Actively Recruiting

Age: 18Years +
All Genders
ID04834869

COVID-19 Vaccines Safety Tracking Global Consortium Study

Led by Masaryk University · Updated on 2022-04-06

30000

Participants Needed

14

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are actively monitoring the side effects of COVID-19 vaccines worldwide in healthcare workers, adults over 65, and schoolteachers. The study aims to estimate how common local and systemic side effects are for each vaccine brand, identify demographic and medical factors influencing side effects, and evaluate long-term consequences. It also compares the relative safety of different COVID-19 vaccines and examines how palliative drugs affect short-term side effect resolution. The project has two phases: a cross-sectional survey and a prospective cohort study. Phase A uses an online questionnaire to collect information about short-term side effects occurring within 30 days after vaccination, covering either the first or second dose. Phase B follows volunteers interested in reporting long-term side effects and vaccine effectiveness after booster doses over five years, starting in 2022. Multiple COVID-19 vaccines are included, such as Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac, Sinopharm, Sputnik V, Janssen, CureVac, Novavax, and Covaxin. Participants provide self-reported data through validated online questionnaires about side effect onset, duration, and intensity. The study tracks local and systemic side effects within 30 days post-vaccination as primary outcomes, with unrecognized side effects as secondary outcomes. Volunteers are followed for long-term safety and vaccine effectiveness, with a total observation period extending up to five years. This ongoing monitoring helps researchers understand vaccine safety profiles and side effect patterns in different populations.

CONDITIONS

Brief Title

COVID-19 Vaccines Safety Tracking (CoVaST)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthcare workers, adults over 65, or schoolteachers who have received a COVID-19 vaccine
  • At least 18 years old
  • Able to give informed consent independently
Not Eligible

You will not qualify if you...

  • Individuals who are not healthcare workers, adults over 65, or schoolteachers who received a COVID-19 vaccine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (online)

Surveillance

Duration - 30 days

Participants complete a self-administered online questionnaire to report short-term side effects occurring within 30 days after receiving a COVID-19 vaccine dose.

1 online questionnaire within 30 days after vaccination

Long-term Monitoring

Duration - 5 years

Participants who consent continue to report long-term side effects and vaccine effectiveness after booster doses using online questionnaires over five years.

Periodic online questionnaires after booster doses

Trial Site Locations

Total: 14 locations

1

American College of Physicians

Philadelphia, Pennsylvania, United States, 19106

Not Yet Recruiting

2

McMaster University

Hamilton, Ontario, Canada

Not Yet Recruiting

3

University of Split

Split, Croatia

Not Yet Recruiting

4

Masaryk University

Brno, Czechia

Actively Recruiting

5

University of Tartu

Tartu, Estonia

Not Yet Recruiting

6

Jimma University

Jimma, Ethiopia

Actively Recruiting

7

Justus-Liebig University Giessen

Giessen, Germany

Actively Recruiting

8

University of Ghana

Accra, Ghana

Not Yet Recruiting

9

Sinaloa's Pediatric Hospital

Culiacán, Mexico

Not Yet Recruiting

10

Medical University of Silesia

Katowice, Poland

Actively Recruiting

11

Nursing School of Coimbra

Coimbra, Portugal

Not Yet Recruiting

12

Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences

Irkutsk, Russia, 664033

Actively Recruiting

13

University of Belgrade

Belgrade, Serbia, 11221

Actively Recruiting

14

University of Ljubljana

Ljubljana, Slovenia

Not Yet Recruiting

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Research Team

M

Miloslav Klugar, PhD

A

Abanoub Riad, DDS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

11

Frequently Asked Questions

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Published Research Related To This Trial

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

Abanoub Riad, Holger Schünemann, Sameh Attia...

https://pubmed.ncbi.nlm.nih.gov/34360156