此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

2014年6月16日 更新者：Novartis Vaccines

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

7109

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 哥伦比亚
    • Bogota
      • Avenida Carrera 68、Bogota、哥伦比亚
        • 209, Centro de Investigacion CAFAM
      • Carrera 42A、Bogota、哥伦比亚、1750
        • 206, Centro de Atencion e Investigacion Medica CAIMED
      • Carrera 42A、Bogota、哥伦比亚、1750
        • 213, Centro de Atencion e Investigacion Medica CAIMED
      • Cra 14 No Piso Sexto、Bogota、哥伦比亚
        • 207, Centro de Investigacion Cafesalud Medicina Prepagada
  • 巴拿马
      • Clayton ciudad del Saber Edificio 118、巴拿马
        • 203, Health Research International HRI
      • Consultorios Royal Center 108、巴拿马
        • 205, Medical and Research Center Calle 53 Urbanizacion Marbella
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85253
        • 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
    • Florida
      • Deland、Florida、美国、32720
        • 318 Avail Clinical Research, 860 Peachwood Drive
      • Jacksonville、Florida、美国、32205
        • 306 Westside Center for Clinical Research, 810 Lane Avenue South
      • Miami、Florida、美国、33143
        • 328 Miami Research Associates, 6141 Sunset Drive
    • Kansas
      • Lenexa、Kansas、美国、66219
        • 320 Johnson County Clin-Trials, 15602 College Blvd
      • Newton、Kansas、美国、67114
        • 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
      • Wichita、Kansas、美国、67205
        • 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
      • Wichita、Kansas、美国、67207
        • 322 Heartland Research Associates Wichita, 1709 S. Rock Road
    • Missouri
      • Saint Louis、Missouri、美国、63104
        • 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
      • Saint Louis、Missouri、美国、63141
        • 330 Mercy Health Research, 12680 Olive Blvd Suite 200
    • Nevada
      • Las Vegas、Nevada、美国、89130
        • 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
    • New York
      • Endwell、New York、美国、13760
        • 311 Regional Clinical Research INC, 415 Hooper Road
    • North Carolina
      • Raleigh、North Carolina、美国、27612
        • 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
      • Winston-Salem、North Carolina、美国、27103
        • 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
    • Ohio
      • Franklin、Ohio、美国、45005
        • 303 Prestige Clinical Research, 333 Conover Drive
    • Rhode Island
      • Warwick、Rhode Island、美国、02886
        • 325 Omega Medical Research, 400 Bald Hill Road
    • South Carolina
      • Spartanburg、South Carolina、美国、29303
        • 312 Spartanburg Regional Medical Center, 485 Simuel Road
    • Utah
      • Jordan、Utah、美国
        • 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
      • Salt Lake City、Utah、美国、84109
        • 317 J. Lewis Research Inc., 2295 Foothill Drive
      • Salt Lake City、Utah、美国、84121
        • 305 Foothill Family Clinic South, 6360 South 3000 East
    • Virginia
      • Fairfax、Virginia、美国、22030
        • 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
  • 菲律宾
      • Pasay City、菲律宾、1300
        • 110, San Juan de Dios Hospital, 2772 Roxas Blvd
      • Quezon City、菲律宾、1102
        • 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
    • Cavite
      • DBB B Dasmarinas、Cavite、菲律宾、4114
        • 103, De La Salle Health Sciences Institute
      • Dbbb Dasmarinas、Cavite、菲律宾、4114
        • 102, De La Salle Health Sciences Institute
    • Manila
      • Ermita、Manila、菲律宾、1000
        • 105, Manila Doctors Hospital, 667 United Nations Avenue
      • Mesa、Manila、菲律宾、1016
        • 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
      • Rizal Avenue Avenida Cruz、Manila、菲律宾、1003
        • 104 Jose Reyes Memorial Medical Center
      • Taft Avenue、Manila、菲律宾、1000
        • 107 Philippine General Hospital
    • Muntinlupa
      • Corporate City Alabang、Muntinlupa、菲律宾、1781
        • 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
      • Corporate City Alabang、Muntinlupa、菲律宾
        • 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
    • Rosa City
      • City Health Office 1、Rosa City、菲律宾、4026
        • 108, City Health Office 1 Rosa City

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.

Exclusion Criteria:

  1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
  2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
  3. Known or suspected impairment/alteration of immune function.
  4. Individuals with a known bleeding diathesis.
  5. History of Guillain-Barré syndrome.
  6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
  7. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
  8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
  9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
  10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
  11. Individuals with history of substance or alcohol abuse within the past 2 years.
  12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
  13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
  14. Subjects from whom blood could not be drawn at visit 1.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：aTIV
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
生物：MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
其他名称：
  • 流体
实验性的：Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
生物：Non-adjuvanted trivalent subunit influenza vaccine (TIV)
one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
其他名称：
  • 农业流感

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
大体时间：Day 22 post vaccination
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
大体时间：Day 22 post vaccination
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
大体时间：Day 22 post vaccination

The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
大体时间：Day 22 post vaccination
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
大体时间：Day 22 post vaccination

The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
大体时间：Day 22 post vaccination
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Day 22 post vaccination
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
大体时间：Day 22 post vaccination

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
大体时间：Day 22 post vaccination
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Day 22 post vaccination
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
大体时间：Day 22 post vaccination
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Day 22 post vaccination
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
大体时间：Day 22 post vaccination
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Day 22 post vaccination
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
大体时间：Day 22 post vaccination

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination

次要结果测量

结果测量
措施说明
大体时间
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
大体时间：Day 22 post vaccination
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Day 22 post vaccination
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
大体时间：Day 22 post vaccination

The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
大体时间：Day 22 post vaccination
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Day 22 post vaccination
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
大体时间：Day 22 postvaccination

The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 postvaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
大体时间：Day 22 post vaccination
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
大体时间：Day 22 post vaccination
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
Day 22 post vaccination
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
大体时间：Day 22 postvaccination

The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 postvaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
大体时间：Day 22 post vaccination

The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 22 post vaccination
Persistence of GMTs Against Homologous and Heterologous Strains
大体时间：Day 181, Day 366 post vaccination
The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Day 181, Day 366 post vaccination
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
大体时间：Day 181, Day 366 post vaccination

The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Day 181, Day 366 post vaccination
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
大体时间：Day 22 through Day 366 post vaccination
The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
Day 22 through Day 366 post vaccination
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
大体时间：Day 1 through Day 366 post vaccination
The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
Day 1 through Day 366 post vaccination
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
大体时间：Day 1 through Day 366 post vaccination
The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
Day 1 through Day 366 post vaccination
All Cause Mortality Rate, Across Vaccine Groups
大体时间：Day 1 through Day 366 post vaccination
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Day 1 through Day 366 post vaccination
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
大体时间：Day 1 through Day 7 post vaccination
The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
Day 1 through Day 7 post vaccination

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Vaccines

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年11月1日

研究注册日期

首次提交

2010年7月13日

首先提交符合 QC 标准的

2010年7月13日

首次发布 (估计)

2010年7月14日

研究记录更新

最后更新发布 (估计)

2014年6月26日

上次提交的符合 QC 标准的更新

2014年6月16日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • V70_27

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