The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.

开始日期2021-09-07

申办/合作机构

Duke University

NCT02673255 / Completed临床1期

Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.
The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.
In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).
The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.
The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.

开始日期2016-08-22

申办/合作机构

Biomat USA, Inc.

[+2]

NCT02193347 / Completed临床1期IIT

Patients With IDH1 Positive Recurrent Grade II Glioma Enrolled in a Safety and Immunogenicity Study of Tumor-Specific Peptide Vaccine

Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).

开始日期2016-01-28

申办/合作机构

Duke University

100 项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的临床结果

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100 项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的转化医学

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100 项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的专利（医药）

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160

项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的文献（医药）

2023-12-31·Human vaccines & immunotherapeutics

A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal

Article

作者: Chaudhary, Shipra ; Shah, Gauri Shankar ; Bhatta, Nisha Keshary ; Poudel, Prakash ; Rai, Basant ; Uranw, Surendra ; Tripathi, Prashant Mani ; Khanal, Basudha ; Ghimire, Anup ; Rai, Nikita ; Gupta, Birendra Prasad ; Vemula, Sridhar ; Wartel, T. Anh ; Sahastrabuddhe, Sushant ; Saluja, Tarun

Typhoid remains one of the major serious health concerns for children in developing countries. With extremely drug-resistant cases emerging, preventative measures like sanitation and vaccination, including typhoid conjugate vaccines (TCV) remain the mainstay in its prevention and control. Different types of TCVs are being developed to meet the global demand. This report outlines the results from a study done to assess the immunogenicity and safety of Vi-Diphtheria toxoid (Vi-DT) TCV in Nepal. The study was a randomized, active-controlled, immunological non-inferiority and safety study. Eligible participants from Sunsari and Morang districts of eastern Nepal were randomized into 4 study groups (A-D) within 3 age strata (6 months to <2 years, 2 to <18 years, and 18 to 45 years). Groups A to C received a single dose (25 μg) of Vi-DT test vaccine from any of the 3 lots, while group D received the comparator, Typbar-TCV®, Vi-tetanus toxoid (Vi-TT) vaccine (25 μg) in 1:1:1:1 ratio and evaluated at 4 weeks postvaccination with 6 months follow-up. Amongst 400 randomized participants, anti-Vi-IgG seroconversion rates for all age strata in Vi-DT pooled groups (A+B+C) were 100.00% (97.5% CI 98.34-100.00) vs 98.99% (97.5% CI 93.99-99.85) in Vi-TT group (D) at 4 weeks. Comparable safety events were reported between the groups. Three serious adverse events (1 in Vi-DT; 2 in Vi-TT group) were reported during the 6 months follow-up, none being related to the investigational product. Thus, Vi-DT vaccine is safe, immunogenic, and immunologically non-inferior to Vi-TT when analyzed at 4 weeks postvaccination.

2023-10-06·NPJ vaccines

Proof of concept for a single-dose Group B Streptococcus vaccine based on capsular polysaccharide conjugated to Qβ virus-like particles.

Article

作者: Filippo Carboni ; Roberta Cozzi ; Giacomo Romagnoli ; Giovanna Tuscano ; Cristiana Balocchi ; Giada Buffi ; Margherita Bodini ; Cecilia Brettoni ; Fabiola Giusti ; Sara Marchi ; Giulia Brogioni ; Barbara Brogioni ; Paolo Cinelli ; Luigia Cappelli ; Chiara Nocciolini ; Silvia Senesi ; Claudia Facciotti ; Elisabetta Frigimelica ; Monica Fabbrini ; Daniela Stranges ; Silvana Savino ; Domenico Maione ; Benjamin Wizel ; Immaculada Margarit ; Maria Rosaria Romano

A maternal vaccine to protect neonates against Group B Streptococcus invasive infection is an unmet medical need. Such a vaccine should ideally be offered during the third trimester of pregnancy and induce strong immune responses after a single dose to maximize the time for placental transfer of protective antibodies. A key target antigen is the capsular polysaccharide, an anti-phagocytic virulence factor that elicits protective antibodies when conjugated to carrier proteins. The most prevalent polysaccharide serotypes conjugated to tetanus or diphtheria toxoids have been tested in humans as monovalent and multivalent formulations, showing excellent safety profiles and immunogenicity. However, responses were suboptimal in unprimed individuals after a single shot, the ideal schedule for vaccination during the third trimester of pregnancy. In the present study, we obtained and optimized self-assembling virus-like particles conjugated to Group B Streptococcus capsular polysaccharides. The resulting glyco-nanoparticles elicited strong immune responses in mice already after one immunization, providing pre-clinical proof of concept for a single-dose vaccine.

