EUCTR2012-000819-82-Outside-EU/EEA进行中（未招募）不适用
A phase III, multi-centre, open study to assess antibody persistence after completion of the 3-dose primary vaccination course with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in study 10PN-PD-DIT-048 (111654) in Singapore as well as the safety, reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a booster dose at 18-21 months of age. - 10PN-PD-DIT-049 BST:048
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
- 238
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 the investigator believes that their par-ent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
- •Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- •Written informed consent obtained from the parents/LAR(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: 238
- •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 other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
- •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 product.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vac-cination.
- •A family history of congenital or hereditary immunodeficiency.
- •Administration of immunoglobulins and/ or any blood products within the three months preceding vaccination or planned use during the study period.
- •Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before booster vaccination and during the entire study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- •Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
- •Fever at the time of vaccination.
- •Acute disease at the time of enrolment.
- •Child in care.
研究者
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