EUCTR2004-004370-85-SK进行中（未招募）1 期
A phase III, multicentric open study to evaluate the immunological memory induced by a 3-dose primary vaccination followed by a booster dose with GSK Biologicals’ 11-valent conjugate pneumococcal vaccine compared to unprimed subjects by giving a single dose of Aventis Pasteur’s 23-valent pneumococcal polysaccharide vaccine (Pneumo 23). - 11PN-037: EXT 010 (= the extension study of POET – 347414/010)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •? Male and female subjects who participated in study Undeca-Pn-010 (347414/010) and received the full vaccination course (4 doses) of GSK Biologicals’ 11Pn-PD vaccine vaccine or were part of the control group who received Havrix™ vaccine. All should be part of the ‘blood’ subset for Undeca-Pn-010 study.
- •? Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •? Written informed consent obtained from the parents or guardians of the subject.
- •? Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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:
- •? Participation in another clinical trial at the time of this trial and during the study period
- •? Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the single dose of study vaccine, or planned use during the study period
- •? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the single dose of study vaccine. (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 one month before the administration of the study vaccine and during the study period
- •? Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)
- •? Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •? A family history of congenital or hereditary immunodeficiency.
- •? History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •? Major congenital defects or serious chronic illness.
- •? History of any neurologic disorders or seizures.
- •? 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 / axillary temperature <37.5°C / rectal temperature <38°C.)
研究者
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