NCT00400309已完成3 期
A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
研究概览
简要总结
Primary objective:
- To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.
Secondary objectives:
- To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
- To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.
- •Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.
排除标准
- •Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine
- •Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
- •Known immunological deficiency
- •Known malignant disease
- •Known neurological disorder
- •Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days
- •Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- •Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3
- •Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination
结局指标
主要结局
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
时间窗: 7 days
次要结局
- injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events(14 days)
研究者
研究点 (4)
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