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 2022/23.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,001
- 试验地点
- 15
- 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 is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination.
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 2022/23.
The secondary objectives of the study are:
- To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®)
- To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS
详细描述
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
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 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)
- Vaccinees' reporting rate of ADRs according to age group(Within 7 days after vaccination)