流行性感冒疫苗的预防效果观察

为了解流行性感冒（流感）疫苗的预防效果和安全性,于1996～1998年为健康军人及其家属共2 378人接种流感疫苗（免疫组）,并按儿童、成人、老年3个年龄段选取2 280人设立对照组。经6个月追踪观察结果显示,流感疫苗对流感样症状的预防有效率在儿童、成人、老年组中为 82.7％、69.6％和78.6％,平均77.4％,对预防上呼吸道感染症状的有效率分别是44.6％、50.7％和46.7％,平均47.8％。在第2年的观察中,接种流感疫苗的副反应率为1.2％。证实流感疫苗具有良好预防效果和安全性。     

流行性感冒疫苗的预防效果观察

为了解流行性感冒（流感）疫苗的预防效果和安全性,于2012～2013年为洮南市三个社区2378人接种流感疫苗（免疫组）,并接儿童、成人、老年3个年龄段选取2280人设立对照组。经6个月追踪观察结果显示,流感疫苗对流感样症状的预防有效率在儿童、成人、老年组中为82．7％、69．6％和78．6％,平均77．4％,对预防上呼吸道感染症状的有效率分别是44．6％、50．7％和46．7％．平均47．8％。在第2年的观察中,接种流感疫苗的副反应率为1．2％。证实流感疫苗具有良好预防效果和安全性。     

流行性感冒裂解疫苗与亚单位疫苗的血清学效果观察

为了观察流行性感冒 (流感 )亚单位疫苗和裂解疫苗的安全性和血清学效果 ,选择 2 39名 2 2～ 6 6岁 (平均 37岁 )健康人群 ,分两组于 2 0 0 3年 9月接种流感疫苗。第 1组接种流感亚单位疫苗 ,第 2组接种流感裂解疫苗 ,应用血凝抑制试验 (HI)检测流感抗体 ,同时进行临床反应观察。结果显示 :接种两组疫苗的发热弱、中反应发生率分别为 6 19%、5 5 5 % ,接种两组疫苗后 3个型别抗体阳转 (含HI抗体≥ 4倍增长 )率平均分别为 94 %～ 96 %、93%～94 %、90 %～ 92 %。抗体保护水平 (≥ 1∶4 0 )亚单位与裂解疫苗均达到 10 0 %。接种两组疫苗前后 3个型别抗体几何平均滴度增长倍数为 :流感亚单位疫苗增长 4～ 6倍 ,流感裂解疫苗增长 4～ 7倍。两组疫苗不良反应发生率与血清学效果差异均无显著的统计学意义。表明观察的两种流感疫苗均具有良好的安全性和血清学效果。     

小儿流感疫苗接种对小儿流感预防的预防效果分析

目的:探究小儿流感疫苗接种对小儿流感预防的效果.方法:选取流感疫苗接种小儿200例作为实验组,时间为2015年1月-2016年1月,同时选取未接种流感疫苗小儿200例作为对照组,对这2组小儿流感的发生情况进行观察分析.结果:实验组小儿在流感疫苗接种之后,存在4.00%的小儿出现不良反应(5例发热,3例头痛),其不良症状均在3天内消失.实验组小儿经流感疫苗接种后一年的流感发生率(8.00%)明显低于对照组未接种流感疫苗的小儿流感发生率(31.50%),P<0.05.结论:小儿接种流感疫苗,可以有效对流感进行预防,且安全性较好,具有较高的可行性.     

北京市老年人群流行性感冒疫苗免疫效果及成本效益评价

目的评价老年人群接种流行性感冒(流感)疫苗的效果和效益。方法选取北京市朝阳区和宣武区590名接种过流感疫苗,且年龄>60岁的老年人群为接种组,在社区中随机选择与接种组年龄、性别、健康状况等相匹配的602名未接种流感疫苗者为对照组。采用流行病学试验方法,在基线调查的基础上,分别于流感疫苗接种(基线调查)后的第1、3和6个月对试验组和对照组进行随访调查。结果接种组流感样疾病的发病率和就诊率均低于对照组,接种后第1、3和6个月内流感疫苗对流感样疾病的保护率分别为52.38%、36.84%和37.89%;接种流感疫苗减少流感样疾病就诊率分别为45.16%、50.54%和50.54%。接种组患感冒、其他呼吸系统疾病和慢性病的发病率和就诊率低于对照组,接种流感疫苗对感冒、其他呼吸道疾病和其他慢性疾病的保护率分别为49.54%、64.54%和38.82%。老年人群接种流感疫苗后第3和6个月内所获得的效益成本比为4.97∶1和4.98∶1。结论老年人群接种流感疫苗能有效地预防流感样疾病的发生,降低流感相关慢性疾病的发病率和复发率,且能够获得较高的成本效益。     

