Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study

This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine. The study focuses on participants from a community with known prior PFNA exposure through contaminated drinking water. The main question it aims to answer is:
* Does exposure to PFNA weaken the body's initial immune response, leading to lower levels of protective antibodies after vaccination?
Participants will:
* Receive Tetanus and Diphtheria (Td) booster vaccination
* Visit the study office 7 times over a 30-day period
* Have blood and saliva collected at each study visit

开始日期2024-11-04

申办/合作机构

Rutgers State University of New Jersey

NCT05077137

/ Recruiting临床1期IIT

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

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.

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

Iranian Journal of Pharmaceutical Research

A Preliminary Study to Evaluate the Immune Response to a Booster Dose of the Adult Tetanus-Diphtheria Vaccine (Td) Available in Iran

Article

作者: Baghaei, Masoumeh ; Niazi, Mohammad-Javad ; Noorian, Sepideh ; Soltany-Rezaee-Rad, Mohammad ; Mottaghi-Dastjerdi, Negar ; Montazeri, Hamed

Background: Despite the availability of tetanus-diphtheria (TD) vaccines in Iran, the seroconversion rate of these products as a booster dose is unknown. Objectives: This study evaluates the seroconversion rate of the Iranian Td vaccine in adults who have not been vaccinated in the past decade. Methods: In this study, 20 adult volunteers aged 18 to 60 who had not received the Td vaccine in the past decade received a booster dose of the Iranian Td vaccine. Twenty-eight days after vaccination, the seroconversion rate was evaluated using the ELISA method. Vaccine adverse events were monitored at three time points after vaccination. Results: Seroconversion rates with the Iranian Td vaccine boosters were 75% and 90%, respectively, based on a 4-fold increase in anti-tetanus toxoid antibody titers and a 2- and 4-fold combination. Significant associations were found between the demographic data, specifically female gender and age 43 years and older, with seroconversion rates. Injection-site pain was the most common adverse reaction, with a frequency of 35%. No adverse events were reported between one week and one month after vaccination. Conclusions: Results showed that a booster dose of the Iranian Td vaccine produced a protective titer (> 0.1 IU/mL) and a long-term protective titer (> 1.0 IU/mL) in 100% of participants. The seroconversion rate of the Iranian Td vaccine was comparable to other common tetanus vaccines, including Tenivac®, Adacel®, Infanrix®, Tetavax®, and Vacteta®. The proportion of suitable candidates for plasma donation, based on minimum (2 IU/mL) and maximum (10 IU/mL) anti-tetanus toxoid antibody titers, was 100% and 45%, respectively.

