EUCTR2012-001230-34-CZ进行中（未招募）不适用
A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI). - FLU D-QIV-009 EXT 004
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 452
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 parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- •Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Subjects in stable health as determined 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: 452
- •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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
- •Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
- •Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Any contraindication to intramuscular injection.
- •Acute disease and/or fever at the time of enrolment:
- •- Fever is defined as temperature = 37.5°C by any route.
- •- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
研究者
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