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 产品介绍
 华兰大事记
1992----华兰生物工程有限公司成立
1993----华兰工程开工建设
1995----获得“人血白蛋白”生产文号
1996----国内首家使用进口“全自动采浆机”采集血浆,充分的保护了...
 企业理念
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 0.5mL/瓶
 
 
产品优势
>世界第一支甲型H1N1流感病毒裂解疫苗
>2009年全国接种达到4000万人次,安全性得到最充
  分的验证
>采用一人份一支包装,有效保证注射剂量的准确性
>采用世界一流生产设备生产,质量优异,生产能力
  有效保证大流感应对
>副反应率低,只有全国平均水平的1/5
 
0.5mL/瓶
0.5mL//支
 

    核准日期:2009年09月04日
    修订日期:2009年11月12日
     

    甲型H1N1流感病毒裂解疫苗说明书
    警示语
    本品按照国家统一的免疫策略和接种方案使用
     

    【药品名称】
    通用名称:甲型H1N1流感病毒裂解疫苗
    英文名称:H1N1 Influenza A Vaccine(Split Virion),Inactivated
    汉语拼音:Jiaxing H1N1 Liugan Bingdu Liejie Yimiao
    【成份与性状】
        本品系采用世界卫生组织(WHO)推荐的甲型H1N1流感病毒株(2009)接种鸡胚,经病毒培养、收获病毒液、灭活病毒、浓缩、纯化、裂解后制成。
        本品主要成分为甲型H1N1流感病毒血凝素抗原。辅料为氯化钠、磷酸氢二钠、磷酸二氢钠。含硫柳汞防腐剂。
        本品外观为轻微乳白色液体。
    【接种对象】
        本品用于3岁及3岁以上易感人群的预防接种。
    【作用与用途】
        接种本疫苗后,可刺激机体产生针对甲型H1N1流感病毒的抗体,用于此型病毒所致流感流行的免疫预防。
    【规格】
        本品为每瓶0.5ml。每1次人用剂量为0.5ml,含甲型H1N1流感病毒血凝素15µg。
    【免疫程序和剂量】
        本疫苗接种1剂15μg。于上臂外侧三角肌肌内注射。
    【不良反应】
        基于已完成的国内10家临床试验结果的汇总分析(详见【临床试验】),疫苗组(15μg+30μg,下同)不良反应总体发生率为17.40%,安慰剂组不良反应总体发生率为10.98%。
        不良反应表现常见发热、注射部位疼痛、头痛和疲劳乏力,偶见咳嗽、腹泻、肌肉痛、局部瘙痒、恶心呕吐、局部红、肿、硬结、荨麻疹、斑丘疹和疹(注射部位),其它表现还偶见头晕、咽痛、腹痛和关节痛。
        不良反应多集中发生于接种后0~3天,期间不良反应发生率疫苗组为16.67%,安慰剂组为9.85%。
        接种季节性流感疫苗还可能发生极罕见的不良反应,如:休克、血管炎样一过性肾功能受损,神经系统疾病,例如脑脊髓炎、神经炎、神经痛、感觉异常、惊厥、一过性血小板减少、格林-巴利(Guillain-Barre)综合征等。虽然本疫苗临床试验中未发现以上反应,接种本疫苗时,应注意密切观察。
        如出现以上未提及的不良反应,应及时与医生取得联系。
    【禁忌】
        1.对鸡蛋或疫苗中任何其他成份(包括辅料、甲醛、裂解剂等),特别是卵清蛋白过敏者。
        2.患急性疾病、严重慢性疾病、慢性疾病的急性发作期和发热者。
        3.未控制的癫痫和患其他进行性神经系统疾病者,有格林巴利综合征病史者。
    【注意事项】
        1.本品严禁静脉注射!
        2.以下情况者慎用:家族和个人有惊厥史者、患慢性疾病者、有癫痫史者、过敏体质者。
        3.注射现场应备有肾上腺素等药物和其他抢救措施,以备偶有发生严重过敏反应时急救使用。接受疫苗注射者在注射后应留观至少30分钟。
        4.疫苗瓶有裂纹、标签不清或失效者、疫苗外观出现异常、浑浊者均不得使用。
        5.用前摇匀,疫苗瓶开启后应立即使用。
        6.注射免疫球蛋白者应至少间隔1个月以上接种本疫苗,以免影响免疫效果。
        7.本品注射后出现任何神经系统反应者,禁止再次使用。
        8.本品严禁冻结!
        9.特殊人群的使用:
        孕妇:目前尚无此人群的相关研究数据,应充分权衡利弊后决定是否使用本品。
        哺乳期妇女:目前尚无此人群的相关研究数据,应充分权衡利弊后决定是否使用本品。
        10.药物的相互作用与其他疫苗同时接种:目前没有数据可以评估本品与其他疫苗共同接种的反应。本品尚未进行同期(先、后或同时)接种季节性流感疫苗对本疫苗免疫原性影响的临床研究。
        免疫抑制药物:包括免疫抑制剂、化疗药、抗代谢药物、烷化剂、细胞毒素类药物、皮质类固醇类药物等,可能会降低机体对本品的免疫应答。
        正在接受治疗的患者:为避免可能的药物间相互作用,建议咨询医生。
    【临床试验】
        汇总国内10家已 完成的临床试验结果,对其中15µg 、30µg 剂量组和安慰剂组共计9562例受试者(3~87岁)数据进行了分析。疫苗一剂接种后安全性结果如下表1所示,免疫原性结果如下表2所示。
     

