Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,540
- 试验地点
- 4
- 主要终点
- Oral Side Effects
研究概览
简要总结
This study is a multicenter cross-sectional survey-based study conducted in four European countries (Czech Republic, Germany, Slovak Republic, and Turkey). An online questionnaire will be utilized to collect data from volunteer subjects following the STROBE reporting guidelines of cross-sectional studies.
详细描述
The primary objective of this multicentre cross-sectional survey-based study is to estimate the prevalence of oral side effects of COVID-19 vaccine in the short term.
The secondary objectives are:
- to identify the risk factors of COVID-19 vaccine oral side effects in the short term.
- to evaluate the relationship between oral side effects and other inflammatory side effects of COVID-19 vaccine in the short term.
The target population is healthcare workers as they are identified among the priority groups of COVID-19 vaccine deployment plans in the EU/EEA and the UK. One more reason to select the healthcare workers among different groups of the population, their higher awareness about the possible vaccine-related oral side-effects so that more accurate and reliable results can be obtained.
A self-administered questionnaire will be developed, and its content validity will be tested using a panel of experts. The test re-test reliability of the questionnaire will be tested by 30 volunteers (10 Czech, 10 Turkish, 10 German) to achieve at least a Cronbach's alpha of 0.70. The questionnaire will be available in five languages; Czech, English, German, Slovak and Turkish. Dual forward translation and expert panels will produce equivalent Czech, German, Slovak and Turkish versions of the questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare workers who received COVID-19 vaccine during the last 30 days.
- •Participating subjects should be at least 18-year-old and able to give their informed consent independently.
排除标准
- •The healthcare workers who did not receive the COVID-19 vaccine recently.
- •Non-healthcare workers who received the COVID-19 vaccine recently.
结局指标
主要结局
Oral Side Effects
时间窗: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of oral side effects (e.g. ulcers, vesicles, blisters, plaque, mouth odour, bleeding gum, burning gingiva, etc) following receiving the COVID-19 vaccine.
次要结局
- General (common) Side Effects(0-30 days after the COVID-19 vaccine shot)
- Dermatologic Side Effects(0-30 days after the COVID-19 vaccine shot)