EUCTR2013-001094-25-DE进行中（未招募）不适用
A Phase III, open-label, non-randomised, multi-centre, single dose study to assess the immunogenicity and safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Influsplit Tetra (Fluarix Tetra) (2013/2014 season) injected intramuscularly in adults (18 to 60 years) and in the elderly (over 60 years) - FLU D-QIV-011
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Female subjects of non-childbearing potential may be enrolled in the
- •- Non-childbearing potential is defined as pre-menarche, current tubal
- •ligation, hysterectomy, ovariectomy or post-menopause
- •Female subjects of childbearing potential may be enrolled in the study,
- •if the subject:
- •- has practiced adequate contraception for 30 days prior to vaccination,
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Participation in previous year's Fluarix registration study (116663)
- •Use of any investigational or non-registered product (drug or vaccine)
- •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 immunemodifying
- •drugs within the six months prior to vaccination. Inhaled and
- •topical steroids are allowed.
- •Any administration of a long-acting immune-modifying drug within 6
- •months before study start, or planned administration during the study
- •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 twelve months
- •preceding the study vaccination.
- •Receipt of a vaccine other than the study vaccine within 30 days before
- •study vaccination and/or plan to receive any vaccine other than the
- •study vaccine 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.
- •- Fever is defined as temperature = 37.5°C/99.5°F on oral, axillary or
- •tympanic setting, or = 38.0°C/100.4°F on rectal setting. The preferred
- •route for recording temperature in this study will be axillary.
- •- Subjects with a minor illness (such as mild diarrhoea, mild upper
- •respiratory infection) without fever may be enrolled at the discretion of
- •the investigator.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal
- •functional abnormality, as determined by physical examination or
- •laboratory screening tests.
- •Chronic underlying disease (such as cancer, chronic obstructive
- •pulmonary disease under oxygen therapy, insulin-dependent diabetes
- •mellitus), 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 (no
- •laboratory testing required).
- •History of Guillain-Barré syndrome.
- •History of allergic disease or reactions likely to be exacerbated by any
- •component of the vaccine including latex.
- •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 or would make intramuscular
- •injection unsafe.
研究者
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