EUCTR2017-002941-31-GB进行中（未招募）1 期
A Phase 2, randomised, observer-blind, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' GSK3277511A investigational vaccine when administered intramuscularly according to two different vaccine schedules in adults aged 40 to 80 years old. - NTHI MCAT-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
- •Current or former smoker with a cigarette smoking history of = 10 pack-years.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •- Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral 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, 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 the vaccination series.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 1), or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone =20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first and ending 30 days after the last dose of vaccine administration, with the exception of any influenza or pneumococcal vaccine which may be administered = 15 days preceding or following any study vaccine dose.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- •Previous vaccination with any vaccine containing NTHi and/or Mcat antigens.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of or current autoimmune disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Acute disease and/or fever at the time of enrolment.
- •- Fever is defined as temperature =37.5°C. The preferred location for measuring temperature in this study will be the oral cavity or the axilla.
- •- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Current alcoholism and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Diagnosed with a respiratory disorder.
- •Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
- •Malignancies within previous 5 years or lymphoproliferative disorders.
- •Any other condition that the investigator judges may interfere with study findings.
研究者
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