A Phase II, randomised, observer-blind, placebo-controlled, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ investigational vaccine GSK2838504A, when administered intramuscularly according to a 0, 2 month schedule to COPD patients aged 40 to 80 years - NTHI-004

GlaxoSmithKline Biologicals0 个研究点目标入组 140 人开始时间: 2015年2月23日最近更新: 2017年7月3日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals
入组人数: 140

研究概览入排标准研究者记录与标识符相似试验

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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% and = 30% predicted.
•Current or former smoker with a cigarette smoking history of = 10 pack-years.
•Stable COPD patient with documented history of at least 1 moderate or severe acute exacerbation of COPD within the 12 months before Screening.
•Regular sputum producer.
•Capable to comply with the daily electronic Diary Card completion throughout the study period, according to investigator’s judgement at Visit 1.
•Female subjects of non-childbearing potential may be enrolled in the study.
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

排除标准

•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.
•Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use 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 dose and ending 30 days after the last dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may be administered = 15 days preceding or following any study vaccine dose.
•Previous vaccination with any vaccine containing NTHi antigens.
•Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•Chronic administration of non-steroid immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of immune-mediated disease other than COPD.
•Administration of systemic corticosteroids within the 30 days before Screening.
•Administration of systemic antibiotics within the 30 days before Screening.
•Chronic use of antibiotics for prevention of acute exacerbations of COPD (AECOPD).
•Receiving oxygen therapy.
•Planned lung transplantation.
•Planned/ underwent lung resection surgery.
•Diagnosis of a-1 antitrypsin deficiency as the underlying cause of COPD.
•Diagnosed with a respiratory disorder other than COPD, or chest X-ray/ CT scan revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD. Subjects with allergic rhinitis can be enrolled.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines and/ or the bronchodilator used for spirometry assessment during the study.
•Contraindication for spirometry testing.
•Clinically significant abnormality in haematology or biochemistry parameter.
•Acute cardiac insufficiency.
•Malignancies within the previous 5 years or lymphoproliferative disorder.
•Any known disease or condition likely to cause death during the study period.
•Acute disease and/ or fever at the time of Screening. Fever is defined as oral or axillary temperature = 37.5°C. The preferred route for recording temperature in this study will be oral. Subjects with acute disease and/ or fever at the time of Screening may be enrolled at a later date if enrolment is still open. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
•Pregnant or lactating female.
•Current alcoholism and/or drug abuse.
•Other condition which the investigator judges may put the safety of the subject at risk through study participation or which may interfere with the study findings.
•Planned move to a location that will complicate participation in the trial through study end.

研究者

发起方

GlaxoSmithKline Biologicals

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