DRKS00000180已完成3 期
A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and Older - RPV02C
Sanofi Pasteur MSD0 个研究点目标入组 456 人开始时间: 2009年10月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 456
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •* Healthy adults aged >=18 years
- •* Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence)
- •* Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the local vaccination calendar
- •* Negative urine pregnancy test for female subjects of child-bearing potential. A female subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period
- •* Subject having signed the informed consent form prior to participation in the study
排除标准
- •* Acute severe illness or fever (>=38.0°C) within the last 3 days
- •* Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde)
- •* Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids or poliomyelitis viruses or pertussis (acellular or whole cell)
- •* Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine
- •* Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens
- •* Progressive or unstable neurological disorder, uncontrolled seizures or progressive encephalopathy not stabilized
- •Known malignant disease, note:
- •o subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
- •o subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
- •o subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrollment
- •Immunosuppressive therapy:
- •o High dose (>= 20 mg/day prednisone equivalent) systemic (>= 14 days) corticosteroid treatment daily or on alternate day within the last 28 days (inhaled corticosteroids allowed)
- •o Chemotherapeutic agents used to treat cancer or other conditions
- •o Treatments associated with organ or bone marrow transplantation
- •* Immune dysfunction caused by a medical condition, or any other cause (e.g., congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or generalized malignancy)
- •* Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection
- •* Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3
- •* Recent administration of a live vaccine (<=28 days) or an inactivated vaccine (<=14 days) or vaccination planned before Visit 3
- •* For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3
- •* Planned participation in another clinical study during the present study period
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