    表1:甲型H1N1流感病毒裂解疫苗不良反应发生率和程度一览表

    剂量  15 μg组  15 μg+30μg
    合计
     安慰剂组
    例数(N)    4520 8069 1493
     总体反应率n(%)     703(15.55)  1404(17.40)  164(10.98)
     1级   610(13.50)  1157(14.34)  146(9.78)
     2级    79(1.75)  210(2.60)  17(1.14)
     3级     14(0.31)  37(0.46)  1(0.07)
     局部反应率n(%)  170(3.76)   363(4.49)  23(1.54)
     疼痛   147(3.25)   313(3.88)  18(1.21)
     瘙痒    16(0.35)   38(0.47)  4(0.27)
     红斑     15(0.33)  29(0.36)  2(0.13)
     肿胀   9(0.20)   26(0.32)   0(0.00)
     硬结   6(0.13)  22(0.27)    0(0.00)
    斑丘疹(注射部位)   2(0.04)   6(0.07)   0(0.00)
     全身反应率n(%)    583(12.90)  1164(14.43)  144(9.65)
     发热   464(10.27)   918(11.38)   110(7.37)
     头痛     57(1.26)  127(1.57)  20(1.34)
     疲劳乏力    53(1.17)   123(1.52)  15(1.00)
     咳嗽    26(0.58)   60(0.74)  6(0.40)
     腹泻    25(0.55)  46(0.57)  6(0.40) 
     恶心呕吐   16(0.35)   33(0.41)   5(0.33)
     肌肉痛     11(0.24) 40(0.50)  5(0.33) 
     荨麻疹    3(0.07)   15(0.19)  2(0.13)
     其它反应n(%)    21(0.46)   38(0.47)  5(0.33)

    注:安慰剂组主要为18~59岁人群,由于样本量及人群代表性的不可比性,因此进行疫苗组和安慰剂的比较时应慎重。
     

    表2:15 μg甲型H1N1流感病毒裂解疫苗免前、免后第21天HI抗体反应

    时    间      指标 3~11岁  12~17岁 18~59岁 60岁以上 合计
    免前
     
     
    人数      1143 1108 1178 999 4428
    GMT  5.28  6.94  6.27  6.20  6.14
    保护率%  0.96  6.14  2.97  3.30  3.32
    免后
    21天
     
     
     
    GMT  82.06  473.40  329.17  150.21  211.02
     GMT增长
    倍数 
     15.54   68.26   52.49  24.23    34.39
     阳转率%
    (95%CI) 
     79.44
    (76.98~81.75) 
     93.86
    (92.28~95.20) 
      92.95
    (91.34~94.35)
      80.98
    (78.41~83.37)
     86.99
    (85.97~87.97)
     保护率%
    (95%CI)  
     79.62
    (77.16~81.92)
    95.22
    (93.79~96.40)  
      93.72
    (92.18~95.04)
     82.38
    (79.88~84.70) 
     87.90
    (86.90~88.84)

