Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular 破伤风类毒素,减低白喉类毒素与无细胞-医学精
外伤后破伤风疫苗和被动免疫制剂使用指南(2019年版)
外伤后破伤风疫苗和被动免疫制剂使用指南（2019 年版）外伤后破伤风是非新生儿破伤风的主要类型。
为指导基层医疗机构做好外伤后破伤风的预防控制工作，尤其是外伤后的预防处置，降低破伤风发病率及病死率，中国疾病预防控制中心国家免疫规划技术工作组参考《2017 年世界卫生组织破伤风立场文件》，以及国内外最新研究进展，制定了本指南。
一、破伤风免疫制剂破伤风主动免疫制剂为含破伤风类毒素疫苗（tetanus toxoid-containing vaccine,TTCV）。
TTCV包括吸附破伤风疫苗（Tetanus vaccine,adsorbed,TT）、吸附白喉破伤风联合疫苗（Diphtheria and tetanus combined vaccine, adsorbed, DT）以及吸附无细胞百白破疫苗（Diphtheria, tetanus and acellular pertussis combined vaccine, adsorbed, DTaP）等。
破伤风被动免疫制剂包含破伤风抗毒素（Tetanus antitoxin,TAT）、马破伤风免疫球蛋白[equine anti-tetanusF(ab')2, F(ab')2] 和破伤风人免疫球蛋白（Human tetanusimmunoglobulin,HTIG）。
其中F(ab')2是在原有使用马血清生产 TAT 工艺的基础上，经加用柱色谱法纯化工序降低 IgG 等大分子蛋白的含量、提高有效成分抗体片段F(ab')的相对含量，2使之安全性较TAT 得到较大提高。
在 HTIG 难以获得时，应当优，其次选择 TAT。
先选择F(ab')2二、外伤后破伤风预防处置的基本流程外伤后进行伤口处置和合理使用破伤风免疫制剂对预防破伤风感染至关重要。
外伤后伤口处置按照外科诊疗常规要求，破伤风疫苗和被动免疫制剂使用基本流程如下：（一）根据伤口的情况进行分类在接诊外伤患者时，应当获取患者完整病史，包括受伤的环境和受伤的过程，对伤口进行分类。
DTaP—IPV／Hib五联疫苗与单苗接种不良反应对比分析
DTaP—IPV／Hib五联疫苗与单苗接种不良反应对比分析目的比较接种单剂吸附无细胞百白破联合疫苗（DTaP）、脊髓灰质炎灭活疫苗（IPV）及B型流感嗜血杆菌疫苗（Hib）与DTaP-IPV/Hib五联疫苗（简称五联疫苗）接种后的不良反应，探求更合理的免疫程序。
方法在我院免疫接种的378例健康婴幼儿，按照监护人自愿原则分为两组，A组接种五联疫苗，B组接种DTaP、Hib结合疫苗和IPV，48 h后随访两组婴幼儿不良反应情况，并对两组不良反应进行对比分析。
结果A、B组注射部位红肿的发生率分别为16.5%、10.0%。
全身不良反应主要表现为发热、异常哭闹、嗜睡、易激惹、食欲下降，A、B组的发生率相当。
结论五联疫苗的不良反应与常规单剂免疫接种相似，它简化了免疫程序，应推荐接种。
标签：疫苗；预防接种；不良反应预防接种是控制传染病最经济、有效的措施。
百日咳、白喉、破伤风、脊髓灰质炎、b型流感嗜血杆菌引起的感染性疾病是常见的严重危害儿童健康的传染病。
通常预防这五种疾病需要分別接种吸附无细胞百白破联合疫苗（DTaP）、注射用灭活脊髓灰质炎疫苗（IPV）和Hib疫苗，2岁前幼儿完成全程免疫累计需要接种12剂次[1-2]。
随着用于儿童的疫苗数量大幅度增加，不但增加了为接种所需的服务成本，而且还增加了发生疑似预防接种异常反应的风险。
因此，联合疫苗的应用成为公共医疗卫生优先考虑和关注的问题。
吸附无细胞百白破（DTaP）、灭活脊髓灰质炎和b型流感嗜血杆菌（结合）联合疫苗（DTaP-IPV/Hib 五联疫苗，简称五联疫苗），接种五联疫苗预防上述五种疾病，幼儿完成全程免疫累计仅需接种4剂次[3]。
现将接种单剂吸附无细胞百白破联合疫苗（DTaP）、灭活脊髓灰质炎疫苗（IPV）及b型流感嗜血杆菌疫苗（Hib）与DTaP-IPV/Hib 五联疫苗（简称五联疫苗）接种后的不良反应进行比较，探求更合理的免疫程序。
1资料与方法2013年1月～10月在我院预防接种门诊接种的378例健康婴幼儿，按照监护人自愿的原则分为两组。
细菌胞外多糖生物活性的研究进展_赵霞
网络出版时间：2016-03-22 16:00:27网络出版地址：/kcms/detail/62.1120.R.20160322.1600.002.html细菌胞外多糖生物活性的研究进展赵霞综述，王若愚审校中国科学院寒区旱区环境与工程研究所生态与农业研究室，甘肃兰州 730000摘要：细菌胞外多糖（Exopolysaccharides，EPS）是细菌产生的一类重要的生物大分子，在许多重要生命过程中起着非常关键的作用，由于其具有多种生物活性成为近年来研究的热点。
目前，细菌EPS作为天然产物，可大量发酵提取，且可降低成本，特别是一些乳酸杆菌和海洋细菌的新型EPS被证实具有多样化结构多糖的、潜在的有益生物活性，如抗肿瘤、免疫调节和抗氧化等，其在食品、医学等领域被广泛应用。
本文就细菌EPS在生物材料和药品方面的应用、免疫调节功能、抗肿瘤活性及抗氧化活性作一综述。
关键字：细菌；胞外多糖；抗肿瘤；抗氧化；免疫调节中图分类号：Q936文献标识码：A 文章编号： DOI：Progress of bioactivities for bacterial exopolysaccharidesZHAO Xia, WANG Ruo-yuKeyLaboratory of Ecological and Agricultural Research, Cold and Arid Regions Environmental and Engineering ResearchInstitute, Chinese Academy of Sciences, Lanzhou730000，Gansu Province, ChinaCorresponding author: WANG Ruo-yu, E-mail: wangruoyu@Abstract：Bacrerial exopolysaccharides (EPS）were produced from bacteria, which is a type of large biological moleculeand takes a cruicial effect in many process of life, and becomes a hot focus in recent years because it has a variety ofbiological activities. At present the bacterial EPS as a natural product may be extracted in large quanties by thefermentation process with a reduced cost, particularly some new types EPS from Lactobacillaceae and ocean bacteria havebeen identified to having polysaccharides with multiple-structure and potential biological benefitactivities,such asanti-tumor, anti-oxidationand immuno-modulatory effects. The bacterial EPS hasbeen found an outstanding prospect infood industry and medicine.. In this paper,applications of bacteria EPSare reviewed, including in biomedicinematerials,pharmaceiticals and health preparation, .andanti-tumor, anti-oxidationand immuno-modulatory effects.Key word：Bacteria; Exopolysaccharide(EPS); Anti-tumor; Anti-oxidation; Immuno-modulation多糖是一类由醛糖或酮糖通过糖苷键连接而成的天然高分子聚合物，广泛存在于植物、真菌、藻类和细菌中。
生物制药-药典释义
百日咳疫苗pertussis vaccine/whoopingcough白喉diphtheria破伤风tetanus百日咳Adsorbed Purified Pertussis VaccineAdsorbed Purified Pertussis Vaccine is a liquid for injection prepared by adding an aluminum salt to a liquid containing the protective antigen of Bordetella pertussis to make the antigen insoluble.It conforms to the requirements of Adsorbed Puri-fied Pertussis Vaccine in the Minimum Requirements for Biological Products.Description Adsorbed Purified Pertussis Vaccine forms a homogeneous, white turbidity on shaking.吸附精制百日咳疫苗是制备注射加铝盐液体含百日咳杆菌保护性抗原使抗原不溶液。
它符合生物制品的最低要求的吸附纯化百日咳疫苗要求。
描述吸附精制百日咳疫苗外是一种均匀白色混浊液。
白喉Freeze-dried Diphtheria Antitoxin,EquineFreeze-dried Diphtheria Antitoxin, Equine, is a preparation for injection which is dissolved before use.It contains diphtheria antitoxin in immunoglobulin of horse origin. It conforms to the requirements of Freeze-dried Diphtheria Antitoxin, Equine, in the Minimum Re-quirements for Biological Products.Description Freeze-dried Diphtheria Antitoxin, Equine,becomes a colorless or light yellow-brown, clear liquid or aslightly whitish turbid liquid on addition of solvent。
b型流感嗜血杆菌如何传染？介绍专业知识【健康必备常识】
b型流感嗜血杆菌如何传染？介绍专业知识
文章导读
b型流感嗜血杆菌进入人体后会引发多种疾病，最常见的两种疾病是脑膜炎和肺炎，这些疾病会直接导致人的死亡，所以有必要了解这种细菌的传染方式以及相应的预防措施。
