NCT00928785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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
研究概览
简要总结
The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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:
- •subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
- •subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
- •subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrollment
- •Immunosuppressive therapy:
- •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)
- •Chemotherapeutic agents used to treat cancer or other conditions
- •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
结局指标
主要结局
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
时间窗: 10 days
次要结局
- Percentage of subjects with serious adverse events(D0 to Day 28)
- Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events(D0 to Day 7)
- The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)(Day 28)
- Geometric Mean Titre (GMT) for tetanus antibodies in both groups(Day 0, Day 1 and Day 28)
研究者
研究点 (13)
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