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临床试验/ISRCTN63282459
ISRCTN63282459已完成不适用

Evaluation of alternative vaccination schedules for Pneumococcal Conjugate Vaccine (PCV) (Philippines)

Research Institute of Tropical Medicine (Philippines)0 个研究点目标入组 900 人开始时间: 2004年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Children who:
  • 1. Are considered to be in good health on the basis of medical history and physical examination
  • 2. Born at full term of pregnancy (=37 weeks)
  • 3. Are at least 6 weeks (max 9 weeks) of age when starting the Diphtheria, Tetanus, Pertussis (DTP)
  • 4. Whose parents have lived in the study area at least 3 months and have no intention to move out of the area during the next 9 months
  • 5. For whom at least one of the parents or other legally acceptable representative has given his/her informed consent attested by a signature

排除标准

  • Children who:
  • 1. Have neurologic disease (an absolute contraindication to the DTP vaccine)
  • 2. Have known or suspected impairment of immunological function
  • 3. Have acute illness at the time of inclusion or have fever (rectal temperature =38°C)
  • 4. Have already got their first DTP vaccine dose or first Hepatitis B Virus (HBV) dose, or first Haemophilus influenzae type b (Hib) dose
  • 5. Have known or suspected history of severe atopy
  • 6. Are enrolled or scheduled to be enrolled in another clinical trial
  • 7. Have a history of documented invasive pneumococcal disease
  • 8. Have received a corticosteroid therapy or immunoglobulin or blood products since birth
  • 9. Will be unable to attend the schedule visits and to comply with the study procedures

研究者

发起方
Research Institute of Tropical Medicine (Philippines)

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