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

2026-05-04

·生物狗科普

IgA肾病专题（二）斯贝利单抗I期临床研究设计解析

从本期开始，我们将为大家介绍斯贝利单抗（Sibeprenlimab，研发代号VIS649）的临床研究设计与开发策略。作为一款靶向APRIL的人源化IgG2单克隆抗体，该产品在IgA肾病的治疗领域备受关注。本期，我们先从其I期临床研究说起，看看这款产品的I期临床研究设计。考虑到有不少新关注公众号的读者，在正式展开这款产品的研究解读前，我想先说明一下我个人对上市药物临床设计与开发策略的解读习惯。上市药物的临床资料通常较多，但由于我个人时间有限，通常会分阶段拆解分析。例如斯贝利单抗（VIS649）共开展了五项临床研究，但本期仅围绕I期研究展开，我所参考的资料也仅为I期相关数据。因此，基于I期结果得出的后续开发策略判断，可能会与后期结合III期数据后的分析存在一定的差异，也希望小伙伴们能够理解。那么回到这款产品本身。VIS649的上市前临床研究遵循了经典的I、II、III期路径。由于药物本身毒性较低，其I期临床与常规非肿瘤产品一致，在健康人群中开展药代动力学（PK）探索。本品在开发过程中有一个比较特殊且值得关注的点，早期阶段进行了两种给药方式（皮下注射和静脉输注）的PK探索，II期研究选用了静脉输注，而III期又选择了皮下注射。这种给药途径的变化在临床研究早期比较常见，但是II期给药方式与III期不一致还是相对比较少见的。给药方式的变化理论上也体现了药企在不同阶段对疗效、安全性、等多方面的综合权衡。图 1 VIS649开展临床研究 VIS649-101基本研究设计和风险获益评估本期计划介绍的101研究是一项I期、随机、安慰剂对照、单剂量递增、首次人体临床研究。VIS649选用的给药方式是静脉注射，在健康受试者中评估安全性、耐受性、PK、药效学（PD）和免疫原性特征。研究分为五个连续的剂量组，其中组1至组4给药剂量分别为0.5、2.0、6.0和12.0 mg/kg，每组入组9例受试者（7例活性药物，其中4例日本人；2例安慰剂，其中1例日本人，初步评估安全性、PK、PD与人种的关系）。每个剂量组设置了哨兵受试者，即先为1例试验药物组与1例安慰剂组受试者给药，观察至少24小时确认无安全性风险后，再为组内剩余受试者给药。组5则专门探索6.0mg/kg剂量给药后接种TENIVAC破伤风-白喉疫苗对VIS649安全性以及PK/PD 的影响。该组别招募15例非日本受试者，按10:5的比例随机分配至活性药物联合疫苗组或安慰剂联合疫苗组，受试者于第1天接受试验用药品，第28天接种TENIVAC疫苗。整个研究的访视周期持续20至28周（5至7个月），包含4周筛选期，受试者给药后需住院观察2至3天，常规安全性随访至第16周（第112天），后续还会在第20周和24周开展延长随访，若受试者免疫球蛋白未恢复至基线水平或出现其他需延长访视的信号（如抗药抗体），随访周期还会进一步延长。图 2 101研究流程图 VIS649是一种人源化免疫球蛋白G2（IgG2）单克隆抗体，专门结合并阻断一种叫做APRIL的B细胞生长因子，因此对APRIL的抑制会影响B细胞产生的一些免疫球蛋白水平，如IgA、IgG等。非临床研究发现，VIS649对动物体内IgM的影响较小，对IgA和IgG均有一定降低作用，且对IgA的抑制效果最为显著，但APRIL抑制无法完全阻断IgA生成，且血清IgA的抑制程度呈可逆性，恢复时间与剂量存在明显的剂量反应关系。基于临床前研究结果，预计VIS649治疗可降低人体IgA水平，重复给药下最大降幅约为基线的75%。但鉴于本研究是在健康受试者中开展的单次给药研究，不太可能达到这种程度的抑制，但预计在较高剂量组别中，受试者用药后IgA水平会降低至基线以下，且效应可能持续数周。那么对于这种全新机制的药物，在首次临床研究的时候应该如何基于非临床数据评估临床上的潜在风险呢？在这项研究中主要是通过临床上与免疫球蛋白降低有关的疾病状态进行评估的。结合前述非临床研究结果可知，VIS649 预计会对人体 IgA 水平造成显著影响。而 IgA 水平下降所带来的潜在风险，可参照临床选择性 IgA 缺乏症的病症表现进行预估。该类患者通常易出现反复鼻窦肺部感染、过敏反应、自身免疫病变以及胃肠道菌群紊乱等问题。但本研究中发生上述并发症的风险整体偏低，原因主要有两点：其一，本研究为单次给药设计，药物对 IgA 水平的影响在理论上具有一过性；其二，临床中选择性 IgA 缺乏症患者，往往同时合并 T 细胞功能异常、普通变异型免疫缺陷病等其他免疫损伤，而本研究入组受试者均为健康人群，无基础免疫异常问题。基于非临床研究，预计VIS649治疗对人体IgG水平也有中度影响，降幅约为基线水平的40%。IgG缺乏的潜在风险可参考常见变异型免疫缺陷病（也称为获得性低丙种球蛋白血症），这类患者总IgG水平通常低于250 mg/dL，常发生复发性中耳炎、慢性鼻窦炎和复发性肺炎，伴有支气管扩张，纵向研究表明其淋巴瘤和自身免疫性疾病的发生率很高。同样，由于本研究预期IgG水平的降低是适度且短暂的，因此这些并发症的风险被认为非常低。通过这种角度分析，能够更好地帮助大家体会全新机制产品首次临床研究中单次给药评估安全性的重要意义，以及安全性评估需要关注哪些要点。在梳理完 VIS649 的潜在用药风险后，我们再回忆一下本研究在分组设计上的特殊之处——疫苗联用组的设置。事实上，在该研究最初的临床研究方案中并没有该组别，疫苗联用的设计是在研究推进过程中通过方案修订补充的，这一后续增设的设计，具备极强的科学合理性与临床实用价值。 IgA 肾病往往需要长期乃至终身干预治疗，因此在研发的过程其实需要考虑，若患者长期抑制 APRIL 靶点是否会影响患者正常的体液免疫过程，是否会让患者面临较高的严重感染风险，以及对于这类潜在风险应该如何预防。在临床常规诊疗中，对于存在免疫功能缺陷的人群，普遍建议及时接种灭活疫苗，提前防范感染事件。很多免疫抑制剂产品，如补体抑制剂，在说明书及诊疗指南中也会建议患者在使用药品前以及在用药过程中进行疫苗的接种。由此便衍生出一个关键问题：如果应用 VIS649 干预后，是否有影响对疫苗的免疫应答？提前在健康受试者中开展疫苗联用探索，能够在药物推进至患者人群研究之前，率先建立重要的安全性边界，同时也可为后续患者临床试验、以及药物上市后人群的疫苗接种策略，提供严谨的循证依据与临床指导。因此这项研究在后期的设计中增加了一个破伤风-白喉疫苗接种，以评估联用疫苗的安全性和对疫苗疗效的影响。