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Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

2018年7月4日 更新者:GlaxoSmithKline

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

研究概览

详细说明

The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.

The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.

研究类型

介入性

注册 (实际的)

168

阶段

  • 阶段2

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

      • Eskilstuna、瑞典、SE-631 88
        • GSK Investigational Site
      • Örebro、瑞典、SE-703 62
        • GSK Investigational Site

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

61年 及以上 (成人、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:

  • Male or female subjects 61 years of age or older at the time of the first vaccination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Access to a consistent means of telephone contact.

Exclusion Criteria:

  • Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
  • Previous administration of a pandemic influenza vaccine.
  • Administration of any vaccine within 30 days before first vaccination.
  • Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of an oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
  • Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Serious chronic disease as determined by medical history and physical examination.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
  • Any known or suspected allergy to any constituent of influenza vaccines.
  • History of chronic alcohol consumption and/or drug abuse.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
其他名称:
  • 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Intramuscular injection, 1 dose
实验性的:Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
其他名称:
  • 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Intramuscular injection, 1 dose

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
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
大体时间:21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
大体时间:21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
大体时间:21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

次要结果测量

结果测量
措施说明
大体时间
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
大体时间:Days 0, 21, 42, 182, 364

Titers are expressed as GMTs.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Days 0, 21, 42, 182, 364
Number of Seroconverted Subjects
大体时间:at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Seroprotected Subjects
大体时间:at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Geometric Mean Fold Rise (GMFR)
大体时间:at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Subjects With Titers Equal to or Above Titer 1:10
大体时间:Days 0, 21, 42, 182, 364

The cut-off 1:10 was considered as seropositivity.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Days 0, 21, 42, 182, 364
Number of Subjects With Solicited Local and General Symptoms
大体时间:Within 7 days (Day 0-Day 6) after each vaccination
Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).
Within 7 days (Day 0-Day 6) after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
大体时间:From Day 0 to Day 83
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
From Day 0 to Day 83
Number of Subjects With Adverse Events of Specific Interest
大体时间:From Day 0 to Day 364
Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
From Day 0 to Day 364
Number of Subjects With Serious Adverse Events (SAEs)
大体时间:From Day 0 to Day 364
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Day 0 to Day 364

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。

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。

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

2009年9月12日

初级完成 (实际的)

2010年9月23日

研究完成 (实际的)

2010年9月23日

研究注册日期

首次提交

2009年8月27日

首先提交符合 QC 标准的

2009年8月27日

首次发布 (估计)

2009年8月31日

研究记录更新

最后更新发布 (实际的)

2018年8月20日

上次提交的符合 QC 标准的更新

2018年7月4日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

研究数据/文件

  1. 带注释的病例报告表
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  2. 数据集规范
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  3. 个人参与者数据集
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  4. 统计分析计划
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  5. 知情同意书
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  6. 研究协议
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  7. 临床研究报告
    信息标识符:113525
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register

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.

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