2022-11-01·American family physician

Adult Vaccination.

Article

作者: Grant M Greenberg ; Princy A Koshy ; Mary Jane S Hanson

Adult vaccination rates are low in the United States, despite clear benefits for reducing morbidity and mortality. Vaccine science is evolving rapidly, and family physicians must maintain familiarity with the most recent guidelines. The recommended adult immunization schedule is updated annually by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. All eligible patients should receive SARS-CoV-2 vaccines according to the current guidelines. Adults without contraindications should also receive an annual influenza vaccine. Hepatitis A vaccine is recommended for adults with specific risk factors. All pregnant patients, adults younger than 60 years, and those 60 years and older who have risk factors should receive a hepatitis B vaccine. A 15- or 20-valent pneumococcal conjugate vaccine is recommended for all patients who are 65 years and older. Patients who receive 15-valent pneumococcal conjugate vaccine should receive a dose of 23-valent pneumococcal polysaccharide vaccine one year later. Adults 19 to 64 years of age should receive a pneumococcal vaccination if they have medical risk factors. A single dose of measles, mumps, and rubella vaccine is recommended for adults without presumptive immunity, and additional doses are recommended for patients with HIV and postdelivery for pregnant patients who are not immune to rubella. A tetanus and diphtheria toxoids booster is recommended every 10 years. For pregnant patients and those in close contact with young infants, a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine should be administered. The human papillomavirus vaccine is recommended for all people through 26 years of age. Herpes zoster vaccine is indicated for all adults 50 years and older. .

项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的新闻（医药）

2022-06-28

·PRNewswire

United States Human Vaccines Markets, 2018-2021 & Forecast to 2028: Approval/launches of the New Vaccines / Rising Focus on Immunization Programs / Increasing Investments and Government Support

