2015-2019年河南省洛阳市含无细胞百白破成分联合疫苗预防接种安全性分析

目的 分析河南省洛阳市无细胞百白破联合疫苗（DTaP）、无细胞百白破b型流感嗜血杆菌（结合）联合疫苗（DTaP-Hib）、无细胞百白破灭活脊灰和b型流感嗜血杆菌（结合）联合疫苗（DTaP-IPV/Hib）的预防接种安全性。方法通过中国免疫规划信息管理系统收集2015-2019年洛阳市报告的DTaP、DTaP-Hib和DTaP-IPV/Hib疑似预防接种异常反应（AEFI）个案数据,采用描述流行病学方法进行分析。结果 2015-2019年洛阳市含DTaP成分疫苗报告AEFI个案2 924例,报告发生率160.06/10万剂,其中DTaP为154.82/10万剂、DTaP-Hib为239.48/10万剂、DTaP-IPV/Hib为234.20/10万剂,3类疫苗AEFI报告发生率差异具有统计学意义（χ2=46.283,P<0.05）;男女比例1.34∶1,3～24月龄2 728例（93.30%）,接种后1 d内报告2 724例（93.16%）;一般反应报告2 890例（98.84%）,多以发热、红肿、硬结为主,异常反应报告29例（0.99%）,主要临床诊断为过敏性反应疾病、局部化脓性...     

2018—2021年扬州市无细胞百白破联合疫苗预防接种安全性评价

目的：分析扬州市无细胞百白破联合疫苗（DTap）接种后出现疑似预防接种异常反应（AEFI）的发生特征及分布情况,为进一步评价DTaP疫苗预防接种的安全性提供依据。方法：通过中国免疫规划信息管理系统的AEFI监测系统收集2018年1月1日—2021年12月31日扬州市报告的DTaP疫苗相关AEFI个案数据,采用描述流行病学方法进行分析。结果：2018—2021年扬州市共接种DTaP疫苗365 215剂次,共报告DTaP疫苗相关AEFI个案1 055例,年均报告发生率为288.87/10万剂次,其中,一般反应1 015例,占96.21%,报告发生率为277.92/10万剂次,临床表现主要为发热、红肿、硬结;异常反应38例,占3.60%,报告发生率为10.40/10万剂次,主要为过敏性皮疹和荨麻疹;偶合症最少,共2例,占0.19%,报告发生率为0.55/10万剂次,均为热性惊厥;无心因性反应、疫苗质量事故及预防接种事故发生。9个县（市、区）各年度均有DTaP疫苗相关AEFI个案报告,其中,报告发生例数最多的为江都区,为232例;各月份均有DTaP疫苗相关AEFI个案报告,其中5、6、7月份报...     

2018—2021 预防接种安全性评价 年扬州市无细胞百白破联合疫苗

摘 要：目的：分析扬州市无细胞百白破联合疫苗 （DTap） 接种后出现疑似预防接种异常反应 （AEFI） 的发生特征及 分布情况,为进一步评价DTaP疫苗预防接种的安全性提供依据。方法：通过中国免疫规划信息管理系统的AEFI监测系统收 集 2018 年 1 月 1 日—2021 年 12 月 31 日扬州市报告的 DTaP疫苗相关 AEFI个案数据,采用描述流行病学方法进行分析。结 果：2018—2021 年扬州市共接种 DTaP 疫苗 365 215 剂次,共报告 DTaP 疫苗相关 AEFI 个案 1 055 例,年均报告发生率为 288.87/10万剂次,其中,一般反应1 015例,占96.21%,报告发生率为277.92/10万剂次,临床表现主要为发热、红肿、硬 结;异常反应 38 例,占 3.60%,报告发生率为 10.40/10 万剂次,主要为过敏性皮疹和荨麻疹;偶合症最少,共 2 例,占 0.19%,报告发生率为 0.55/10 万剂次,均为热性惊厥;无心因性反应、疫苗质量事故及预防接种事故发生。9 个县 （市、 区）各年度均有DTaP疫苗相关AEFI个案报告,其中,报告发生例数最多的为江都区,为232例;各月份均有DTaP疫苗相关 AEFI个案报告,其中5、6、7月份报告例数较多。1 055例AEFI个案中,男性621例,女性434例,男女性别比为1.43∶1; 年龄分布主要以0岁组 （271例） 和1岁组 （731例） 病例为主;97.91%的病例随访结果为好转或痊愈。结论：扬州市DTap 疫苗预防接种安全性较好,监测系统敏感性较高。     

2017-2019年天津市某区含无细胞百白破联合疫苗预防接种安全性评价

目的 评价天津市滨海新区含无细胞百日咳、白喉和破伤风联合疫苗(DTaP)成分的联合疫苗预防接种安全性.方法 通过中国免疫规划信息管理系统AEFI信息管理系统收集2017-2019年天津市滨海新区报告的DTaP、DTaP-b型流感嗜血杆菌联合疫苗(DTaP-Hib)和DTaP-灭活脊髓灰质炎-Hib联合疫苗(DTaP-I...     

