Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
2018年6月12日 更新者：GlaxoSmithKline
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. 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 best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
研究概览
研究类型
介入性
注册 (实际的)
845
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。
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 至 61年 (成人)
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 completed participation in primary phase of this study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- 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 or be post-menopausal; if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Administration of any licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of chronic alcohol consumption and/or drug abuse.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first visit or planned use during the study.
- Pregnant or 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 visit, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation 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：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：GSK1562902A M6 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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实验性的：GSK1562902A M12 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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实验性的：GSK1562902A M36 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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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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Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value
大体时间：At Month 12 + 21 days
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
大体时间：At Month 12 + 21 days
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value
大体时间：At Month 36 + 21 days
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 + 21 days
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Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
大体时间：At Month 36 + 21 days
|
Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 + 21 days
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Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
大体时间：At Month 12 + 21 days
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Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
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At Month 12 + 21 days
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Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
大体时间：At Month 36 + 21 Days
|
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
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At Month 36 + 21 Days
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
大体时间：At Month 12 + 21 days
|
GMFR, also known as seroconversion factor (SCF), was 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 flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
大体时间：At Month 36 +21 days
|
GMFR, also known as seroconversion factor (SCF), was 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 flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 +21 days
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Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
大体时间：At Month 12 + 21 days
|
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
大体时间：At Month 36 + 21 days
|
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
|
At Month 36 + 21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Seropositive Subjects for H5N1 HI Antibodies
大体时间：At Months 18, 24, 30 and 36
|
Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24, 30 and 36
|
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Number of Seropositive Subjects for H5N1 HI Antibodies
大体时间：At Months 42 and 48
|
Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 42 and 48
|
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Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12
大体时间：At Months 18, 24 and 30
|
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer.
The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24 and 30
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Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies
大体时间：At Months 18, 24 and 30
|
Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24 and 30
|
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Booster Vaccine Response for H5N1 HI Antibodies
大体时间：At Months 36, 42 and 48
|
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 36, 42 and 48
|
|
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
大体时间：At Months 18, 24, 30
|
GMFR, also known as seroconversion factor (SCF), was 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 18, 24, 30
|
|
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
大体时间：At Months 36, 42 and 48
|
GMFR, also known as seroconversion factor (SCF), was 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 36, 42 and 48
|
|
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
大体时间：At Months 18, 24 and 30
|
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 18, 24 and 30
|
|
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
大体时间：At Months 36, 42 and 48
|
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
|
At Months 36, 42 and 48
|
|
Titers for Serum Neutralizing Antibodies
大体时间：At Months 6/12, 6/12 + 21 days, 24, 36 and 48
|
Titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:28.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 6/12, 6/12 + 21 days, 24, 36 and 48
|
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Booster Vaccine Response for Neutralizing Antibodies
大体时间：At Months 6/12/36 + 21 days, 12, 24, 36 and 48
|
Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
大体时间：At Months 6/12/36 + 21 days, 12, 24, 36 and 48
|
Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/Indonesia/05/2005.
|
At Months 6/12/36 + 21 days, 12, 24, 36 and 48
|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off
大体时间：At Months 6/12/36 + 21 days, 12, 24, 36 and 48
|
Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/Vietnam/1194/2004.
|
At Months 6/12/36 + 21 days, 12, 24, 36 and 48
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
大体时间：During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36
|
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36
|
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptom
大体时间：During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36
|
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as causally related to the study vaccination.
|
During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36
|
|
Number of Subjects With Adverse Events of Specific Interest (AESIs)
大体时间：During the entire study period (From Month 12 to Month 48)
|
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
|
During the entire study period (From Month 12 to Month 48)
|
|
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
大体时间：At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Indonesia/05/2005.
|
At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
|
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
大体时间：At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Vietnam/1194/2004.
|
At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
|
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
大体时间：At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Indonesia/05/2005.
|
At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
|
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
大体时间：At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Vietnam/1194/2004.
|
At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
大体时间：During the 30-day (Days 0-29) follow-up period after vaccination
|
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.
|
During the 30-day (Days 0-29) follow-up period after vaccination
|
|
Number of Subjects With Serious Adverse Events (SAEs)
大体时间：During the entire study period (From Month 12 up to Month 48)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
During the entire study period (From Month 12 up to Month 48)
|
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)
2008年3月23日
初级完成 (实际的)
2011年6月8日
研究完成 (实际的)
2011年6月8日
研究注册日期
首次提交
2008年3月21日
首先提交符合 QC 标准的
2008年4月1日
首次发布 (估计)
2008年4月4日
研究记录更新
最后更新发布 (实际的)
2018年8月2日
上次提交的符合 QC 标准的更新
2018年6月12日
最后验证
2018年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 111443
- 111470
- 111471
- 111472
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
-
临床研究报告
信息标识符：111443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：111443信息评论：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 111470 are summarised with studies 111443, 111471, and 111472 on the GSK Clinical Study Register.
-
研究协议
信息标识符：111443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：111443信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
统计分析计划
信息标识符：111443信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符：111443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.