EUCTR2006-000442-39-BE进行中（未招募）1 期
An open, phase I/II study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ 11PCV combined with adjuvant AS02V given as a 2-dose vaccination in adults aged 18-40 years old. - EXPLO-CRD-006
适应症
试验速览
- 阶段
- 1 期
- 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
- •The cohort to be enrolled is 23-valent pneumococcal polysaccharide vaccine naïve adults aged between 18 and 40 years old, in good general health at the time of the first vaccine dose.
- •All subjects must satisfy to the following criteria at study entry:
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- •A male or female between 18 and 40 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •Previous vaccination against Streptococcus pneumoniae.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests, at the discretion of the investigator.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C or Axillary temperature <37.5°C.
- •History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
- •Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
- •History of administration of an experimental/licensed vaccine containing MPL or QS21.
- •History of chronic alcohol consumption and/or drug abuse.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究者
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