    注:GMT增长倍数为免后GMT与免前GMT的比值。 

    【贮藏】严格于2~8℃避光保存和运输,严防冻结。
    【包装】西林瓶包装:1瓶/盒、5瓶/盒、10瓶/盒。
    【有效期】自疫苗生产之日起有效期暂定12个月。
    【执行标准】YBS00422009
    【批准文号】国药准字S20090015
    【生产企业】
    企业名称:华兰生物疫苗有限公司
    生产地址:河南省新乡市华兰大道甲1号附1号
    邮政编码:453003    电话号码:(0373)3519992    传真号码:(0373)3519991
    网址:http://www.hualanbio.com

    状 态:已上市
    中文品名:甲型H1N1流感病毒裂解疫苗
    英文品名:H1N1 Influenza A Vaccine(Split Virion)
    产品类别:疫苗类
        本品系采用世界卫生组织(WHO)推荐的甲型H1N1流感病毒株(2009)接种鸡胚,经病毒培养、收获病毒液、灭活病毒、浓缩、纯化、裂解后制成。接种后可刺激机体产生抗甲型H1N1流感病毒的抗体。
    规格:本品每剂0.5ml,含甲型H1N1流感病毒株血凝素不低于15μg。有预充式注射器和西林瓶两种包装形式。

        2009年10月21日《新英格兰医学杂志》(The New England Journal of Medicine,NEJM)在第361卷发表了华兰生物疫苗有限公司生产的甲型H1N1流感病毒裂解疫苗的临床研究报告----《一种新型甲型H1N1流感疫苗在各年龄人群中的观察》[Anovel influenz a a(H1N1)vaccine in various age groups],研究采用随机、安慰剂对照、双盲实验设计,全面评估了疫苗的安全性和免疫原性。
     

    临床试验
        汇总国内10家已 完成的临床试验结果,对其中15µg 、30µg 剂量组和安慰剂组共计9562例受试者(3~87岁)数据进行了分析。疫苗一剂接种后安全性结果如下表1所示,免疫原性结果如下表2所示。
     

     表1:甲型H1N1流感病毒裂解疫苗不良反应发生率和程度一览表

     

    剂量  15 μg组  15 μg+30μg
    合计
     安慰剂组
    例数(N)    4520 8069 1493
     总体反应率n(%)     703(15.55)  1404(17.40)  164(10.98)
     1级   610(13.50)  1157(14.34)  146(9.78)
     2级    79(1.75)  210(2.60)  17(1.14)
     3级     14(0.31)  37(0.46)  1(0.07)
     局部反应率n(%)  170(3.76)   363(4.49)  23(1.54)
     疼痛   147(3.25)   313(3.88)  18(1.21)
     瘙痒    16(0.35)   38(0.47)  4(0.27)
     红斑     15(0.33)  29(0.36)  2(0.13)
     肿胀   9(0.20)   26(0.32)   0(0.00)
     硬结   6(0.13)  22(0.27)    0(0.00)
    斑丘疹(注射部位)   2(0.04)   6(0.07)   0(0.00)
     全身反应率n(%)    583(12.90)  1164(14.43)  144(9.65)
     发热   464(10.27)   918(11.38)   110(7.37)
     头痛     57(1.26)  127(1.57)  20(1.34)
     疲劳乏力    53(1.17)   123(1.52)  15(1.00)
     咳嗽    26(0.58)   60(0.74)  6(0.40)
     腹泻    25(0.55)  46(0.57)  6(0.40) 
     恶心呕吐   16(0.35)   33(0.41)   5(0.33)
     肌肉痛     11(0.24) 40(0.50)  5(0.33) 
     荨麻疹    3(0.07)   15(0.19)  2(0.13)
     其它反应n(%)    21(0.46)   38(0.47)  5(0.33)

    注:安慰剂组主要为18~59岁人群,由于样本量及人群代表性的不可比性,因此进行疫苗组和安慰剂的比较时应慎重。
     

    表2:15 μg甲型H1N1流感病毒裂解疫苗免前、免后第21天HI抗体反应

    时    间      指标 3~11岁  12~17岁 18~59岁 60岁以上 合计
    免前
     
     
    人数      1143 1108 1178 999 4428
    GMT  5.28  6.94  6.27  6.20  6.14
    保护率%  0.96  6.14  2.97  3.30  3.32
    免后
    21天
     
