Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe, a High-dose Trivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 670
- 主要终点
- Occurrence of Serious Adverse Events (SAE)
研究概览
简要总结
To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans".
The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adults aged 65 years or older on the day of enrollment
- •The informed consent form has been signed and dated
- •Receipt of 1 dose of Efluelda® on the day of enrollment according to the approved local product label
- •Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
排除标准
- •Previous history of enrollment in this study
- •Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
研究组 & 干预措施
Efluelda® Vaccination Group
Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1
干预措施: Efluelda® Pre-filled syringe (Biological)
结局指标
主要结局
Occurrence of Serious Adverse Events (SAE)
时间窗: From vaccination to participant's last contact (up to approximately 42 days)
Number of participants experiencing SAEs
Occurrence of unexpected Serious Adverse Drug Reactions (SADR)
时间窗: From vaccination to participant's last contact (up to approximately 42 days)
Number of participants experiencing unexpected SADRs
Occurrence of solicited injected site reactions.
时间窗: Up to 7 days after vaccination
Number of participants experiencing solicited injection site reactions
Occurrence of solicited systemic reactions
时间窗: Up to 7 days after vaccination
Number of participants experiencing solicited systemic reactions
Occurrence of unsolicited Adverse Events (AE)
时间窗: From vaccination to Visit 2 (up to approximately 42 days)
Number of participants experiencing AEs
Occurrence of unsolicited Adverse Drug Reactions (ADR)
时间窗: From vaccination to Visit 2 (up to approximately 42 days)
Number of participants experiencing ADRs
Occurrence of unexpected Adverse Events (AE)
时间窗: From vaccination to participant's last contact (up to approximately 42 days)
Number of participants experiencing unexpected AEs
Occurrence of unexpected Adverse Drug Reactions (ADR)
时间窗: From vaccination to participant's last contact (up to approximately 42 days)
Number of participants experiencing unexpected ADRs
Occurrence of Adverse Event of Special Interest (AESI)
时间窗: From vaccination to participant's last contact (up to approximately 42 days)
Number of participants experiencing AESIs
次要结局
未报告次要终点