一、b型流感嗜血杆菌是什么
“b型流行性感冒嗜血杆菌”简称“HIB”HIB，即b型流感嗜血细菌，是儿童鼻咽部常见的共生细菌，是主要通过脑膜炎和肺炎每年估计造成约300万人严重患病并估计造成38.6万人死亡的一种细菌。
几乎所有患者都是5岁以下儿童，年龄为4至18个月的儿童尤为脆弱。
在应用疫苗前，大多数儿童都会在某段时期携带Hib，有时携带数月，但细菌定植率依年龄与社会经济状况不同相差很大。
在Hib疫苗接种率高的地区，由于Hib结合疫苗的群体免疫作用，细菌在鼻咽部的定植率非常低。
二、传染方式
HIB多寄居在鼻咽部黏膜，通过空气飞沫和密切接触在人与人之间传播，新生儿可通过母亲的产道感染。
流感嗜血杆菌只引起人类感染，对动物无致病性。
同样，寄居于禽类、猪、犬的嗜血杆菌也不感染人类。
有研究表明，人群对流感嗜血杆菌普遍易感。
新生儿由母体抗体被动免疫，3个月～3岁儿童的抗体水平最低，对该菌最易感，HIB在学龄前儿童带菌率为5.4%～6.9%。
成人可为无症状带菌者，其发病多有免疫缺陷。
HIB带菌率与季节有关，感染多散发，一年四季皆可发病，但多从秋季开始增加，冬季达高峰。
HIB通过飞沫进入人的呼吸道，侵入血液繁殖，可扩散至人体多个器官，引起组。
静脉血二氧化碳结合力与动脉血碳酸氢根离子浓度相关性研究
齐齐哈尔医学院学报 2020 年第 4丨卷第 4 期 Journal of Qiqihar Medical UniVersity ，2020，Vol.41，N 〇.4• 417 •recommendations for use of tetanus toxoid, reduced diphtheria [ 8]toxoid, and acellular pertussis vaccine ( Tdap ) in pregnant women 一Advisory Committee on Immunization Practices ( A C IP ), 2012[J].M orb Mortal Wkly R ep ,2013,62： 131-135. [9][2] 王武超，薛晓艳.我国气管切开治疗重症破伤风患者的荟萃分析[J ].中国急救医学，2010,30 (1丨）：2470-2471.[3] 潘孝彰，破伤风，陈灏珠.实用内科学[M ].12版.北京：人民卫 [10]生出版社,2005:590-593.[4 ] Ablett JJL. Analyses and main experiences in 82 Patients treated inthe Leeds Tetanus Unit. In Symposium on tetanus in Great Britsin [11]Edited by ： Ellis M. Boston [ J ]. National Lending Library , 1967,8(2)：1-10. [12][5] Rodrigo C,Fernando D,Rajapakse S.Pharmacological managementof tetanus ： an evidence - based review [ J ]. Critical Care, 2014, 18(2)：217. [13][6] N6brega MV, Reis RC, Aguiar ICV, et al. Patients with severe accidental tetanus admitted to an intensive care unit inNortheastern Brazil ： clinical — epidemiological profile and risk [ 14 ]factors for mortality[ J] .Braz J Infect D is,2016,20(5) ：457-461.[7] Kyu HH,Mumforcl JE,Stanaway JD ,e t al. Mortality from tetanusbetween 1990 and 2015 ： findings from the global burden of disease study 2015[J].B M C Public Health ,2017,17( 1).Pathirana J , Nkambule J , Black S. Determinants of maternalimmunization in developing countries[ J] .V accine,2015,33( 26)： 2971-2977.Centers for Disease Control and Prevention. Epidemiology andPrevention of Vaccine - Preventable Diseases [ M ]. 13th ed. Washington, DC ： Public Health Foundation,2015.王雪霏，郭树彬，魏学，等.人破伤风免疫球蛋白在预防破伤风 使用中的问题及对策[J ].中华急诊医学杂志，2015,24(5):573-575.陈实，李承红.电子支气管镜在重症破伤风合并肺部感染患者 中的应用观察[J ].中国内镜杂志，2016，（ 11) :34-37. Mukhopadhyay A ，Henry J ，Ong V ，et al. Association of modified NUTRIC score with 28-day mortality in critically ill patients [ J ]. Clini Nutrition,2017,36(4) ： 1143-1148.Amare A , Yami A. Case - fatality of adult tetanus at JimmaUniversity Teaching Hospital, Southwest Ethiopia [ J ]. AfricanHealth S c i ,2011,l l (l )：36-40.王宝枝，钱世鵾，朱景辉，等.早期气管切开及联合应用高剂董 镇静、肌松剂在救治重症破伤风中的应用[J ].中华普通外科杂志，2013,28(5) :396-397.(收稿日期:2019-10-14)静脉血二氧化碳结合力与动脉血碳酸氢根离子 浓度相关性研究陈科谭早红【摘要】目的分析静脉血二氧化碳结合力与动脉血碳酸氢根离子浓度之间的关联。
B型流感嗜血杆菌疫苗的研究进展
（ WHO） 2012 年 4 月统计报道，2008 年全世界因 Hib 感染死亡的 5 岁以下儿童人数为 20． 3 万，而目前预防 Hib 最有效的措施是
接种 Hib 疫苗。本文回顾了 Hib 疫苗的发展，对现有 Hib 结合疫苗的免疫原性、结合方式、结合策略进行综述。
关键词 B 型流感嗜血杆菌 结合疫苗 免疫原性 结合策略
·155·
·综述与进展·
J Med Ｒes，Jun 2015，Vol． 44 No． 6
和化学性质稳定； ③临床安全无内在毒性； ④能够诱 导机体产生高水平抗体或者调理素； ⑤诱导产生相应 的免疫记忆。
目前市场上的 Hib 主要由以下 4 种蛋白作为载 体而合成的结合疫苗： 白喉类毒素（ diphtheria toxoid， DT） ，破伤风类毒素（ tetanus toxoid，TT） ，无毒白喉类 毒素变异体（ CＲM197） 和脑膜炎球菌外膜蛋白复合 体（ OMP） 。虽然以这些蛋白为载体的结合疫苗都具 有较好的免 疫 原 性，但 是 他 们 具 有 不 同 的 免 疫 学 特 性。因此，在体内反应速度、产生抗体浓度、亲合力和 接种后 个 体 基 因 型 的 不 同 而 存 在 差 异［11］。研 究 表 明，即使在 3 次加强免疫后，PＲP － D 所产生的抗体 应答效应 也 是 最 低 的［12］。 在 另 一 个 双 盲 实 验 中，随 机对照实验比较 4 种疫苗的免疫原性和反应原性，4 种疫苗分别在婴儿 2、4 和 6 个月龄时各免疫 1 次，共 免疫 3 次，结果显示 4 种不同的 PＲP 结合疫苗的抗 体 水 平 如 下： PＲP － D （ 0． 28μg / ml ） ，PＲP － OMP （ 1. 14μg / ml） ，PＲP － CＲM197 （ 3. 08μg / ml） ，PＲP － T （ 3． 64μg / ml） ，表明 PＲP － D 所产生的抗体水平仍然 是最低的。在免疫婴儿中 PＲP － D 产生抗体浓度≥ 1μg / ml，在所免疫的婴儿中占 29% ； 而另外 3 种疫苗 分别为 PＲP － OMP 为 55% ，PＲP － CＲM197 为 75% ， PＲP － T 为 83%［13］。由此可见 PＲP － D 对婴儿不能 产生较好的保护效果，即使在 3 剂加强免疫后，抗体 水平≥1μg / ml 的比例也仅有 48% 。 ［12］
流感嗜血杆菌感染
流感嗜血杆菌感染流感嗜血杆菌较广泛地寄居于正常人上呼吸道。
通常以冬季带菌率较高，发病也增多，对人类可引起原发性化脓性感染，也可引起继发性感染。
本病遍布世界各国，在小儿中每年由ｂ型流感嗜血杆菌（Hemophilus influenzae type b，Ｈｉｂ）引起的严重病例至少３００万例，死亡４０～７０万例。
以４个月～１８个月龄儿童发病率最高，３个月以下的婴儿和６岁以后的儿童发病减少。
在发达国家内由Ｈｉｂ引起的病例，以脑膜炎多见，在发展国家内该菌常引起急性呼吸道感染，每年可引起约２００～３００万例肺炎。
Ｈｉｂ偶联菌苗从９０年代起被列入常规儿童免疫计划以后，在西欧、加拿大、美国、澳大利亚和新西兰等国家内由Ｈｉｂ引起的病例明显地减少了。
至今在亚洲大部分地区和新独立国家内很少见到有关人群感染Ｈｉｂ的监测报道，亚洲国家尚未将Ｈｉｂ偶联菌苗列入常规的计划免疫。
一、病原 流感嗜血杆菌（Hemophilus influenzae，Ｈｉｂ）简称流感杆菌，又名费佛氏杆菌（Pfeiffer ' s bacillus），为革兰氏阴性短小杆菌，大小为０.８～１.５ｍｍ×０.３～０.４ｍｍ，两端钝圆。
从病灶中新分离的菌株多呈球杆状或双球状，有时可呈短链。
在陈旧培养物中呈多形性，有长杆状或丝状体。
本菌无动力、无芽孢，粘液型菌株有荚膜。
Ｈｉｂ为需氧菌，培养较困难，由于该菌氧化还原酶系统不完善，生长时需要“Ｘ”和“Ｖ”两种生长辅助因子。
“Ｘ”因子存在于血红蛋白中，可耐高温。
“Ｖ”因子存在血液中，耐热性较差。
在血液中“Ｖ”因子处于被抑制状态，加热７５～１００℃，５～１０分钟，抑制物被破坏后才被１８～２４小时，菌落微小，无色，透明似露珠，４８小时后形成灰白色较大的菌落、圆形、透明。
如以Ｈｉｂ和金黄色葡萄球菌在同一巧克力琼脂平皿上培养，由于葡萄球菌能合成较多的“Ｖ”因子，并弥散到培养基里，可促进Ｈｉｂ的生长，故在葡萄球菌菌落周围生长的Ｈｉｂ的菌落较大，距离葡萄球菌菌落越远的Ｈｉｂ的菌落越小。
外伤后破伤风疫苗和被动免疫制剂使用指南(2019版)
附件 1外伤后破伤风疫苗和被动免疫制剂使用指南（2019 年版）外伤后破伤风是非新生儿破伤风的主要类型。
为指导基层医疗机构做好外伤后破伤风的预防控制工作，尤其是外伤后的预防处置，降低破伤风发病率及病死率，中国疾病预防控制中心国家免疫规划技术工作组参考《2017 年世界卫生组织破伤风立场文件》，以及国内外最新研究进展，制定了本指南。
一、破伤风免疫制剂破伤风主动免疫制剂为含破伤风类毒素疫苗（tetanus toxoid-containing vaccine, TTCV）。