破伤风和白喉类毒素是临床广泛使用的疫苗，免疫应答机制相对明确，且基于美国的疫苗接种建议，该类疫苗应在7岁及以上人群主动免疫，每10年进行一次加强接种，因此即使对受试者而言，疫苗接种本身是可以获益的。图 3 CDC疫苗接种建议基于上文的描述，在这项研究中，药企将IgA、IgG、IgM以及全血循环淋巴细胞亚群的变化作为PD指标进行检测，以进一步评估产品对机体的免疫细胞影响。出于安全性考虑，免疫球蛋白在临床研究中的持续降低也会作为一个研究暂停标准。图 4 研究暂停标准设置 VIS649-101人群选择与其他设置本研究的关键入选人群为18至55岁、BMI在18至32kg/m²之间的健康受试者；关键排除标准除了1期研究研究常规对可能影响PK参数的药物、饮食及生活方式限制（如饮酒、吸烟、咖啡因、黄嘌呤、葡萄柚摄入等），关键的排除因素多与疫苗接种及受试者免疫状态直接相关。与疫苗接种相关的排除标准包括：既往接受TENIVAC®，或者任何含有破伤风、白喉成分的疫苗时，发生过严重的过敏反应（如过敏性休克）既往接种破伤风疫苗时，发生过Arthus反应【一种特殊的严重局部反应，一般表现为注射部位剧烈疼痛、严重肿胀、皮肤变硬、水肿甚至淤青，通常发生在通常注射后的4-12小时】既往有格林巴利综合征（Guillain-Barré syndrome, GBS）病史【我们在以前的介绍中也提到过，这是疫苗接种后可能发生的罕见但严重的不良反应，可参考《FDA联合CDC开展调查，获批不到一年的RSV疫苗可能有潜在安全性风险》】既往5年内没有接受过破伤风疫苗与受试者免疫状态相关的排除标准包括：受试者有蛋白尿病史或现存蛋白尿、慢性肾脏病、需要免疫抑制治疗（包括全身性类固醇）的疾病，或因任何其他原因被视为免疫抑制状态；既往有伴有全身性荨麻疹、血管性水肿或过敏性休克的严重过敏反应史；已知的低丙种球蛋白血症疾病（即普通变异型免疫缺陷病、X连锁无丙种球蛋白血症、选择性IgA缺乏症、选择性IgM缺乏症）；既往存在潜伏感染（如结核病）病史，或任何需要住院或接受抗病毒或抗生素治疗的感染，或在给予研究药物前30天内接种过疫苗；伴随使用上市或研究性的全身性免疫抑制剂或免疫调节药物（例如皮质类固醇、甲氨蝶呤、硫唑嘌呤等和/或生物制剂），并且需要在筛选前进行洗脱期（30天或5个半衰期，以较长者为准之所以设置上述严格的免疫相关排除标准，核心原因在于VIS649非临床研究已证实对 IgG、IgA 存在抑制作用，若受试者存在免疫相关疾病或近期使用免疫抑制剂，会进一步加重免疫系统影响，不仅影响PD指标的判定还可能对受试者安全性有比较严重的影响。另一方面，我们可以看到研究对全身性荨麻疹、血管性水肿或过敏性休克等严重过敏反应史的限制，这不仅是基于产品对免疫系统的潜在影响以及常规的过敏反应排除，还与单克隆抗体作为治疗性蛋白的特性相关。根据FDA发布的《Guidance for industry immunogenicity assessment for therapeutic protein products》，治疗性蛋白引发的免疫反应可能影响患者安全与药物疗效。基于免疫学的不良事件，如过敏性休克、细胞因子释放综合征以及介导关键功能的内源性蛋白的交叉反应性中和，最终可能导致终止原本可能有效的治疗性蛋白产品的开发。因此治疗性蛋白产品临床研究中抗药抗体的检测和免疫相关不良事件需要被重点关注，对这类受试者的排除也能尽可能保障入组受试者的安全性。值得一提的是，国内研发的泰它西普作为BLyS/APRIL双靶点融合蛋白抑制剂，在I期临床研究的入选排除标准中设置了一条与VIS649不同的标准：“有异常出血或凝血障碍的病史（例如：易淤青、牙龈出血、拔牙后出血时间较长、关节出血;最近一年因月出血、产后出血、维生素K缺乏、由获得性凝血因子抗体引起的出血性疾病、外伤或术后出血等引起的贫血”。这一原因可能与APRIL蛋白能促进造血干细胞的增殖和分化，因此理论上可能会对受试者血小板数量和凝血功能有影响。所以我们可以看出，同一靶点、不同药物的临床研究入选排除标准设置可能会有细微的差别，这些差别的考量可能会基于药物作用机制、非临床安全性结果、甚至药企的计划研发成本等多重因素。通常而言，I期研究的入组人群确认更侧重产品机制、非临床的安全性结果等，而II、III期研究则会结合早期临床安全性数据与产品上市后的目标人群特征进一步调整。接下来我们继续看一下研究对应设置的特别关注不良事件（AESI），这一设置也与面前提到的免疫及治疗性蛋白产品相关的安全性有关，包括：输注反应：发热、寒战、恶心、呕吐、疼痛、头痛、头晕、呼吸急促、支气管痉挛、低血压、高血压、瘙痒、皮疹、荨麻疹、血管性水肿、腹泻、心动过速和胸痛迟发性过敏反应：血清病（即荨麻疹、发热、全身腺体肿大、关节痛）一般情况：注射部位反应任何记录在案的感染由于1期研究以PK探索为核心，需严格控制可能干扰药物代谢的生活习惯，在这项研究中包括：尼古丁：在研究药物给药前的3个月内至整个研究期间，禁止使用含尼古丁的产品（包括但不限于香烟、雪茄、咀嚼烟草或鼻烟）。咖啡因：禁止每天摄入超过500 mg的咖啡因或含黄嘌呤的产品（例如：咖啡、茶、软饮料、能量饮料或巧克力）。同时受试者必须从入住临床研究中心前48小时开始，直到研究结束完全戒除含咖啡因或黄嘌呤产品的摄入。酒精：受试者给药前每周（7天）饮酒量不得超过21个单位。受试者必须从入住临床研究中心前48小时开始，直到研究结束完全戒酒。葡萄柚：受试者从入住临床研究中心前48小时开始，直到研究结束，禁止食用葡萄柚类食物或饮料，以及含塞维利亚橙（如橙子果酱）的食物或饮料。由于篇幅的原因本期仅介绍了这项研究的设计，对于研究结果的解读我们在下一期会继续为大家介绍，我们下期见。参考文献 Elíasdóttir S, Khramova A, Saeed A, et al. Serum levels of galactose-deficient IgA are elevated in patients with IgA nephropathy but do not correlate to disease activity or progression. BMC Nephrol. 2023;24(1):160. Published 2023 Jun 7. doi:10.1186/s12882-023-03198-y Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. Published 2022 Feb 8. doi:10.1016/j.ekir.2022.01.1073 图片转自Pixabay

