NCT01287949已完成3 期
An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 12
- 主要终点
- Polio seroprotection rate
研究概览
简要总结
Primary objective:
- To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects
Secondary objectives:
- If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To describe the immune responses to REPEVAX in these subjects
- To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥40 years
- •No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years
排除标准
- •Medically diagnosed pertussis disease within the last 10 years
- •Receipt of medication / vaccine that may interfere with study assessments
- •Febrile illness or moderate or severe acute illness/infection
- •Know pregnancy
- •History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
- •History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
- •History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
- •Known or suspected immune dysfunction
- •Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
- •Chronic disease or intercurrent illness that might interfere with study assessments
研究组 & 干预措施
REPEVAX followed by REVAXIS administration
Experimental
干预措施: Diphtheria, tetanus, polio and pertussis vaccination (Biological)
结局指标
主要结局
Polio seroprotection rate
时间窗: 28 to 35 days after each vaccine administration
Diphtheria seroprotection rate
时间窗: 28 to 35 days afeter each vaccine administration
Pertussis response rate
时间窗: 28 to 35 days after REPEVAX administration
Tetanus seroprotection rate
时间窗: 28 to 35 days after each vaccine administration
次要结局
- Solicited injection-site reactions, solicited systemic reactions(From day 0 to day 7 following REPEVAX and REVAXIS vaccination)
- Unsolicited injection-site adverse reactions and systemic adverse events(From day 0 to day 28 following REPEVAX and REVAXIS vaccination)
- Number and proportion of Serious adverse events(From the first vaccination to the last visit of the subject)
研究者
研究点 (12)
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