北京市城区居民流行性感冒样病例发病情况快速调查

为了解 2 0 0 1年冬季北京市城区居民流行性感冒 (流感 )样病例发病及流感疫苗接种情况 ,使用北京市 8个城区的电话局向号和随机数字相结合产生的电话号码 ,对城区居民进行电话调查 ,同时对部分 3～ 6岁幼儿和≥ 6 0岁老人开展自我管理式问卷调查。结果显示 :2 0 0 1年冬季北京市城区居民流感样疾病罹患率为 10 8% ,≤ 6岁、7～18岁、19～ 5 9岁、≥ 6 0岁人群流感样疾病罹患率分别为 4 0 0 %、16 7%、9 2 %、6 7% ,各年龄组人群罹患率差异有显著的统计学意义。≥ 6 0岁患慢性病老人罹患率为 8 3% ,非慢性病老人罹患率为 4 3% ,差异有显著的统计学意义。城区居民流感疫苗接种率为 10 5 % ,≤ 6岁、7～ 18岁、19～ 5 9岁、≥ 6 0岁人群流感疫苗接种率分别为36 8%、2 8 8%、6 7%、7 9%。接种组和未接种组幼儿流感样病例罹患率和≥ 6 0岁老人的人周发病率差异均无显著的统计学意义。表明 2 0 0 1年冬季北京市城区居民存在流感样病例流行 ,幼儿和患慢性病老人是预防流感样病例的重点人群 ,流感疫苗幼儿接种率较高 ,≥ 6 0岁老人接种率低 ,应积极在老年人群中推广流感疫苗的使用     

流行性感冒裂解疫苗临床安全性调查

目的了解流行性感冒(流感)疫苗临床接种安全性和预防效果,为开展流感预防研究提供科学依据。方法对2006~2007年免疫组936人和对照组907人进行6个月追踪观察,并进行统计分析。结果在接种流感疫苗的936人中,出现接种部位疼痛7例(0.75%),皮肤瘙痒2例(0.21%),发热(≥37.5℃)2例(0.21%),皮疹发生1例(0.11%)。流感样症状的发生率两组比较差异有统计学意义(P0.01)。结论接种流感疫苗能极显著地减少流感样症状的发生,对儿童的预防作用尤为明显。     

东丽区65岁以上老人流感疫苗接种效果评估

目的评价东丽区65岁以上户籍老年人免费接种流感疫苗的效果。方法选取东丽区2 0 1 4年免费接种过流感疫苗的51 2人65岁以上老年人为接种组,同时选取与接种组性别、年龄、身体状况等相匹配未接种过流感疫苗的3 60名65岁以上老年人为对照组,在流感疫苗接种后半年开展问卷调查,分析两组流感样症状及并发症的发病情况。结果接种流感疫苗对流感样症状的保护率为83.4 7%;对感冒后合并心肺并发症的保护率为81.73%;对普通感冒样症状的保护率为2 8.4 6%;接种流感疫苗发生接种反应的发生率为4.4 9%,均为一般反应。结论老年人接种流感疫苗安全有效。     

东丽区老年人流感疫苗免费接种调查分析

目的评价天津市东丽区6 5岁以上老年人接种流感疫苗的免疫效果及对流感知识认知程度、接种服务满意度。方法采用自制问卷调查相关情况,建立Epidata数据库进行数据录入、分析。结果经调查、统计,流感疫苗保护率为84.97%,疑似预防接种异常反应(AEFI)全部为一般反应,全身反应发生率为1.3 6%,局部反应发生率为3.1 3%。无异常、偶合反应发生。接种组与对照组对流感传播途径、疫苗预防及接种时间的回答差异有统计学意义。接种组人群对接种流感服务满意度较高。结论本次调查结果表明,流感疫苗对老年人的保护性、安全性较好。尽管是免费接种流感疫苗,6 5岁及以上老年人的接种率仅为44.90%,要形成有效的流感的免疫屏障,还需扩大接种人群范围,提高接种率。疾控中心、社区卫生服务中心可采取适用于老年人的宣教形式,丰富老年人健康知识的获得途径。     

