EUCTR2016-002733-30-GB进行中（未招募）1 期
A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers - RSV F-004
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, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written informed consent for study participation of the mother obtained from the mother or the mother and father, as applicable by local law, prior to performance of any study specific procedure.
- •Written informed consent for study participation of the infant obtained from the infant’s mother and/or father, as applicable by local law, or LAR prior to performance of any study specific procedure.
- •Subjects between, and including, 18 and 40 years of age at the time of the first study visit
- •Pregnant females > 24 weeks of gestation at the time of screening and at 28 0/7 to 33 6/7 weeks of gestation at the time of vaccination, as established by ultrasound examination and last menstrual period date.
- •Healthy pregnant females as established by medical history and clinical examination before entering into the study.
- •Pregnant females not at high risk for complications, as determined by the obstetrical risk assessment form.
- •No significant foetal findings observed during a second or third trimester ultrasound.
- •Subjects who are willing to provide cord blood.
- •Subjects who do not plan to give their child for adoption or place the child in care.
- •Re-signed (confirmed) written informed consent for study participation of the infant obtained from the infant’s mother and/or father, as applicable by local law, or LAR.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •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 (drug or vaccine) other than the study vaccines during the period starting 30 days before vaccination (Day -29 to Day 0), or planned use during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before vaccination and ending at delivery with the exception of seasonal influenza vaccine and dTpa/Tdap vac-cine as part of SOC which may be administered = 15 days before or after study vaccination.
- •Chronic administration (defined as more than 14 consecutive days) of systemic 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 up to delivery. Topical steroids are allowed. Inhaled steroids are allowed up to the limit of = 500 µg/day for beclomethasone or fluticasone, or = 800 µg/day for budesonide.
- •Administration of immunoglobulins (with the exception of prophylactic anti-Rh0D immune globulin) and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
- •Previous experimental vaccination against RSV.
- •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.
- •Low lying placenta (placenta praevia) during the current pregnancy, unless there is documented sonographic evidence that the placenta has moved up prior to enrolment (Visit 1).
- •Any abnormal finding observed in nuchal translucency scan, serum testing and any other prenatal tests, if conducted.
- •Incompetent cervix or cerclage during the current pregnancy.
- •Having received medical treatment for suspected preterm delivery (e.g. systemic steroids or progesterone) during the current pregnancy.
- •Prior preterm delivery (= 34 weeks gestation) or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm delivery.
- •Prior stillbirth or neonatal death, or =2 spontaneous abortions.
- •Personal history of major congenital anomalies or early onset (<34 weeks of gestation) of eclampsia/preeclampsia in previous pregnancy.
- •1st degree family history of major congenital anomalies and/ or hereditary immunodeficiency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical his-tory and physical examination.
- •Hemodynamically significant cardiac disorders (previously corrected patent ductus arteriosis is allowed)
- •Gestational diabetes as determined by glucose challenge/tolerance test conducted after 20 weeks of gestation or as per local recommendations of the country, requiring intervention other than diet for control.
- •History of gestational diabetes in previous pregnancy(ies).
- •Hypertension during the current pregnancy or if any antihypertensive medication is being pro-vided.
- •Current obstetric cholestasis or history of it during previous pregnancy(ies).
- •Current obstetric cholestasis or history of obstetric cholestasis.
- •Asthma and/or COPD if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids > 500 µg/day of beclomethasone or fluticasone, or > 800 µg/day of budesonide.
- •Significant neuropsychiatric illness deemed likely to interfere with protocol complian
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