中国2018-2019年和2019-2020年流感季流感疫苗疑似预防接种异常反应监测

目的 分析中国流感疫苗(Influenza vaccine, InfV)疑似预防接种异常反应(Adverse events following immunization, AEFI)发生特征。方法 通过中国疾病预防控制信息系统收集2018-2019年和2019-2020年流感季InfV接种数据及AEFI报告数据,描述性分析AEFI分布特征和报告发生率。结果 两个流感季中国共报告12 383例InfV AEFI,总报告发生率为41.04/10万,其中一般反应、异常反应分别为37.41/10万、2.19/10万。一般反应中高热、局部红肿(直径>2.5cm)、局部硬结(直径>2.5cm)报告发生率分别为18.28/10万、5.95/10万、1.85/10万;异常反应中过敏性皮疹、热性惊厥、血管性水肿报告发生率分别为1.51/10万、0.16/10万、0.16/10万。结论 中国2018-2019年和2019-2020年流感季InfV不良反应报告水平在可接受范围内,应继续加强InfV AEFI监测,提高监测质量。     

鞍山市2015-2018年儿童免疫规划疫苗安全性监测分析

目的 通过分析鞍山市2015-2018年疑似预防接种异常反应(AEFI)的发生特征, 评价鞍山市儿童免疫规划疫苗的安全性。方法 通过AEFI信息管理系统收集2015-2018年鞍山市AEFI个案数据, 采用描述性流行病学方法进行分析。结果 鞍山市2015-2018年累计报告儿童免疫规划疫苗AEFI病例863例, 其中2015年报告199例、2016年报告231例、2017年报告170例、2018年报告263例。总报告发生率为42.53/10⁵, 其中一般反应796例, 占92.24%;异常反应39例, 占4.52%;偶合症26例, 占3.01%;心因性反应1例, 占0.12%;待定1例, 占0.12%。0~1岁年龄段共报告649例, 占总报告数的75.20%。报告数和发生率最高的疫苗为吸附无细胞百白破联合疫苗, 报告336例(93.19/10万)。结论 鞍山市AEFI监测灵敏度较高, 儿童免疫规划疫苗安全性较好。     

2016 - 2018年浦东新区流感疫苗疑似预防接种异常反应监测结果分析

目的 评价浦东新区2016 - 2018年流感疫苗预防接种的安全性,为流感疫苗接种提供科学依据。方法 收集疑似预防接种异常反应信息管理系统中2016 - 2018年浦东新区流感疫苗疑似预防接种异常反应（adverse events following immunization,AEFI）监测数据,采用R3.4软件进行统计分析。结果 2016 - 2018年浦东新区流感疫苗AEFI报告发生率为15.72/100万剂次,其中一般反应报告发生率为15.68/100万剂次,异常反应报告发生率为0.05/100万剂次,未发现偶合症和心因性反应。2016 - 2018年接种疫苗发热者288例,占82.76%;局部红肿64例,占18.39%,局部硬结14例,占4.02%,其他症状间73例,占20.98%。接种0.25 ml剂量发热者199例(69.10%),接种0.50 ml剂量发热者89例(30.90%),不同接种剂量发热率差异有统计学意义（P = 0.040）。结论 浦东新区流感疫苗AEFI报告发生率低于其他省份,应继续强化接种门诊人员培训,积极开展预防接种宣传,加强流感疫苗AEFI监测,提升疫苗AEFI数据的可信性。     

2015 - 2018年简阳市疑似预防接种异常反应监测分析

目的 分析简阳市2015 - 2018年疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）特征,评价监测系统运转情况及AEFI监测工作质量。方法 通过中国免疫规划信息管理系统收集简阳市2015 - 2018年AEFI数据,采用描述流行病学的方法对监测数据进行统计分析。结果 简阳市2015 - 2018年共报告AEFI个案320例,乡镇覆盖率100%。其中一般反应282例,异常反应33例,偶合症5例。报告发生率为25.95/10万剂,其中一般反应发生率为22.87例/10万剂,异常反应发生率为1.76例/10万剂,无心因性反应、接种事故和疫苗质量事故发生。AEFI病例主要分布在1岁及以下儿童,占41.88%。 接种后1 d内发生的AEFI有281例,占87.81%。 48 h内报告率为99.06%,48 h内调查率100%,个案调查表在调查后3 d内报告率为86.84%,AEFI分类率100%。结论 简阳市2015 - 2018年AEFI报告例数逐年增加,但监测敏感性在成都市所有区县中仍处于较低水平,存在迟报、漏报现象,可通过加强设施设备投入,加强督导考核、培训宣传等方法,进一步提高AEFI监测工作质量。     

