Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

开始日期2018-10-04

申办/合作机构

Sanofi Pasteur SA

NCT03537508

/ Completed临床3期

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

开始日期2018-04-25

申办/合作机构

Sanofi Pasteur SA

CTRI/2012/08/002872

/ Active, not recruiting临床3期

Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants.

开始日期2012-09-03

申办/合作机构

Sanofi Healthcare India Pvt Ltd.

100 项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的临床结果

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100 项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的转化医学

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100 项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的专利（医药）

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项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的文献（医药）

2023-06-01·Vaccine

Immunogenicity of the pentavalent DTwP-HB-Hib vaccine (Shan-5) used in the Thai Expanded Program on Immunization compared to the hexavalent DTaP-HB-Hib-IPV and DTwP-HB-Hib (Quinvaxem) vaccines administered to infants at 2, 4, 6 months of age

Article

作者: Wanlapakorn, Nasamon ; Thongmee, Thanunrat ; Pruetarat, Napa ; Posuwan, Nawarat ; Sarawanangkoor, Nasiri ; Thatsanathorn, Thaksaporn ; Srimuan, Donchida ; Poovorawan, Yong ; Phanphanit, Kanchana

BACKGROUND:

The pentavalent DTwP-HB-Hib (Shan-5) vaccine was first introduced into the Thailand Expanded Program on Immunization (EPI) in 2019. The Shan-5 vaccine is administered to infants at 2, 4, and 6 months of age, after initial vaccination with monovalent hepatitis B (HepB) and Bacillus Calmette-Guérin (BCG) vaccines at birth. This study compared the immunogenicity of the HepB, diphtheria, tetanus, and Bordetella pertussis antigens incorporated in the EPI Shan-5 vaccine versus the optional pentavalent (DTwP-HB-Hib) Quinvaxem and hexavalent (DTaP-HB-Hib-IPV) Infanrix-hexa vaccine.

METHODS:

Three-dose Shan-5-vaccinated children were prospectively enrolled at the Regional Health Promotion Centre 5, Ratchaburi province, Thailand, between May 2020 and May 2021. Blood sampling was performed at months 7 and 18. The levels of HepB surface antibody (anti-HBs), anti-diphtheria toxoid (DT) IgG, anti-tetanus toxoid (TT) IgG, and anti-pertussis toxin (PT) IgG were evaluated using commercially available enzyme-linked immunoassays.

RESULTS:

Anti-HBs levels of ≥10 mIU/mL were achieved in 100 %, 99.2 %, and 99.2 % of infants in the Shan-5 EPI group, hexavalent group and Quinvaxem group one month after four dose immunization (at 0, 2, 4, 6 months of age), respectively. The geometric mean concentrations of the EPI Shan-5 and hexavalent groups were comparable but were higher than those of the Quinvaxem group. At one month after primary vaccination (month 7), infants in the Shan-5 EPI group had significantly higher levels of anti-DT IgG, anti-TT IgG, and anti-PT IgG than infants in the hexavalent and Quinvaxem groups.

CONCLUSIONS:

The immunogenicity of the HepB surface antigen in the EPI Shan-5 vaccine was similar to that achieved by the hexavalent vaccine, but was higher than that achieved by the Quinvaxem vaccine. The Shan-5 vaccine is highly immunogenic and generates robust antibody responses after primary immunization.

2021-12-01·Indian pediatrics4区 · 医学

Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study

4区 · 医学

Article

作者: Esteghamati, Abdoulreza ; Rajabnejad, Maryam ; Shirvani, Fariba ; Mohammadi, Sousan ; Zahraei, Seyed Mohsen ; Karimi, Abdollah ; Shamshiri, Ahmadreza ; Faghihian, Reyhaneh ; Faghihian, Eiman ; Azimi, Leila ; Tabatabaei, Sedigheh Rafiei

BACKGROUND:

The pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014.

OBJECTIVE:

To compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.).

DESIGN:

Randomized, phase III study.

