NCT01531322已完成1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of participants reporting Adverse Events
研究概览
简要总结
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 42 Days 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at the time of enrollment is:
- •18 through 55 years (before the fifty sixth birthday) for Group
- •3 through 5 years (before the sixth birthday) for Group
- •42 to 98 days for Group
- •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
排除标准
- •Previous vaccination with licensed or investigational pneumococcal vaccine.
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with pneumococcal vaccine.
研究组 & 干预措施
Group 1
Experimental
Adults aged 18 through 55 years (before the fifty sixth birthday)
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 3
Experimental
Infants aged approximately 2 months (42 to 98 days)
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 2
Experimental
Children aged 3 through 5 years (before the sixth birthday)
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
结局指标
主要结局
Number of participants reporting Adverse Events
时间窗: Baseline to Month 1
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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