A Safety Study of Quadrivalent Subunit Influenza Vaccine in a Large-Scale Population Aged 3 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42,881
- 试验地点
- 8
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of <0.01%).
详细描述
This is a large-scale, multicenter, open-label, single-arm, non-controlled real-world safety observational study following influenza vaccination. It is designed to assess the occurrence of very rare adverse reactions (incidence <0.01%) following vaccination with a quadrivalent influenza subunit vaccine and to demonstrate its superior safety profile.
A total of 42,881 participants aged 3 years and above were enrolled. Each received a single 0.5 ml dose of the quadrivalent influenza subunit vaccine. Safety monitoring included immediate observation for 30 minutes post-vaccination and systematic surveillance over the subsequent 28 days. Data on adverse events (AEs) and serious adverse events (SAEs) were collected during two time intervals: from 30 minutes to 7 days (inclusive) and from 8 to 28 days (inclusive) after vaccination. Any newly identified adverse reactions during the study period were also recorded.
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
- •Healthy individuals aged 3 years or above.
- •The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.
排除标准
- •Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-
- •Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
- •Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
- •Any other condition considered by the investigator as inappropriate for participation in this study.
研究组 & 干预措施
One dose Vaccine in aged 3 years and older
干预措施: quadrivalent subunit influenza vaccine (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 30 minutes, 7 days, and 28 days after vaccination
Occurrence of adverse events (AEs) within 30 minutes, 7 days, and 28 days after vaccination
Adverse Drug Reactions（ADR）
时间窗: 30 minutes, 7 days, and 28 days after vaccination
Incidence of known adverse drug reactions (ADRs) within 30 minutes, 7 days, and 28 days after vaccination
Serious Adverse Events (SAEs)
时间窗: 28 days after vaccination
Occurrence of serious adverse events (SAEs) within 28 days after vaccination; Incidence of new adverse reactions following vaccination
次要结局
未报告次要终点