EUCTR2015-005190-21-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of ADACEL Polio (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose (Pre-School Booster) in Healthy Children in Taiwan
Sanofi Pasteur SA0 个研究点目标入组 132 人开始时间: 2015年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- •1) Aged 6 to 8 years on the day of inclusion
- •2) Informed consent form signed by the parent(s) or another legally acceptable representative
- •3) Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •4) Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
- •5) Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 132
- •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
- •1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •4) Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
- •5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •6) Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
- •7) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •8) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •9) Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- •10) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
- •11) History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •12) Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine
- •13) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- •14) Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial
- •15) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- •16) Febrile illness (temperature = 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
研究者
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