Survey of Symptoms After a COVID Vaccination in Employees

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT06035926
• Collaborator: (none)
• Enrollment: 1,093
• Location: 1
• Actual Duration (Months): 30.9
• Patients Per Site Per Month: 35.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Symptoms Recoding SARS-CoV-2 After Vaccination	Other: questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 1093 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Survey of Symptoms After a COVID Vaccination in Employees: a Retrospective Study.
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jul 31, 2023
• Actual Study Completion Date: Jul 31, 2023

Outcome Measures

Primary Outcome Measures

1. Occurrence of symptoms after the respective vaccination [10 Minutes]

   Occurence of symptoms, assessed by a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

• Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT06035926
• Other Study ID Numbers: EC number: 34-326 ex 21/22
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Graz: SARS-CoV-2; Symptoms

Study Results

No Results Posted as of Sep 13, 2023