     
     
    GMT  82.06  473.40  329.17  150.21  211.02
     GMT增长
    倍数 
     15.54   68.26   52.49  24.23    34.39
     阳转率%
    (95%CI) 
     79.44
    (76.98~81.75) 
     93.86
    (92.28~95.20) 
      92.95
    (91.34~94.35)
      80.98
    (78.41~83.37)
     86.99
    (85.97~87.97)
     保护率%
    (95%CI)  
     79.62
    (77.16~81.92)
    95.22
    (93.79~96.40)  
      93.72
    (92.18~95.04)
     82.38
    (79.88~84.70) 
     87.90
    (86.90~88.84)

    注:GMT增长倍数为免后GMT与免前GMT的比值。

     

    (1) Sun YZ, Bian C, Xu K, et al. Immune protection induced on day 10 following administration of the 2009 A/H1N1 pandemic influenza vaccine.PLoS One. 2010 Dec 9;5(12):e14270.

    Abstract
    Background:
    The 2009 swine-origin influenza virus (S-OIV) H1N1 pandemic has caused more than 18,000 deaths worldwide.Vaccines against the 2009 A/H1N1 influenza virus are useful for preventing infection and controlling the pandemic. The kinetics of the immune response following vaccination with the 2009 A/H1N1 influenza vaccine need further investigation.
    Methodology/Principal Findings: 58 volunteers were vaccinated with a 2009 A/H1N1 pandemic influenza monovalent split-virus vaccine (15 mg, single-dose). The sera were collected before Day 0 (pre-vaccination) and on Days 3, 5, 10, 14, 21,30, 45 and 60 post vaccination. Specific antibody responses induced by the vaccination were analyzed using hemagglutination inhibition (HI) assay and enzyme-linked immunosorbent assay (ELISA). After administration of the 2009 A/H1N1 influenza vaccine, specific and protective antibody response with a major subtype of IgG was sufficiently developed as early as Day 10 (seroprotection rate: 93%). This specific antibody response could maintain for at least 60 days without significant reduction. Antibody response induced by the 2009 A/H1N1 influenza vaccine could not render protection against seasonal H1N1 influenza (seroconversion rate: 3% on Day 21). However, volunteers with higher pre-existing seasonal influenza antibody levels (pre-vaccination HI titer ≥1:40, Group 1) more easily developed a strong antibody protection effect against the 2009 A/H1N1 influenza vaccine as compared with those showing lower pre-existing seasonal influenza antibody levels (pre-vaccination HI titer ,1:40, Group 2). The titer of the specific antibody against the 2009 A/H1N1 influenza was much higher in Group 1 (geometric mean titer: 146 on Day 21) than that in Group 2 (geometric mean titer: 70 on Day 21).
    Conclusions/Significance: Recipients could gain sufficient protection as early as 10 days after vaccine administration. The protection could last at least 60 days. Individuals with a stronger pre-existing seasonal influenza antibody response may have a relatively higher potential for developing a stronger humoral immune response after vaccination with the 2009 A/H1N1 pandemic influenza vaccine.

    (1).pdf
    文件类型: .pdf 84a465bbd1ebb7343e4e8cb487a01521.pdf (144.60 KB)

    (2) Liang XF, Wang HQ, Wang JZ et al.Safety and immunogenicity of 2009 pandemic influenza A(H1N1)vaccines in China: a multicentre, double-blind,randomised, placebo-controlled trial.Lancet. 2010 May 15;375(9727):1694.

