EUCTR2010-020312-12-FI进行中（未招募）1 期
A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix™. - FLU D-QIV-AS03-005
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
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
入选标准
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, available for phone contact).
- •Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
- •Born after gestation period of 36 to 42 weeks inclusive
- •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
- •Child in care”
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period.
- •Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone >0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •A family history (parents or siblings) of congenital or hereditary immunodeficiency.
- •A family history (parents or siblings) of febrile seizures or/and epilepsy
- •Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins.
- •History of any progressive neurological disorders or seizures (including febrile convulsion).
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- •Acute disease and/or fever at the time of enrolment:
- •?Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or =38.0°C on rectal setting.
- •?Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- •Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
研究者
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