TTCV 包括吸附破伤风疫苗（Tetanus vaccine, adsorbed, TT）、吸附白喉破伤风联合疫苗（Diphtheria and tetanus combined vaccine, adsorbed, DT）以及吸附无细胞百白破疫苗（Diphtheria, tetanus and acellular pertussis combined vaccine, adsorbed, DTaP）等。
破伤风被动免疫制剂包含破伤风抗毒素（Tetanus antitoxin, TAT）、马破伤风免疫球蛋白[equine anti-tetanus F(ab')2, F(ab')2] 和破伤风人免疫球蛋白（Human tetanus immunoglobulin, HTIG）。
其中F(ab')2是在原有使用马血清生产TAT 工艺的基础上，经加用柱色谱法纯化工序降低IgG 等大分子蛋白的含量、提高有效成分抗体片段F(ab')2的相对含量，使之安全性较TAT 得到较大提高。
在HTIG 难以获得时，应当优先选择F(ab')2，其次选择TAT。
二、外伤后破伤风预防处置的基本流程外伤后进行伤口处置和合理使用破伤风免疫制剂对预防破伤风感染至关重要。
外伤后伤口处置按照外科诊疗常规要求，破伤风疫苗和被动免疫制剂使用基本流程如下：（一）根据伤口的情况进行分类在接诊外伤患者时，应当获取患者完整病史，包括受伤的环境和受伤的过程，对伤口进行分类。
出国免疫接种情况表中文翻译
I authorize Illinois Institute of Technology to release this immunization record to the Illinois Department of Public Health (IDPH), or its designated representative for compliance audits or in the event of a health or safety emergency. All immunization documents submitted to IIT become the property of the University. I understand that, unless required to do so by law, IIT will not re-release my immunization records to any third party.我授权伊利诺理工大学来发布这份免疫记录给伊利诺斯州卫生部门，或者它指定的符合性审计的代表，或者一个健康的事件，或安全相关的紧急情况。
Please complete either Option A or Option B (choose one)请完成选项A或者B（二选一）。
❑ Option A: Attach a copy of your Official Immunization records proving ALL immunizations are current. Skip Option B.提供一份你的官方的免疫记录的副本，以证明现有的所有的免疫注射情况。
❑ Option B: See below – Remainder of form to be completed and signed by physician or health care provider.Option B: To be completed and signed by physician or health care provider. Please note the following: Exemptions: The following exemptions will be accepted with official supporting documentation.由（内科）医生或卫生保健提供者完成。
白喉杆菌Cdiphtheria白喉
nhibition protein synthesis) ，引起组织变性与坏死。
• 白喉外毒素(带毒素基因的溶原性ß噬菌 04%亚碲酸钾血琼脂平板
（Chinese letters) 04%亚碲酸钾血琼脂平板
体的菌株才产生毒素） 预防trivalent vaccine
，引起组织变性与
坏死。 作用：抑制蛋白质合成(inhibition protein synthesis) ，引起组织变性与坏死。
白喉杆菌 C diphtheria —— 白喉
病死率仍相对较高10%
04%亚碲酸钾血琼脂平板
预防trivalent vaccine
• 白、百、破混合疫苗diphtheria toxoid, pertussis vaccine, and tetanus toxoid (DPT or DTP vaccine)
预防trivalent vaccine
白喉杆菌 C diphtheria ——
• 作用：抑制蛋白质合成(inhibition 白喉
白喉外毒素(带毒素基因的溶原性ß噬菌体的菌株才产生毒素）
白喉杆菌 C diphtheria ——
protein 白喉
预防trivalent vaccine
synthesis)
白喉杆菌 C diphtheria —— 白喉
近年白喉发病率 在0.01／10万以下 病死率仍相对较 高10%
白喉杆菌排列方式
珊栏样排列，字母型 （Chinese letters)
培养特性
• 黑色菌落
0.03%0.04%亚 碲酸钾 血琼脂 平板
致病物质
作用：抑制蛋白质合成(inhibition protein synthesis) ，引起组织变性与坏死。
美国FDA批准四联疫苗Quadracel上市
美国FDA批准四联疫苗Quadracel上市
佚名
【期刊名称】《中国执业药师》
【年(卷),期】2015(0)6
【摘要】美国FDA于2015年3月24日批准赛诺菲巴斯德（Sanofi Pasteur ）公司的Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovims Vaccine （参考译名：白喉、破伤风、百日咳吸附-脊髓灰质炎灭活疫苗，商品名：Quadracel）注射用混悬液上市，用于4～6岁儿童白喉、破伤风、百日咳、脊髓灰质炎的主动免疫。
【总页数】1页(P35-35)
【关键词】美国FDA;FDA批准;四联疫苗;脊髓灰质炎灭活疫苗;上市;主动免疫;破伤风;百日咳
【正文语种】中文
【中图分类】R95
【相关文献】
1.默克联合疫苗Proquad获美国FDA上市批准 [J],
2.美国FDA批准宫颈癌疫苗上市 [J],
3.美国FDA紧急批准第2种新冠疫苗——莫德纳COVID‐19疫苗 [J], 夏训明(编译)
4.美国FDA紧急批准第3种新冠疫苗——杨森COVID-19疫苗 [J], 夏训明(编译)
5.美国FDA批准重组人乳头瘤病毒9价疫苗上市 [J],
因版权原因，仅展示原文概要，查看原文内容请购买。
十种常见疫苗禁忌及不良反应(Ten common vaccines, contraindications and adverse reactions)
十种常见疫苗禁忌及不良反应（Ten common vaccines, contraindications and adverse reactions）Any vaccine may cause an adverse reaction after inoculation. So what is the taboo when the baby is vaccinated? Please read this carefully.1 、 measles vaccineMeasles vaccine is a live attenuated vaccine, the vaccination reaction is mild, the immunity is good, and the baby is vaccinated regularly after birth, so it can prevent measles.[reaction] after injection, the local general no response. On the 6-10 day, a few people may have a fever, usually not more than 2 days, and occasionally have a rash.[contraindications] no serious illness, fever, or allergies (especially those with an allergy to eggs) are not allowed.[note] the skin should be sterilized with 75% alcohol and injected after being dry. The vaccine should be injected at least 6 weeks intervals after the injection of gamma globulin. At least 2 weeks after the inoculation of measles vaccine, gamma globulin can be injected.[inoculation site] the upper arm, deltoid muscle attachment, subcutaneous injection.[dose] 0.2ml2, the polio vaccine (referred to as polio candy)The pill is an oral polio vaccine formulation, white granulated sugar pills, vaccination safety. After birth, according to the plan take candy, can effectively prevent poliomyelitis (polio).[reaction] only a small number of infants after polio vaccine has a transient diarrhea, can not cure self-healing.[contraindications] there is no immune restriction, and no use during the course of the immunosuppressive treatment. The milk and milk products are forbidden to take the pill allergy vaccine, can take liquid vaccine.[note] this vaccine is for oral use only. This product is a live vaccine. Do not take it in hot water or hot food. Occasionally, over dosage, multiple doses of the vaccine are harmless to the human body.[inoculation site] oral.