COVID-19 Vaccines Safety Tracking (CoVaST)
1 other identifier
observational
30,000
14 countries
14
Brief Summary
This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
14 active sites
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
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 6, 2022
October 1, 2021
4.8 years
April 6, 2021
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Local Side Effects
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
0-30 days after the COVID-19 vaccine shot
Systemic Side Effects
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
0-30 days after the COVID-19 vaccine shot
Secondary Outcomes (1)
Unrecognized Side Effects
0-30 days after the COVID-19 vaccine shot
Study Arms (11)
Pfizer-BioNTech COVID-19 Vaccine
Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
Moderna COVID-19 Vaccine
Recently vaccinated individuals by Moderna COVID-19 Vaccine
AstraZeneca-Oxford University COVID-19 Vaccine
Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
CoronaVac
Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
Sinopharm
Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
Sputnik V
Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
Janssen
Recently vaccinated individuals by Janssen COVID-19 Vaccine
CureVac
Recently vaccinated individuals by CureVac COVID-19 Vaccine
Novavax
Recently vaccinated individuals by Novavax COVID-19 Vaccine
Covaxin
Recently vaccinated individuals by Covaxin COVID-19 Vaccine
CanSino
Recently vaccinated individuals by CanSino COVID-19 Vaccine
Interventions
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
Eligibility Criteria
In Phase A, a pragmatic approach will track each target group according to the governmental plan; in most countries, it went from HCW to OA to ST. The sample of Phase B will be pre-identified based on the outcome of Phase A. If ≥ 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest to join Phase B, no additional recruitment will be required. If \< 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest in Phase B, additional recruitment will be carried out targeting healthcare workers who will receive booster doses. In case of the emergence of special side effects after booster doses, additional recruitment of healthcare workers will be required.
You may qualify if:
- HCW, OA and ST who received COVID-19 vaccine.
- Participating subjects should be at least 18-year-old and able to give their informed consent independently.
You may not qualify if:
- Non HCW, OA and ST who received the COVID-19.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
American College of Physicians
Philadelphia, Pennsylvania, 19106, United States
McMaster University
Hamilton, Ontario, Canada
University of Split
Split, Croatia
Masaryk University
Brno, Czechia
University of Tartu
Tartu, Estonia
Jimma University
Jimma, Ethiopia
Justus-Liebig University Giessen
Giessen, Germany
University of Ghana
Accra, Ghana
Sinaloa's Pediatric Hospital
Culiacán, Mexico
Medical University of Silesia
Katowice, Poland
Nursing School of Coimbra
Coimbra, Portugal
Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences
Irkutsk, 664033, Russia
University of Belgrade
Belgrade, 11221, Serbia
University of Ljubljana
Ljubljana, Slovenia
Related Publications (2)
Riad A, Pokorna A, Attia S, Klugarova J, Koscik M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428.
PMID: 33916020BACKGROUNDRiad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects. Int J Environ Res Public Health. 2021 Jul 25;18(15):7859. doi: 10.3390/ijerph18157859.
PMID: 34360156DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 8, 2021
Study Start
April 1, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
April 6, 2022
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share