NCT00447525已完成3 期
Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 64
研究概览
简要总结
Primary objective:
To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .
Secondary objectives:
- Additional immunogenicity assessments.
- To describe the safety profile of a single dose of REVAXIS® or DT-Polio®
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
- 6 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy child without chronic severe disease of either gender,
- •6 year-old child on vaccination day,
- •Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
- •Consent form signed by both parents, or by the legal representative, properly informed about the study.
排除标准
- •Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
- •Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
- •Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
- •Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
- •Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
- •Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
- •Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- •Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
- •Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- •Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination
研究组 & 干预措施
1
Experimental
干预措施: REVAXIS® (Biological)
2
Active Comparator
干预措施: DT-Polio® (Biological)
研究者
研究点 (64)
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