Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,798
- 主要终点
- Percentage of Participants With Any Adverse Experience
研究概览
简要总结
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included
排除标准
- •Participants who are vaccinated with Rotateq before study start
- •Participant who has a contraindication to Rotateq according to the local label
结局指标
主要结局
Percentage of Participants With Any Adverse Experience
时间窗: Up to 42 days after any Rotateq vaccination
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Percentage of Participants With Any Adverse Drug Reaction
时间窗: Up to 42 days after any Rotateq vaccination
An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out
次要结局
未报告次要终点