PARTICIPANTS:

900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age.

INTERVENTION:

Infants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups.

OUTCOMES:

The antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary.

RESULTS:

All vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05).

CONCLUSIONS:

Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.

2016-04-02·Human vaccines & immunotherapeutics3区 · 医学

Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants

3区 · 医学

Article

作者: Kundu, Ritabrata ; Mathew, Leni G ; Ravi, Mandyam D ; Chhatwal, Jugesh ; Ravinuthala, Suresh ; Dhingra, Mandeep S ; Sil, Arijit ; Gupta, Madhu ; Gandhi, Dulari J ; Dhaded, Sangappa M ; Bavdekar, Sandeep B ; Dubey, Anand P ; Lalwani, Sanjay K ; Jayanth, Midde V ; Sharma, Shiv D

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.

项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的新闻（医药）

2023-11-04

·医药观澜

ORR达44.3%！迪哲医药JAK1抑制剂「戈利昔替尼」入选ASH年会口头报告

▎药明康德内容团队报道11月3日，迪哲医药宣布，该公司两款原研新药JAK1抑制剂戈利昔替尼和LYN/BTK双靶点抑制剂DZD8586在淋巴瘤领域的4项研究成果入选第65届美国血液学会（ASH）年会。其中，戈利昔替尼的全球多中心关键性临床试验（JACKPOT8的B部分）将以口头报告形式亮相。ASH年会是血液学领域的国际学术盛会，本届大会将于2023年12月9日-12日在美国圣地亚哥举行。JAK1抑制剂戈利昔替尼戈利昔替尼是迪哲医药开发的一款高选择性JAK1抑制剂，其首个适应症为复发/难治性外周T细胞淋巴瘤（r/r PTCL），正在中国、美国、韩国和澳大利亚等国家开展关键性临床试验。戈利昔替尼用于治疗r/r PTCL的申请已于2022年2月获美国FDA授予快速通道资格。2023年9月，中国国家药监局药品审评中心（CDE）已将戈利昔替尼的上市申请纳入优先审评，用于r/r PTCL的治疗。本次ASH大会上，戈利昔替尼共有2项相关研究入选。其中，戈利昔替尼针对r/r PTCL的全球多中心关键性注册临床试验（JACKPOT8的B部分）将在2023 ASH大会口头报告环节公布。试验数据显示，该研究达到主要研究终点，由独立影像评估委员会（IRC）评估的客观缓解率（ORR）高达44.3%，与日前在2023 ASCO口头汇报的初步分析结果一致，高于现有治疗方案近2倍，安全且耐受性良好，有望破局r/r PTCL治疗困境。PTCL患者在接受一线标准治疗后，约40%的CR患者和80%的部分缓解（PR）患者在初次肿瘤缓解后的2年内会出现疾病复发或进展，患者预后极差，缺乏标准的维持治疗。一项2期临床试验（JACKPOT26）结果显示，PTCL患者接受一线治疗首次缓解后，戈利昔替尼作为维持/巩固治疗安全有效。该研究的最新疗效和安全性数据也将在大会期间以壁报形式公布。LYN/BTK双靶点抑制剂DZD8586DZD8586是一款具有完全穿透血脑屏障潜力的全新非共价LYN/BTK双靶点抑制剂，针对的适应症为B细胞非霍奇金淋巴瘤（B-NHL）。DZD8586的临床前研究和1期临床研究汇总分析入选大会。现有治疗B-NHL的药物中，BTK抑制剂虽表现出临床疗效，但耐药问题仍是临床面临的严峻挑战。耐药机制主要有BTK通路依赖和非BTK通路依赖两种，目前尚无可以同时应对这两种耐药机制的药物，亟需一款安全、有效的复发或难治性（r/r）B-NHL治疗药物。临床前研究表明，DZD8586可同时阻断BTK依赖性和非依赖性BCR信号通路，有效抑制多种B-NHL亚型细胞的生长，并具备完全穿透血脑屏障的能力，有望克服现有BTK抑制剂的耐药问题。目前，DZD8586正在全球开展两项针对r/r B-NHL的1期临床试验（TAI-SHAN1和TAI-SHAN5）。研究初步结果提示，该候选药具有令人鼓舞的药代动力学（PK）特征、安全性和抗肿瘤活性。来自这两项研究的最新疗效和安全性汇总分析结果也将在本次大会全球首发。参考资料：[1]戈利昔替尼斩获ASH口头报告！DZD8586全球首发！迪哲医药将携4项研究成果耀动全球血液学顶级盛会. Retrieved Nov 3 , 2023, from https://mp.weixin.qq.com/s/vtPBoEETzX9ot6XzkPXyZg本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