    Summary
    Background
    The current influenza pandemic calls for a safe and effective vaccine. We assessed the safety and immunogenicity of eight formulations of 2009 pandemic influenza A H1N1 vaccine produced by ten Chinese manufacturers.
    Methods In this multicentre, double-blind, randomised trial, 12691 people aged 3 years or older were recruited in ten centres in China. In each centre, participants were stratifi ed by age and randomly assigned by a random number table to receive one of several vaccine formulations or placebo. The study assessed eight formulations: split-virion formulation containing 7.5μg, 15 μg, or 30μg haemagglutinin per dose, with or without aluminium hydroxide adjuvant, and whole-virion formulation containing 5μg or 10μg haemagglutinin per dose, with adjuvant. All formulations were produced from the reassortant strain X-179A (A/California/07/2009-A/PR/8/34). We analysed the safety (adverse events), immunogenicity (geometric mean titre [GMT] of haemagglutination inhibition antibody), and seroprotection (GMT ≥1:40) of the formulations. Analysis was by per protocol. Two sites registered their trial with ClinicalTrials.gov, numbers NCT00956111 and NCT00975572. The other eight studies were registered with the State Food and Drug Administration of China.
    Findings 12691 participants received the first dose on day 0, and 12348 participants received the second dose on day 21. The seroprotection rate 21 days after the first dose of vaccine ranged from 69.5% (95% CI 65.9–72.8) for the 7.5μg adjuvant split-virion formulation to 92.8% (91.9–93.6) for the 30μg non-adjuvant split-virion formulation. The seroprotection rate was 86.5% (796 of 920; 84.1–88.7) in recipients of one dose of the 7.5μg non-adjuvant splitvirion vaccine compared with 9.8% (140 of 1432; 8.3–11.4) in recipients of placebo (p<0.0001). One dose of the 7.5μg non-adjuvant split-virion vaccine induced seroprotection in 178 of 232 children (aged 3 years to <12 years; 76.7%, 70.7–82.0), 211 of 218 adolescents (12 years to <18 years; 96.8%, 93.5–98.7), 289 of 323 adults (18–60 years; 89.5%, 85.6–92.6), and 118 of 147 adults older than 60 years (80.3%, 72.9–86.4), meeting the European Union’s licensure criteria for seroprotection in all age-groups. In children, a second dose of the 7.5μg formulation increased the seroprotection rate to 97.7% (215 of 220, 94.8–99.3). Adverse reactions were mostly mild or moderate, and self-limited. Severe adverse effects occurred in 69 (0.6%, 0.5–0.8) recipients of vaccine compared with one recipient (0.1%, 0–0.2) of placebo. The most common severe adverse reaction was fever, which occurred in 25 (0.22%; 0.14–0.33) recipients of vaccine after the first dose and four (0.04%; 0.01–0.09) recipients of vaccine after the second dose compared with no recipients of placebo after either dose.
    Interpretation One dose of non-adjuvant split-virion vaccine containing 7.5μg haemagglutinin could be promoted as the formulation of choice against 2009 pandemic influenza A H1N1 for people aged 12 years or older. In children (aged <12 years), two 7.5μg doses might be needed.
    Funding Sinovac Biotech, Hualan Biological Bacterin, China National Biotec Group, Beijing Tiantan Biological Products, Changchun Institute of Biological Products, Changchun Changsheng Life Sciences, Jiangsu Yanshen Biological Technology Stock, Zhejiang Tianyuan Bio-Pharmaceutical, Lanzhou Institute of Biological Products, Shanghai Institute of Biological Products, and Dalian Aleph Biomedical.


    (3)Zhu FC, Wang H, Fang HH, et al. A novel infl uenza A (H1N1) vaccine in various age groups. N Engl J Med 2009; published online, Oct 21. DOI:10.1056/ NEJMoa0908535.

