A Multi-centre, Prospective, Observational Post-marketing Surveillance to Investigate the Long-term Safety of SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE Under Routine Clinical Care in Korea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,207
- 试验地点
- 49
- 主要终点
- Number of Participants With AEs
研究概览
简要总结
The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be 18 years or older for SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, and 12 years or older for SPIKEVAX XBB.1.5 and SPIKEVAX JN.
- •Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 for active immunization to prevent COVID-19 caused by SARS-CoV-
- •Participant who will be vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 following local label approved by Ministry of Food and Drug Safety (MFDS).
- •Participant who will be vaccinated with at least one dose of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1.
排除标准
- •Participant whose participation is deemed inappropriate at the investigator's discretion.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
干预措施: SPIKEVAX Bivalent BA.1 (Biological)
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
干预措施: SPIKEVAX Bivalent BA.4/5 (Biological)
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
干预措施: SPIKEVAX XBB.1.5 (Biological)
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
干预措施: SPIKEVAX JN.1 (Biological)
结局指标
主要结局
Number of Participants With AEs
时间窗: Up to 28 days post vaccination
次要结局
未报告次要终点