Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
研究概览
简要总结
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine.
The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information.
We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- 否
入选标准
- •This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older
排除标准
- 未提供
研究组 & 干预措施
COMIRNATY
COVID-19 mRNA vaccine
干预措施: BNT162b2 (Biological)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
时间窗: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Number of Participants With SAEs After Booster Dose
时间窗: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.
Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose
时间窗: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Number of Participants With Non SAEs After Booster Dose
时间窗: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.
次要结局
- Number of SAEs Reported According to Time of Onset(Within 30min and>30min after vacc., secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days)included AEs reported following administration vacc. from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))
- Number of Participants According to Causality of SAEs(The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))
- Number of Participants According to Type of AEs(The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))
- Number of AEs Reported According to Solicited and Unsolicited AEs(The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))
- Number and Type of Solicited AEs Reported(The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))
- Number and Type of Unsolicited AEs Reported(The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years))