EUCTR2018-001340-62-DE进行中（未招募）1 期
A study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ investigational unadjuvanted RSV maternal vaccine compared to placebo when administered to healthy non-pregnant women - RSV MAT-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
- •Written informed consent obtained from the subject;
- •Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
- •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 until 90 days after vaccination
- •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 500
- •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 preceding vaccination or any planned use during the study period;
- •Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an in-vestigational or a non-investigational vaccine/product
- •Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (=) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed;
- •Administration or planned administration of immunoglobulins and/or any blood products during the period starting 3 months before or 3 months after
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered = 15 days before or after study vaccination;
- •Previous experimental vaccination against RSV;
- •Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
- •Family history of congenital or hereditary immunodeficiency;
- •Any confirmed or suspected immunosuppressive or immunodeficient condition;
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- •Any acute or chronic, clinically significant disease
- •The following conditions will be exclusionary:
- •?Diabetes mellitus,
- •?Respiratory diseases, such as:
- •oChronic Pulmonary diseases, including Chronic Obstructive Pulmonary Disease (COPD),
- •oBronchopulmonary dysplasia (note: history of past bronchopulmonary dysplasia as a neonate/infant will not be exclusionary),
- •oUncontrolled asthma or asthma necessitating treatment with chronic systemic glucocorticoids
- •?Significant and/or uncontrolled psychiatric illness:
- •ohospitalization for psychiatric illness, history of suicide attempt(s) or confinement for danger to self or others within 10 years
- •oclinically significant depression
- •?Major neurological disease including:
- •oseizure or adulthood epilepsy
- •omyasthenia gravis
- •ohistory of repetitive migraine mal/status mi-grainosus
- •?Significant cardiovascular disease, including:
- •oUncontrolled arterial hypertension,
- •oCongenital heart disease (with the exception of corrected atrial or ventricular septal defects),
- •oPrevious myocardial infarction,
- •oValvular heart disease or history of rheumatic fever,
- •oPrevious bacterial endocarditis,
- •oHistory of cardiac surgery (with the exception of corrected atrial or ventricular septal defects),
- •oPersonal or family history of cardiomyopathy or sudden adult death.
- •?Known or suspected Hepatitis B or Hepatitis C infection,
- •?Any other significant uncontrolled medical illness, defined as any illness requiring new medical and/or surgical treatment or significant modification of treatment dose due to uncontrolled symptoms or drug toxicity, within 3 months prior to study vaccination.
- •History of or current autoimmune disease;
- •Body mass index (BMI) > 40 Kilograms (kg)/square meters(m^2);
- •Pregnant or lactating femal
研究者
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