EUCTR2005-001446-16-FR进行中（未招募）1 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 - REVAXIS® versus DT Polio® as a second booster in 6 year-old children
Sanofi Pasteur MSD0 个研究点目标入组 760 人开始时间: 2006年7月12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
- 760
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
- •Subjects will be included in the study if they meet all of the following inclusion criteria:
- •1.Healthy child without chronic severe disease of either gender and affiliated to a health social secrurity system,
- •2.6 year-old child (from 1st day to last day of 7th year),
- •3.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 14 - 20 months of life,
- •4.Consent form signed by both parents, or by the legal representative, properly informed about the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Subjects will not be included in the study if they meet any of the non-inclusion criteria:
- •1.Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine given alone or in combination,
- •2.Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
- •3.Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
- •4.Child who present with immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity or who had received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term ( = 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [= 20mg/day prednisone equivalent] ),
- •5.Child who had received within the previous 3 months (150 days) or who will receive during the course of the study, any immunoglobulin or blood products,
- •6.Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
- •7.Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- •8.Child who had presented severe hypersensitivity following an earlier immunisation against diphtheria and/or tetanus,
- •9.Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- •10.Any medical condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives,
- •11.Child who had participated in another clinical study in the previous 30 days or who will participate in another clinical study during the whole study period,
- •12.Acute severe febrile illness and/or rectal equivalent temperature = 38.0°C at the time of vaccination. Defer vaccination until 72 hours after fever resolution
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