适龄儿童接种无细胞百白破b型流感嗜血杆菌联合疫苗疑似预防接种异常反应主动监测北大核心

目的评价无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP-Hib)的疑似预防接种异常反应(AEFI)发生率。方法于2019年7月-2020年6月采用方便抽样,选取中国7个省份172个区县1151个接种门诊的3-24月龄健康儿童接种4剂次DTaP-Hib,通过每日电话随访收集每剂次接种后7d内发生的AEFI,描述性分析AEFI发生率。结果适龄儿童接种DTaP-Hib的AEFI总发生率为35.3/万剂(1240/351598)。局部反应发生率(/万剂)为25.3,其中肿胀、发红、硬结分别为19.2、18.2、11.7;全身反应发生率(/万剂)为9.2,其中发热、过敏反应分别为8.4、0.3。1级、2级、3级、4级AEFI发生率(/万剂)分别为18.7、12.0、2.1、0.0。结论适龄儿童接种DTaP-Hib的AEFI发生率在预期范围内,以轻微不良反应为主,严重不良反应罕见。     

2015-2017年湖北省含B型流感嗜血杆菌成分疫苗安全性分析

目的 分析2015-2017年湖北省3种含B型流感嗜血杆菌成分疫苗的疑似预防接种异常反应(adverse events following immunization,AEFI)发生特征,评价预防接种安全性。方法 收集2015-2017年湖北省在中国AEFI信息管理系统接种报告的B型流感嗜血杆菌结合疫苗(Hib)、DTaP-b型流感嗜血杆菌联合疫苗(DTaP-Hib)与DTaP-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗(DTaP-IPV/Hib)个案数据,采用描述性流行病学方法分析。结果 2015-2017年湖北省共报告含B型流感嗜血杆菌成分疫苗的AEFI 1391例(50.80/10万剂),其中一般反应1276例(46.60/10万剂),异常反应100例(3.65/10万剂);Hib、DTaP-Hib、DTaP-IPV/Hib 3种疫苗的AEFI分别为753例(37.40/10万剂)、354例(88.41/10万剂)、284例(87.56/10万剂)。DTaP-Hib和DTaP-IPV/Hib疫苗一般反应报告发生率高于Hib疫苗一般反应报告发生率;3种疫苗加强免疫报告发生率高于基础免疫报告发生率。3种疫苗一般反应均以发热(27.61/10万剂)、局部红肿(21.51/10万剂)、局部硬结(10.19/10万剂)为主;异常反应主要为过敏性皮疹(3.36/10万剂)。结论 含B型流感嗜血杆菌成分的3种疫苗AEFI报告发生率较低,均具有良好的安全性。     

2010-2019年灌云县无细胞百白破疫苗安全性分析

目的 .了解近10年灌云县无细胞百白破疫苗(DTaP)接种安全性.方法 采用描述性流行病学方法,对2010-2019年灌云县DTaP接种和疑似预防接种异常反应(AEFI)个案进行分析.结果 2010-2019年,灌云县共报告DTaP AEFI581例,年报告发生率(86.55～296.86)/10万剂次,平均170.4...     

吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析

目的 评价中国(未包括香港、澳门特别行政区和台湾地区,下同)吸附无细胞百白破联合疫苗(Diphtheria Teta-nus and Acellular Pertusis Combined Vaccine,Absorbed;DTaP)和吸附全细胞百白破联合疫苗(Diphtheria,Tetanus andwhole-cell Pertusis Combined Vaccine,Absorbed;DTwP)上市后预防接种的安全性.方法 通过全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测系统,收集10个试点省2005～2006年DTaP和DTwP严重不良反应监测数据,采用描述性方法对两种疫苗不良反应的发生特征进行比较分析.结果 中国DTaP和DTwP上市后,严重不良反应总发生率分别为3.5/10万剂和3.3/10万剂;DTaP以过敏反应为主,且第4剂反应危险性高;DTwP以无菌脓肿为主,高危险性反应剂次因反应的临床损害不同而异;部分疫苗品种和批号的反应存在聚集性,DTwP聚集性反应危险高于DTaP.结论 DTaP和DTwP上市后均具有较好的预防接种安全性;聚集性分析显示,DTaP安全性优于DTwP;需进一步加强对每批DTaP或DTwP上市前的质量控制.     

