NCT00195390已完成不适用
Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 600 人开始时间: 2004年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.
- Adverse reactions (especially serious adverse reactions)
- Incidences of adverse reactions under routine vaccine use
- Factors that may affect the safety of the vaccine
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.
排除标准
- •Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
- •Suffering from a current or recent febrile illness.
研究者
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