ASCO会议优先审批临床结果临床1期临床2期

2023-11-03

·美通社

戈利昔替尼斩获ASH口头报告！DZD8586全球首发！迪哲医药将携4项研究成果耀动全球血液学顶级盛会

上海2023年11月3日 /美通社/ -- 美国血液学会（ASH）官网宣布，迪哲医药（股票代码：688192.SH）两款原研新药戈利昔替尼和DZD8586在淋巴瘤领域的4项研究成果入选第65届ASH年会。其中，戈利昔替尼的全球多中心关键性临床试验（JACKPOT8的B部分）将以口头报告形式重磅亮相。 ASH年会是血液学领域规模最大的国际学术盛会，大会每年展示的前沿研究代表了全球血液学领域的最高学术水平。本届大会将于2023年12月9日-12日在美国圣地亚哥举行。戈利昔替尼：淋巴瘤领域全球首款 JAK1 抑制剂戈利昔替尼是淋巴瘤领域全球首个且迄今为止唯一处于NDA申报阶段的高选择性JAK1抑制剂，首个申报适应症用于治疗复发/难治性（r/r ）外周T细胞淋巴瘤(PTCL)。本次大会，戈利昔替尼共有2项相关研究入选。戈利昔替尼针对r/r PTCL的全球多中心关键性注册临床试验（JACKPOT8的B部分）达到主要研究终点，独立影像评估委员会（IRC）评估的客观缓解率（ORR）高达44.3%，与日前在2023 ASCO口头汇报的初步分析结果一致，高于现有治疗方案近2倍，安全且耐受性良好，有望破局r/r PTCL治疗困境。详细生存数据将在2023 ASH大会口头报告环节公布。 PTCL患者在接受一线标准治疗后，约40%的CR患者和80%的部分缓解（PR）患者在初次肿瘤缓解后的2年内会出现疾病复发或进展，患者预后极差，缺乏标准的维持治疗。一项II期临床试验（JACKPOT26）结果显示，PTCL患者接受一线治疗首次缓解后，戈利昔替尼作为维持/巩固治疗安全有效。该研究的最新疗效和安全性数据将在大会期间公布。 DZD8586 ：全球首创 LYN/BTK 双靶点抑制剂 DZD8586是一款能完全穿透血脑屏障的全新非共价LYN/BTK双靶点抑制剂，针对B细胞非霍奇金淋巴瘤（B-NHL）。DZD8586的临床前研究和I期临床研究汇总分析入选大会。现有治疗B-NHL的药物中，BTK抑制剂虽表现出临床疗效，但耐药问题仍是临床面临的严峻挑战。耐药机制主要有BTK通路依赖和非BTK通路依赖两种，目前尚无可以同时应对这两种耐药机制的药物，亟需一款安全、有效的复发或难治性（r/r）B-NHL治疗药物。临床前研究表明，DZD8586可同时阻断BTK依赖性和非依赖性BCR信号通路，有效抑制多种B-NHL亚型细胞的生长，并具备完全穿透血脑屏障的能力，有望克服现有BTK抑制剂的耐药问题。强效抑制LYN和BTK靶点，同时具有良好的选择性针对C481S 突变BTK，以及导致Pirtobrutinib（LOXO-305）耐药的 BTK 突变，均显示出显著的抑制作用可有效抑制弥漫性大 B 细胞淋巴瘤（DLBCL）细胞的增殖在动物模型中，DZD8586的K puu,CSF （脑脊液与血浆中游离药物浓度的比值）大于1，证实其能完全穿透血脑屏障目前，DZD8586正在全球开展两项针对r/r B-NHL的Ⅰ期临床试验（TAI-SHAN1和TAI-SHAN5），研究初步结果提示令人鼓舞的药代动力学 (PK) 特征、安全性和抗肿瘤活性。来自这两项研究的最新疗效和安全性汇总分析结果，将在本次大会全球首发。口头报告摘要标题：戈利昔替尼治疗难治性或复发性外周T细胞淋巴瘤：国际多中心关键性研究（JACKPOT8）结果的完整分析 Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8) 汇报人：宋玉琴北京大学肿瘤医院摘要编号：305 报告时间：12/9/2023，5pm（太平洋标准时间PST）报告地点：Hall B 壁报展示摘要标题：戈利昔替尼，一款高选择性JAK1抑制剂，用于外周T细胞淋巴瘤患者一线系统性治疗后的维持治疗II期研究 (JACKPOT26) Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26) 