临床2期疫苗临床1期临床结果临床3期

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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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AM51	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
白喉	美国	Sanofi-Aventis Canada, Inc.	2000-02-24
白喉	美国	Sanofi Pasteur, Inc.	2000-02-24
破伤风	美国	Sanofi Pasteur, Inc.	2000-02-24
破伤风	美国	Sanofi-Aventis Canada, Inc.	2000-02-24

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临床结果

适应症

分期

评价

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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


NCT06588530 (CTgov)	临床4期	白喉 \| 接种疫苗 \| 破伤风	20	PFNA (High PFNA Exposure)	鬱積積蓋膚夢觸觸鹽遞(鑰艱膚鬱顧網簾蓋鑰襯) = 鬱鹽窪鏇選餘鑰齋鏇壓醖繭觸夢憲廠築鹽鹹餘 (觸顧衊艱願觸廠觸憲蓋, 1.83) 更多	-	2025-12-30
				PFNA (Low PFNA Exposure)	鬱積積蓋膚夢觸觸鹽遞(鑰艱膚鬱顧網簾蓋鑰襯) = 獵蓋選餘鬱繭繭築製衊醖繭觸夢憲廠築鹽鹹餘 (觸顧衊艱願觸廠觸憲蓋, 1.91) 更多
NCT00601835 (CTgov)	临床4期	白喉 \| 破伤风	3,651	Tetanus and Diphtheria Toxoids Adsorbed (+Td) Vaccine (Canadian Td Vaccine Group)	膚膚廠觸鑰構衊壓鬱艱 = 鏇膚鏇鑰壓鹽憲襯繭選衊壓糧衊衊糧憲顧廠鬱 (蓋願構築積膚壓觸構淵, 廠鑰窪鏇網憲選範糧獵 ~ 蓋鑰簾鏇顧製選選積糧) 更多	-	2011-02-18
				Tetanus and Diphtheria Toxoids Adsorbed (+Td) Vaccine (United States Td Vaccine Group)	膚膚廠觸鑰構衊壓鬱艱 = 壓艱餘網繭夢鏇顧鹽蓋衊壓糧衊衊糧憲顧廠鬱 (蓋願構築積膚壓觸構淵, 鏇壓選壓壓顧簾選齋蓋 ~ 憲壓鏇繭壓衊齋觸衊觸) 更多