EUCTR2011-004434-33-Outside-EU/EEA进行中（未招募）不适用
Phase III, randomized, blind-observer, single-center, controlled trial of the DTaP-IPV-Hep B-PRP-T vaccine in 266 healthy Peruvian infants.
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
- 266
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 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) Mother negative for HBsAg in approximately the last 30 days of pregnancy (=36 weeks of amenorrhea) or in the 30 days post-partum
- •4) Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject’s grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
- •5) Able to attend all scheduled visits and to comply with all trial procedures
- •6) 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: 266
- •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) Known 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 (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
- •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 during the trial (until V06), except the study vaccines, rotavirus vaccine, and pneumococcal conjugate vaccines
- •9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically)
- •10) Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s)
- •11) Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity
- •12) Known thrombocytopenia or bleeding disorder contraindicating IM vaccination
- •13) History of seizures
- •14) Febrile (temperature =38.0°C) or acute illness on the day of inclusion.
研究者
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