Safety profile of COVID-19 vaccines and the comparison to COVID-19 symptomatology

Recruiting

• Conditions: Z20.8; U07.1; Contact with and exposure to other communicable diseases; COVID-19, virus identified

• Registration Number: DRKS00024800
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 7800

Inclusion Criteria

Included in the study are:
- Subjects 18 years of age and older  
- Subjects who have received COVID-19 vaccination and have not had COVID-19. 
- Subjects who have received COVID-19 vaccination and have had COVID-19. 
- Subjects who had COVID-19 and were not vaccinated 
- Subjects who have not had COVID-19 disease.
- Ability to give consent and signed informed consent form.

Exclusion Criteria

Subjects without an understanding of the German language will be excluded from the study.  Participants will also be excluded if they are participating or have participated in another (clinical) study that has not been completed 3 months prior to study participation.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective parameter is to assess adverse vaccination reactions in COVID-19 vaccinated individuals compared to the adverse health effects in COVID-19 diseased and non-diseased individuals, respectively. The target parameter will be collected using a newly developed online questionnaire.

Secondary Outcome Measures

Name	Time	Method
All other analyses involving predictors influencing vaccination responses or general or health impairments resulting from COVID-19 disease are exploratory.