[dosage] sugar pills type 1, liquid dosage form 2 drops3, preparation of DPTIt is made of Pertussis Vaccine, refined diphtheria toxoid and purified tetanus toxoid, which can prevent whooping cough, diphtheria and tetanus simultaneously.[reaction] local redness, pain, itching, or low fever, fatigue,headache, etc.. Generally do not require special treatment, that is, self extinction. Occasionally allergic skin rash, vascular edema. Aseptic purulent. Multi line injection too shallow or vaccine is not shaken, induration can not be absorbed, and the formation of injection site purulent. If the whole body response is heavy, should promptly go to the hospital to carry on the diagnosis and treatment.Contraindicated in epilepsy, nervous system diseases and convulsions; acute infectious diseases (including convalescence) and fever; suspension of injection; child immune preparations; adults banned.[note] must fully shake when in use; products can not be frozen, freeze after clot, cannot be used; by intramuscular injection, there may be local induration, can be gradually absorbed, second injections should be replaced with the other side; there should be 1:1000 for emergency epinephrine, occasionally occurring shock; first needle injection after the high fever, convulsions and other abnormal conditions occur, no second injections.[inoculation site] 1/4 or upper arm deltoid muscle on the hip, intramuscular injection.4 BCG vaccineIt is safe and effective, which is made of nontoxic bovine tubercle bacillus. Vaccination after birth is a reliable measure for the prevention of tuberculosis.BCG is an attenuated live bacterial vaccine designed to prevent the development of tuberculosis. Generally, in countries with high TB cases, it is advocated that the newborn be inoculated with BCG vaccine when it is not infected so as to produce resistance to tuberculosis.[reaction] 2 weeks or so, local redness and swelling can occur. If subsequently fester, form small ulcer, can use 1% dragon courage to daub, in case infection. Generally 8~12 weeks after scab, normal response. In case of lymph node enlargement, can be treated with hot packs. As has been softened to form pustules, available sterile syringes. Don't open. As an aspiration healed, also repeated aspiration, until the recovery so far. As has been broken, it is healing time longer, can expand the wound drainage, and at the same time with isoniazid or topical pasid ointment, once every 2~3 days for dressing, it can shorten the healing time and treatment.[contraindication] any person suffering from tuberculosis, acute infectious diseases, nephritis, heart disease, eczema, immunodeficiency or other skin diseases shall not be inoculated.[notice] no subcutaneous or intramuscular injection; inoculation of products containing adsorbent within 4 weeks of the same arm can not be vaccinated; BCG vaccination, 4 weeks with the arm can not be vaccinated other vaccines.[site of inoculation] upper arm lateral deltoid, intradermal injection.[dose] 0.1ml5 、 encephalitis B vaccineJapanese encephalitis vaccine infected Japanese B encephalitis virus infected hamster kidney cells, and then harvested and harvested the virus to freeze dried to make attenuated live vaccine for preventing epidemic encephalitis B.(1) inactivated JE vaccine[response] most people were vaccinated without reaction. Only after the injection of some children did they develop redness and pain, and subsided within 1~2 days. A small number of fever, are generally below 38 degrees C. A few have dizziness, headache, discomfort and other self-conscious symptoms. Occasional rash, vascular edema and anaphylactic shock rate increased with the number of vaccination. It usually occurs 10~30 minutes after injection and rarely exceeds 24 hours. This kind of vaccination reaction is more frequently seen in repeated injection, especially in children over 7 years old.[contraindications] fever and acute diseases; severe chronic diseases; disorders of the brain and nervous system; allergic diseases; previous history of allergies to antibiotics and vaccines.[note] vaccine (yellow) color, opacity, ampoule crack, foreign bodies were not used; after vaccination, a moment of rest in the field, to prevent the occurrence of adverse reactions; there should be 1:1000 for emergency epinephrine, accidentalshock; people over the age of 10 has been due to latent infection and acquired immunity therefore, there is no need to be vaccinated.[inoculation site] the upper arm, deltoid muscle attachment, subcutaneous injection.[dose] 0.5ml(2) live attenuated JE vaccine[reaction] after the injection of general no response, a small number of local redness and swelling, and occasionally fever and allergic rash.[taboo] fever; acute infectious disease; otitis media; heart, kidney and liver diseases; active tuberculosis; history of allergy or ventilation history; known to have defects in the immune system, recent or ongoing immunosuppressive therapy.