EUCTR2014-004178-40-Outside-EU/EEA进行中（未招募）不适用
A Phase 4, Open-label Trial to Assess the Safety, Tolerability, and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer, Inc.
- 入组人数
- 506
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. Evidence of a personally signed and dated informed consent document indicating that the parent/legal guardian has been informed of all pertinent aspects of the study.
- •2. Parent/legal guardian willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Chinese male or female subject.
- •4. Aged 121 days to less than (<) 72 months at the time of enrollment.
- •5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 506
- •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. Previous vaccination with licensed or investigational pneumococcal vaccine.
- •2. Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •3. Contraindication to vaccination with pneumococcal vaccine.
- •4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •5. Known or suspected immune deficiency or suppression.
- •6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
- •7. Receipt of blood products or gamma-globulin within 12 weeks before the first dose of Prevenar until the blood draw approximately 1 month after the last dose of Prevenar.
- •8. Major known congenital malformation or serious chronic disorder.
- •9. Significant neurological disorder or history of seizure (including febrile seizure for
- •groups 1, 2, and 3), or significant stable or evolving disorders such as cerebral palsy,
- •encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving
- •syndromes due to birth trauma, such as Erb’s palsy.
- •10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
- •that may increase the risk associated with study participation or investigational product
- •administration or may interfere with the interpretation of study results and, in the
- •judgment of the investigator, would make the subject inappropriate for entry into this
- •11. Receipt of any investigational drugs or medical devices within 28 days before the first
- •dose of Prevenar until the blood draw approximately 1 month after the last dose of
- •12. Direct descendent (child or grandchild) of any study personnel or Pfizer employee.
研究者
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