Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
2018年5月9日 更新者：GlaxoSmithKline
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
研究概览
研究类型
介入性
注册 (实际的)
4561
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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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3K 6R8
- GSK Investigational Site
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Truro、Nova Scotia、加拿大、B2N 1L2
- GSK Investigational Site
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Ontario
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London、Ontario、加拿大、N5W 6A2
- GSK Investigational Site
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Sarnia、Ontario、加拿大、N7T 4X3
- GSK Investigational Site
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Sudbury、Ontario、加拿大、P3E 6C3
- GSK Investigational Site
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Woodstock、Ontario、加拿大、N4S 4G3
- GSK Investigational Site
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Quebec
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Pointe-Claire、Quebec、加拿大、H9R 4S3
- GSK Investigational Site
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Quebec City、Quebec、加拿大、G1E 7G9
- GSK Investigational Site
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Sherbrooke、Quebec、加拿大、J1H 4J6
- GSK Investigational Site
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St-Romuald、Quebec、加拿大、G6W 5M6
- GSK Investigational Site
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Alabama
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Huntsville、Alabama、美国、35802
- GSK Investigational Site
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Arizona
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Phoenix、Arizona、美国、85020
- GSK Investigational Site
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California
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Anaheim、California、美国、92801
- GSK Investigational Site
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Florida
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Jacksonville、Florida、美国、32216
- GSK Investigational Site
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Melbourne、Florida、美国、32935
- GSK Investigational Site
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Miami、Florida、美国、33143
- GSK Investigational Site
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Pembroke Pines、Florida、美国、33024
- GSK Investigational Site
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Georgia
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Stockbridge、Georgia、美国、30281
- GSK Investigational Site
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Illinois
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Chicago、Illinois、美国、60610
- GSK Investigational Site
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Peoria、Illinois、美国、61602
- GSK Investigational Site
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Indiana
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South Bend、Indiana、美国、46601
- GSK Investigational Site
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Kansas
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Lenexa、Kansas、美国、66219
- GSK Investigational Site
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Wichita、Kansas、美国、67207
- GSK Investigational Site
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Louisiana
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Metairie、Louisiana、美国、70006
- GSK Investigational Site
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Maryland
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Rockville、Maryland、美国、20850
- GSK Investigational Site
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Missouri
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Saint Louis、Missouri、美国、63141
- GSK Investigational Site
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Montana
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Missoula、Montana、美国、59801
- GSK Investigational Site
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Nevada
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Las Vegas、Nevada、美国、89104
- GSK Investigational Site
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New Jersey
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Edison、New Jersey、美国、08817
- GSK Investigational Site
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New York
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Poughkeepsie、New York、美国、12601
- GSK Investigational Site
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Rochester、New York、美国、14609
- GSK Investigational Site
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North Carolina
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Raleigh、North Carolina、美国、27612
- GSK Investigational Site
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Ohio
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Cleveland、Ohio、美国、44122
- GSK Investigational Site
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Pennsylvania
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Erie、Pennsylvania、美国、16506
- GSK Investigational Site
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Pittsburgh、Pennsylvania、美国、15236
- GSK Investigational Site
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South Carolina
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Spartanburg、South Carolina、美国、29303
- GSK Investigational Site
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Tennessee
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Nashville、Tennessee、美国、37203
- GSK Investigational Site
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Texas
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Austin、Texas、美国、78705
- GSK Investigational Site
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Fort Worth、Texas、美国、76135
- GSK Investigational Site
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San Angelo、Texas、美国、76904
- 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:
- A male or female 18 years of age or greater at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
- Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
- Access to a consistent means of telephone contact.
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Exclusion Criteria:
- Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
- Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- Administration of any vaccines within 30 days before study enrollment.
- Previous administration of any H5N1 vaccine.
- Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
- Lactating or nursing.
- Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
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 |
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实验性的：Influenza A (H5N1) 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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安慰剂比较：Placebo 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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实验性的：Influenza A (H5N1) >64Y Group
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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安慰剂比较：Placebo >64Y Group
Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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实验性的：Influenza A (H5N1) Group
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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安慰剂比较：Placebo Group
Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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实验性的：Influenza A (H5N1) 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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安慰剂比较：Placebo 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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实验性的：Influenza A (H5N1) >60Y Group
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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安慰剂比较：Placebo >60Y Group
Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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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 Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
大体时间：At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
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At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
大体时间：At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Subjects With Any Solicited Local Symptoms.
大体时间：During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Number of Subjects With Any Solicited General Symptoms.
大体时间：During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Number of Subjects With Any Unsolicited Adverse Events (AEs).
大体时间：During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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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.
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During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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Number of Subjects With Serious Adverse Events (SAEs)
大体时间：From Day 0 through Day 182 and through Day 379.
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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.
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From Day 0 through Day 182 and through Day 379.
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Number of Subjects With Medically Attended Events (MAEs)
大体时间：From Day 0 through Day 182 and through Day 364.
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From Day 0 through Day 182 and through Day 364.
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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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Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
大体时间：At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
大体时间：At Month 6 (Day 182) post Dose 1
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At Month 6 (Day 182) post Dose 1
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
大体时间：At Month 6 (Day 182) after Dose 1
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
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At Month 6 (Day 182) after Dose 1
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Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
大体时间：At Month 6 (Day 182) after Dose 1
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At Month 6 (Day 182) after Dose 1
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Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
大体时间：At Month 6 (Day 182) after Dose 1
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
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At Month 6 (Day 182) after Dose 1
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Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
大体时间：At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers.
The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
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At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
大体时间：At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Titers were expressed as Geometric Mean Titers (GMTs).
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At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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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
2008年1月23日
初级完成 (实际的)
2008年10月15日
研究完成 (实际的)
2009年3月19日
研究注册日期
首次提交
2008年1月28日
首先提交符合 QC 标准的
2008年2月5日
首次发布 (估计)
2008年2月15日
研究记录更新
最后更新发布 (实际的)
2018年6月8日
上次提交的符合 QC 标准的更新
2018年5月9日
最后验证
2016年10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
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统计分析计划
信息标识符：110464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：110464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：110464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：110464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：110464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：110464信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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研究协议
信息标识符：110464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.