DUBLIN, June 28, 2022 /PRNewswire/ -- The "United States Human Vaccines Market Size, Share, Top 45 Human Vaccines Brand In-depth Analysis, Emerging Trends, Current Analysis, Growth, Demand, Opportunity, and Forecast 2022 - 2028" report has been added to ResearchAndMarkets.com's offering. Amid the COVID-19 crisis, the United States human vaccines market is poised to grow by US$ 31,517 million by 2028, accelerating at a CAGR of 7% during the forecast period. The prominent factors that are expected to contribute to the growth of the United States human vaccines market: Increased Disease Awareness Approval/launches of the New Vaccines Rising Focus on Immunization Programs Increasing Investments and Government Support for the Vaccines Development The report contains a deep analysis of the United States human vaccines market size in terms of value. The report provides a clear insight into current and future developments of the United States vaccines market. The report also explores the detailed analysis, insights of the top 45 vaccines market assessment in the United States from 2018 to 2021, and forecasts to 2028. The report also details the latest information about the vaccine's pricing analysis, insights, and trends, and the regulatory framework of the United States human vaccines market. After conducting thorough research on the historical and current growth parameters, the growth prospects of the United States human vaccines market are obtained with maximum precision. This new 2022 market report provides a holistic analysis of the entire United States human vaccines market. The report offers the most up-to-date industry data on the actual market situation and future outlook for the United States' human vaccines market. The report also tracks and analyses competitive developments, including collaboration, partnership deals, distribution, exclusive and licensing agreements, new vaccine developments, and R&D activities in the market. The report also delivers an in-depth analysis of evolving market trends, drivers, and restraining forces that influence the growth of the market. The report also analyses detailed profiles of innovative and leading players with information on business overview, companies' vaccines portfolio, promising vaccines in the clinical development, and the newest developments The report will serve as a source for a 360-degree analysis, thoroughly integrating different models. This Newest and Comprehensive the United States Human Vaccines Market Research Report 2022 Delivers: Comprehensive Research Methodology of the United States Human Vaccines Market Detailed and Extensive Market Overview with Key Analyst Insights Insights about Market Determinants that are Stimulating the United States Human Vaccines Market To Analyze the Historical Growth in the Market Size of the United States Human Vaccines Market from 2018 to 2021 To Estimate and Forecast the Market Size of the United States Human Vaccines Market from 2022 to 2028 and Growth Rate until 2028 Detailed Insights of the Top 45 Human Vaccines Market Value Used in the U.S. with Six Years Forecast An Insightful Analysis of the Top 45 Vaccines Brand Market Share and Y-o-Y Growth Rate Delivers All-inclusive Insights on the Latest Pricing Analysis, Insights, and Trends Delivers an In-Depth Analysis of Evolving Market Trends, Drivers, and Restraints of the United States Human Vaccines Market An Insightful Investigation has been done on Promising Human Vaccines in the Clinical Development Delivers Comprehensive Insights into the Regulatory Framework of the United States Human Vaccines Market Tracks Competitive Developments, Approaches, Recent Industry Developments, Partnership, Collaboration Deals, Distribution, Exclusive, and Licensing Agreement A Comprehensive List of the Leading Companies along with the Analysis of their Current Vaccines Portfolio, Promising Human Vaccines in the Clinical Development, and Present Development The Report Helps Answer the Following Questions: What is the current scenario of the United States human vaccines market? What is the total market size and forecast (until 2028) of the United States human vaccines market? How big is the United States human vaccines market? At what CAGR is the U.S. human vaccines market projected to grow in the forecast period (2022-2028)? What are the leading human vaccines? What are their revenue potentials to 2028? Which human vaccine brand provides the highest market share? What is the regulatory framework in the United States vaccines market? What are the key factors driving the United States human vaccines market? What are the key challenges of the United States human vaccines market? What are the major deals and agreement happenings in the United States human vaccines market? What are the United States human vaccines pricing trends and analysis? What are the various human vaccines available in the United States? Who are the topmost market players? What are their happenings, current developments, and scenarios? How is the market predicted to develop in the future? Key Topics Covered: 1. Executive Summary 2. United States Human Vaccines Market Size and Forecast (2018 - 2028) 3. United States Human Vaccines Brand Market Share and Y-o-Y Growth (%), 2018 - 2028 4. Key Market Growth Drivers and Challenges in the United States Human Vaccines Market 4.1 Key Market Growth Drivers 4.2 Key Market Challenges 5. United States Top 45 Human Vaccines Market Value Analysis, Insights and Forecasts, 2018 - 2028 5.1 Daptacel 5.2 Quadracel 5.3 Kinrix 5.4 Vaxelis 5.5 IPOL 5.6 Vaqta 5.7 Havrix 5.8 Twinrix 5.9 Engerix B 5.10 PedvaxHIB 5.11 ActHIB 5.12 Hiberix 5.13 MenQuadfi 5.14 Tenivac 5.15 Imovax 5.16 FluMist Quadrivalent 5.17 Prevnar 13 5.18 Gardasil 9 5.19 Fluzone Quadrivalent 5.20 Flublok 5.21 Flucelvax Quadrivalent 5.22 Afluria Quadrivalent 5.23 Fluad 5.24 Varivax 5.25 Menactra 5.26 Proquad 5.27 Pneumovax 23 5.28 Fluarix 5.29 FluLaval 5.30 M-M-R II 5.31 Adacel 5.32 Boostrix 5.33 Bexsero 5.34 Menveo 5.35 Trumenba 5.36 Shingrix 5.37 Pentacel 5.38 Recombivax HB 5.39 Rotateq 5.40 Rotarix 5.41 Pediarix 5.42 Infanrix 5.43 Heplisav-B 5.44 TDVAX 5.45 BioThrax 5.46 Other Vaccines 6. United States Human Vaccines Pricing Analysis, Insights and Trends 7. Regulatory Framework of the United States Human Vaccines Market 8. Major Deals and Agreement Happenings in the Human Vaccines Market 8.1 Merger & Acquisitions 8.2 Collaboration Deals 8.3 Licensing Agreement 8.4 Exclusive Agreement 8.5 Distribution Agreement 8.6 Partnership Deals 9. Leading Companies in the United States Human Vaccines Market 9.1 Sanofi Pasteur 9.1.1 Business Overview 9.1.2 Human Vaccines Portfolio 9.1.3 Promising Human Vaccines in the Clinical Development 9.1.4 Recent Development 9.3 Merck 9.4 Pfizer 9.5 Seqirus (CSL Limited) 9.6 AstraZeneca 9.7 Dynavax Technologies Corporation 9.8 Emergent BioSolutions Inc. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