[note] open the ampoule injection and do not allow the disinfectant contact vaccine; vaccine dissolution after shake ampoule scattered the clot, crack, can not be used; the vaccine before dissolution discoloration (red), do not use.[inoculation site] the upper arm, deltoid muscle attachment, subcutaneous injection.[dose] 0.5ml6, a meningococcal vaccineGroup A Neisseria meningitidis was prepared by chemical method of polysaccharide antigen lyophilized. For the prevention of meningococcal A caused the epidemic cerebrospinal meningitis in.Injection of meningococcal vaccine to prevent epidemic cerebrospinal meningitis (referred to as ECM). The disease is acute respiratory tract caused by meningococcal infectious disease incidence and epidemic in winter and spring, mainly in children under 15 years of age onset, manifested as high fever, severe headache, vomiting, skin spray a little bleeding point, stiff neck, convulsions, coma, shock, the mortality rate is relatively high.Children will be born in the vaccine injection within six months, the general basis of needle injection only once (but in endemic areas after three months to at once). Second years must be stepped up to maintain effective antibody levels. This vaccine and encephalitis B vaccine is a seasonal epidemic, usually in the 2-4 month popular peak, so the vaccine before this 1-2 months 7-10 days after injection, the injection can test bleeding protective antibody Qing, reached a peak at 2-4 weeks, then just enter the flow line of ECM to protect the antibody peak. The children don't get sick.Most areas are still 11-12 in the injection of meningococcal vaccine (Beijing in December), if your child is over 6 months in September, to wait until December before injection of vaccine, if in December during the injection of meningococcal vaccine your child is 6 months old,That will not wait until December of next year.After the reaction of epidemic cerebrospinal meningitis vaccine were mild, occasionally brief fever, some older children (8~12 years old) occasional allergic reactions, namely herpes after inoculation of skin at ten hours, should consult a doctor. Local injection may appear red and tender, usually subsided within 24 hours, do not have special treatment.7. Hepatitis A vaccineThe Department will be harmless to people, hepatitis A virus has good immunogenicity of attenuated strains inoculated in human diploid cells, cultured after isolated and purified salt solution in the balance of amino acids, for the prevention of hepatitis a virus.What are the targets of hepatitis A vaccine?All children who are susceptible to hepatitis A virus should be vaccinated for children aged 1 and over. Inactivated hepatitis A vaccine for children, medical workers, food industry practitioners, professional nature of contact with hepatitis A virus, the child's first free time is one year old, no age limit for adults. Vaccination should be delayed in febrile, acute, and progressive chronic conditions. Intensive immunization is available 3 years after vaccination. What is the immune effect of intramuscular injection of hepatitis A vaccine at 1ml per person per dose?After the inoculation of hepatitis A vaccine, it can produce high antibody in 8 weeks or so, and obtain good immunity. Positive seroconversion rate was 98-100%., and no hepatitis A occurred after vaccination. Therefore, hepatitis A vaccine has a good immune protection effect.What reaction does hepatitis A vaccine have after inoculation?After the inoculation of hepatitis A vaccine, there were no adverse reactions in both the local and the whole body.8 、 genetically engineered hepatitis B vaccineIs a kind of hepatitis B subunit vaccine, the hepatitis B virus surface antigen gene was cloned into expression in yeast by using modern biological technology, through the cultivation of the recombinant yeast to obtain HBsAg subunit, purified with adjuvant made after adsorption. This new generation of hepatitis B vaccine has the advantages of safety, efficiency and so on.[response] there are very few adverse reactions. Occasionally, redness or pain, fever and headache are present at the site of the vaccination, without any treatment.[taboo] fever, suffering from hepatitis, acute infection or other acute and chronic serious diseases prohibited; have allergies history disabled.[cautions] shake well when used. Ampoule should not be used whenbroken or shaken. Do not use epinephrine. Use when allergic reactions occur.[site of inoculation] upper arm deltoid muscle injection.[dosage] 1 (5 g/ branch, yeast vaccine or 10 mu g/ branch, 20 g/ branch, CHO vaccine)9 、 live mumps vaccineThe mumps virus attenuated strain was inoculated into chicken embryo cells and cultured to obtain the virus and then freeze dried. Used to prevent mumps.