A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
2018年8月9日 更新者：GlaxoSmithKline
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
研究概览
研究类型
介入性
注册 (实际的)
119
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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Sachsen
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Dresden、Sachsen、德国、01309
- GSK Investigational Site
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Dresden、Sachsen、德国、01097
- GSK Investigational Site
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Dresden、Sachsen、德国、01099
- GSK Investigational Site
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Dresden、Sachsen、德国、01129
- 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
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 can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
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 during the entire treatment period and for 2 months after completion of vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- 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 period.
- Administration of an influenza vaccine within the six months preceding the study vaccination.
- Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- Acute disease and/or fever at the time of enrolment.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic underlying disease, not stabilized or clinically serious.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of Guillain-Barré syndrome.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Anaphylaxis following the administration of vaccine(s).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject 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：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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实验性的：Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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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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Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
大体时间：At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
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At Day 0 and Day 21
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Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 0 and Day 21
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Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
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At Day 0 and Day 21
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Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 21
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A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 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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At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 21
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MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.
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At Day 21
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Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
大体时间：At Day 21
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SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
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At Day 21
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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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Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains included H1N1, H3N2 and Yamagata antigens.
The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.
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At Day 0 and Day 21
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Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 0 and Day 21
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Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
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At Day 0 and Day 21
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Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 21
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SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
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At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
大体时间：At Day 21
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MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
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At Day 21
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Duration of Solicited Local Symptoms.
大体时间：During the 4-day follow-up period (Days 0-3) after vaccination
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Duration was defined as number of days with any grade of local symptoms.
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During the 4-day follow-up period (Days 0-3) after vaccination
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
大体时间：During the 4-day (Day 0-Day 3) follow-up period after vaccination
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Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling.
Any was defined as any solicited local symptom reported irrespective of intensity.
Grade 3 pain was defined as pain that prevented normal everyday activities.
Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
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During the 4-day (Day 0-Day 3) follow-up period after vaccination
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Duration of Solicited General Symptoms.
大体时间：During the 4-day follow-up period (Days 0-3) after vaccination
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Duration was defined as number of days with any grade of general symptoms.
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During the 4-day follow-up period (Days 0-3) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
大体时间：During the 4-day follow-up period (Day 0-3) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C |
During the 4-day follow-up period (Day 0-3) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
大体时间：During the 21-day follow-up period (Days 0-20) after vaccination
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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 or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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During the 21-day follow-up period (Days 0-20) after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
大体时间：During the entire study period (Days 0-21)
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A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (Days 0-21)
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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。
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
2012年7月10日
初级完成 (实际的)
2012年7月31日
研究完成 (实际的)
2012年7月31日
研究注册日期
首次提交
2012年5月24日
首先提交符合 QC 标准的
2012年5月24日
首次发布 (估计)
2012年5月28日
研究记录更新
最后更新发布 (实际的)
2018年9月7日
上次提交的符合 QC 标准的更新
2018年8月9日
最后验证
2013年11月1日
更多信息
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.