EUCTR2014-004180-20-Outside-EU/EEA进行中（未招募）不适用
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and 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）
- 发起方
- Pfizer Inc
- 入组人数
- 72
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 subject (or a parent/legal guardian) has been informed of all pertinent aspects of the study.
- •2. Chinese male or female subject.
- •3. Age at the time of enrollment: 18 through 55 years (before the fifty sixth birthday) for Group 1, 3 through 5 years (before the sixth birthday) for Group 2 and 42 to 98 days for Group 3.
- •4. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- •5. Subjects or parent/legal guardian/caregiver willing and able to comply with scheduled visits and study procedures.
- •6. All male and female subjects (in Group 1) biologically capable of having children agreed and committed to use a reliable method of birth control from the signing of the informed consent form (ICF) until the end of the study.
- •7. Negative urine pregnancy test for female subjects (in Group 1) who were biologically capable of having children.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 72
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •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. Woman who were breastfeeding or pregnant (known or suspected).
- •5. Bleeding diathesis or condition associated with prolonged bleeding time that contraindicated intramuscular injection.
- •6. Known or suspected immune deficiency or suppression.
- •7. Major known congenital malformation or serious chronic disorder.
- •8. Significant neurological disorder or history of seizure (including febrile seizure for Group 3), or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
- •9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator made the subject inappropriate for entry into this study.
- •10. Receipt of any investigational products or medical devices within 28 days before investigational product administration and during the study.
- •11. Subjects related to investigational site staff members or Pfizer employees directly involved in the conduct of the trial. Direct descendent (child or grandchild) of any study personnel or Pfizer employee.
研究者
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