EUCTR2015-005742-58-BE进行中（未招募）1 期
A phase II, randomised, observer-blind, controlled, study to assess the reactogenicity and safety of a single intramuscular dose of GlaxoSmithKline (GSK) Biologicals’ investigational respiratory syncytial virus (RSV) vaccine (GSK3003891A) in 18 to 45 year-old healthy non-pregnant women. - RSV F-024
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •Non-pregnant female between, and including, 18 and 45 years of age at the time of vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •- has practiced adequate contraception for 30 days prior to vaccination, and
- •- has a negative pregnancy test on the day of vaccination and
- •- has agreed to continue adequate contraception dur-ing the entire study period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •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 other than the study vaccine within 30 days prior to study vaccination, or planned use 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 vaccine/product.
- •Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccina-tion, with the exception of any licensed influenza vaccine which may be administered 15 days before or after study vaccination.
- •Previous experimental vaccination against RSV.
- •Family history of congenital or hereditary immunodefi-ciency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of or current auto-immune disease
- •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality as de-termined by physical examination and/or Medical History
- •Lymphoproliferative disorder or malignancy within previous 5 years.
- •History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis vaccine or to any com-ponent of Boostrix.
- •History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
- •History of any neurological disorders or seizures.
- •History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/or tetanus.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Hypersensitivity to latex.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Current chronic alcohol consumption and/or drug abuse.
- •Acute disease and/or fever at the time of enrolment.
- •Body mass index (BMI) > 40 kg/m2.
- •Pregnant or lactating female.
- •Planned move to a location that will prohibit participating in the trial until study end.
- •Any other condition that the investigator judges may interfere with study procedures.
研究者
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