Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,087
- 主要终点
- Number of Participants With Adverse Reactions
研究概览
简要总结
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
详细描述
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
- •Infants aged 2 months, inclusive, to 7 months, exclusive
- •Infants with no history of administration of pneumococcal vaccines including Prevenar 13
- •Infants expected to receive 4 vaccinations
排除标准
- •Vaccines must not be performed if the vaccinee corresponds to any of the following:
- •Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
- •Persons with evident pyrexia
- •Persons who evidently have serious acute diseases
- •Besides the persons listed above, persons who are in a status inappropriate for immunization
研究组 & 干预措施
Prevenar (13v)
干预措施: Prevenar (13v) (Drug)
结局指标
主要结局
Number of Participants With Adverse Reactions
时间窗: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
次要结局
未报告次要终点