EUCTR2011-004458-25-FR进行中（未招募）1 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 - Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE
Sanofi Pasteur MSD0 个研究点目标入组 476 人开始时间: 2011年10月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 476
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy child of either gender 11 to 13 years of age and vaccinated in Study F05-TdI-301 with either REVAXIS or DT Polio at approximately 6 years of age,
- •Consent form signed by both parents, or by the legal guardian, properly informed about the study,
- •Assent form signed by the child,
- •Affiliated to a health social security system.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 476
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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,
- •Immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity,
- •Receipt of any chemotherapy agents to treat cancer received within 6 months prior to vaccination
- •Receipt of serum immune globulin or any other blood-derived product within 3 months prior to vaccination
- •Receipt of immunomodulator therapy within 6 weeks prior to vaccination
- •Receipt of daily -or on alternate days- systemic corticosteroids at a dose =20 mg/day of prednisone (or equivalent) for =14 days within 4 weeks prior to vaccination
- •Receipt of any live non-study vaccine within 28 days or of any inactivated non-study vaccine within 14 days prior to vaccination or with a vaccination planned during the whole study period,
- •Known true hypersensitivity to at least one of the components of TETRAVAC-ACELLULAIRE, to glutaraldehyde, neomycin, streptomycin and polymyxin B, to pertussis, vaccines (acellular or whole cell pertussis), or to a vaccine containing the same substances,
- •Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- •Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- •Any medical condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives,
- •Child who participated in another clinical study within 28 days prior to vaccination or would participate in another clinical study during the whole study period,
- •Acute severe febrile illness and/or body temperature >=38.0°C within 72 hours prior to vaccination.
研究者
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