[caution] those who are allergic to egg products should be used with caution, and forbidden by pregnant women. IVIG should be suspended for one month, and gamma globulin should not be used within 2 weeks after vaccination. Infants under 1 years of age should not accept this product because the neutralizing antibodies from the mother may interfere with the immune response.[drug name] mumps vaccine Mumps Vaccine[drug alias] Parotidic, Vaccine, Live[Specification] injection preparation: 2 servings.[indications] prevention of mumps.[usage] dissolve the water for injection, inject 0.25ml intothe lateral part of the deltoid muscle of the upper arm, dissolve the liquid, use up in 1H, and discard the rest.10 rubella vaccineWith rubella virus BPD strain reducing culture made II infection of human diploid cells, the freeze-dried vaccine was dissolved after the clarification of orange. For the prevention of rubella.[adverse reactions] fever, skin rash, local induration, erythema, tenderness and lymph node enlargement. 2 months after immunization, temporary arthritis, joint pain and multiple neuritis may occur. There are very few chronic arthritis and encephalitis. The incidence of adverse reactions increases with age, and is higher in women.[usage] subcutaneous injection, 0.5ml injection into the upper arm of the lateral surface, 8h did not run out, should be abandoned.[notice] there is fever, acute disease, serious chronic organic disease, nervous system disease, allergic history, and pregnant women, lactating women and menstrual period women are prohibited.[name of drug] rubella vaccine Rubellavaccine[preparation Specification] injection: 1ml.[indications] prevention of rubella.How many taboos are there for baby vaccinations?No baby can be vaccinated anytime, anywhere. The timing of the vaccination, the conditions of the vaccinated person, and any contraindications, etc., have an impact on the efficacy of the vaccine and the possible adverse reactions that may occur after vaccination. Children in the following circumstances should be contraindicated or suspended vaccination:The patients suffering from severe heart, liver, kidney disease and active tuberculosis baby should not be vaccinated;The temperatures above 37.5 degrees Celsius, or with axillary lymph node enlargement baby should not be vaccinated, should find out the pathogeny cure after inoculation;The severe malnutrition, severe rickets, congenital immunodeficiency baby should not be vaccinated;I have asthma, urticaria and other allergic baby should not be vaccinated;The nervous system consists of brain development is not normal, encephalitis sequela, epilepsy baby should not be vaccinated;Such suffering from dermatitis, purulent skin disease, severe eczema baby should not be vaccinated, waiting for the recovery will be carried out after the inoculation;If the baby stool every day, more than four times, to berecovered after two weeks before taking polio vaccine;Recently, the injected polyvalent immunoglobulin baby should not be vaccinated within six weeks;Mild, cold, fever and other general diseases as the case may suspend the vaccination; not that hunger when vaccination. In addition, parents in the baby vaccination, must be the baby's physical condition at the time to reflect on the doctor, it is best to carry relevant medical history information.Pay attention to the discomfort after the baby is vaccinated Any vaccine may cause an adverse reaction after inoculation.If the baby after the inoculation appeared local redness and swelling, pain, lymph node enlargement, fever and other symptoms, but soon subsided, this is a normal discomfort reaction. If these symptoms increase, it is best to go to the hospital as soon as possible treatment.In addition some babies may cause allergic reactions to vaccines appear rash, allergic purpura, angioedema, and even shock and other symptoms, then cause allergic components in vaccine containing immunizations, must be careful, best not to the same vaccine inoculation.If you have to inject, you must reflect the baby's allergies to the doctor, the doctor prepared rescue measures after vaccination. Special remind parents, must choose regular medical institutions to vaccinate, do not buy the baby aftertheir own inoculation, so as to avoid adverse consequences.。
Immunization免疫,免疫系统,全英版
GENETICALLY ENGINEERED VACCINES
Hepatitis
B
American Academy of Family PhysiciansMorbidity and (AAFP) Mortality Weekly Report (MMWR).
Vaccine development and testing.
VACCINATION SCHEDULE
1. 2. 3. 4. 5. 6. 7.
The followings are the common infectious diseases against which world health organization(WHO) recommends routine immunization. Tuberculosis Diphtheria Pertusis Tetanus Polio Measles Hepatitis B.
HERD IMMUNITY
Herd immunity exists if the number of people in a community who have active immunity against an infection exceeds a critical level. If these level is achieved then even nonvaccinated individuals are protected from getting the disease. In this way transmission falls or stops without universal immunity.
