EUCTR2011-004455-39-Outside-EU/EEA进行中（未招募）不适用
Phase III, randomized, blind-observer, multicenter, four-arm study of three batches of the DTaP-IPV-Hep B-PRP-T vaccine and one arm receiving Infanrix hexa™.
适应症
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
- 1,190
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) Two months old infants (50 to 71 days old) on the day of inclusion
- •2) Born at full term of pregnancy (> or =37 weeks) with a birth weight > or =2.5 kg
- •3) Informed Consent Form signed by one or both parents or by the guardian and two independent witnesses
- •4) Able to attend all scheduled visits and to comply with all trial procedures
- •5) Received Bacillus Calmette-Guerin (BCG) vaccine between birth and 1 month of life in agreement with the national immunization calendar
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1190
- •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 four weeks preceding the (first) trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Congenital or acquired immunodeficiency
- •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 since birth
- •7) Any vaccination in the 4 weeks preceding the first trial visit
- •8) Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
- •9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- •10) Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
- •11) Known personal or maternal history of HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
- •12) Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- •13) History of seizures
- •14) Febrile (rectal equivalent temperature =38.0°C) or acute illness on the day of inclusion
研究者
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