A Phase III Randomised Open label double arm, multicentric study to Evaluate the Immunogenisity and safety of Meningococcal Polysaccharide Vaccine group ACYW 135 in 2 - 55 years of Indian subjects, compared with MENO-MUNE:Prospective study

开始日期2016-12-20

申办/合作机构-

ISRCTN78147026

/ Completed临床2期

A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age

开始日期2006-08-28

申办/合作机构

Serum Institute of India Pvt Ltd.

[+1]

NCT01661751

/ Completed临床3期

Phase III Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

开始日期2006-05-01

申办/合作机构

华兰生物工程股份有限公司

100 项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的临床结果

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100 项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的转化医学

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100 项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的专利（医药）

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项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的文献（医药）

2020-08-01·Journal of Microbiology, Immunology and Infection

Disseminated gonococcal infection in a patient with paroxysmal nocturnal hemoglobinuria having received ravulizumab and meningococcal vaccine

Letter

作者: Lin, Yu-Jen ; Yu, Zhi-Ye ; Tsai, Ming-Jui ; Chou, Sheng-Chieh ; Liu, Wang-Da ; Hung, Chien-Ching

Here we present a 24-yr-old man with PNH, who had received ravulizumab, a complement component 5 (C5) inhibitor, for three years, with subsequent development of disseminated gonococcal infection.He presented with acute onset of fever up to 41.2 C three days prior to this admission, along with severe headaches, sore throat, rhinorrhea, and mild exertional dyspnea. Arthralgias of the right knee and left ankle were also reported.To prevent meningococcal infection, he had received meningococcal ACYW-135 vaccine at the time when treatment with ravulizumab was initiated.Blood examinations revealed anemia (10.7 g/dL) and a normal white blood-cell count (6.1 103/mL).Other biochem. tests were normal except for an elevated C-reactive protein level (12.9 mg/dL).Cerebrospinal fluid anal. revealed no pleocytosis and normal glucose and lactate dehydrogenase levels.Our case highlights that gonococcal infection should be included in the etiol. of disseminated infections in patients with PNH who receive terminal complement monoclonal antibody and have unprotected sex.Because of its overlapping symptoms with acute retroviral syndrome,6 counseling for HIV testing and prevention should be provided for individuals with unprotected sex and sexually transmitted infections.

2009-09-01·International Journal of Nursing Studies1区 · 医学

Attitudes of nurses toward current and proposed vaccines for public programs: A questionnaire survey

1区 · 医学

Article

作者: Nicole Boulianne ; Eve Dubé ; Manale Ouakki ; Chantal Sauvageau ; Vladimir Gilca

BACKGROUNDIn most countries registered nurses play a key role in vaccination. The number of recommended childhood vaccines has increased and several other new vaccines are in the implementation phase or are being considered for public programs. Little is known about nurses' perceived usefulness of recommended vaccines and no recent study has assessed nurses' opinions regarding new candidate vaccines for the public programs.OBJECTIVESThe main purpose of this survey was to assess nurses' opinions regarding already recommended and new candidate vaccines for public programs; based on nurses responses, to assess the perceived priority of implementation of new vaccination programs, and to determine factors associated with the intention to recommend a new vaccine.DESIGNCross-sectional survey.SETTING AND PARTICIPANTSThe survey was conducted in June-July 2008 with registered nurses (N=299) randomly sampled from the Quebec Order of Nurses registry.RESULTSThe great majority (97.8%) of nurses somewhat or strongly agreed that the vaccines recommended by public health authorities are very useful. The proportion of nurses that perceived different recommended vaccines as useful varied from 80% to 99%. A high heterogeneity was observed among nurses' opinions regarding the safety and efficacy profile of different new vaccines. From 35% to 69% of nurses self-estimated the information they received on new vaccines as sufficient for their needs. The priority rating of new vaccines was as follows: (1) combined hepatitis A and B vaccine; (2) measles mumps rubella and varicella vaccine; (3) hexavalent diphtheria-tetanus-pertussis based vaccine; (4) pneumococcal 10-valent vaccine; (5) meningococcal ACYW-135 vaccine; (6) human papillomavirus vaccine and (7) Rotaviral vaccine. The willingness to recommend a new vaccine was consistently associated with the perceived vaccine safety, usefulness of a potential immunization program and the perceived professional support of a new vaccine.CONCLUSIONThe general attitudes of nurses toward vaccines recommended by public health authorities are positive and were not negatively affected by the recent implementation of the pneumococcal, varicella and influenza vaccines in the childhood vaccination program. Important differences are observed when comparing the perceived usefulness, safety, efficacy, acceptability, and intention to recommend new vaccines. Nurses clearly give their priority to combined vaccines and to vaccines they had received more information about. The delivery of clear evidence-based information about the new immunization program targets and vaccine safety, as well as professional support fostering would increase nurses' willingness to recommend new vaccines.

2005-10-01·Clinical and Vaccine Immunology

Immunogenicity of Meningococcal ACYW135 Polysaccharide Vaccine in Saudi Children 5 to 9 Years of Age

Article

作者: Al-Mazrou, Y. ; Borrow, R. ; Balmer, P. ; Andrews, N. ; Khalil, M. ; Bramwell, J.