接种流感疫苗的免疫效果与接种安全性的研究

目的:研究接种流感疫苗的免疫效果与接种安全性。方法:选取2015年11月-2017年2月我医院的136例接种流感疫苗的人群作为试验组,选取同期未接种流感疫苗的136例作为对照组,比较2组流感样症状发生率,并评价安全性。结果:试验组流感样症状发生率明显低于对照组,组间具有统计学差异(P0.05);观察组不良反应发生率仅为7.4%。结论:接种流感疫苗可显著提高免疫效果,无明显不良反应,安全可靠。     

甲型H1N1流行性感冒病毒裂解疫苗的安全性研究

目的评价甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)的安全性。方法设立主动监测点,通过全国疑似预防接种异常反应信息管理系统,收集全市接种甲流疫苗和主动监测点接种季节性流感疫苗后的AEFI个案信息,采用描述性方法对相关指标进行流行病学分析。结果邯郸市常规报告接种甲流疫苗后AEFI发生率14.64/10万,以一般反应为主,占88.57%,症状主要为38.5℃以下的低热,无严重不良反应和接种事故发生。主动监测点接种甲流疫苗后AEFI发生率752.63/10万,全部为一般反应,以发热为主。主动监测点接种季节性流感疫苗后AEFI发生率203.14/10万,全部为一般反应,均为发热。结论甲流疫苗接种后AEFI发生率高于季节性流感疫苗,但低于欧盟流感疫苗评价指标。甲流疫苗接种后AEFI反应类型以一般反应为主,且多为低热。甲流疫苗是安全的。     

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。     

国产流感裂解疫苗接种人体后安全性和免疫原性评价

目的:评价变更后流感毒株生产的国产流感裂解疫苗安全性和免疫原性。方法:对宁波市宁海县559例分组接种流感裂解疫苗者进行临床指标(局部反应、全身反应)的监测,并抽取其中213例,用流感病毒HI抗体测定法对接种者免疫前后的抗体滴度进行测定,比较免疫前后抗体阳转率及几何平均滴度(GMT)。结果:观察对象接种疫苗后发热反应发生率为1.22%,全身其他反应发生率为1.22%,局部反应发生率为1.07%,且以轻度反应为主。H1N1型、H3N2型、B型免后抗体阳转率分别为84.04%、85.45%、83.57%;不同年龄组免后抗体滴度的增长倍数,H1N1型在5.50～16.00倍之间,H3N2型在13.16～39.33倍之间,B型在7.28～24.85倍之间,各年龄组各抗体型别免疫前后GMT差别均有统计学意义。结论:国产流感裂解疫苗具有良好的安全性和免疫原性。     

流行性感冒病毒裂解疫苗在18岁以上健康人群中应用的安全性及免疫原性研究

目的 评价流感病毒裂解疫苗安尔来福(R)的免疫原性及安全性.方法 2010年8-9月在沈阳市开展开放式临床试验,选择18～60岁及＞60岁健康成年人接种安尔来福(R)进行安全性观察,并采集受试者免疫前及免疫后21 d 血清标本,采用血凝抑制试验(HI)进行流感病毒裂解疫苗甲型H1N1、甲型H3N2及乙型3个型别抗体检测.结果 130名观察对象完成疫苗接种并进行安全性观察,其中120人完成免疫前及免疫后采血.总体不良反应发生率为2.3%(3/130),均为全身不良反应,未出现严重不良反应.接种疫苗后21 d,成年组甲型H1N1、甲型H3N2及乙型3个型别抗体阳转率分别为82.5%、93.7%、92.1%,GMT增长倍数分别为20.2、32.0、11.4,保护率分别为92.1%、98.4%、98.4%;老年组3个型别抗体阳转率分别为89.5%、91.2%、87.7%,GMT增长倍数分别为23.9、39.8、15.1,保护率分别为93.0%、94.7%、96.5%.结论 疫苗安尔来福(R)接种后甲型H1N1、甲型H3N2及乙型3个型别抗体各项指标均超过欧盟标准,表明其免疫原性及安全性良好.