汇报人：金洁浙江大学医学院附属一院摘要编号：4430 报告时间：12/11/2023，6pm-8pm（太平洋标准时间PST）报告地点：Hall G-H 摘要标题：DZD8586，一款能完全穿透血脑屏障的非共价LYN和BTK双靶点抑制剂，用于治疗B细胞非霍奇金淋巴瘤（B-NHL）的临床前研究 Preclinical Study of DZD8586 , a Non-Covalent LYN/BTK Dual Inhibitor with Excellent BBB Penetration, for the Treatment of B-Cell Non-Hodgkin Lymphoma (B-NHL) 汇报人：白瑜迪哲医药摘要编号：2822 报告时间：12/10/2023，6pm-8pm（太平洋标准时间PST）报告地点：Hall G-H 摘要标题：DZD8586，一款能穿透血脑屏障的LYN/BTK双靶点抑制剂，用于B细胞非霍奇金淋巴瘤（B-NHL）患者I期临床研究的首次汇报 First Report of Phase 1 Studies of DZD8586 , a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL) 汇报人：宋玉琴北京大学肿瘤医院摘要编号：4465 报告时间：12/11/2023，6pm-8pm（太平洋标准时间PST）报告地点：Hall G-H 关于戈利昔替尼戈利昔替尼是T细胞淋巴瘤领域全球首个且迄今为止唯一处于全球注册临床阶段的高选择性JAK1抑制剂，首个适应症为复发/难治性外周T细胞淋巴瘤（r/r PTCL），正在中国、美国、韩国和澳大利亚等国家开展关键性临床试验。截至2023年2月16日，国际多中心关键临床研究（JACKPOT8 的B部分）中，戈利昔替尼单药显示出强效持久的抗肿瘤活性，客观缓解率（ORR）达44.3%，且其中一半以上肿瘤缓解的受试者达到了完全缓解（CR），CR率达23.9%。最长治疗持续时间达到18 个月。戈利昔替尼用于治疗r/r PTCL，于2022年2月获美国食品药品监督管理局（FDA）“快速通道认定”（Fast Track Designation），新药上市申请于2023年9月获药品监督管理局（NMPA）新药审评中心（CDE）纳入优先审评。戈利昔替尼I期临床试验（JACKPOT8的A部分）研究成果发表于国际顶级期刊《肿瘤学年鉴》（Annals of Oncology），影响因子：51.8。关于DZD8586 DZD8586是公司自主研发的一款可完全穿透血脑屏障的全新非共价LYN/BTK双靶点抑制剂。可同时作用于BTK依赖性和非依赖性BCR信号通路，有效抑制多种B细胞非霍奇金淋巴瘤（B-NHL）细胞的生长。截至 2022 年末，DZD8586已完成在美国开展的健康受试者 I 期临床试验，同时针对复发难治性（r/r） B 细胞 B-NHL的全球多中心I/II临床试验正在积极推进中，初步结果提示DZD8586 在 r/r B-NHL患者中展示出令人鼓舞的药代动力学 (PK) 特征、安全性和抗肿瘤活性。关于迪哲医药迪哲医药（股票代码：688192）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了五款具备全球竞争力的产品管线，两大领先产品处于全球关键性临床试验阶段，其中一款已获批上市。欲了解更多信息，请关注微信公众号：迪哲Dizal，或访问 www.dizalpharma.com 。前瞻性声明本新闻所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”、“有望”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员概不承担（a）更正或更新本网站所载前瞻性表述的任何义务；及（b）若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。更多信息，敬请联系投资者关系： ir@dizalpharma.com 商务合作： bd@dizalpharma.com