2015-2018年天津市疑似预防接种异常反应监测分析

目的 对2015-2018年天津市疑似预防接种异常反应(adverse events following immunization,AEFI))监测结果进行流行病学特征分析,为疫苗的安全使用提供依据。方法 采用描述流行病学方法,对2015-2018年天津市AEFI监测资料进行统计学分析。结果 2015-2018年天津市共报告AEFI病例10378例,报告发生率分别为60.03/10万、57.32/10万、62.53/10万和67.48/10万,2016-2018年报告发生率有上升趋势(〖XC小五号.EPS;P〗趋势=35.256,P＜0.001)。小于等于1岁组最多(占74.40%)。5-8月份高发。88.01%发生在接种疫苗后48小时内。一般反应和偶合症的构成逐年上升(〖XC小五号.EPS;P〗趋势=4.026,P=0.045;〖XC小五号.EPS;P〗趋势=11.896,P=0.001)。一般反应以发热为主,异常反应以过敏性皮疹为主。AEFI报告发生率前3位为麻风疫苗(314.07/10万)、DTaP-IPV-Hib五联疫苗(289.22/10万)、23价肺炎疫苗(268.56/10万)。麻疹和麻风疫苗、3种含百白破成分的疫苗、乙脑减毒和灭活疫苗、EV71(Vero)和EV71(二倍体)AEFI发生率均有统计学差异(〖XC小五号.EPS;P〗=204.003,P<0.001;〖XC小五号.EPS;P〗=59.864,P<0.001;〖XC小五号.EPS;P〗=57.975,P<0.001;〖XC小五号.EPS;P〗=8.106,P=0.004)。结论 疫苗安全性较好,AEFI监测能科学评价接种疫苗的利弊,并能及时进行处置,应进一步加强AEFI监测工作。     

2019—2021年广东省流感疫苗疑似预防接种异常反应监测分析

目的 评估广东省流感疫苗安全性。方法 通过中国疾病预防控制信息系统—免疫规划模块收集2019年1月至2021年5月广东省流感疫苗疑似预防接种异常反应（AEFI）监测数据,采用STATA 14.0进行数据分析。结果 2019年1月至2021年5月广东省流感疫苗共报告AEFI 1 431例,报告发生率20.32/10万剂次,三价流感疫苗报告发生率（21.52/10万剂次）高于四价流感疫苗（17.65/10万剂次）。不良反应1 239例,报告发生率为17.60/10万剂次。一般反应987例,报告发生率为14.02/10万剂次,以发热为主（75.76%）;异常反应252例,报告发生率为3.58/10万剂次,以过敏性皮疹为主（71.43%）。异常反应疾病转归为好转或治愈占97.62%。结论 广东省流感疫苗接种具有良好的安全性。     

长兴县2015-2018年疑似预防接种异常反应监测

目的了解长兴县疑似预防接种异常反应(AEFI)病例报告发生情况,评价监测工作质量。方法采用描述性流行病学方法,对中国免疫规划信息管理系统中长兴县AEFI报告病例资料进行统计分析。结果长兴县2015-2018年报告AEFI病例299例,年均报告发生率为38.44/10万,不同年份报告发生率差异有统计学意义(χ^2=40.29,P<0.05)。一般反应占86.62%,异常反应占12.71%,偶合症占0.67%。AEFI各项监测指标完成率均为100.00%。报告发生率较高月份为5月(72.21/10万)、6月(56.03/10万),不同月份间AEFI报告发生率差异有统计学意义(χ^2=49.46,P<0.01)。全县各辖区均有AEFI病例报告,报告发生率最高为吕山乡(97.14/10万),不同地区报告发生率差异有统计学意义(χ^2=64.17,P<0.01)。男女比为0.94 1,≤1岁组病例占69.90%。接种疫苗后24h内发生占70.90%,24~48h内占21.07%。涉及AEFI报告疫苗29种,报告发生率最高为DTaP-IPV-Hib五联疫苗(177.37/10万),不同疫苗间AEFI报告发生率差异有统计学意义(χ^2=270.62,P<0.01)。结论长兴县AEFI病例监测工作质量较高,但仍需进一步加强人员培训,定期分析监测数据,提高AEFI监测敏感性。     