    Background
    There is an urgent need for a vaccine that is effective against the 2009 pandemic influenza A (H1N1) virus.
    Methods
    A split-virus, inactivated candidate vaccine against the 2009 H1N1 virus was manufactured, and we evaluated its safety and immunogenicity in a randomized clinical trial. Subjects were between 3 and 77 years of age, stratified into four age groups. The immunization schedule consisted of two vaccinations, 21 days apart. Subjects were injected with placebo or with vaccine, with or without alum adjuvant, at doses of 7.5μg, 15μg, or 30μg. Serologic analysis was performed at baseline and on days 21 and 35.
    Results
    A total of 2200 subjects received one dose, and 2103 (95.6%) received the second dose, of vaccine or placebo. No severe adverse side effects associated with the vaccine were noted. In the nonadjuvanted-vaccine groups, injection-site or systemic reactions, most mild in nature, were noted in 5.5 to 15.9% of subjects. Among the subjects receiving 15μg of nonadjuvanted vaccine, a hemagglutination-inhibition titer of 1:40 or more was achieved by day 21 in 74.5% of subjects between 3 and 11 years of age, 97.1% of subjects between 12 and 17 years, 97.1% of subjects between 18 and 60 years, and 79.1% of subjects 61 years of age or older; by day 35, the titer had been achieved in 98.1%, 100%, 97.1%, and 93.3% of subjects, respectively. The proportion with a titer of 1:40 or more was generally highest among the subjects receiving 30μg of vaccine, with or without adjuvant. Vaccine without adjuvant was associated with fewer local reactions and greater immune responses than was vaccine with adjuvant.
    Conclusions
    These data suggest that a single dose of 15μg of hemagglutinin antigen without alum adjuvant induces a typically protective immune response in the majority of subjects between 12 and 60 years of age. Lesser immune responses were seen after a single dose of vaccine in younger and older subjects. (ClinicalTrials.gov number,NCT00975572.)


    (4) Partridge J, Kieny MP; World Health Organization H1N1 influenza vaccine Task Force. Global production of seasonal and pandemic (H1N1) influenza vaccines in 2009–2010 and comparison with previous estimates and global action plan targets. Vaccine. 2010 Jul 5;28(30):4709-12. Epub 2010 May 18.

    Abstract
    Immunization against influenza is considered among the most important interventions in reducing the public health impact of seasonal epidemic and pandemic influenza infections. However, there are marked differences across countries with regards to production, supply and access to influenza vaccines. A global action plan (GAP) to increase supply of pandemic influenza vaccine was developed by the World Health Organization in May 2006 to reduce the anticipated gap between potential vaccine demand and supply during an influenza pandemic. To quantify the increase in global influenza vaccine production capacity and actual production in response to the influenza A(H1N1) 2009 pandemic, 3 years after the development of the GAP, the WHO conducted a survey of vaccine producers from December 2009 through February 2010, and compared the results of this survey with results from surveys conducted in 2006–2007 and May 2009.
    (4).pdf
    文件类型: .pdf b8f8f9fa52dae3c0abf51d2d5c022956.pdf (281.34 KB)


    (5) Liang XF, Li L, Liu DW, et al. Safety of Influenza A (H1N1) Vaccine in Postmarketing Surveillance in China. N Engl J Med. 2011 Feb 17;364(7):638-47. Epub 2011 Feb 2.

    BACKGROUND
    On September 21, 2009, China began administering vaccines, obtained from 10 different manufacturers, against 2009 pandemic influenza A (H1N1) virus infection in priority populations. We aimed to assess the safety of this vaccination program.
    METHODS
    We designed a plan for passive surveillance for adverse events after immunization with the influenza A (H1N1) vaccine. Physicians or vaccination providers were required to report the numbers of vaccinees and all adverse events to their local Center for Disease Control and Prevention (CDC), which then reported the data to the Chinese CDC through the online National Immunization Information System’s National Adverse Event Following Immunization Surveillance System. Data were collected through March 21, 2010, and were verified and analyzed by the Chinese CDC.
    RESULTS
    A total of 89.6 million doses of vaccine were administered from September 21, 2009, through March 21, 2010, and 8067 vaccinees reported having an adverse event, for a rate of 90.0 per 1 million doses. The age-specific rates of adverse events ranged from 31.4 per 1 million doses among persons 60 years of age or older to 130.6 per 1 million doses among persons 9 years of age or younger, and the manufacturerspecific rates ranged from 4.6 to 185.4 per 1 million doses. A total of 6552 of the 8067 adverse events (81.2%; rate, 73.1 per 1 million doses) were verified as vaccine reactions; 1083 of the 8067 (13.4%; rate, 12.1 per 1 million doses) were rare and more serious (vs. common, minor events), most of which (1050) were allergic reactions. Eleven cases of the Guillain–Barré syndrome were reported, for a rate of 0.1 per 1 million doses, which is lower than the background rate in China.
    CONCLUSIONS
    No pattern of adverse events that would be of concern was observed after the administration of influenza A (H1N1) vaccine, nor was there evidence of an increased risk of the Guillain–Barré syndrome.

 

 
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