Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age
2016年6月16日 更新者:GlaxoSmithKline
An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.
研究概览
地位
撤销
条件
研究类型
介入性
阶段
- 阶段1
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 至 60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:
- Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Healthy subjects as established by medical history and physical examination.
- Access to a consistent means of telephone contact.
- For subjects who undergo a screening visit: Results of screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.
- Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if they
- have practiced adequate contraception for 30 days prior to vaccination, and
- have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after the last dose administered.
Exclusion Criteria:
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
- Diagnosed with cancer, or treatment for cancer within three years.
- Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), 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 (HIV) infection.
- Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
- Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
- Previous administration of any H7 vaccine or physician-confirmed H7 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including 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 (β-hCG) test result before the first dose of study vaccine/placebo.
- Lactating or nursing women.
- 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: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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安慰剂比较:安慰剂组
该组中的受试者将以 21 天的间隔接受两剂安慰剂
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One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21
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实验性的:Formulation 1 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
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实验性的:Formulation 2 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
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实验性的:Formulation 3 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
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实验性的:Formulation 4 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
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实验性的:Formulation 5 Group
Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval
|
One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
大体时间:At Day 42.
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At Day 42.
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Occurrence of each solicited local symptom
大体时间:During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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Occurrence of each solicited general symptom
大体时间:During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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Occurrence of clinical safety laboratory abnormalities reported for samples
大体时间:At the Day 0, 7, 21, 28 and 42 visits.
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At the Day 0, 7, 21, 28 and 42 visits.
|
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Occurrence of unsolicited adverse events (AEs)
大体时间:21 days after each dose.
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21 days after each dose.
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Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]
大体时间:From Day 0 until Day 42.
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From Day 0 until Day 42.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers
大体时间:At Day 42.
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At Day 42.
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Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group
大体时间:At Day 42.
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At Day 42.
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Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.
大体时间:GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
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GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
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Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.
大体时间:GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
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GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
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Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.
大体时间:GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
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GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
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Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)
大体时间:GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
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GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
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Occurrence of MAEs, pIMDs and SAEs
大体时间:Until the Month 12 visit.
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Until the Month 12 visit.
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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
2016年3月1日
初级完成 (预期的)
2016年6月1日
研究完成 (预期的)
2017年5月1日
研究注册日期
首次提交
2014年6月19日
首先提交符合 QC 标准的
2014年6月26日
首次发布 (估计)
2014年6月30日
研究记录更新
最后更新发布 (估计)
2016年6月20日
上次提交的符合 QC 标准的更新
2016年6月16日
最后验证
2016年6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.