疫苗并购

100 项与 Tetanus and diphtheria toxoids adsorbed(Sanofi) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

适应症	最高研发状态	国家/地区	公司
破伤风	批准上市	美国更多	Sanofi Pasteur Ltd. 更多
白喉	批准上市	美国更多	Sanofi Pasteur Ltd. 更多

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00601835 (CTgov)	临床4期	破伤风 \| 白喉	3,651	Tetanus (Canadian Td Vaccine Group)	鑰餘簾製遞簾鏇淵繭選(鑰願鑰願艱網蓋夢醖願) = 構簾齋糧襯鑰壓壓積積壓蓋選衊糧鏇積願衊積 (襯餘鏇顧蓋範廠鬱襯遞, 餘淵餘鹹壓鏇遞觸醖蓋 ~ 築構繭積積積廠願廠鑰) 更多	-	2011-02-18
				Tetanus (United States Td Vaccine Group)	鑰餘簾製遞簾鏇淵繭選(鑰願鑰願艱網蓋夢醖願) = 夢蓋鹹鏇糧艱遞艱範艱壓蓋選衊糧鏇積願衊積 (襯餘鏇顧蓋範廠鬱襯遞, 選製艱選顧選選衊糧壓 ~ 夢蓋鏇鏇鏇廠構觸範膚) 更多
NCT02193347 (CTgov)	临床1期	IDH1突变胶质瘤	24	Temozolomide+Tetanus-Diphtheria Toxoid (Td)+PEPIDH1M vaccine	壓襯網觸齋鹹鑰範夢齋(鹹鬱獵鏇餘齋網齋鬱醖) = 餘窪鏇醖築廠糧鏇願遞獵鑰艱糧鏇艱窪餘選鹽 (衊獵鏇繭鹹憲憲糧壓簾, 鬱艱齋憲顧鬱齋齋鹽憲 ~ 構願鏇衊廠網觸範願廠) 更多	-	2021-03-15
IMS2021	临床3期	复发性多发性骨髓瘤	417	CPT+TD	(積衊鏇醖遞製獵獵襯願) = 顧繭蓋壓鑰鏇範鬱願夢選構鹹網餘積顧憲膚遞 (憲築顧鏇鏇鬱鹹壓簾艱 )	积极	2021-09-08
				placebo+TD	(積衊鏇醖遞製獵獵襯願) = 憲壓鑰願選憲鑰餘蓋憲選構鹹網餘積顧憲膚遞 (憲築顧鏇鏇鬱鹹壓簾艱 )
NCT00457249 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	1,564	ADACEL (ADACEL® Vaccine Group)	(廠構製範蓋網蓋顧範衊) = 齋鹽鑰選鹹遞衊積襯顧簾鏇願鏇蓋獵醖襯衊廠 (製窪遞製淵獵鹽網衊醖, 廠鏇構築繭顧選繭齋鹹 ~ 構鹹獵願獵鑰築糧網壓) 更多	-	2012-10-19
				DECAVAC (DECAVAC® Vaccine Group)	(廠構製範蓋網蓋顧範衊) = 網鹽蓋餘簾觸衊選壓簾簾鏇願鏇蓋獵醖襯衊廠 (製窪遞製淵獵鹽網衊醖, 繭襯繭艱憲積製構鹽製 ~ 醖網鹽鹹積憲夢製夢構) 更多
NCT00835237 (CTgov)	临床3期	破伤风 \| 白喉 \| 百日咳	1,332	Boostrix® (Boostrix Group)	餘繭淵獵廠窪鬱構淵選(鏇夢衊鹽繭窪衊淵觸範) = 遞選廠廠範齋選願鑰蓋築淵齋鹽選憲夢繭鑰選 (顧製衊糧顧願蓋鏇遞製, 夢膚簾鬱餘範憲觸艱繭 ~ 艱觸築遞構淵餘簾鹽鹽) 更多	-	2010-08-05
				Decavac™ (Decavac Group)	餘繭淵獵廠窪鬱構淵選(鏇夢衊鹽繭窪衊淵觸範) = 餘糧選繭糧築膚鑰範糧築淵齋鹽選憲夢繭鑰選 (顧製衊糧顧願蓋鏇遞製, 製憲膚蓋鹽淵範廠鬱構 ~ 醖膚選鹽蓋顧鑰蓋衊選) 更多