EUCTR2015-005403-87-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given as a booster dose at 4 to 6 years of life in children previously vaccinated with PENTAXIM™ in the study E2I34
SANOFI PASTEUR SA0 个研究点目标入组 167 人开始时间: 2015年12月4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
- 167
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial
- •enrollment:
- •1) Aged 4-6 years inclusive on the day of inclusion
- •2) Child having completed the three-dose vaccination and the booster
- •vaccination with DTacP-IPV//PRP~T combined vaccine (Pentaxim™) of the study E2I34
- •3) Informed consent form signed by the parent(s) or other legal representative
- •4) Able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 167
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Participation in another clinical trial in the 4 weeks preceding the trial inclusion
- •2) Planned participation in another clinical trial during the present trial period
- •3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •4) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- •5) Chronic illness at a stage that could interfere with trial conduct or completion
- •6) Blood or blood–derived products received in the past or current or planned administration during the trial (including immunoglobulins)
- •7) Any vaccination in the 4 weeks preceding the trial vaccination
- •8) History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •9) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- •10) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
- •11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •12) History of/current major neurological diseases or seizures
- •13) Febrile illness (temperature = 38°C) or acute illness on the day of inclusion.
- •14) Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
- •encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
- •temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
- •inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
- •hypotonic hyporesponsive episode within 48 hours following vaccine injection,
- •seizures with or without fever within 3 days following vaccine injection.
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