EUCTR2008-007605-37-DE进行中（未招募）不适用
A phase III, open, multicentre, extension study to assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 10PN-PD-DIT-008 BST: 003 (106623). - 10PN-PD-DIT-061 EXT: 008 Y4
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
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, 46-50 months of age at the time of vaccination.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for the follow-up visit).
- •Subjects who previously participated in the 10PN-PD-DIT-008 BST: 003 study in centres with more than 2 subjects and received a booster dose of 23vPS vaccine.
- •Written informed consent obtained from both parents/guardians of the subject.
- •Healthy subjects 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) other than the study vaccine(s) 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 six months prior to the vaccination. (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 during the period starting one month before study vaccination and during the entire study period.
- •Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-008 BST: 003 (106623).
- •Administration of immunoglobulins and/or any blood products less than 3 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 any neurologic disorders or seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included).
- •Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- •History of hypotonic-hyporesponsive episode after any previous vaccination.
- •Major congenital defects or serious chronic illness.
- •History of invasive pneumococcal diseases.
- •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).
- •Rectal temperature = 38.0°C or oral/axillary/tympanic temperature = 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
研究者
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