NCT00488800已完成不适用
A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 1,000 人开始时间: 2006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
- 1,000
研究概览
简要总结
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
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