General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14,570
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Serious Adverse Events
研究概览
简要总结
Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
详细描述
The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected.
If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.
If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.
排除标准
- •No exclusion criteria.
研究组 & 干预措施
COMIRNATY
COVID-19 mRNA vaccine (nucleoside-modified)
干预措施: BNT162b2 (Biological)
结局指标
主要结局
Proportion of Participants With Serious Adverse Events
时间窗: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Proportion of Participants With Severe COVID-19
时间窗: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Proportion of Participants With Serious Adverse Reactions
时间窗: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
Number of Participants With Serious Adverse Events After Booster Vaccination
时间窗: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Number of Participants With Severe COVID-19 After Booster Vaccination
时间窗: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Number of Participants With Serious Adverse Reactions After Booster Vaccination
时间窗: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
次要结局
未报告次要终点