Abstract：

Objective To evaluate the safety and immunogenicity of split influenza vaccine (Anflu(R) ). Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged over 60 years from August to September, 2010 in Shenyang, Liaoning province. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained prior to vaccination and 21 days post vaccination. A/H1N1, A/H3N2 and B antibodies against influenza virus were measured using micro-hemagglutination inhibition (HI) assay. Results A total of 130 subjects were recruited and 120 paired serum samples were obtained. The overall rate of adverse events was 2.3% (3/130) and all of them with systemic reaction. No single serious adverse event was reported. 21 days after the vaccination, the sero-conversion rates of A/H1N1, A/H3N2 and B antibodies against influenza virus among adults were 82.5%, 93.7% and 92.1%, respectively. The Geometric Mean Titer (GMT) ratios were 20.2, 32.0 and 11.4, while the sero-protection rates were 92.1%, 98.4% and 98.4%, respectively. The sero-conversion rates of antibodies among elders were 89.5%, 91.2% and 87.7%, with the GMT ratios as 23.9, 39.8 and 15.1, respectively. The seroprotection rates were 93.0%, 94.7% and 96.5%,respectively. Conclusion All indexes ofA/H1N1,A/H3N2 and B antibodies exceeded the licensure criteria established by the EU Committee for Medicinal Products for Human Use,proving the trial vaccine Anflu(R) with good safety and immunogenicity.     

Safety and immunogenicity of adjuvanted and unadjuvanted subunit influenza vaccines administered intranasally to healthy adults

Antigen-specific mucosal immunity is thought to be important for protection against influenza virus infection. Currently licensed parenteral influenza vaccines stimulate the production of serum antibodies, but are poor inducers of mucosal immunity. The adjuvant MF59 has been shown to enhance the humoral immune response to parenteral influenza vaccine in humans and the mucosal immune response to intranasally-administered influenza vaccine in mice. We conducted an open-label safety study followed by an observer-blind, randomized trial comparing the immune response to intranasally-administered subunit influenza vaccine adjuvanted with MF59, unadjuvanted subunit influenza vaccine, and placebo. Adverse reactions did not occur significantly more frequently in vaccinees than placebo recipients. Of 31 subjects receiving 2 doses of MF59-adjuvanted influenza vaccine, 19 (61%), 8 (26%), and 11 (35%) developed a mucosal IgA response to influenza A/H1N1, A/H3N2, and B, respectively. The percentage of subjects with a serum antibody response was slightly lower. The immune responses to adjuvanted vaccine were not significantly different from those to unadjuvanted vaccine. Both vaccines gave more frequent responses than seen in placebo recipients, indicating the potential of intranasal inactivated vaccines to stimulate local IgA responses.     

广州市2000～2003年流感疫苗需求发展动态分析

目的 通过健康教育增加疫苗的使用，使人们认识到可以通过接种疫苗，达到以非常低的成本来预防疾病的效果。方法 分析2000-2003年流感疫苗销售量，从疫苗分类明细中提取4a的流感疫苗销售数量进行统计，并查询2000～2003年广州市计划免疫年报中的全市常住人口资料进行标化后再统计。用发展速度和增长速度分析研究流感疫苗需求的发展变化规律。结果 流感疫苗4a销售量分别为11286、58570、84945及390138支，2000～2003年流感疫苗使用量分别占全市总人口的0．16％、0．85％、1．23％及5．66％，流感疫苗的人均消费4a分别为0．07、0．38、1．23元及2．40元；流感疫苗的销售量2001-2003年定基比发展速度分别是518．96％、752．66％及3456．83％；环比发展速度分别是518．96％、145．03％及459．28％；2003年流感疫苗销量达390138支，相当于2000年销量的518．96％。结论 以上数据显示随着社会的发展，物质生活水平的提高，人们对健康的观念认识已经从满足温饱的基本生理需求上升到躯体无病、身心健康的高度，“医”和衣食住行并列成为现代社会人类生活的五大必需要素，尤其2003年非典型肺炎疫情的影响，使得人们的防病意识进一步加强，主动要求接种流感疫苗，主动愿意为健康和长寿投资。     