2015 - 2017年湖北省口服轮状病毒减毒活疫苗安全性监测分析

目的 分析湖北省2015 - 2017年口服轮状病毒减毒活疫苗（oral live attenuated rotavirus vaccine,ORV）疑似预防接种异常反应（adverse Events following Immunization, AEFI）的发生特征,评价ORV预防接种的安全性。方法 通过中国AEFI信息管理系统,收集湖北省2015 - 2017年接种ORV发生的AEFI个案数据,采用描述流行病学方法进行分析。结果 湖北省2015 - 2017年接种ORV发生AEFI 223例（33.82/10万剂）,未报告肠套叠等严重AEFI病例,其中一般反应、异常反应分别为197例（29.88/10万剂）和20例（3.03/10万剂次）。一般反应主要表现为发热（25.63/10万剂）和胃肠道反应（9.71/10万剂）,异常反应主要为过敏性皮疹（2.12/10万剂）和荨麻疹（0.91/10万剂）。发病年龄集中在2岁以下,其中51.57%发生在＜1岁,35.43%发生在1~2岁;各剂次中,首剂接种后发生186例（83.41%）、第2剂30例（13.45%）、第3剂7例(3.14%);66.37%的病例发生在接种当天;17.04%发生在接种后1 d;4.48%发生在接种后2 d,0.45%发生在接种后3 d及以上;联合接种时92.04%为一般反应;98.21%病例治愈或好转,无后遗症和死亡病例报告。结论 口服轮状病毒减毒活疫苗具有良好的安全性。     

云浮市2015-2019年疑似预防接种异常反应监测分析

目的 分析云浮市2015-2019年疑似预防接种异常反应(AE FI)的发生特征和AEFI监测系统运转情况.方法 通过全国AEFI信息管理系统收集云浮市2015-2019年报告的个案数据,采用描述性流行病学方法分析AEFI发生情况.结果 云浮市2015-2019年共报告AEFI个案578例,报告发生率8.69/10万剂次.主要发生在5-8月份,共281例,占报告总数的48.62％;年龄以0岁组为主,共217例,占37.54％.90.83％的AEFI病例发生在接种疫苗后24h内.除2015年48 h内报告率、调查表及时报告率和2016年48 h内报告率不达标,其余各年份各指标均达到国家AEFI监测方案的要求.一般反应359例,占62.11％;异常反应192例,占33.22％.报告病例数涉及的的疫苗主要是无细胞百白破联合疫苗(DTaP)、麻疹-风疹联合减毒活疫苗(MR)和流行性乙型脑炎减毒活疫苗(JEV-L);99.48％的病例预后良好.结论 云浮市AEFI监测工作运行良好,预防接种安全.     

Efficacy,immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Background

A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra?, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged?≥?3?years. This study examined the efficacy and safety of IIV4 in children aged 6–35?months.

流感减毒活疫苗预防儿童季节性流感保护效果的Meta分析

目的评价流感减毒活疫苗(LAIV)预防2~17岁儿童季节性流感的保护效果。方法通过Web of Science、PubMed和ScienceDirect数据库,检索2003年1月至2018年11月期间发表的、研究设计为病例对照的、关于研究LAIV预防儿童季节性流感保护效果的相关文献,采用Stata 13.1软件对纳入文献进行Meta分析。结果共纳入文献14篇,均为检测阴性设计(Test-negative design,TND)研究。结果显示LAIV预防儿童季节性流感的保护效果为49%(95%CI:40%~57%)。亚组分析发现:LAIV预防A(H1N1)pdm09型、A(H3N2)型和B型流感的保护效果分别为35%(95%CI:5%~56%)、35%(95%CI:21%~46%)和71%(95%CI:55%~82%);三价LAIV和四价LAIV在儿童中的保护效果分别为56%(95%CI:48%~63%)和44%(95%CI:27%~57%);LAIV在欧洲地区和北美洲地区的保护效果分别为65%(95%CI:47%~77%)和46%(95%CI:36%~55%)。结论LAIV对2~17岁儿童季节性流感具有一定的预防作用。     

2010-2018年衢州市出生儿童含b型流感嗜血杆菌成分疫苗接种情况分析

目的分析衢州市2010-2018年出生儿童含b型流感嗜血杆菌(Hib)成分疫苗接种情况,为制定Hib相关免疫决策提供依据。方法从浙江省免疫规划信息管理平台选取2010-2018年出生儿童为研究对象,分析含Hib成分疫苗的接种信息,进行描述性分析。结果 2010-2018年出生儿童共193 560名,含Hib成分疫苗≥1剂次、≥3剂次接种率分别为67.29%、29.32%;本地儿童≥1剂次总接种率(68.40%)高于流动儿童(65.34%),接种率差异有统计学意义(χ²=187.72,P<0.01),≥3剂次总接种率(29.36%)与流动儿童接种率(29.24%)差异无统计学意义(χ²=0.34,P=0.559);城区Men ACHib、DTaP-Hib、DTaP-IPV/Hib接种率(3.56%、6.74%、10.96%)均高于农村地区(2.87%、1.11%、2.83%),各接种率差异均有统计学意义(均P<0.01);首剂次接种月龄<3月龄、3～6月龄、12～23月龄的接种比例分别为14.65%、31.05%、31.88%...     