南平市2017-2019年无细胞百白破疫苗疑似预防接种异常反应监测分析

目的 分析南平市无细胞百白破疫苗的疑似预防接种异常反应(AEFI)病例发生特征,评价监测系统运转情况,为疫苗安全性评价提供依据.方法 用描述性流行病学方法,用Excel软件整理数据、SPSS 18.0软件统计分析.结果 南平市2017-2019年共报告无细胞百白破疫苗相关AEFI病例238例(一般反应235例、异常反应...     

2019-2021年河南省漯河市无细胞百白破疫苗疑似预防接种异常反应监测

目的 分析河南省漯河市无细胞百白破疫苗（DTaP）疑似预防接种异常反应（AEFI）的发生特点。方法 通过中国免疫规划信息管理系统AEFI信息管理系统收集漯河市2019-2021年DTaP AEFI个案信息,通过河南省免疫规划信息系统收集DTaP接种剂次数据,采用描述性流行病学方法进行分析。结果 共接种DTaP 204 488剂次,报告AEFI病例551例,报告发生率269.45/10万剂;2019-2021年报告发生率分别为263.74/10万剂、329.98/10万剂、206.37/10万剂,不同年度差异有统计学意义（P<0.05）;男女性别比为1.32∶1,2岁以下儿童占93.28%;各月均有病例报告,主要在5-7月,占39.20%;以一般反应为主,占98.73%,主要表现为发热。发生AEFI后到医疗机构就诊率为36.12%,不同年度就诊率差异有统计学意义（P<0.05）。结论 漯河市DTaP预防接种安全性良好,应加强监测,规范开展接种告知。     

Persistence of antibodies 3 years after booster vaccination of adults with combined acellular pertussis, diphtheria and tetanus toxoids vaccine

The duration of protection after vaccination with reduced antigen content diphtheria, tetanus and acellular pertussis vaccines (Tdap) is not known. Long-term post-vaccination serological data will help to improve understanding of the duration of humoral immunity and guide vaccination policy for the timing of repeat dose administration. The persistence of antibodies to Tdap antigens was measured 3 years after vaccination of adults 19-64 years of age with one of 2 Tdap vaccines (Boostrix^®, GlaxoSmithKline Biologicals; Tdap-B: or Adacel^®, Sanofi Pasteur; Tdap-A). In both groups, geometric mean concentrations for antibodies to diphtheria, tetanus, and pertussis vaccine antigens were decreased at year 3 relative to levels observed 1 month and 1 year following vaccination, but remained higher than pre-vaccination levels. Seroprotection rates for diphtheria and tetanus remained high for both Tdap vaccines (for diphtheria, 96.9% and 97.8% for the Tdap-B and Tdap-A groups, respectively; for tetanus, 98.1% and 99.6%, respectively).     

周口市川汇区城区3～6月龄婴儿接种无细胞百白破三联疫苗不良反应观察

[目的]观察无细胞百白破三联疫苗(DTaP)免疫接种后不良反应发生情况。[方法]2010年4~5月,对周口市川汇区所辖城区接种门诊3~6月龄健康婴儿接种DTaP后的不良反应。[结果]接种DTaP儿童391名,合计接种1 039针次,发生不良反应的59例次,发生率为5.68%。不良反应发生率,基础免疫第1针、第2针、第3针分别为8.95%、5.56%、3.09%,加强免疫为2.99%(P<0.01);局部、全身反应分别为2.50%、3.18%,弱、中、强反应发生率分别为4.42%、1.07%、0.19%。[结论]DTaP安全可靠。     

Post-licensure comparison of the safety profile of diphtheria/tetanus/whole cell pertussis/haemophilus influenza type b vaccine and a 5-in-1 diphtheria/tetanus/acellular pertussis/haemophilus influenza type b/polio vaccine in the United Kingdom

General practitioner consultation data were used to compare the reactogenicity in infants of a 5-in-1 acellular pertussis vaccine (DTaP₅/Hib/IPV) introduced in the United Kingdom in 2004 to the 4-in-1 whole cell-pertussis vaccine (DTwP/Hib) that it replaced. For each vaccine the incidence in the week following vaccination was compared to other periods to obtain a relative incidence. A lower relative incidence of crying, fever and local reactions was seen with DTaP₅/Hib/IPV than DTwP/Hib. Although there were no other significant differences between vaccines the relative incidence was significantly above one on the day of vaccination for convulsions following DTwP/Hib and for apnoea/collapse following DTaP₅/Hib/IPV.     

