EUCTR2012-002587-27-Outside-EU/EEA进行中（未招募）不适用
A phase II, double-blind, multicenter, randomized study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A compared with GSK Biologicals’ trivalent influenza vaccine, Fluarix™, administered intramuscularly in children (18-47 months of age) in both unprimed subjects and in primed subjects who previously participated in the 111751 study - FLU D-QIV-002
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
- 600
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.
- •A male or female child between, and including, 18 and 47 months of age at the time of the first vaccination.
- •Written informed consent obtained from the par-ent(s)/LAR(s) of the subject.
- •Children who had not received 2 doses of influenza vaccine in a previous season.
- •In addition, primed subjects from the 111751 study (FluarixUS-007) willing to participate in this study had to satisfy the following criterion at study entry:
- •Children who had received 2 doses of Fluarix (0.5 mL) in the 111751 study (FluarixUS-007).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 599
- •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 (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.
- •History of hypersensitivity to any vaccine.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine (including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium de-oxycholate).
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
- •Acute or chronic clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by medical history and physical examination.
- •Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. All vaccines could be adminis-tered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F).
- •History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition based on medical history and physical examination (no laboratory testing required).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination (for corti-costeroids, this meant prednisone greater than or equal to 10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids were allowed.
- •Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vac-cine or planned administration during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
研究者
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