Survey of Symptoms After a COVID Vaccination in Employees | NCT06035926

Studies
Survey of Symptoms After a COVID Vaccination in Employees

NCT06035926

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

1,093Actual

Phase

Not provided

Conditions

Symptoms Recoding SARS-CoV-2 After Vaccination

Interventions

questionnaire

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jul 31, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

Aug 28, 2023

First Submission Date that Met QC Criteria

Sep 6, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,093Actual

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of symptoms after the respective vaccination	Occurence of symptoms, assessed by a questionnaire	10 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no booster vaccination.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8036	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41272132	Derived	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.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms