NCT06035926

Brief Summary

Background: SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its grip for more than two years. In January 2021, the quality and risk management unit of the LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for employees and subsequently for high-risk patients. In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The primary immunization, booster vaccination and booster vaccination were carried out. Despite the small number of incidents in the sense of an immediate reaction, there were numerous sick leave. Methods: For this reason, in the course of the booster vaccination, starting from October 2021 to January 2022, every vaccinated person was asked to fill out a questionnaire. Participation was voluntary and was supported by the works councils of the Medical University and the LKH-University clinic Graz approved. The survey served to retrospectively record how many employees developed symptoms in response to the respective vaccination. With this approach it will be possible to subject the responses to an in-depth statistical analysis in order to obtain a data-based contribution to the side effects of vaccines categorized with different vaccination schemes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,093

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

August 28, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

SARS-CoV-2Symptoms

Outcome Measures

Primary Outcomes (1)

  • Occurrence of symptoms after the respective vaccination

    Occurence of symptoms, assessed by a questionnaire

    10 Minutes

Interventions

questionnaire

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Employees of the University Clinic Graz who get a booster vaccination.

You may qualify if:

  • Employees with appropriate indication (\>4 months after the second vaccination) according to the recommendations of the national vaccination committee.
  • Signed vaccination information sheet.

You may not qualify if:

  • no booster vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (1)

  • Schwarz-Martelanz CM, Hoffmann M, Wedrich A, Berghold A, Reininghaus E, Reinisch S, Borenich A, Sendlhofer G. Vaccine side effects after vaccination against COVID-19 in employees at an University Hospital in Austria. Sci Rep. 2025 Nov 21;15(1):41353. doi: 10.1038/s41598-025-25329-1.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 13, 2023

Study Start

January 1, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations