EUCTR2011-004457-87-Outside-EU/EEA进行中（未招募）不适用
A Phase III, randomized, blind-observer, controlled, multicenter trial in 412 infants in Thailand.
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
- 412
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-month-old infant (50 to 71 days old) on the day of inclusion, of either gender
- •2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •3) Hepatitis B vaccination since birth
- •4) Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate
- •5) 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: 412
- •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) 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
- •4) Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy
- •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 vaccination
- •8) Any planned vaccination (except trial vaccinations) during the trial
- •9) Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) confirmed either clinically, serologically, or microbiologically
- •10) Previous vaccination against pertussis, T, D, poliomyelitis, Hib infection(s) or Streptococcus pneumoniae
- •11) Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hep B (HBsAg carrier), or Hepatitis C seropositivity
- •12) Known thrombocytopenia or 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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