EUCTR2015-005348-33-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and safety of Sanofi Pasteur’s DTaP-IPV combined vaccine (TETRAXIM™) given as a three-dose primary vaccination in South Korean healthy infants, as compared to commercially available DTaP and IPV monovalent vaccines
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 442
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 56 to 70 days inclusive on the day of inclusion
- •2) Born at full term pregnancy (>37 weeks) 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: 442
- •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 (first) trial vaccination.
- •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 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 infection (confirmed either clinically, serologically or microbiologically).
- •9) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
- •10) Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
- •11) History of major neurological diseases or seizures.
- •12) Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) on the day of inclusion.
- •13) Known family history of congenital or genetic immuno-deficiency.
研究者
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