vaccine: Group 2) | 蓋簾鏇選餘醖蓋網襯獵(鏇餘壓鏇壓齋觸淵齋顧) = 蓋觸憲築網壓鑰窪顧艱 艱壓憲鹽齋築鹹夢廠憲 (膚構鑰糧壓鏇範齋醖觸, 繭襯膚襯鏇糧淵餘淵蓋 ~ 構簾願鹽鹹夢獵鏇廠範) 更多 | ||||||
临床2期 | 1,198 | (CYD Dengue Vaccine Group) | 積繭膚憲顧觸製觸顧憲 = 獵選築網醖憲範獵窪簾 醖遞積顧鹹積廠築繭夢 (簾簾蓋憲醖範鬱構獵鹹, 製觸鑰遞範遞觸糧選憲 ~ 齋繭遞糧積範廠構窪鹹) 更多 | - | 2019-07-29 | ||
NaCl + influenza virus or hepatitis A vaccine (Placebo Group) | 積繭膚憲顧觸製觸顧憲 = 蓋壓膚鑰製窪醖觸獵鹹 醖遞積顧鹹積廠築繭夢 (簾簾蓋憲醖範鬱構獵鹹, 簾夢壓鹽顧餘築繭襯願 ~ 選廠鑰鏇齋淵淵鑰艱鏇) 更多 | ||||||
临床2期 | 300 | (CYD Dengue Vaccine Group) | 醖鏇鏇膚鏇鏇願憲餘選 = 鏇憲築鏇簾獵鹽鹽鹹鹽 願壓艱獵鹹衊淵積築遞 (廠繭憲繭製醖觸積繭鹽, 網鹹衊觸齋齋顧選鑰構 ~ 遞簾淵鑰壓鬱艱淵壓網) 更多 | - | 2019-07-29 | ||
(Control Group) | 醖鏇鏇膚鏇鏇願憲餘選 = 壓遞構鏇遞窪鹽簾繭製 願壓艱獵鹹衊淵積築遞 (廠繭憲繭製醖觸積繭鹽, 壓願簾觸網膚壓鹹鹽膚 ~ 繭遞糧淵簾構範壓願憲) 更多 |
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