EUCTR2018-001604-10-SK进行中（未招募）1 期
A single blind, randomized comparative and multicentre clinical trial of the immunogenicity and safety of booster immunisation with bivalent vaccine against tetanus and diphtheria VACDITE (BIODRUG) and IMOVAX D.T. ADULT (Sanofi Pasteur SA) in healthy adults. - Immunogenicity and safety of vaccine VACDITE in health adults
BIODRUG s.r.o.0 个研究点目标入组 200 人开始时间: 2018年7月20日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •1.Subject provides written informed consent with the study participation
- •2.Subjects must have written confirmation on previous immunisation against tetanus and diphtheriae not later than 15.9 years and not early than 9.9 years
- •3.Men and women aged 24.1- 64.9 years
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject with acute infectious diseases.
- •2.Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and reference vaccine).
- •3.Subject with Guillain-Barré syndrome or neuropathy, some anaphylactic or other allergic reactions after previous vaccination against tetanus and diphtheriae.
- •4.Pregnant woman and breastfeeding (anamnestically).
- •5.Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, drugs or other causes induced immunodeficiency).
- •6.Subject with progressive or unstable neurological disorder.
- •7.Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use.
- •8.Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
- •9.Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry.
- •10.Subject - pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment.*
- •11.Subject unable to understand consent or follow study protocol.
- •12.Subject addicted to alcohol or drugs.
- •13.Subject currently participating in another clinical trial of a medication or in a trial that has taken place in the last 4 weeks.
- •14.A subject requiring tetanus vaccination after an injury
研究者
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