NCT04686409

Brief Summary

The study investigates the side effects of different COVID-19 vaccines.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

December 22, 2020

Last Update Submit

December 22, 2020

Conditions

Adverse Events in COVID-19 Vaccination

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related side effects

    Number of participants with treatment-related side effects as assessed by the toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (status September 2007)

    4 weeks

Secondary Outcomes (1)

  • Distribution and deviation of documented side effects

    4 weeks

Interventions

COVID-19 vaccinesBIOLOGICAL

Participants will be vaccinated with one of the approved COVID-19 vaccines

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.

You may qualify if:

  • received COVID-19 vaccination
  • age ≥ 18 years
  • mobile device (iOS or Android)

You may not qualify if:

  • No knowledge of German or English language
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Thomas Seufferlein, Prof. Dr.

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Seufferlein, Prof. Dr.

CONTACT

+4973150044501thomas.seufferlein@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

January 11, 2021

Primary Completion

January 31, 2022

Study Completion

August 31, 2022

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations

DE(1)