HPLC-RID法测定吸附无细胞百白破联合疫苗中甘油的残留量

通过对婴儿接种吸附无细胞百白破联合疫苗（diphtheria, tetanus and acellular pertussis combined vaccine, DTaP）后局部不良反应的主动监测,评价婴儿接种DTaP的安全性。

于2020 年 7 月— 2021 年 3 月,对在江苏省滨海县东坎镇、陈涛镇、界牌镇、滨海现代农业产业园4个乡镇卫生院接种DTaP的3～5月龄婴儿局部不良反应进行主动监测,并按照《预防用疫苗临床试验研究不良事件分级标准指导原则》（2019 年第102号）对发生的局部不良反应进行分级,用描述流行病学方法进行局部不良反应分析。

共有2 490人次纳入至本次DTaP接种后局部不良反应主动监测分析中。DTaP 接种后,局部不良反应1 009例次,总发生率为40.52%,其中局部硬结和红晕发生率最高,分别为14.4%和17.0%。1 级局部不良反应发生率为35.9%（893/2 490）,其中硬结和红晕占比最高,分别占38.18%（341/893）和42.89%（383/893）;2 级局部不良反应发生率为4.66%（116/2 490）,其中红晕和触痛占比最高,分别占34.48%（40/116）和26.72%（31/116）;未见 3 级及以上局部不良反应。局部不良反应多发生在 DTaP接种后 3d 内,占总发生率的 98.0%（988/1 009）。硬结和红晕的发生率在 3 个不同厂家（A、B、C厂家）DTaP 受种儿间差异有统计学意义（P < 0.05）。不同剂次 DTaP 接种后,硬结、肿胀、红晕和皮疹发生率差异有统计学意义（P < 0.05）,其中第 2 剂、第 3 剂 DTaP 接种后硬结、肿胀、红晕发生率明显高于第 1 剂（P < 0.01）,第 3 剂 DTaP 接种后皮疹发生率明显高于第1 剂（P < 0.05）。男、女婴儿接种DTaP后局部不良反应发生率分别为 40.71%（517/1270）和40.33%（492/1220）,差异无统计学意义（P > 0.05）。

硬结、红晕和肿胀为3～5月龄婴儿DTaP 接种后发生的主要局部不良反应。

     

吸附无细胞百白破联合疫苗安全性研究

目的研究吸附无细胞百白破联合疫苗在人群中应用的安全性,为评价纳入国家免疫规划疫苗安全性提供依据。方法在浙江省4个县（市、区）选择3—5月龄的初免儿童3235人,18～2,4月龄加强免疫儿童3198名,按照免疫程序接种本次研究观察的无细胞百白破疫苗,进行接种后安全性观察。结果初免儿童3剂次基础免疫总不良反应发生率分别为6．28％、6．39％、6．26％,差异无统计学意义（X2=0．05,P〉0．05）。基础免疫平均不良反应发生率为6．31％,与加强免疫的总体不良反应发生率14．57％比较差异有统计学意义（X2=1049,P〈0．01）。大部分不良反应发生在接种后30min内。全身不良反应以发热和皮疹为主,局部反应以注射处触痛为主。各剂次不良反应发生程度均以轻度和中度反应为主,未见严重不良反应及新的、罕见的不良反应。结论本次观察研究中的无细胞百白破疫苗临床反应轻微,具有良好的安全性。     

Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose

Background

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine during adulthood is not currently recommended.

Methods

This open-label, multicenter study compared the safety and immunogenicity of a first dose of an adult formulation of tetanus, diphtheria, and acelluar pertussis vaccine (Tdap) with a repeat dose of Tdap in adults who had received Tdap 10 years previously.

Results

A total of 769 participants ranging in age from 20 to 72 years took part in this study; 92.3% of naïve and 92.7% of repeat-dose participants had at least one solicited adverse event. Injection-site pain (84.4% and 87.8%), erythema (29.7% and 23.1%), and swelling (23.3% and 20.5%), and myalgia (53.5% and 60.1%), headache (37.6% and 40.6%), malaise (29.0% and 29.4%), and fever (4.9% and 4.2%) were the most common solicited adverse events reported in the naïve and repeat-dose groups, respectively. Postvaccination antibody levels ≥0.1 IU/mL were achieved by 99.7% of the naïve-group participants and all of the repeat-dose participants for tetanus and 96.1% of the naïve group and 98.5% of the repeat-dose group for diphtheria, both meeting the predefined noninferiority criteria. For pertussis antibodies, anti-PT (89.2 EU/mL vs. 116 EU/mL) was higher in the repeat-dose group, anti-FHA (249 vs. 214) and anti-PRN (216 vs. 266) were similar, and anti-FIM (1015 vs. 779) was higher in the naïve group. Noninferiority criteria were met for all antigens except for anti-FIM.

