EUCTR2015-003458-42-Outside-EU/EEA进行中（未招募）1 期
A phase II observer-blind, multicentre, dose-ranging study of children 6 to less than 36 months of age who are to be primed with a 2-dose series of GSK Biologicals’ AS03-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine. - FLU Q-PAN H5N1=AS03-023
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
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
- •Subject's parent(s)/ Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Male or female children 6 months to less than 36 months old at the time of the first vaccination. Children who are not 36 months old as of Day 0, the day of first vaccine dose under this protocol, can be enrolled.
- •Written informed consent obtained from the parent(s)/legally acceptable representative(s) [LAR(s)] of the subject prior to performance of any study specific procedure.
- •Healthy subjects as established by medical history and standard physical examination before entering into the study.
- •Born full-term to be confirmed by interview with parent/LAR or available medical records.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 185
- •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
- •Medical history of physician-confirmed infection with an H5N1 virus.
- •Previous vaccination at any time with an H5N1 vaccine.
- •Concurrently participating in another clinical study, or use of an investigational or a non-registered vaccine, pharmaceutical product, or device within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Presence in the parent(s) / LAR(s) of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.
- •Acute disease and/or fever at the time of enrolment.
- •Administration of immunoglobulins, any blood products, or long-acting immune-modifying drugs during the period starting 3 months before the first dose of study vaccine, or planned administration during the study period.
- •History of any neurological disorders or seizures, or Guillain-Barré Syndrome.
- •Diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject’s parent or sibling.
- •Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first vaccination.
- •Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42 or planned administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days be-fore through 30 days after the booster vaccination. Note: routine vaccinations may be provided on Day 42 after all study assessments have been performed.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean a dose of prednisone or equivalent of > 2 mg/kg/day of body weight or = 20 mg/day (for persons who weigh = 10 kg). Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
研究者
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