EUCTR2012-000826-23-Outside-EU/EEA进行中（未招募）不适用
A phase III, open, single centre study to assess the safety, reac-togenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate (10Pn-PD-DiT) vaccine (GSK 1024850A), when either given as a booster dose (at 15-21 months of age) in children previously primed with three doses of 10Pn-PD-DiT vaccine, or when given as a two-dose catch-up immunization (at 15-21 and 17-23 months of age) in unprimed children, all previously enrolled in the 10PN-PD-DIT-032 primary vaccination study in Nigeria - 10PN-PD-DIT-068 BST:032
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
- 107
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 parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- •A male or female, between and including 15-21 months of age at the time of visit 1.
- •For the Pn-Pn group, subjects who completed the full vaccination course in study 10PN-PD-DIT-032. For the Zil-Pn group, subjects who were previously enrolled in the control group of study 10PN-PD-DIT-032.
- •Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- •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: 107
- •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)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are al-ways allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- •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.
- •Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-032.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, since the end of study 10PN-PD-DIT-032, based on medical history and physical examination.
- •Major congenital defects or serious chronic illness.
- •History of any progressive neurological disorders or sei-zures.
- •Acute disease and/or fever at the time of enrolment.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
- •Child in care.
研究者
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