EXPANDED PROGRAMME ON IMMUNIZATION (EPI)
医学微生物学――第十一章 厌氧性细菌
医学微生物学――第十一章厌氧性细菌1．厌氧芽胞梭菌与无芽胞厌氧菌具有的共性是____________。
a．形态染色性b．专性厌氧c．在人体的分布d．致病性e．对人体的危害2．厌氧芽胞梭菌能耐受恶劣环境条件是因为有____________。
a．菌毛b．鞭毛c．荚膜d．芽胞e．内毒素3．破伤风梭菌除致破伤风外还能引起____________。
a．菌血症b．食物中毒c．组织坏死d．坏死性肠炎e．以上都不是4．关于破伤风梭菌的致病性，叙述正确的是____________。
a．该菌污染意外创伤部位或手术伤口而感染b．该菌及其产生的毒素入血引起脓毒血症c．毒素入血产生全身中毒症状d．毒素通过神经、淋巴液、血液到达中枢与周围神经系统e．毒素通过重链与脊髓及脑干组织细胞表面受体结合，通过轻链毒性作用而使肌肉痉挛5．破伤风痉挛毒素作用于____________。
a．神经细胞b．红细胞c．粒细胞d．巨噬细胞e．成纤维细胞6．破伤风梭菌感染的重要条件是____________。
a．该菌芽胞污染伤口b．菌群失调c．伤口厌氧微环境d．该菌的繁殖体污染伤口e．机体无免疫力7．关于破伤风痉挛毒素的特性，叙述正确的是____________。
a．属神经毒素b．属肠毒素c．属细胞毒素d．仅作用于外周神经e．毒性不强8．当一民工因铁钉深刺足底送医院急诊时，医生应首先考虑注射____ ________。
a．破伤风类毒素b．破伤风抗毒素c．白百破三联疫苗d．丙种球蛋白e．破伤风菌苗9．用破伤风抗毒素治疗破伤风，其目的是____________。
a．抑制破伤风梭菌的生长b．阻止细菌产生毒素c．中和结合神经细胞上的外毒素d．中和游离在神经细胞外的外毒素e．中和进入血液中的外毒素10．产气荚膜梭菌可分为多个血清型，对人致病的主要为___________ _。
a．E型b．D型c．C型d．B型e．A型11．产气荚膜梭菌除可引起气性坏疽外，还可引起____________。
成人预防接种
（二）、目前最常被建议的成人预防注射的项目？
5、Ａ型肝炎疫苗：(Hepatitis A vaccine)
(1)、只要是没有A 型肝炎保护抗体的人，接可以考虑接种。 (2)、高危险群策略：针对高危险群(有比较高的机会会被感染)
接种疫苗，使他们可以免于被感染。哪些人是高危险群呢？ 计有： 1)、将到疫苗区旅行或工作的人。 2)、同性恋者或多重伴侣者。 3)、静脉药瘾者。 4)、慢性肝病者、B 型、C 型肝病带原者。 5)、工作中有接触A 型肝炎病毒机会者，如实验工作者。 6)、A 型肝炎病患的家人或性伴侣。
PRINCIPLES OF IMMUNIZATION
一. Active immunization: inducing B-cell proliferation antibody response T-cell sensitization *derived from: whole killed bacteria live attenuated bacteria or viruses antigenic subunits of organisms
（二）、目前Biblioteka 常被建议的成人预防注射的项目？ 6、水痘疫苗：（Varicella vaccine） (1)、一般小孩子罹患水痘后的严重并发症(如肺炎、脑炎等)很少见，在年纪愈长时(青少 年以上)才罹患，其临床症状一般较为严重，且发生严重并发症的机会比在孩童时期就 罹患者来得高。
(2)、接种方法：若未曾得过水痘者， 1)、满12 个月以上但小于或等于12 岁者：施打一剂即可。 2)、13 岁以上：施打两剂，间隔为4-8 星期。每剂0.5cc。
immunization rates
出国留学疫苗英文缩写及全称
常用：◆卡介苗BCG (Bacille Calmette-Guerin vaccine)◆A 型肝炎疫苗HepA (Hepatitis A vaccine )◆B 型肝炎疫苗HepB (Hepatitis B vaccine )◆百白破联合疫苗. 即百日咳、白喉和破伤风的联合疫苗DPT (Diphtheria，Pertussis，Tetanus)◆白喉、破伤风、非细胞性百日咳混合疫苗（加强针）DTaP (Diphtheria andtetanus toxoid with acellular pertussis vaccine)◆麻疹、腮腺炎、麻疹混合疫苗MMR麻疹疫苗Measles （Measles vaccine）腮腺炎疫苗Mumps （Mumps vaccine）风疹疫苗Rubella (Rubella vaccine )◆结核菌检测PPD (肺结核TuBerculosis)◆水痘疫苗Chicken poxVaricella (Varicella vaccine )◆流脑/脑膜炎Meningitis流行性脑脊髓膜炎疫苗（A、C 型）MenAC (Meningococcal AC )流行性脑脊髓膜炎疫苗（A、C 、Y 、W 135型）MenACWY (Meningococcal ACWY )◆脊髓灰质炎(小儿麻痹症疫苗) Poliomyelitis口服小儿麻痺疫苗（减毒糖丸）OPV（Oral polio vaccine）注射式小儿麻痹疫苗（灭活脊髓疫苗）IPV (Inactivated polio vaccine ) ◆日本脑炎疫苗（乙脑）JE (Japanese encephalitis vaccine)◆黄热病疫苗YF (Yell ow fever vaccine )PS: BASIC SERIES : 你初次接种的时间(你出生之后注射疫苗的记录本上有) MOST RECENT BOOSTER : 这次注射的时间不常用：人类乳突病毒(只有女学生) HPV (Human Papillomavirus Vaccine)流行性感冒疫苗Influenza (Influenza vaccine)A 型肝炎、B 型肝炎混合疫苗HepA-HepB (Hepatitis A and hepatitis B vaccine ) 德国麻疹疫苗Rubella（Rubella vaccine ）麻疹、腮腺炎混合疫苗MM (Measles and mumps virus vaccine )麻疹、德国麻疹混合疫苗或腮腺炎、德国麻疹混合疫苗MR (Measles and rubella vaccine or Mumps and rubella vaccine )麻疹、腮腺炎、德国麻疹、水痘混合疫苗MMRV (Measl es, mumps, rubella, and varicella virus vaccine )流行性脑脊髓膜炎疫苗（结合型）MCV4 （Meningococcal conjugate vaccine ）流行性脑脊髓膜炎疫苗（多醣体型）MPSV4 （Meningococcal polysaccharide vaccine ）白喉、破伤风混合疫苗DT (Tetanus and diphtheria toxoid chil drens' dose)白喉、破伤风、全细胞性百日咳混合疫苗DTwP (Diphtheria and tetanus toxoid with whole cell pertussis vaccine)白喉、破伤风、非细胞性百日咳、b 型嗜血杆菌混合疫苗DTaP-Hib (Diphtheria and tetanus toxoid with acellular pertussis and haemophilus influenzae type bvaccine )白喉、破伤风、非细胞性百日咳、B 型肝炎、不活化小儿麻痺混合疫苗DTaP-HepB-IPV (Diphtheria and tetanus toxoid with acellular pertussis, hepatitis B and Inactivated polio vaccine )白喉、破伤风、非细胞性百日咳、b 型嗜血杆菌、不活化小儿麻痺混合疫苗DTaP-Hib-IPV (Diphtheria and tetanus toxoid with acellular pertussis, haemophilus influenzae type b and Inactivated polio vaccine )肺炎双球菌疫苗（结合型）PCV （Pneumococcal conjugate vaccine）肺炎链球菌疫苗（多醣体型）PPV （Pneumococcal polysaccharide vaccine ）狂犬病疫苗Rabies（Rabies vaccine ）破伤风、减毒白喉混合疫苗Td （Tetanus and diphtheria toxoid for older children/adults ）破伤风类毒素疫苗TT (Tetanus toxoid)伤寒疫苗Typhoid (Typhoid fever vaccine )b 型嗜血杆菌疫苗Hib (Haemophilus influenzae type b vaccine )b 型嗜血桿菌、B 型肝炎混合疫苗Hib-HepB (Haemophilus influenzae type b and hepatitis B vaccine )轮状病毒疫苗Rota (Rotavirus vaccine)。
疫苗缩写英文全称及相关儿科常见词汇
