Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in 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
- 682
- 试验地点
- 12
- 主要终点
- Occurrence of serious adverse events (SAEs) throughout the study participation
研究概览
简要总结
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.
详细描述
The planned duration of each participant'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
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6 to 35 months on the day of enrolment
- •Informed consent form has been signed and dated by the parent or other legally acceptable representative
- •Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert
排除标准
- •Participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) 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
Occurrence of serious adverse events (SAEs) throughout the study participation
时间窗: Up to 21(+7) days after vaccination
Percentage of participants with SAEs, including AESIs, throughout the study
Occurence of 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 for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability * systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering
Occurence of unsolicited adverse events (AEs)
时间窗: Up to 21(+7) days after vaccination
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