EUCTR2008-003950-14-SK进行中（未招募）1 期
A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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 or female between, and including, approximately 36-46 months of age at the time of vaccination.
- •For primed subjects: having completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539).
- •Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •Written informed consent obtained from the parent(s)/guardian(s) 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
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccination. (For corticosteroids, this will mean prednisone, or equivalent, equal or above 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •For primed subjects: administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-002 (105539).
- •For unprimed subjects: previous vaccination with any pneumococcal vaccine.
- •Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned use during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
- •Acute disease at the time of vaccination (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 or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved).
研究者
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