Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,804
- 试验地点
- 15
- 主要终点
- Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
研究概览
简要总结
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22.
The secondary objectives of the study are:
- To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.
- To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.
- To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.
详细描述
Study duration per participant is maximum 2 months.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
时间窗: Within 7 days after vaccination
The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards
ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
时间窗: Within 7 days after vaccination
The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards
次要结局
- Vaccinees' reporting rate according to age group(Within 7 days after vaccination)
- ADR reporting rate according to age group(Within 7 days after vaccination)
- Serious suspected ADR reporting rate at any time following vaccination within the EPSS period(From vaccination to end of data collection (maximum 2 months following first vaccination))
- Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period(From vaccination to end of data collection (maximum 2 months following first vaccination))