A Multicenter, Post-marketing Surveillance Study to Monitor the Safety of Novartis Vaccine MF59-adjuvanted Influenza Subunit Vaccine FLUAD® and Sandoz Korea Vaccine MF59-adjuvanted Influenza Subunit Vaccine VANTAFLU® Administered According to the Prescribing Information in Korean Subjects Aged 65 Years or Older at the Time of Vaccination.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 767
- 试验地点
- 42
- 主要终点
- Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
研究概览
简要总结
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination.
- •In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures.
排除标准
- •History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
- •Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to Study Day 1, or planning to receive some other vaccination before the final study visit (about Day 29 after vaccination).
- •Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
研究组 & 干预措施
Fluad
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
干预措施: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine (Biological)
Vantaflu_aTIV
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
干预措施: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine (Biological)
结局指标
主要结局
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
时间窗: Day 1 through Day 4 after vaccination
The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Number of Subjects Reporting Unsolicited AEs After Vaccination.
时间窗: Day 1 through Day 28 post vaccination
The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.
时间窗: Day 1 through Day 28 post vaccination
The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.
次要结局
未报告次要终点