Conclusion

A repeat dose of Tdap vaccine 10 years after the first dose was well tolerated and immunogenic in adults (ClinicalTrials.gov identifier: NCT00712959).     

Immunogenicity of a low-dose diphtheria,tetanus and acellular pertussis combination vaccine with either inactivated or oral polio vaccine compared to standard-dose diphtheria,tetanus, acellular pertussis when used as a pre-school booster in UK children: A 5-year follow-up of a randomised controlled study

This serological follow up study assessed the kinetics of antibody response in children who previously participated in a single centre, open-label, randomised controlled trial of low-dose compared to standard-dose diphtheria booster preschool vaccinations in the United Kingdom (UK). Children had previously been randomised to receive one of three combination vaccines: either a combined adsorbed tetanus, low-dose diphtheria, 5-component acellular pertussis and inactivated polio vaccine (IPV) (Tdap–IPV, Repevax^®; Sanofi Pasteur MSD); a combined adsorbed tetanus, low-dose diphtheria and 5-component acellular pertussis vaccine (Tdap, Covaxis^®; Sanofi Pasteur MSD) given concomitantly with oral polio vaccine (OPV); or a combined adsorbed standard-dose diphtheria, tetanus, 2-component acellular pertussis and IPV (DTap–IPV, Tetravac^®; Sanofi Pasteur MSD). Blood samples for the follow-up study were taken at 1, 3 and 5 years after participation in the original trial (median, 5.07 years of age at year 1), and antibody persistence to each vaccine antigen measured against defined serological thresholds of protection.All participants had evidence of immunity to diphtheria with antitoxin concentrations greater than 0.01 IU/mL five years after booster vaccination and 75%, 67% and 79% of children who received Tdap–IPV, Tdap + OPV and DTap–IPV, respectively, had protective antitoxin levels greater than 0.1 IU/mL. Long lasting protective immune responses to tetanus and polio antigens were also observed in all groups, though polio responses were lower in the sera of those who received OPV.Low-dose diphtheria vaccines provided comparable protection to the standard-dose vaccine and are suitable for use for pre-school booster vaccination.     

Comparison of whole-cell versus acellular pertussis vaccine effectiveness in school clusters of pertussis,France, 2013

Objectives and methodWe conducted a prospective study in 2013 to compare the whole-cell versus acellular pertussis vaccines effectiveness and duration of protection, following the occurrence of pertussis clusters.ResultsDuring seven school outbreaks, we identified 102 clinical pertussis cases, including 10 cases biologically confirmed by Bordetella pertussis specific PCR, among a cohort of 305 children in 2nd to 6th grade. The risk of pertussis when vaccinated with an acellular vaccine alone was 1.6 (RR = 1.6; 95% CI = 1.1–2.5) times higher than when vaccinated with a whole-cell vaccine or using a combined schedule.ConclusionsThe limited duration of protection conferred by the acellular vaccine reinforces the 2013 introduction of the pertussis booster at six years old.     

Tolerability and antibody response in adolescents and adults revaccinated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) 4-5 years after a previous dose

Background

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine is not currently recommended for adults.

Methods

This open-label, postmarketing, multicenter study evaluated the tolerability and immunogenicity of a second dose of an adult formulation of tetanus, diphtheria, and pertussis vaccine (Tdap) in adolescents and adults 5 years after a first dose.

Results

A total of 545 participants from previous Tdap vaccine studies, ranging in age from 15 to 69 years, participated in this study. Of these participants, 94.2% had at least one solicited adverse event after the booster dose such as injection-site erythema (28.6%), swelling (25.6%), or pain (87.6%) or a systemic adverse event such as myalgia (61.0%), headache (53.2%), malaise (38.2%), or fever (6.5%). These adverse events were slightly more frequent than after the initial dose. Postvaccination, 100% of participants had a tetanus antibody level ≥0.10 IU/mL and 95% had a diphtheria antibody level ≥0.10 IU/mL. For pertussis, 82.1% (pertussis toxoid), 96.7% (filamentous hemagglutinin), 95.6% (pertactin), and 99.8% (fimbriae) had a postvaccination antibody threshold of ≥50 EU/mL.

Conclusion

A second dose of Tdap vaccine 5 years after the initial dose was well tolerated and immunogenic in adolescents and adults.