Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,143
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Reactions
研究概览
简要总结
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.
This surveillance will specifically focus on the occurrence of the following:
- Local reactions at the injection site
- Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
详细描述
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size 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 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants at the age of more than 2 and less than 7 months
- •Infants who have been vaccinated with Prevenar for the first time
- •Infants expected to complete four vaccinations with Prevenar
排除标准
- •Vaccination with Prevenar must not be given to any of the following;
- •History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
- •Evident pyrexia
- •Evident serious acute disease
- •Any other infants or children ineligible for vaccination
结局指标
主要结局
Number of Participants With Adverse Reactions
时间窗: 28 days
An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
次要结局
- Number of Participants With Injection Site Reactions(28 days)
- Number of Participants With Serious Adverse Events(28 days)
- Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination(28 days)
- Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination(28 days)