EUCTR2014-001119-38-IT进行中（未招募）1 期
A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix™ in pregnant women. - DTPA (BOOSTRIX)-047
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
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 (e.g. completion of the diary cards,
- •return for follow-up visits); • Written informed consent obtained from the subject prior to
- •performing any study specific procedure, as per local regulations; • A healthy pregnant woman between, and including, 18 and 45 years of
- •age at the time of screening; • Pregnant subjects at 270/7-366/7 weeks (completed 27 weeks but
- •not 37 weeks) of gestation at the time of vac-cination (Visit 1), as established by ultrasound examination.
- •Not at high risk for complications, as determined by the obstetrical algorithm for identification of eligible subjects and the Obstetrical Risk Assessment Form;
- •No significant foetal abnormalities, as observed by the level II ultrasound testing conducted after 18 weeks of gestation; • Nuchal translucency scan, serum testing and any other prenatal tests,
- •if conducted, should suggest normal preg-nancy.
- •Willing to have the infant born immunised with Infanrix hexa and Prevenar 13, as per national recommendations, in the follow-up clinical
- •studies DTPA (BOOSTRIX)-048 PRI and DTPA (BOOSTRIX)-049 BST: 048; • Subjects who do not plan to give their child for adoption or place the
- •child in care.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 680
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects diagnosed with multiple pregnancies (twins, triplets etc.) • Previous vaccination containing diphtheria, tetanus or pertussis antigens or diphtheria and tetanus toxoids at any time during the current pregnancy •Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the
- •pregnancy course and outcomes •Gestational diabetes as determined by glucose tolerance test conducted after 20 weeks of gestation, as per
- •local recommendations of the country •History of early onset (<34 weeks of gestation) of eclampsia/pre-eclampsia in previous pregnancy •
- •History of major congenital anomalies in previous pregnancies •Use of any investigational or non-registered product other than the study
- •vaccine anytime during the current pregnancy or planned use during the study period • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe •Chronic
- •administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the 1st vaccine. For corticosteroids,
- •this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed •Administration of long-acting immunemodifying
- •drugs at any time during the study period •Planned
- •administration/administration of a vaccine not foreseen by the study protocol in the period within the period starting 30 days before and 30
- •days after the dose of vaccine with the exception of seasonal influenza vaccine that can be administered anytime 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 •Serious underlying medical condition •History of an encephalopathy of unknown
- •aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine •History of transient thrombocytopenia or
- •neurological complications following an earlier immunisation against
- •diphtheria and/or tetanus •Significant mental illness •Family history (1st degree relatives only) of congenital anomalies, recurrent pregnancy
- •losses (2 or more consecutive losses) and unexplained neonatal death(s)
- •in the subject •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
- •examination •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine •History of febrile illness
- •within the past 72 hours •History of physician-diagnosed or laboratory confirmed pertussis within the past 5 years • Anything that would
- •prevent subject from completing the study or put the subject at risk, as determined by the investigator •Acute disease and/or fever at the time
- •of enrolment •Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine, or planned administration during the study period, with the exception of anti-D (Rh)-immunoglobulin •History of chronic excessive alcohol consumption and/or drug abuse.
研究者
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