EUCTR2014-003934-22-DE进行中（未招募）不适用
DOSE-CONFIRMATION, IMMUNOGENICITY AND SAFETY STUDY OF THE CLOSTRIDIUM DIFFICILE VACCINE CANDIDATE VLA84 IN HEALTHY ADULTS AGED 50 YEARS AND OLDER. RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE II STUDY.
试验速览
- 阶段
- 不适用
- 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
- All
入选标准
- •1.Subjects aged =50 years of good general health, including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, or type 2 diabetes mellitus.
- •2.Informed consent form has been signed and dated
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1.Subjects with any confirmed or suspected prior Clostridium difficile infection episode
- •2.Previous vaccination against Clostridium difficile with any (investigational) vaccine or receipt of (investigational) monoclonal antibodies against Clostridium difficile toxins
- •3.Use of any other investigational or non-registered medicinal product within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and throughout the entire study period.
- •4.Active or passive vaccination four weeks before first vaccination at Visit 1 and during the entire study period, except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before and after any trial vaccination
- •5.Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile)
- •6.Known thrombocytopenia, bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion or until Visit 4 (Day28), contraindicating IM vaccination as judged by the investigator
- •7.Clinically relevant renal, hepatic, cardiac, pulmonary or central nervous disorders, as judged by the investigator. Subjects with hypercholesterolemia, hypertension, or type 2 diabetes mellitus requiring medication are allowed if disease is adequately controlled
- •8.Receipt of blood or blood-derived products in the past 3 months or anticipation of such products during the study period
- •9.Known congenital, hereditary or acquired immunodeficiency, including known infection with human immunodeficiency virus (HIV), administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and during the study until Visit 5 (Day 35). For corticosteroids this means prednisone or equivalent = 0.05 mg/kg/day; topical and inhaled steroids are allowed. Periodic steroid injections, e.g., intra-articular, are are not allowed within 30 days prior to first VLA84 vaccination at Visit 1 (Day 0) and until Visit 5 (Day 35)
- •10.History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
- •11.Any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled
- •12.Known hypersensitivity or allergic reactions to one of the components of the vaccine
- •13.Inability or unwillingness to provide informed consent
- •14.Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
- •15.Persons who are in a dependent relationship with the sponsor, an investigator or other study team members (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel
研究者
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