Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
2018年5月28日 更新者：GlaxoSmithKline
A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus.
Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines.
Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.
This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
研究概览
详细说明
This study has 2 phases:
The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.
The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究类型
介入性
注册 (实际的)
5075
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
-
-
-
Ekaterinburg、俄罗斯联邦、620078
- GSK Investigational Site
-
Ekaterinburg、俄罗斯联邦、620028
- GSK Investigational Site
-
Kazan、俄罗斯联邦、420015
- GSK Investigational Site
-
Novokuznetsk、俄罗斯联邦、654063
- GSK Investigational Site
-
Saratov、俄罗斯联邦
- GSK Investigational Site
-
-
-
-
-
Berlin、德国、14057
- GSK Investigational Site
-
Berlin、德国、10117
- GSK Investigational Site
-
Berlin、德国、10787
- GSK Investigational Site
-
Hamburg、德国、22143
- GSK Investigational Site
-
Hamburg、德国、20249
- GSK Investigational Site
-
-
Bayern
-
Muenchen、Bayern、德国、81667
- GSK Investigational Site
-
Muenchen、Bayern、德国、80799
- GSK Investigational Site
-
Regensburg、Bayern、德国、93053
- GSK Investigational Site
-
Wuerzburg、Bayern、德国、97070
- GSK Investigational Site
-
-
Mecklenburg-Vorpommern
-
Schwerin、Mecklenburg-Vorpommern、德国、19055
- GSK Investigational Site
-
-
Niedersachsen
-
Hannover、Niedersachsen、德国、30519
- GSK Investigational Site
-
-
Nordrhein-Westfalen
-
Witten、Nordrhein-Westfalen、德国、58455
- GSK Investigational Site
-
-
Sachsen
-
Dresden、Sachsen、德国、01067
- GSK Investigational Site
-
Leipzig、Sachsen、德国、04229
- GSK Investigational Site
-
Leipzig、Sachsen、德国、04103
- GSK Investigational Site
-
-
-
-
-
Caen cedex 4、法国、14052
- GSK Investigational Site
-
Lagord、法国、17140
- GSK Investigational Site
-
Nantes、法国、44093
- GSK Investigational Site
-
Paris Cedex 18、法国、75877
- GSK Investigational Site
-
Poitiers、法国、86000
- GSK Investigational Site
-
Rouen、法国、76100
- GSK Investigational Site
-
-
-
-
-
Tallinn、爱沙尼亚、10617
- GSK Investigational Site
-
Tartu、爱沙尼亚、50417
- GSK Investigational Site
-
-
-
-
-
Eskilstuna、瑞典、SE-631 88
- GSK Investigational Site
-
Stockholm、瑞典、SE-141 86
- GSK Investigational Site
-
-
-
-
-
Rotterdam、荷兰、3011 EN
- GSK Investigational Site
-
Rotterdam、荷兰、3015 GE
- GSK Investigational Site
-
-
-
-
-
Barcelona、西班牙、08036
- GSK Investigational Site
-
Barcelona、西班牙、08035
- GSK Investigational Site
-
Madrid、西班牙、28041
- GSK Investigational Site
-
Madrid、西班牙、28006
- GSK Investigational Site
-
Madrid、西班牙、28040
- GSK Investigational Site
-
Marid、西班牙、28040
- GSK Investigational Site
-
Valencia、西班牙、46017
- GSK Investigational Site
-
Valencia、西班牙、46014
- 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
18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:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- 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 a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
- Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
- Lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GSK1562902A Group
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
The group was further stratified by age for analyses.
|
2 doses, intramuscular injection
|
|
有源比较器：Fluarix+Placebo Group
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
The group was further stratified by age for analyses.
|
One intramuscular injection
One intramuscular injection
|
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 Subjects With Solicited Local Symptoms
大体时间：During a 7 day follow-up period after each dose of vaccine and overall.
|
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling.
Any = occurrence of symptom regardless of intensity grade.
Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
|
During a 7 day follow-up period after each dose of vaccine and overall.
|
|
Number of Subjects With Solicited General Symptoms (Dose 1)
大体时间：During the 7-day (Days 0-6) after Dose 1
|
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
|
During the 7-day (Days 0-6) after Dose 1
|
|
Number of Subjects With Solicited General Symptoms (Dose 2)
大体时间：During the 7-day (Days 0-6) after Dose 2
|
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
|
During the 7-day (Days 0-6) after Dose 2
|
|
Number of Subjects With Solicited General Symptoms (Across Doses)
大体时间：During the 7-day (Days 0-6) post vaccination across dosses
|
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
|
During the 7-day (Days 0-6) post vaccination across dosses
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
大体时间：During the 21st Day (Days 0-20) post Dose 1
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
Related symptoms were not available.
|
During the 21st Day (Days 0-20) post Dose 1
|
|
Number of Subjects With AEs
大体时间：During the 30 Day (Days 0-29) post Dose 2
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
Related symptoms were not available.
|
During the 30 Day (Days 0-29) post Dose 2
|
|
Number of Subjects With Serious Adverse Events (SAEs)
大体时间：From Day 0 to Day 180
|
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
From Day 0 to Day 180
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs)
大体时间：From Day 0 to Day 180
|
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
|
From Day 0 to Day 180
|
|
Number of Subjects With Medically Significant Conditions (MSCs)
大体时间：From Day 0 to Day 51
|
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits.
Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
|
From Day 0 to Day 51
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
大体时间：At Day 0 (PRE), 21 and 42
|
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
|
At Day 0 (PRE), 21 and 42
|
|
Number of Seroconverted Subjects Against H5N1
大体时间：At Day 21 and Day 42
|
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer.
Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
|
At Day 21 and Day 42
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
大体时间：At Day 21 and Day 42
|
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
|
At Day 21 and Day 42
|
|
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
大体时间：At Day 0 (PRE), Day 21 and Day 42
|
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
|
At Day 0 (PRE), Day 21 and Day 42
|
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 (实际的)
2006年5月1日
初级完成 (实际的)
2007年1月1日
研究完成 (实际的)
2007年7月31日
研究注册日期
首次提交
2006年4月26日
首先提交符合 QC 标准的
2006年4月26日
首次发布 (估计)
2006年4月27日
研究记录更新
最后更新发布 (实际的)
2018年7月23日
上次提交的符合 QC 标准的更新
2018年5月28日
最后验证
2017年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 107064
- 107217 (其他标识符：GSK)
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
-
知情同意书
信息标识符：107064信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符：107064信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符：107064信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
临床研究报告
信息标识符：107064信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
个人参与者数据集
信息标识符：107064信息评论：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
-
统计分析计划
信息标识符：107064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.