EUCTR2012-004513-14-Outside-EU/EEA进行中（未招募）不适用
An open-label study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ IPV vaccine (Poliorix) administered as a booster dose at 18 months of age in healthy Chinese toddlers previously primed with the same vaccine in the study IPV-018 (NCT01323647). - IPV-021 BST:018
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
- 957
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.
- •Subjects who received the complete three-dose primary vaccination course in study IPV-018.
- •Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1.
- •Written informed consent obtained from the par-ent(s)/LAR(s) 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: 957
- •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
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1. For corticosteroids, this will mean prednisone > 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 or planned administration 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.
- •Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study IPV-018.
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature > 37.0°C on oral, axillary or tympanic setting and > 37. 5°C on rectal setting. The preferred route for recording tempera-ture in this study will be axillary.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
研究者
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