疫苗缩写＆英文全称及相关儿科常见词汇疫苗英文缩写及全称卡介苗BCG(Bacille Calmette-Guerin vaccine)轮状病毒疫苗Rota (Rotavirus vaccine)A 型肝炎疫苗HepA (Hepatitis A vaccine )B 型肝炎疫苗HepB (Hepatitis B vaccine )白喉、破伤风、无细胞百日咳混合疫苗DTaP (Diphtheria and tetanus toxoidwith acellular pertussis vaccine)b 型嗜血杆菌疫苗Hib (Haemophilus influenzae type b vaccine )肺炎双球菌疫苗（结合型）PCV （Pneumococcal conjugate vaccine）肺炎链球菌疫苗（多醣体型）PPV （Pneumococcal polysaccharide vaccine ）流行性感冒疫苗Influenza (Influenza vaccine)麻疹、腮腺炎、德国麻疹混合疫苗MMR（Measles, mumps and rubella vaccine）流行性脑脊髓膜炎疫苗（结合型）MCV4 （Meningococcal conjugate vaccine ）流行性脑脊髓膜炎疫苗（多醣体型）MPSV4 （Meningococcal polysaccharidevaccine ）流行性脑脊髓膜炎疫苗（A、C 型）MenAC (Meningococcal AC )流行性脑脊髓膜炎疫苗（A、C 、Y 、W 135型）MenACWY (Meningococcal ACWY )麻疹疫苗Measles （Measles vaccine ）德国麻疹疫苗Rubella（Rubella vaccine ）白喉、破伤风混合疫苗DT (Tetanus and diphtheria toxoid childrens\\\' dose)白喉、破伤风、全细胞性百日咳混合疫苗DTwP (Diphtheria and tetanus toxoidwith whole cell pertussis vaccine)注射式小儿麻痹疫苗IPV (Inactivated polio vaccine )日本脑炎疫苗JE (Japanese encephalitis vaccine)腮腺炎疫苗Mumps （Mumps vaccine ）口服小儿麻痺疫苗OPV（Oral polio vaccine）狂犬病疫苗Rabies（Rabies vaccine ）破伤风、减毒白喉混合疫苗Td （Tetanus and diphtheria toxoid for older children/adults ）破伤风类毒素疫苗TT (Tetanus toxoid)伤寒疫苗Typhoid (Typhoid fever vaccine )水痘疫苗V aricella (Varicella vaccine )黄热病疫苗YF (Yellow fever vaccine )白喉、破伤风、非细胞性百日咳、b 型嗜血杆菌混合疫苗DTaP-Hib (Diphtheria andtetanus toxoid with acellular pertussis and haemophilus influenzae type bvaccine )白喉、破伤风、非细胞性百日咳、B 型肝炎、不活化小儿麻痺混合疫苗DTaP-HepB-IPV(Diphtheria and tetanus toxoid with acellular pertussis, hepatitis B andInactivated polio vaccine )白喉、破伤风、非细胞性百日咳、b 型嗜血杆菌、不活化小儿麻痺混合疫苗DTaP-Hib-IPV (Inactivated polio vaccine )b 型嗜血桿菌、B 型肝炎混合疫苗Hib-HepB (Haemophilus influenzae type b andhepatitis B vaccine )A 型肝炎、B 型肝炎混合疫苗HepA-HepB (Hepatitis A and hepatitis B vaccine )麻疹、腮腺炎混合疫苗MM (Measles and mumps virus vaccine )麻疹、德国麻疹混合疫苗或腮腺炎、德国麻疹混合疫苗MR (Measles and rubellavaccine or Mumps and rubella vaccine )麻疹、腮腺炎、德国麻疹、水痘混合疫苗MMRV (Measles, mumps, rubella, andvaricella virus vaccine )腮腺炎疫苗Mumps (Mumps vaccine)＊儿科医学常见词汇(zt)儿科学Pediatrics儿童保健Child care疾病防治Disease prevention营养基础Basal nutrition婴儿喂养Infants' feeding营养不良Malnutrition小儿肥胖obesity in Childhood解剖Anatomy生理生化Physiology and biochemistry营养代谢Nutrition and Metabolism免疫Immunity病理Pathology疾病的种类Variety of Disease临床表现Clinical Situation诊断Diagnosis治疗Treatment预后Prognosis预防Prevention胎儿期Fetal Stage胚卵期Ovigerm Stage胚胎期Embryo Stage新生儿期Neonatal Period脐带Omphalus足月儿Term Infant早产儿Premature过期产儿Post term Infant围产期Perinatal stage婴儿期Infancy幼儿期Toddler Period学龄期School age青春期Adolescence遗传inheritance性别sex内分泌endocrine孕母情况mother's condition营养nutrition。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
3 ug
Al3+
0.33 mg 0.33 mg
Td 2 Lf 5 Lf
0.33 mg
Basis for Licensure:
Demonstration of non-inferiority of the safety profile of ADACEL™ as compared to a U.S.-licensed Td vaccine.
ADACEL™
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine,
Adsorbed (Tdap)
March 15,2019 FDA Introduction, Martha Monser
Regulatory History
Basis for Licensure (cont):
Demonstration of boosting responses to each of the pertussis antigens.
Demonstration of non-inferiority of the immune responses to the pertussis antigens as compared to the immune responses observed in the Sweden I Efficacy Trial.
APL Manufactured Vaccine Formulations:
Antigen ADACEL™ DAPTACEL®
Diphtheria 2 Lf
15 Lf
Tetanus 5 Lf
5 Lf
PT
2.5 ug
10 ug
FHA
5 ug
5 ug
FIM 2/3 2.5 ug
2.5 ug
PRN
3 ug
Questions:
Are the available data adequate to support the efficacy of ADACEL™ in individuals 11-64 years of age? VOTE
Are the available data adequate to support the safety of ADACEL™ when administered to individuals 11 – 64 years of age? VOTE
Basis for Licensure (cont):
Demonstration of the consistency of manufacture based on safety and immunogenicity of three consecutively produced ADACEL™ vaccine lots.
Discussion:
Please identify any issues which should be
addressed, including post-licensure studies.
Basis for Licensure (cont):
Demonstration of non-inferiority of the immune responses of tetanus and diphtheria, as compared to a U.S.-licensed Td vaccine: – Percentage of subjects attaining seroprotective levels – Booster responses
Manufacturer: Aventis Pasteur Limited (APL), Toronto, Ontario
A3, 2019
Proposed Indication/Dosage:
Active immunization for the prevention of diphtheria, tetanus and pertussis in adolescents and adults aged 11-64 years as a single 0.5 mL intramuscular booster dose