ABSTRACTMeningococcal tetravalent polysaccharide vaccines were observed to be immunogenic in Saudi children 5 to 9 years of age, with >90% having serum bactericidal antibody titers of ≥8 for serogroups A, Y, and W135; for serogroup C, 77% were putatively protected after vaccination.

项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的新闻（医药）

2024-07-04

·赛柏蓝

2024医保谈判，符合条件新药分析（4图）

作者 | 张自然博士编辑 | 相宜 6月28日，国家医保局关于公布《2024年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案》及申报指南等文件的公告（下文简称《方案》）发布，标志着2024年医保谈判正式启动。按《方案》目录外西药和中成药条件1（2019.1.1～2024.6.30批准上市且尚未国谈的新通用名药品），截至6月23日，共有213个上市新药符合条件1，其中，独家品种189个（占89%）、非独家品种24个（11%）。这213个新品种共涉及388张批文，其中，化药260张（占2/3）、生物制品115张（占近1/3）、中药13张（占1/30）。注：本文中的企业均指上市许可持有人。 01 批准时间这388个批文，共分布在6个年头批准，最多的当然是2023年，尚有132个当年批准上市的新药尚未国谈，有资格参与2024年国谈，占了1/3。最少的是2019年，只有19个新药。2020～2022年依次是38个、46个、83个新药。2024.1.1～24.6.23，批准上市新药70个，将首次参加2024年国谈。 02 非独家品种符合目录外条件1的24个非独家品种，共涉及130个批文、96家企业。涉及企业最多的品种是注射用尼可地尔，共涉及15家企业，即石家庄四药、仁合益康、扬子江、成都苑东、北京四环科宝、苏州特瑞、陕西丽彩、天士力之骄、天大药业、海口天行健、江苏博欣医药科技、南京恒道医药科技、云南先施药业、重庆德诚永道医药等14家本土药企，以及1家外企（日本中外制药株式会社）；其次是涉及10～15家企业的有3个品种，即注射用比伐芦定（11家）、盐酸非索非那定片（11家）、普卢利沙星片（10家）；涉及5～10家企业的有4个品种，即四价流感病毒裂解疫苗（8家）、富马酸卢帕他定片（6家）、ACYW135群脑膜炎球菌多糖疫苗（6家）、普乐沙福注射液（5家）；涉及3家企业的有2个品种，即盐酸决奈达隆片、ω-3脂肪酸乙酯90软胶囊。 03 Top企业一、独家品种Top企业 189个独家品种共涉及132家企业（本土企业69家、外企63家），中、外企业数量基本持平。其中，拥有2家独家品种的企业共有27家，外企20家（约占3/4）、本土7家（约占1/4）。拥有独家品种数最多的企业是罗氏，共有9个独家新药符合目录外条件1，如法瑞西单抗注射液、格菲妥单抗注射液、可伐利单抗注射液、利妥昔单抗注射液（皮下注射）、玛巴洛沙韦干混悬剂、帕妥珠曲妥珠单抗注射液(皮下注射)、注射用维泊妥珠单抗、阿替利珠单抗注射液、托珠单抗注射液(皮下注射)；有5个独家品种的有4家企业，即武田、施贵宝、恒瑞、百特；有4个独家品种的有2家企业，即礼来、辉瑞；有3个独家品种的有7家企业，即浙江我武生物、日本协和发酵麒麟、强生、诺华、默沙东、美国健赞、Swedish Orphan Biovitrum AB；有2个独家品种的有13家企业，即兆科、远大在澳洲设立的创新药研发中心、卫材、康希诺、江西青峰药业、葛兰素、东丽株式会社、北京明海生物、安进、阿斯利康、ViiV Healthcare B.V.、NextWave Pharmaceuticals Inc、Napp Pharmaceuticals Limited。二、非独家品种Top企业 24个非独家品种共涉及96家企业，以本土企业为主，涉及本土企业79家（82%）、外企17家（占18%）。其中，拥有非独家品种数≥2个的企业共10家，本土企业8家，外企2家（赛诺菲和雅培），除扬子江有3个品种外，其他都有2个品种。扬子江的3个品种分别是注射用尼可地尔、富马酸卢帕他定片、注射用比伐芦定。其他如北京四环科宝（注射用尼可地尔、富马酸卢帕他定片）、成都盛迪（盐酸非索非那定片、ω-3脂肪酸乙酯90软胶囊）、华兰生物（四价流感病毒裂解疫苗、ACYW135群脑膜炎球菌多糖疫苗）、厦门恩成制药（艾司奥美拉唑镁碳酸氢钠胶囊、兰索拉唑碳酸氢钠胶囊）、石药集团欧意（盐酸决奈达隆片、盐酸伊立替康脂质体注射液）、四川国为制药（ω-3脂肪酸乙酯90软胶囊、二十碳五烯酸乙酯软胶囊）、重庆科瑞制药（普卢利沙星片、盐酸非索非那定片）。 END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入医药代表交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准疫苗

100 项与 ACYW135群脑炎球菌多糖 (华兰生物疫苗) 相关的药物交易

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