EUCTR2015-005293-38-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) versus sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given simultaneously at separate sites with PRP~T conjugate Vaccine (ActHIB™) as a three-dose primary vaccination at 2, 4 and 6 Months of Age in South Korean Infants.
SANOFI PASTEUR SA0 个研究点目标入组 418 人开始时间: 2015年12月4日最近更新:
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
- 418
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 2 months (56 to 70 days) inclusive on the day of inclusion
- •2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •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: 418
- •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 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 3 weeks preceding the first trial vaccination.
- •8) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b 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 or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
- •11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •12) History of/current major neurological diseases or seizures.
- •13) Febrile illness (axillary temperature = 38°C) or acute illness on the day of inclusion.
- •14) Known family history of congenital or genetic immuno-deficiency.
研究者
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