ASCO会议临床结果临床2期临床1期临床终止

2023-05-12

·Firstwordpharma

GSK touts early Phase III data for 5-in-1 meningococcal vaccine candidate

GSK on Friday reported preliminary data from a Phase III trial of its MenABCWY vaccine candidate, which targets the five Neisseria meningitidis serogroups that account for nearly all invasive meningococcal disease cases in most of the world. If approved, the jab could provide "the broadest coverage against the most prevalent meningococcal serogroups and could lead to a simplified immunisation schedule," the company said.Findings from the trial, which began in 2020, were unveiled at the European Society for Paediatric Infectious Diseases (ESPID) conference. "These preliminary data further unlock the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y," remarked chief scientific officer Tony Wood, adding "it's particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB (meningococcal group B) strains to date."The randomised study enrolled 3657 children and young adults ranging in age from 10 to 25 years old, with MenABCWY administered as two doses given six months apart. There are a total of 11 primary endpoints, five for MenABCWY and six for Bexsero, GSK's already licensed MenB vaccine. Bexsero is used as the comparator for the MenB immune responses induced by MenABCWY in the study. The trial is also serving as the confirmatory trial for Bexsero in the US.GSK said its pentavalent vaccine demonstrated non-inferiority in primary endpoints for the N. meningitidis serogroups A, B, C, W and Y, compared to two doses of Bexsero and one dose of its Menveo jab, which prevents invasive meningococcal disease caused by serogroups A, C, Y and W-135. The MenABCWY jab was also generally well tolerated, with a safety profile consistent with Bexsero and Menveo.Pfizer rival jab under reviewIn a separate confirmatory arm of the trial, GSK said MenABCWY showed immunological effectiveness against a panel of 110 diverse MenB invasive strains account for 95% of those circulating in the US. The company indicated it is working with regulatory agencies to review the full Phase III dataset. Detailed results will be submitted to a peer-reviewed scientific journal later this year.Currently, Pfizer markets the MenB vaccine Trumenba, while Sanofi's portfolio includes the MenACWY vaccines Menactra and MenQuadfi. Late last year, the FDA agreed to review a filing seeking approval of Pfizer's pentavalent MenABCWY vaccine candidate for use in young people, with a decision due this October. That application is based on a Phase III trial involving 2431 healthy adolescents and young adults that met all of its primary and secondary endpoints.

疫苗临床3期临床结果优先审批信使RNA

100 项与 DTwP-HebB-Hib vaccine(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA11	-

研发状态

批准上市

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	印度	Sanofi	2014-03-01
嗜血杆菌感染	印度	Sanofi	2014-03-01
乙型肝炎	印度	Sanofi	2014-03-01
破伤风	印度	Sanofi	2014-03-01
百日咳	印度	Sanofi	2014-03-01

未上市

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	泰国	Sanofi Pasteur SA	2020-06-28
脊髓灰质炎	临床3期	泰国	Sanofi Pasteur SA	2020-06-28
轮状病毒感染	临床3期	泰国	Sanofi Pasteur SA	2020-06-28