Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 675
- 试验地点
- 10
- 主要终点
- Number of participants with serious adverse events (SAEs)
研究概览
简要总结
The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.
The planned duration of each subject's participation in the study will be 21 to 28 days.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 3 years and above on the day of enrollment
- •For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
- •For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
- •Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert
排除标准
- •Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
结局指标
主要结局
Number of participants with serious adverse events (SAEs)
时间窗: Up to Day 28
Percentage of participants with SAEs, including AESIs, throughout the study
Number of participants with solicited injection site or systemic reactions
时间窗: Up to 7 days after vaccination
Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions: fever, headache, malaise, myalgia, shivering
Number of participants with unsolicited adverse events
时间窗: Up to Day 28
Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection
次要结局
未报告次要终点