Impact of a quadrivalent inactivated influenza vaccine on influenza-associated complications and health care use in children aged 6 to 35 months: Analysis of data from a phase III trial in the Northern and Southern Hemispheres

Background

A multi-season phase III trial conducted in the Northern and Southern Hemispheres demonstrated the efficacy of a quadrivalent split-virion inactivated influenza vaccine (IIV4) in children 6–35?months of age.

Immunogenicity,reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III,randomized trial

Background

Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.

Methods

Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.

Results

Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.

Conclusion

QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.     

Trends in compliance with two-dose influenza vaccine recommendations among children aged 6 months through 8 years

Children aged <9 years may require two doses of influenza vaccine to achieve an adequate immune response to protect against the disease. We analyzed data for >2 million children in each influenza season from 2007 to 2012 from eight Immunization Information System Sentinel Sites to assess trends in two-dose compliance. Compliance was calculated by influenza season, age group, and influenza vaccination history. Two-dose compliance increased from 49% to 60% among 6–23 month olds from 2007 to 2012; no increase was observed for 2–4 or 5–8 year olds. In each season, compliance was 3–12 times higher among 6–23 month olds compared to older children and was two times higher among influenza vaccine naïve children compared to previously vaccinated children. Improved messaging for providers and parents about the importance of the two-dose recommendation, about which children are eligible for two doses, and provider access to complete influenza vaccination histories for all children are needed.     

Immunogenicity and safety of intradermal influenza vaccine in children

In order to compare the immunogenicity and safety of different doses of trivalent influenza vaccine (TIV) administered intradermallly (ID) with those evoked by a full dose of intramuscular (IM) virosomal-adjuvanted influenza vaccine (VA-TIV), 112 previously primed healthy children aged ≥3 years were randomised to receive 9 μg or 15 μg of each strain of ID-TIV, or a full IM dose (15 μg of each strain) of VA-TIV. The A/H1N1 and A/H3N2 seroconversion and seroprotection rates were ≥90% and geometric mean titres (GMTs) increased 3.2-14.9 times without any statistically significant between-group differences; however, the seroconversion and seroprotection rates against the B strain were significantly higher in the children receiving either ID-TIV dose (p < 0.05) without any differences between them. GMT against B virus was significantly higher in the children receiving the highest dose (p < 0.05). Local reactions were significantly more common among the children receiving either ID-TIV dose (p < 0.05), but systemic reactions were relatively uncommon in all three groups. Our findings suggest that ID-TIV with 15 μg of each viral antigen can confer a significant better protection against influenza than that obtained with the same dose of IM TIV in already primed children aged ≥3 years with an acceptable safety profile. The lower dose of ID-TIV needs further evaluation to analyze persistence of protection.     

Seasonal influenza vaccination coverage in France during two influenza seasons (2007 and 2008) and during a context of pandemic influenza A(H1N1) in 2009

Objectives

To measure the seasonal influenza vaccination coverage rate (VCR) in France in 2009, year of the A(H1N1) influenza pandemic, by age and target disease and compare it with the VCR for the 2007 and 2008 influenza seasons.

Method

At the beginning of each annual seasonal vaccination campaign, the National Health Insurance, covering 86% of the French population, sends free influenza vaccination vouchers to at-risk beneficiaries aged under 65 suffering from diverse chronic diseases and to all individuals aged 65 and over (around 11 million). Vaccination is estimated from refund claims registered in the National Health Insurance Information System.

Results

The global VCR for the target population was 51% in 2007, 55.8% in 2008 and 56.9% in 2009. In 2009, the VCR for children under 10 years old was 24.3%, 28.1% in the 10-19 age range, 39.2% in the 20-64 age range and 63.3% for individuals aged 65 and over, of which 72.3% with a targeted chronic disease and 56.9% without. The inclusion of asthma as a target disease, lowered the global VCR for children under 10 years old (30.6% without asthma) but VCR increased proportionally with the number of annual refunds for drugs against asthma and chronic obstructive pulmonary disease. The 2009 vaccine uptake rates in target group children, adolescents, young adults and to a lesser extent the population aged 65 and over suffering from a chronic disease (particularly chronic respiratory disease), could have been positively impacted by the A(H1N1) influenza context.

Conclusion

The influenza VCR varies considerably according to age and target disease but globally remains inferior to the recommended 75% coverage rate. These results permit the detailed analysis of VCR distribution by disease and target group and highlights areas for reflection and action. Specific studies should be conducted in order to understand why the VCR is lower in certain target groups.