Viewing Study NCT04706156



Ignite Creation Date: 2024-05-06 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 1:53 PM
Study NCT ID: NCT04706156
Status: UNKNOWN
Last Update Posted: 2021-02-25
First Post: 2021-01-11

Brief Title: Oral Side Effects of COVID-19 Vaccine
Sponsor: Masaryk University
Organization: Masaryk University

Study Overview

Official Title: Oral Side Effects of COVID-19 Vaccine A Multicenter Cross-sectional Study
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 EUEEA 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 Cronbachs alpha of 070 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

The questionnaire will be composed of multiple-choice items divided into four main categories a demographic data including gender age location of practice profession and experience b medical anamnesis including medical comorbidities medications and recent oral symptoms c COVID-19 related anamnesis including vaccination date previous infection and exposure to infected cases and d vaccine side effects including inflammatory symptoms cutaneous symptoms and oral symptoms Annex 1

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None