COVID-19 Vaccines Safety Tracking: Global Consortium Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 14
- 主要终点
- Local Side Effects
研究概览
简要总结
This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.
详细描述
Introduction:
COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world's governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines' effectiveness and side effects is vital for improving vaccine uptake.
Public health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines.
Design
This project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCW, OA and ST who received COVID-19 vaccine.
- •Participating subjects should be at least 18-year-old and able to give their informed consent independently.
排除标准
- •Non HCW, OA and ST who received the COVID-19.
结局指标
主要结局
Local Side Effects
时间窗: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
Systemic Side Effects
时间窗: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
次要结局
- Unrecognized Side Effects(0-30 days after the COVID-19 vaccine shot)