EUCTR2016-004934-11-CZ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 tetanus monovalent vaccines VACTETA 40 IU/0,5 ml (BIODRUG) and TETAVAX (Sanofi Pasteur SA) in healthy adults. - Immunogenicity and safety of tetanus vaccine Vacteta 40 IU/0.5 ml in health adults
BIODRUG s.r.o.0 个研究点开始时间: 2017年1月24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
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. Subjects must have signed an approved informed consent after complete information
- •2. Subjects must have written confirmation on previous immunisation against tetanus not older than 15.9 years and not younger 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 without written confirmation of previous vaccination against tetanus, no older than 15.9 years, and not younger than 9.9 years.
- •2. Subject with acute infectious diseases.
- •3. Subjects under 24 years of age or older than 65 years, inclusive.
- •4. Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and comparator tetanus vaccine).
- •5. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus.
- •6. Pregnant woman and breastfeeding (anamnestically).
- •7. 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 imunodefiency).
- •8. Subject with progressive or unstable neurological disorder.
- •9. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use.
- •10. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
- •11. Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry.
- •12. Participants, who may become pregnant and will take at least a reliable method of contraception during the trial and until its completion.
- •Reliable contraceptive method (ie. methods that can achieve a failure rate of less than 1% per year), reliable contraceptive methods are: progestogen only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. Participants may also use contraceptive methods with a low failure rate, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence (if it corresponds with the preferred and usual lifestyle of participants - but periodic abstinence [eg. by calendar or ovulation], and intermittent contact methods are not acceptable contraceptive methods), bilateral tubal occlusion or partner who had a vasectomy with documented aspermia.
- •13. Subject incapable of cooperation, incompetent.
- •14. Subject addicted to alcohol, drugs.
- •15. Subject unwilling to sign an informed consent.
- •16. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
- •17. Dependents (eg soldiers, persons dependent on the researcher - such as subordinates, family members).
- •18. Subject requiring vaccination against tetanus after injury.
研究者
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