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized,double-blind,controlled phase III study in healthy population aged ≥3 years

Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains (H1N1 and H3N2) and one strain from each B lineage (Victoria and Yamagata) may offer broader protection against seasonal influenza. This study examined the immunogenicity and safety of a candidate IIV4. A randomized, double-blind, controlled phase III clinical trial was conducted in healthy subjects aged ≥3 years. Subjects were randomly assigned into three groups in a 2:1:1 ratio, receiving single dose of IIV4 or inactivated trivalent influenza vaccine (IIV3) which contains either B/Victoria strain (BV) or B/Yamagata strain (BY). Blood samples were collected before and 28 days after vaccination to test hemagglutination inhibition (HI) antibodies of the four influenza strains. Safety information was collected for 28 days after vaccination. A total of 2320 subjects (IIV4: 1160, IIV3-BV: 580, IIV3-BY: 580) were enrolled in this study. After vaccination, the seroconversion rates of IIV4 against H1N1, H3N2, BV and BY strains were 77.15%, 81.93%, 60.14% and 64.57%, respectively. Geometric mean titers (GMTs) against the four influenza strains were 523.91, 274.13, 115.35 and 257.81, respectively. The investigational IIV4 was non-inferiority to IIV3 for the four strains, meanwhile superior to IIV3 for additional B strains (B/BV, B/BY). For safety, there had no significant difference in the incidence of the adverse reactions among the three groups (P = 0.5986). No serious adverse events related to vaccination occurred. The IIV4 had good immunogenicity and safety, which added an influenza B protection with no increased safety concerns. (ClinicalTrials.gov number: NCT03853993)     

Variation in influenza vaccine assessment,receipt, and refusal by the concentration of Medicare Advantage enrollees in U.S. nursing homes

BackgroundMore older adults enrolled in Medicare Advantage (MA) are entering nursing homes (NHs), and MA concentration could affect vaccination rates through shifts in resident characteristics and/or payer-related influences on preventive services use. We investigated whether rates of influenza vaccination and refusal differ across NHs with varying concentrations of MA-enrolled residents.MethodsWe analyzed 2014–2015 Medicare enrollment data and Minimum Data Set clinical assessments linked to NH-level characteristics, star ratings, and county-level MA penetration rates. The independent variable was the percentage of residents enrolled in MA at admission and categorized into three equally-sized groups. We examined three NH-level outcomes including the percentages of residents assessed and appropriately considered for influenza vaccination, received influenza vaccination, and refused influenza vaccination.ResultsThere were 936,513 long-stay residents in 12,384 NHs. Categories for the prevalence of MA enrollment in NHs were low (0% to 3.3%; n = 4131 NHs), moderate (3.4% to 18.6%; n = 4127 NHs) and high (>18.6%; n = 4126 NHs). Overall, 81.3% of long-stay residents received influenza vaccination and 14.3% refused the vaccine when offered. Adjusting for covariates, influenza vaccination rates among long-stay residents were higher in NHs with moderate (1.70 percentage points [pp], 95% confidence limits [CL]: 1.15 pp, 2.24 pp), or high (3.05 pp, 95% CL: 2.45 pp, 3.66 pp) MA versus the lowest prevalence of MA. Influenza vaccine refusal was lower in NHs with moderate (-3.10 pp, 95% CL: ?3.53 pp, ?2.68 pp), or high (-4.63 pp, 95% CL: ?5.11 pp, ?4.15 pp) MA compared with NHs with the lowest prevalence of MA.ConclusionA higher concentration of long-stay NH residents enrolled in MA was associated with greater influenza vaccine receipt and lower vaccine refusal. As MA becomes a larger share of the Medicare program, and more MA beneficiaries enter NHs, decisionmakers need to consider how managed care can be leveraged to improve the delivery of preventive services like influenza vaccinations in NH settings.