Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine Following Post-Marketing in China: An Open-Label, Single-Arm Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,105
- 试验地点
- 2
- 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 in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence <0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.
详细描述
This is an open-label, single-arm, non-controlled, real-world safety study of the quadrivalent subunit influenza vaccine, designed to systematically track and evaluate the overall safety profile following vaccine administration.
The core objectives of this study are as follows:
- To assess the occurrence of rare adverse reactions with an incidence rate of less than 0.01% after vaccination;
- To investigate the incidence of cerebral infarction events following receipt of the study vaccine;
- To evaluate the incidence of systemic adverse events after vaccination among participants aged 9 to 17 years.
A total of 3,105 eligible participants aged 3 years and older who voluntarily receive the vaccine will be enrolled. All enrolled participants will be administered a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine.
The safety monitoring protocol is arranged as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
The quadrivalent influenza subunit vaccine Group
receive a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine
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: 6 months after vaccination
Occurrence of serious adverse events (SAEs) within 6 months after vaccination; Incidence of new adverse reactions following vaccination； Incidence of cerebral infarction following vaccination； Incidence of systemic adverse reactions following vaccination in individuals aged 9 to 17 years
次要结局
未报告次要终点