Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
2018年8月22日 更新者:GlaxoSmithKline
Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects
The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine.
Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time.
For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.
研究概览
研究类型
介入性
注册 (实际的)
370
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
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Berlin、德国、13347
- GSK Investigational Site
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Berlin、德国、12627
- GSK Investigational Site
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Berlin、德国、10435
- GSK Investigational Site
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Hamburg、德国、22415
- GSK Investigational Site
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Hamburg、德国、22335
- GSK Investigational Site
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Baden-Wuerttemberg
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Gueglingen、Baden-Wuerttemberg、德国、74363
- GSK Investigational Site
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Mannheim、Baden-Wuerttemberg、德国、68161
- GSK Investigational Site
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Rudersberg、Baden-Wuerttemberg、德国、73635
- GSK Investigational Site
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Weinheim、Baden-Wuerttemberg、德国、69469
- GSK Investigational Site
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Bayern
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Augsburg、Bayern、德国、86150
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen、Nordrhein-Westfalen、德国、45359
- GSK Investigational Site
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Koeln、Nordrhein-Westfalen、德国、51069
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、德国、55131
- GSK Investigational Site
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Rhaunen、Rheinland-Pfalz、德国、55624
- GSK Investigational Site
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Sachsen
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Dresden、Sachsen、德国、01067
- GSK Investigational Site
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Freital、Sachsen、德国、01705
- GSK Investigational Site
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Leipzig、Sachsen、德国、04103
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg、Sachsen-Anhalt、德国、39112
- GSK Investigational Site
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Wolmirstedt、Sachsen-Anhalt、德国、39326
- GSK Investigational Site
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Eskilstuna、瑞典、SE-631 88
- GSK Investigational Site
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Karlskrona、瑞典、SE-371 41
- GSK Investigational Site
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Uppsala、瑞典、SE-751 85
- GSK Investigational Site
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Rotterdam、荷兰、3011 EN
- GSK Investigational Site
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Rotterdam、荷兰、3011 AA
- GSK Investigational Site
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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
19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:
All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
- A male or female aged 19-43 years or >=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for 2 months after the vaccination.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests.
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >=37.5°C on oral setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:New generation influenza vaccine GSK2186877A Group
Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
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Single dose, intramuscular injection
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有源比较器:Fluarix elderly Group
Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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有源比较器:Fluarix young Group
Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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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 |
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请求的一般 AE 的持续时间
大体时间:第 0-6 天
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持续时间定义为具有任何等级的一般症状的天数。
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第 0-6 天
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请求的本地 AE 的持续时间
大体时间:第 0-6 天
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持续时间定义为出现任何级别的局部症状的天数。
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第 0-6 天
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
大体时间:Day 0-6
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Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
大体时间:Day 0-6
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Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
大体时间:Day 0-20
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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.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.
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Day 0-20
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Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
大体时间:Day 0-179
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For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-179
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Number of Subjects Reporting AEs of Specific Interest (AESI)
大体时间:Day 0-179
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AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-179
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
大体时间:Up to Day 180
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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.
Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
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Up to Day 180
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
大体时间:After Day 180
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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.
Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
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After Day 180
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
大体时间:Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains.
The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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Day 0 and Day 21
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HI Antibody Titers at Day 180
大体时间:Day 180
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Antibody titers were expressed as GMTs against separate vaccine strains.
The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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Day 180
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The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
大体时间:Day 0 and Day 21
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 0 and Day 21
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The Number of Subjects Seropositive to HI Antibodies at Day 180
大体时间:Day 180
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 180
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The Number of Subjects Seroconverted to HI Antibodies at Day 21
大体时间:Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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Day 21
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The Number of Subjects Seroconverted to HI Antibodies at Day 180
大体时间:Day 180
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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Day 180
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HI Antibody Seroconversion Factors (SCF) at Day 21
大体时间:At Day 21
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 21
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HI Antibody SCF at Day 180
大体时间:At Day 180
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 180
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The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
大体时间:At Day 0 and Day 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.
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At Day 0 and Day 21
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The Number of Subjects Seroprotected to HI Antibodies at Day 180
大体时间:At Day 180
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A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
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At Day 180
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The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
大体时间:At Day 0 and Day 21
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The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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At Day 0 and Day 21
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The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180
大体时间:At Day 180
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The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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At Day 180
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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10月15日
初级完成 (实际的)
2010年5月27日
研究完成 (实际的)
2010年5月27日
研究注册日期
首次提交
2009年10月1日
首先提交符合 QC 标准的
2009年10月8日
首次发布 (估计)
2009年10月9日
研究记录更新
最后更新发布 (实际的)
2018年9月21日
上次提交的符合 QC 标准的更新
2018年8月22日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 113094
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
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研究协议
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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个人参与者数据集
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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临床研究报告
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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数据集规范
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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知情同意书
信息标识符:113094信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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带注释的病例报告表
信息标识符:113094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.
FluarixTM的临床试验
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GlaxoSmithKline完全的