NCT01546909已完成4 期
Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 45
- 主要终点
- Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
研究概览
简要总结
PRIMARY OBJECTIVES
- To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
- To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3
SECONDARY OBJECTIVES
- To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
- To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
- To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
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
- 11 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301
排除标准
- •Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
- •Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
- •Known or suspected immune dysfunction
- •Receipt of medications / vaccination that may interfere with study assessments
- •Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
- •Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
- •Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- •Any medical condition that might interfere with the evaluation of the study objectives
- •Febrile illness
研究组 & 干预措施
TETRAVAC-ACELLULAIRE
Experimental
干预措施: Diphtheria, tetanus, polio and pertussis vaccination (Biological)
结局指标
主要结局
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
时间窗: Pre-booster dose (Day 0)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
时间窗: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)
时间窗: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)
时间窗: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)
时间窗: Pre-booster dose (Day 0)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
时间窗: 1 month post-booster dose
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
时间窗: 1 month post-booster dose
Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)
时间窗: 1 month post-booster dose
Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)
时间窗: 1 month post-booster dose
Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)
时间窗: 1 month post-booster dose
次要结局
- Geometric mean titer for diphtheria(Pre-booster (Day 0) and 1 month post-booster dose)
- Geometric mean titer for tetanus(Pre-booster (Day 0) and 1 month post-booster dose)
- Geometric mean titer for polio type 1(Pre-booster (Day 0) and 1 month post-booster dose)
- Geometric mean titer for polio type 2(Pre-booster (Day 0) and 1 month post-booster dose)
- Geometric mean titer for polio type 3(Pre-booster (Day 0) and 1 month post-booster dose)
- Solicited injection site and solicited systemic reactions(From Day 0 to Day 7 post vaccination)
- Unsolicited injection site reactions and unsolicited systemic adverse events(From Day 0 to Day 28 days post vaccination)
- Serious adverse events(From signature of informed consent up to last study visit of the subject)
研究者
研究点 (45)
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