Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High Dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2023/24
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,078
- 试验地点
- 11
- 主要终点
- Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
研究概览
简要总结
This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) 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 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination
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
- •There are no formal inclusion criteria. Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations
排除标准
- 未提供
研究组 & 干预措施
VaxigripTetra®
Participant vaccinated with VaxigripTetra® as per routine clinical practice
干预措施: Quadrivalent Influenza Vaccine (Biological)
Efluelda®
Participant vaccinated with Efluelda® as per routine clinical practice
干预措施: High-Dose Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
时间窗: Within 7 days after vaccination
Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed
次要结局
- Vaccinees' reporting rate of ADRs according to age group(Within 7 days after 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))
- Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period(From vaccination to end of data collection (maximum 2 months following first vaccination))